COVID-19 Vaccine FAQs Archive These frequently asked questions and answers are intended for the general public. They are reviewed every week, so the content may change often. If you cannot find your question and answer here, or you have a more clinical question, please read through our COVID-19 Vaccine FAQs for Healthcare Providers and Professionals. Type in the search string and hit Enter. Clear COVID-19 Vaccine Quick Hits Updated 6/4/21 How to get vaccinated. Rhode Island Vaccination data The COVID-19 vaccine is safe, highly effective against serious illness, prevents you from being infected with COVID-19, and protects you from COVID-19 variants. You cannot get COVID-19 from COVID-19 vaccines. You may experience symptoms after vaccination. This means the immune system is working. Symptoms may include: pain or swelling in the upper arm, fatigue, headache, muscle pain, and chills. If you’re fully vaccinated, you can go back to doing most of the things you did before the pandemic, including no longer wearing a mask, with some exceptions. Even if you’re fully vaccinated, you must still wear a mask in certain places. Getting Vaccinated in Rhode Island How do I get vaccinated for COVID-19? Updated 6/9/21 Find a vaccine clinic near you at C19VaccineRI.org. You do not need an appointment at most vaccination sites. You can get vaccinated at State vaccination sites; select local pharmacies and other local and regional vaccination sites, like clinics run by cities and towns, hospitals, community health centers, and other sites in the community. If you need help, you can call 844-930-1779, or 2-1-1. At 2-1-1, a live, trained person can offer free help in multiple languages and is available 24 hours a day, seven days a week. A person may schedule and consent to vaccination, online or on the phone, for someone else with verbal approval. This video by the Rhode Island National Guard explains how to make an appointment. This video was made when Rhode Island first started vaccinating. Some of the details may be out of date, but this video still correctly describes how to use vaccinateRI.org to make appointment and how to get a vaccination at The Dunkin Donuts Center and at Sockanosset: https://fb.watch/3-L0Kz56XS/ Do I need an appointment to get vaccinated? Updated 6/9/21 No. Appointments are no longer needed to get vaccinated at State-run sites and many regional sites and pharmacies. To find a vaccine site near you, view RIDOH’s Vaccine Site Locator. What information do I need for registration? Updated 5/24/21 Vaccines are available at many sites in Rhode Island. If you make an appointment for a State-run or community-based clinic at vaccinateRI.org, you will need to provide personal and contact information. You will be asked about health insurance information. You can skip this section if you do not have health insurance. If you do have health insurance, please enter this information. Next, you will be asked about your health. Then, you can pick a time for your appointment. How do I register to get vaccinated if I don’t have a computer? Updated 5/4/21 If you do not have access to a computer, you can call the automated phone line at 844-930-1779. The phone line is available in English and Spanish. At this number, you will request a call back and someone will help you with your vaccination appointment. You can also call 2-1-1. At 2-1-1, a live, trained person can offer help scheduling appointments on VaccinateRI.org. This help is available in multiple languages, is free to all Rhode Islanders, and is available 24 hours a day, seven days a week. Friends or family can also help you make an appointment. A person may schedule and consent to vaccination, online or on the phone, for someone else with verbal approval. How do I get to my appointment without a car? Updated 4/15/21 Many vaccination sites across the state are accessible by public transportation. To view transportation routes and any possible walking distances, visit www.ripta.com and enter your travel information into RIPTA’s trip planner on the homepage. The website also has detailed maps and timetables for every RIPTA route. If you need help or cannot visit the website, call RIPTA’s Customer Service team at 401-781-9400. Starting Monday, April 19, RIPTA will offer free transportation for anyone traveling to or from a COVID-19 vaccination appointment. For more information or to take advantage of this program, please contact RIPTA Customer Service by e-mailing [email protected] or by calling 781-9400. Anyone enrolled in Medicaid or older than 60 can use the Non-Emergency Medical Transport Service provided by MTM. Transportation can be booked online at https://www.mtm-inc.net/mtm-link/ or by calling MTM at 855-330-9131 (TTY: 711) at least two business days before the appointment. If you are not enrolled in Medicaid, there may be a small cost to schedule a ride. For more information on the Non-Emergency Medical Transport Service, please see this FAQ sheet. Can I get a free Uber or Lyft ride to a COVID-19 vaccination appointment? Yes, for a limited time. In partnership with the White House, Uber and Lyft are offering free rides to vaccine appointments through July 4. Uber will offer up to four rides (up to $25 each) to and from your vaccine appointments. To schedule a ride through Uber, open the Uber app and tap Vaccine. Tap Get your free ride, find your vaccination location and select your ride. To use Lyft, users will be asked to provide a few details to receive a code they can apply to rides requested in the Lyft app to and from a vaccination site near them. Ride codes will cover up to $15 each for two rides. Ride codes can be used for Lyft rideshare, bike or scooter rides during standard pharmacy operating hours (6:00 a.m. to 8:00 p.m.). What happens at my COVID-19 vaccination appointment? Updated 5/24/21 Please show up at your assigned time. Appointments have been spaced out to avoid crowding. You don't need an ID or insurance to be vaccinated, but if you have one we ask that you bring it. Please wear a mask and loose-fitting clothing that allows easy access to your upper arm. Follow social distancing guidelines at your appointment. You will receive a vaccination card that indicates which vaccine you received and the date and location of your vaccination. If you received a vaccine that requires a second dose (e.g., Moderna or Pfizer), the card will also note the earliest date you can receive your second dose. We strongly encourage you to sign up for your second dose while onsite and receiving your first dose. After receiving the vaccine, you will be asked to remain on site for a 15- to 30-minute observation period. You can make your second appointment during this observation period. I cannot receive an injection in my arm. How do I get vaccinated for COVID-19? Most vaccination sites in Rhode Island are equipped to offer non-arm injections. Will I have side effects from getting the vaccine? Updated 6/9/21 Vaccines often cause our immune systems to respond in a way that shows the vaccine is working. This is healthy, normal, and expected. You may experience a sore arm, headache, fever, or body aches, but they should go away within a few days. Some people have no side effects from getting vaccinated. If you have any symptoms of COVID-19 following vaccination, stay home, call a healthcare provider, and get tested. If you have any of the following severe symptoms after vaccination or in general, seek medical care right away: Chest pain; shortness of breath; feelings of having a fast-beating, fluttering, or pounding heart Severe or persistent headaches or blurred vision; shortness of breath; chest pain; leg swelling; persistent abdominal pain; easy bruising or tiny blood spots under the skin beyond the injection site What happens after my COVID-19 vaccination appointment? Updated 5/24/21 If you received a vaccine that requires a second dose (e.g., Moderna or Pfizer), you are encouraged to schedule your second dose before leaving the vaccination site. You can make your second appointment during your observation period. Please continue to wear your mask until fully vaccinated. Fully vaccinated means you’ve gotten all recommended doses of a COVID-19 vaccine authorized by the United States (US) Food and Drug Administration (FDA) or World Health Organization (WHO) and more than 14 days have passed since the final dose. I got vaccinated and now have symptoms of COVID-19. What do I do? Updated 5/14/21 After vaccination, people should continue to follow guidance around prevention, testing, quarantine, and isolation. People are likely to experience symptoms after receiving a COVID-19 vaccine. Here is a list of symptoms and what to do if you experience them: Local symptoms (e.g., redness or swelling where you receive the injection, muscle pain or discomfort in arm) – This is unlikely to be related to COVID-19. It is ok to go to work or school. No additional testing is needed. Generalized symptoms (e.g., fever, headache, whole body muscle aches or joint pain) – These symptoms could be related to either COVID-19 or the COVID-19 vaccine. Please stay home from work or school, call a healthcare provider, and get tested for COVID-19. Respiratory symptoms (e.g., runny nose, congestion, cough, shortness of breath, loss of taste or smell) – These may be related to COVID-19. Please stay home from work or school, call a healthcare provider, and get tested for COVID-19. Gastrointestinal symptoms (e.g., belly pain, nausea, vomiting, diarrhea) – These may be related to COVID-19. Please stay home from work or school, call a healthcare provider, and get tested for COVID-19. If you have questions about any other symptoms you are experiencing after a COVID-19 vaccine, please contact your healthcare provider. Is there a cost or co-pay for COVID-19 vaccine? Updated 6/9/21 COVID-19 vaccines will be provided at no cost. People without health insurance can get the COVID-19 vaccine at no cost. No matter where you are vaccinated, COVID-19 vaccine providers cannot charge people if COVID-19 vaccination is the only service provided. No one can be denied vaccination based on healthcare coverage or network. Providers also cannot require additional medical services to get vaccinated. Can I get the COVID-19 vaccine even if I don't have health insurance? Updated 2/17/21 Yes, people without health insurance will receive the COVID-19 vaccine at no cost. Are undocumented immigrants eligible for COVID-19 vaccine? Updated 2/1/21 Yes. Undocumented immigrants are eligible for vaccine in Rhode Island. No questions about immigration status will be asked at vaccination appointments. We do not share information with immigration authorities. *Please note that for vaccinations happening in Central Falls, you may be asked for proof of residency (e.g., identification, driver’s license, utility bill, rent bill). This is because they are prioritizing vaccine for community members. For more information and resources for undocumented immigrants, please see here. How much COVID-19 vaccine does Rhode Island receive? Updated 1/22/21 Vaccine amounts are allocated on a per capita basis by the federal government. Is it mandatory to get the COVID-19 vaccine? Updated 4/9/2021 The Rhode Island Department of Health does not currently mandate or require people to get vaccinated against COVID-19. However, some employers may require or mandate staff to be vaccinated. Check with your employer to see if they have rules that apply to you. The COVID-19 vaccine is safe, highly effective against serious illness, and prevents you from being infected with COVID-19. Is it mandatory to get any vaccines? Currently, neither states nor the federal government require the general public be vaccinated against any disease, though states require children to be vaccinated against diseases such as polio and measles before they go to school and child care. Rhode Island allows families to opt out of vaccination requirements for medical reasons or because they have religious objections. Rhode Island also requires vaccinations for college students and certain healthcare workers, also with exemptions. Current vaccination requirements in Rhode Island apply to healthcare workers, childcare workers, and students. These requirements are found in the Rhode Island Department of Health (RIDOH)’s Immunization, Testing, and Health Screening for Health Care Workers regulations and Immunization and Communicable Disease Testing in Preschool, School, Colleges or Universities regulations. Both apply to workers employed in State-licensed facilities. How are people who are unable to leave home getting vaccinated? Updated 6/10/21 RIDOH has partnered with three agencies—Alert Ambulance, MedTech Ambulance, and PACE—to administer COVID-19 vaccines to homebound Rhode Island residents where they live. We are now also registering by phone Rhode Islanders who are age 50 or older for appointments at vaccination clinics or for at-home vaccination. RIDOH encourages those who can safely attend vaccination sites outside the home to do so. If you are unable to leave your home, please contact the appropriate partner to schedule an appointment (depending on where you live) by visiting c19vaccineRI.org. Can I choose which COVID-19 vaccine I get? Updated 6/9/21 Yes. There are three COVID-19 vaccines that have received FDA Emergency Use Authorization and are available in Rhode Island: Moderna, Pfizer-BioNTech, and Johnson & Johnson (Janssen). When you look for a vaccine clinic near you at C19VaccineRI.org, you can see which vaccines are available at different clinics. You may also see the vaccine options when you sign up for a vaccination through a local pharmacy. Please talk to a healthcare provider if you have specific questions or concerns about choosing one COVID-19 vaccine versus another. What are the differences among the different vaccine brands (Pfizer-BioNTech, Moderna, Johnson & Johnson)? The Pfizer-BioNTech and Moderna COVID-19 vaccines use messenger RNA (mRNA) to teach our cells how to make the “spike” protein of the SARS-CoV-2 virus (the virus that causes COVID-19). This leads to an immune response in our bodies. While COVID-19 is a new disease caused by a new virus, researchers have been studying and working with mRNA vaccines for decades. The mRNA vaccines require two doses to give you the most protection against the virus that causes COVID-19. You are considered fully vaccinated two weeks after getting your second dose of an mRNA vaccine. The Johnson & Johnson COVID-19 vaccine uses an adenovirus type 26 (Ad26) vector to deliver a piece of the DNA that is used to make the “spike” protein of the SARS-CoV-2 virus (the virus that causes COVID-19). While adenoviruses are a group of viruses that are relatively common, Ad26, which can cause cold symptoms and conjunctivitis (pink eye), has been modified for the vaccine so that it cannot spread in the body to cause illness. After a person gets the vaccine, the body can temporarily make the spike protein, which leads to an immune response against the virus that causes COVID-19. The Johnson & Johnson COVID-19 vaccine requires one dose. You are considered fully vaccinated two weeks after getting vaccinated. All COVID-19 vaccines available in Rhode Island are safe, highly effective against serious illness, and reduce the risk of infecting others. Which COVID-19 vaccines are authorized by the US? Updated 6/8/21 The Pfizer-BioNTech, Moderna, and Johnson & Johnson (Janssen) vaccines are authorized for emergency use in the US. Which COVID-19 vaccines are authorized by the World Health Organization (WHO)? Updated 6/8/21 WHO has authorized the following COVID-19 vaccines: Pfizer-BioNTech; Oxford/AstraZeneca vaccines (including versions produced by AstraZeneca-SKBio [Republic of Korea] and the Serum Institute of India); Johnson & Johnson (Janssen); Moderna; Sinopharm; and Sinovac. What do I do if I received a non-WHO or non-US authorized vaccine in another country? Updated 5/21/21 People may have received a COVID-19 vaccine not currently authorized by WHO or the FDA in the United States. We do not have data on safety or protection if you get a COVID-19 vaccine approved in the United States or by WHO, after getting a COVID-19 vaccine not approved in the United States or WHO. However, some people who got a COVID-19 vaccine not currently authorized by WHO or the FDA n the United States should discuss the risks and benefits of receiving a second COVID-19 vaccine that is authorized by the FDA/WHO with a medical provider. A minimum of 28 days after the last dose of the vaccine series is recommended before a new series with the FDA approved vaccine is started. COVID-19 vaccines not authorized by FDA but authorized for emergency use by WHO People who completed a COVID-19 vaccination series with a vaccine that has been authorized for emergency use by the World Health Organization (WHO) do not need any additional doses with an FDA-authorized COVID-19 vaccine. People who are partially vaccinated with a COVID-19 vaccine series authorized for emergency use by WHO may be offered an FDA-authorized COVID-19 vaccine series. COVID-19 vaccines not authorized by FDA or not authorized for emergency use by WHO People who completed or partially completed a COVID-19 vaccine series with a vaccine that is not authorized by FDA or not authorized for emergency use by WHO may be offered an FDA-authorized COVID-19 vaccine series. Administration of an FDA-authorized COVID-19 vaccine in these people should comply with all conditions of use specified under the EUA for the vaccine being used. If you got a COVID-19 vaccine currently not authorized in the United States and do not have a record of which vaccine you got, you should discuss getting an FDA-authorized COVID-19 vaccine with your healthcare provider. The minimum time between the last dose of a non-FDA authorized vaccine and an FDA-authorized COVID-19 vaccine is 28 days. I received a COVID-19 vaccine that requires two doses and I missed my appointment for the second dose. What should I do? Updated 5/24/21 If you missed your second-dose appointment or did not schedule it while you were at the place where you got your first dose, you may sign up for an appointment for your second dose through vaccinateRI.org or a local pharmacy. Make sure to check off that you are getting a second dose of vaccine, and make sure to get the same vaccine you got for your first dose (i.e., Pfizer-BioNTech or Moderna). Please contact [email protected] or call 844-930-1779 and ask to schedule or reschedule your second dose appointment. You do not need to get your second dose of vaccine where you got your first dose. The CDC states that you should get the second dose as close to the recommended interval (21 days after the first dose for Pfizer-BioNTech vaccines, 28 days for Moderna vaccines) as possible. However, if you can’t get your second dose during this time frame, you may get the second dose of Pfizer-BioNTech and Moderna COVID-19 vaccines up to six weeks (42 days) after the first dose. There are currently limited data on how effective the mRNA COVID-19 vaccines are when they are given after this time frame. However, if you have an unavoidable delay, you may get the second dose after the six-week time frame, and there is no need to restart the vaccination series. I am 16 years old. Can I consent to get vaccinated? Updated 4/28/2021 Yes. A person age 16 or 17 in Rhode Island can sign a vaccination consent form on their own and they do not need to be accompanied by a parent or guardian to receive a vaccine. According to state statute, RIGL 23-4.6-1, “(a) Any person of the age of sixteen (16) or over or married may consent to routine, emergency, medical or surgical care. A minor parent may consent to treatment of his or her child.” Can I cancel my COVID-19 vaccination appointment? Updated 3/17/2021 You can cancel your COVID-19 vaccination appointment by clicking on the “cancel” option in your confirmation email or by emailing [email protected] with your request. Do people who are younger than age 18 years old need to make appointments at certain vaccination sites? Updated 5/24/21 If they are making an appointment at a State-run vaccination site, people who are age 12-17 must sign up for a clinic offering Pfizer-BioNTech COVID-19 vaccine. The Moderna COVID-19 vaccine and Johnson & Johnson (Janssen) COVID-19 vaccine are for people age 18 or older only. COVID-19 Vaccine Record How can I check my vaccination record? Updated 5/27/2021 Rhode Islanders can now get a copy of their COVID-19 vaccine record through portal.ri.gov/VaccineRecord. From this website, you can search for and print proof of your COVID-19 vaccination. If you need a second dose of vaccine, this record will tell you when you are eligible to get your second dose. Please note that only people who have received their COVID-19 vaccination in Rhode Island will be able to look up their vaccination record online. If you are having trouble finding your vaccination record or are not able to go online, you can call 401-222-8022 or 844-930-1779 for help. You can also call your primary care physician to check your vaccine record. We do not currently have the ability to email or mail a vaccine record. Please keep your vaccination card. If you have a smartphone, it is a good idea to take a picture of your vaccination card with your phone so that you always have a copy with you. What is RICAIR? RICAIR provides a lifelong immunization registry used for preventive care and control of vaccine preventable disease. RICAIR maintains all records of immunizations in one secure database, regardless of where the vaccine is administered. Medical providers and pharmacies receiving vaccine supplied by the State of Rhode Island are required to participate in RICAIR by electronic data reporting (or by actively working toward establishing electronic reporting). Only medical providers and authorized users have access to this confidential, secure database to help ensure that Rhode Islanders are protected against vaccine preventable diseases. Please email [email protected] or call 401-222-5960 for questions regarding RICAIR. How do I add vaccine records from another state or information not showing up in RICAIR? To request additions of vaccine records in RICAIR for first doses administered in other states or administered in Rhode Island, but not showing in the RICAIR system after five days, please fill out this form: https://go.usa.gov/xHnX6 and submit the completed form and a copy of their vaccination card to [email protected] or mail to: RICAIR/KIDSNET Updates 3 Capitol Hill, Room 302 Providence, RI 02908 How do I opt-out of RICAIR? You may opt out of RICAIR at any time at https://kidsnet.health.ri.gov/optout/. Please be aware that deleted immunization records cannot be restored and are not available for proof of vaccination. What type of vaccination proof can I show to businesses or accept from customers? Members of the public may choose to carry a physical or digital copy of their vaccination record in case they are asked to show evidence of vaccination. The official COVID-19 vaccination verification documents available in Rhode Island at this time include: • Your COVID-19 Vaccination Record card • A printed or digital photo of the front and back of your COVID-19 Vaccination Record card • A printed copy or screenshot of your COVID-19 vaccination record page from Rhode Island’s Vaccine Record Lookup Portal at portal.ri.gov/VaccineRecord. About COVID-19 Vaccines Do I need a second dose? Updated 3/11/2021 The Moderna and Pfizer vaccines require two doses. The Johnson & Johnson (Janssen) COVID-19 vaccine requires one dose. If you get a first dose of Moderna or Pfizer, it is important to get the second dose because two doses are what was shown to be effective during clinical trials. Do I need to get a COVID-19 vaccine booster? The CDC continues to study and monitor how long COVID vaccines are effective and there are no recommendations yet on whether a booster dose is needed. COVID-19 Vaccine Safety Do the vaccines cause heart problems (myocarditis)? Updated 5/27/21 There have been a small number of cases of myocarditis and pericarditis among people after getting the mRNA COVID-19 vaccines (Pfizer-BioNTech or Moderna vaccines). Myocarditis is inflammation (swelling) of the heart muscle. Pericarditis is inflammation (swelling) of the lining outside the heart. These cases have been extremely rare and are not known to be related to the vaccines. Cases have been mostly in adolescents and young adults; more often in males than in females; more often after the second dose than the first dose; and typically occur within four days after vaccination. Since the cases are rare and mostly mild, the benefits of the COVID-19 vaccines still far outweigh the rare, possible risk of heart complications. The CDC has seen a very small number of these cases and there are more than 4 million people younger than age 18 who have been vaccinated. CDC continues to recommend that everyone age 12 or older get vaccinated. Multiple safety systems, including the Vaccine Adverse Event Reporting System (VAERS) and the Vaccine Safety Datalink (VSD) continue to monitor reports of myocarditis/pericarditis closely. What are the symptoms of myocarditis? Updated 5/27/21 Be on the lookout for any of the following symptoms: Chest pain Shortness of breath Feelings of having a fast-beating, fluttering, or pounding heart Seek medical care immediately if you think you or your child have any of these symptoms within a week after COVID-19 vaccination. Will I get sick with COVID-19 from the vaccine? 4/13/2021 No. Vaccines do not cause COVID-19 disease. However, vaccines can cause your immune system to respond. This is a sign that the vaccine—and your body’s immune system—is working. We expect people to have symptoms after vaccination with any of the currently available vaccines. People may feel some soreness in their upper arms, some aches, fever, and fatigue. These symptoms may be more noticeable than those that occur with a flu vaccine. This is completely normal and they will clear up in a few days. Some people may experience no symptoms. What are COVID-19 vaccine breakthrough cases? COVID-19 vaccines are very safe, highly effective at preventing serious illness, and even prevent symptoms of COVID and transmitting disease. A very small percentage of fully vaccinated people will still get COVID-19. These are known as COVID-19 vaccine breakthrough cases. People are considered fully vaccinated two or more weeks after they get a single dose of the Johnson & Johnson (Janssen) vaccine or the second dose of a two-dose series (Pfizer and Moderna vaccines). COVID-19 vaccine breakthrough cases are only reported for vaccines approved by the Food and Drug Administration (FDA). They are not reported for non-FDA-approved vaccines, such as AstraZeneca. What causes COVID-19 vaccine breakthrough cases? Even though the COVID-19 vaccines are highly effective, they are not 100% effective. Some people who are fully vaccinated against COVID-19 will still get infected with COVID-19. You can also be fully vaccinated and get infected, but not have any symptoms. What percentage of people who receive COVID-19 vaccines become infected after being fully vaccinated? Nationally, only a very small percent of fully vaccinated people got COVID-19. From January 2021 to April 2021, only 1 person per 10,000 people or 0.01% of people vaccinated in the US and US territories reported infection. As of May 1, 2021, the Centers for Disease Control and Prevention (CDC) is only reporting breakthrough cases for people who were hospitalized or died. Of these cases, fewer than 1 person per 10,000 people or 0.01% of people vaccinated in the US and US territories reported infection. Are COVID-19 vaccines safe? Safety is a top priority. COVID-19 vaccines have been tested in large clinical trials with people of different ages, races, ethnicities, and people with different health conditions to make sure they are safe. No steps involving safety have been skipped—COVID-19 vaccines are being held to the same standards as other vaccines to make sure they are safe. To ensure the safety of all vaccines in the United States, there is a rigorous vaccine development and approval process. Once a vaccine is available for use, there are additional systems in place to continue to ensure safety. What steps are taken to make sure COVID-19 vaccines stay safe? After any vaccine is approved and distributed in the United States, there are systems to monitor their safety. If something unexpected happens, experts study the event to determine whether changes are needed in vaccine recommendations. The Vaccine Adverse Event Reporting System (VAERS) is a national vaccine safety surveillance program of the FDA and CDC. An “adverse event” is any problem or “side effect” that happens after vaccination. VAERS cannot tell if the vaccine caused the event, but can decide whether further investigation is needed. Anyone (healthcare providers, patients, family members, etc.) can submit a report to VAERS by going to this link: https://vaers.hhs.gov/index. There are several other systems to monitor vaccine safety. You can learn more about vaccine safety monitoring at the CDC’s page on Ensuring the Safety of Vaccines: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety.html What is v-safe? V-safe is a smartphone-based tool—developed by CDC—that uses text messaging and web surveys to provide personalized health check-ins after you receive a COVID-19 vaccination. Through v-safe, you can quickly tell CDC if you have any side effects after getting the COVID-19 vaccine. Depending on your answers, someone from CDC may call to check on you and get more information. And v-safe will remind you to get your second COVID-19 vaccine dose if you need one. Your participation in CDC’s v-safe makes a difference—it helps keep COVID-19 vaccines safe. For more on v-safe, visit CDC’s site. Was the vaccine tested with people like me? Updated 3/11/2021 The COVID-19 vaccines that have been authorized were tested in large clinical trials with people of different ages, races, and ethnicities, as well as people with different underlying health conditions. Nearly half (42%) of Moderna’s study participants belong to high-risk groups. This means that they are older than 65 or have chronic conditions like diabetes, severe obesity, and cardiac disease. More than one third (37%) of study participants belong to communities of color. Ten percent of people who enrolled in both the Pfizer and Moderna clinical trials are Black. See the demographic and age information from Pfizer, Moderna, and Johnson & Johnson clinical trials. Are COVID-19 vaccines safe for children? Updated 5/14/21 The Pfizer vaccine has been authorized for people 12 years old and older. The Moderna vaccine and the Janssen COVID-19 vaccine (Johnson & Johnson) have been authorized for people 18 years old and older. Both Moderna and Pfizer have started clinical trials for their COVID-19 vaccines in younger children. They hope to have results by late summer 2021. COVID-19 Vaccine for Adolescents Age 12-15 Why should adolescents age 12 to 15 get vaccinated for COVID-19? Vaccination is key to protecting adolescents both in school and out. Adolescents account for a growing proportion of COVID-19 cases in Rhode Island and nationally. A small percentage of adolescents infected with COVID-19 can develop a serious inflammatory condition, MIS-C in two to six weeks after COVID-19 infection. The Pfizer-BioNTech (Pfizer) COVID-19 vaccine was 100% effective protecting against COVID-19 infection with symptoms out of more than 2,200 participants age 12 to 15 in the clinical trial. Is the COVID-19 vaccine safe for adolescents age 12-15? Yes. The United States (US) Food and Drug Administration (FDA) has authorized the Pfizer-BioNTech COVID-19 vaccine for use in adolescents age 12 and older. A large clinical trial that included more than 2,200 adolescents age 12-15 showed that adolescents in this age group tolerated the vaccine well. The adolescents in the trial experienced mild post-vaccination symptoms (side effects) similar to the symptoms people age 16-25 had experienced in earlier studies. As of now, adolescents age 12-15 are eligible for the Pfizer-BioNTech vaccine only. The Moderna and Johnson & Johnson (Janssen) COVID-19 vaccines are authorized for people age 18 and older only. Is the COVID-19 vaccine effective for adolescents age 12-15? In a large clinical trial, the Pfizer-BioNTech vaccine demonstrated 100% effectiveness in preventing COVID-19 infection with symptoms and led to strong immune responses among more than 2,200 participants age 12-15 without earlier evidence of COVID-19. In the trial, there were 16 cases of COVID-19 among 978 adolescents in the group that did not get vaccinated and 0 cases among the 1,005 vaccinated study participants. How was the COVID-19 vaccine made and approved so fast? The COVID-19 vaccines are being held to the same standards as other vaccines to make sure they are safe. No steps involving safety have been skipped. There are some reasons why the COVID-19 vaccines became available much faster than a typical vaccine. Importantly, there has been much collaboration across the scientific community to develop a vaccine. This is a global pandemic. As a result, a lot of time and resources from across the globe have gone into developing several COVID-19 vaccines. Further, researchers had a head start on vaccine development because of research already done on similar coronaviruses. This includes the viruses that caused Middle East Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS). Also, the government began producing doses of certain COVID-19 vaccines when they reached Phase 3 trials. This way, when these vaccines were determined to be safe and effective, people could get them immediately. Does my child need to wait to get the COVID-19 vaccine if they have gotten other immunizations recently? Updated 5/20/21 No. According to CDC, it is safe to get the COVID-19 vaccine even if you have gotten another vaccine recently. CDC had recommended waiting 14 days between someone’s last immunization and their first dose of COVID-19 vaccine, but updated guidance says that COVID-19 vaccines may be given at or around the same time as other vaccines. If you have any questions or concerns, check with your healthcare provider. Will my child have post-vaccination symptoms (side effects) from getting the COVID-19 vaccine? It is common to have symptoms after getting the COVID-19 vaccine. In a large clinical trial, participants age 12-15 experienced symptoms similar to those observed in participants age 16-25 from earlier studies. All participants in the clinical trial will continue to be monitored for long-term protection and safety for an additional two years after their second dose. Post-vaccination symptoms of the Pfizer-BioNTech COVID-19 vaccine include pain in the arm where someone got the shot as well as tiredness, headache, chills, muscle pain, fever, and joint pain. These should go away within a few days. With the exception of pain at the injection site, more adolescents reported these post-vaccination symptoms after the second dose than after the first dose. Some people do not have any symptoms after getting vaccinated. Symptoms are normal and show that the body is building protection. If symptoms do not go away after a few days, people should contact a healthcare provider. Do adolescents need a different vaccination dosage or schedule? Updated 5/20/21 No. The dosage of the Pfizer-BioNTech COVID-19 vaccine is the same for all people age 12 or older—regardless of weight or size. Additionally, adolescents age 12 or older should follow the standard two-dose schedule for the Pfizer-BioNTech vaccine. They should get the second dose of vaccine 21 days after getting the first dose. For more information, please review the Fact Sheet for Healthcare Providers Administering Vaccine. Will a parent/guardian need to accompany an adolescent age 12-15 when they get vaccinated or will online consent be enough? Adolescents age 12 to 15 should be accompanied by a parent, legal guardian, or other individual age 16 or older when getting a COVID-19 vaccination at any State-sponsored, mass vaccination clinic (while not required by law, this is highly preferred). Also, when registering either in advance or on-site, consent must be granted by a parent or legal guardian. Will the State get consent first from a parent or guardian? Yes. A parent or guardian will need to give consent first on www.vaccinateRI.org or before vaccination on site. Adolescents age 12-15 cannot get a vaccine appointment without consent from a parent or guardian. If an adolescent age 12-15 signs up for a vaccination appointment through www.vaccinateRI.org and consents for “Self,” but their parent/guardian is present at the vaccination event, do they need to re-register? No. As long as a parent/guardian consents to vaccination on the adolescent’s behalf before the adolescent is vaccinated, they do not need to re-register. Registration is not a legally significant part of the vaccination process. Can a parent/guardian provide consent for an adolescent age 12-15 over the phone? No. There would be no way to verify parenthood or guardianship, and there would be no written or recorded proof of consent. Does someone under age 16 who is married need consent from a parent/guardian? According to Rhode Island state statute, any person of the age of 16 or over or married may consent to routine, emergency, medical, or surgical care. A minor parent or guardian may consent to the treatment of his or her child. Can an adolescent age 12-15 get vaccinated at any type of vaccination clinic? Yes, adolescents age 12-15 can get a COVID-19 vaccine appointment at a State-run, regional or local, or select pharmacy as long as the clinic offers the Pfizer-BioNTech vaccine. Only the Pfizer-BioNTech vaccine is authorized for adolescents age 12 and older. The Moderna and Johnson & Johnson (Janssen) vaccines are authorized for people age 18 and older. Can adolescents age 12-15 get a COVID-19 vaccine appointment on site? Yes, but adolescents age 12-15 must have a parent or guardian with them to give consent for vaccination. Adolescents age 12 to 15 should be accompanied by a parent, legal guardian, or other individual age 16 years or older when getting a COVID-19 vaccination at any State-sponsored, mass vaccination clinic (while not required by law, this is highly preferred). Also, when registering either in advance or on-site, consent must be granted by a parent or legal guardian. How can students and school communities get vaccinated if they miss the school events? Students can ask school administrators if there are more clinics being held throughout the district. We urge students, families, and staff not to wait if they miss the school event. Many appointments are available now at different locations across the state. Find a vaccine clinic near you at C19VaccineRI.org. COVID-19 Vaccine and Contraindications Can I get a COVID-19 vaccine if I have allergies? Updated 3/24/21 If you have allergies that are not related to vaccines (e.g., food allergies, pet allergies, latex allergies), the CDC recommends that you get the COVID-19 vaccine. Please discuss with a healthcare provider if you have any questions. If you have had an allergic reaction to other types of vaccines, CDC recommends that you speak with a healthcare provider about whether to get a COVID-19 vaccine. If you have had a severe allergic reaction or an immediate allergic reaction—even if it was not severe—to any ingredient in an mRNA COVID-19 vaccine, you should not get either of the currently available mRNA COVID-19 vaccines. If you have had a severe or immediate allergic reaction to any ingredient in the Johnson & Johnson (Janssen) COVID-19 vaccine, you should not get the Johnson & Johnson vaccine. Learn more about the different types of COVID-19 vaccines and their ingredients on the CDC website. If you have an allergic reaction to an mRNA COVID-19 vaccine, CDC recommends that you should not get the second dose. Examples of allergic reactions include hives, swelling, wheezing, dizziness and weakness, and reactions that need to be treated with epinephrine or EpiPen© or hospital care. If you are not able to get the second shot of an mRNA vaccine because you had an allergic reaction to the first shot, ask your doctor if you should get a different type of COVID-19 vaccine. See CDC’s recommendations for people with allergies. What is a “severe” allergic reaction? What is an “immediate” allergic reaction? Updated 4/1/2021 An allergic reaction is considered severe when a person needs to be treated with epinephrine or EpiPen© or if they must go to the hospital. An example of a severe reaction is stopped breathing. An immediate allergic reaction means a reaction within four hours of getting vaccinated, and includes symptoms like hives, swelling, or wheezing (respiratory distress). Is the COVID-19 vaccine recommended for pregnant or breastfeeding people? Updated 4/28/21 Getting vaccinated is a personal choice. According to the CDC, any of the currently authorized COVID-19 vaccines can be offered to people who are pregnant or breastfeeding. Pregnant and breastfeeding people should discuss benefits and risks of vaccination with their healthcare provider before getting vaccinated. For people who are pregnant: Pregnant people are more likely to get severely ill with COVID-19 compared to non-pregnant people. Pregnant people with COVID-19 might be at increased risk of adverse pregnancy outcomes, such as preterm birth, compared with pregnant women without COVID-19. CDC recommends that pregnant people receive a COVID-19 vaccine. Getting a COVID-19 vaccine during pregnancy can protect against severe COVID-19. Pregnant people should consider their risk of exposure to COVID-19, the risks of severe disease, the known benefits of vaccination, and the limited but growing evidence on the safety of COVID-19 vaccines during pregnancy. A conversation with a healthcare provider may help them decide when to be vaccinated. CDC and FDA have safety monitoring systems in place to gather information about vaccination during pregnancy and will closely monitor that information. Most of the pregnancies in these systems are ongoing, so we don’t yet have information on the outcomes of these pregnancies. We need to continue to follow pregnancies long-term to understand effects on pregnancy and infants. Read the CDC's new report in the New England Journal of Medicine: Preliminary Findings of mRNA COVID-19 Vaccine Safety in Pregnant Persons. For more information, see CDC’s page on COVID-19 vaccination considerations for people who are pregnant. For people who are breastfeeding: Clinical trials for the COVID-19 vaccines currently authorized for use under an Emergency Use Authorization in the United States did not include people who are breastfeeding. Because the vaccines have not been studied on lactating people, there are no data available on: The safety of COVID-19 vaccines in lactating people The effects of vaccination on the breastfed infant The effects on milk production or excretion The COVID-19 vaccines authorized now are non-replicating vaccines, meaning they are able to create an immune response but do not reproduce inside host cells. Because non-replicating vaccines pose no risk for lactating people or their infants, COVID-19 vaccines are also thought to not be a risk to the breastfeeding infant. Therefore, lactating people may choose to be vaccinated. Should I get the COVID-19 vaccine if I already had COVID-19? Updated 6/23/21 Yes, you should still get the COVID-19 vaccine. We do not know how long you are protected from getting sick again after recovering from COVID-19, and vaccination can protect you from other variants of COVID-19. Can I get the COVID-19 vaccine if I currently have COVID-19? Updated 1/4/21 No, you cannot get the COVID-19 vaccine if you are currently infected. If you have tested positive for COVID-19, you must wait until you have completed your isolation period and are considered recovered. It is uncommon for people who do get COVID-19 again to get it within 90 days of when they recovered from their first infection. For this reason, you can delay your vaccination until 90 days after infection, if you would like. Can I take medications before receiving my vaccine to prevent post-vaccination symptoms? Updated 2/26/21 Taking antihistamines or fever-reducing medications before vaccination is not recommended. This is because there is not enough information on their impact on mRNA COVID-19 vaccine effectiveness, and because they could prevent you from noticing a symptom of allergic reaction or anaphylaxis. However, you may take fever-reducing medications after vaccination, if medically appropriate. Can I get the COVID-19 vaccine if I just received a different vaccine? Updated 5/18/21 Yes. According to CDC, it is safe to get the COVID-19 vaccine even if you have gotten another vaccine recently. CDC had recommended waiting 14 days between someone’s last immunization and their first dose of COVID-19 vaccine, but updated guidance says that COVID-19 vaccines may be given at or around the same time as other vaccines. If you have any questions or concerns, check with your healthcare provider. Can I get the COVID-19 vaccine and other vaccines at the same time? Updated 5/18/21 Yes. According to CDC, it is safe to get the COVID-19 vaccine at the same time as other vaccinations. Your healthcare provider will decide the timing that is best for you. If you are getting the COVID-19 vaccine at the same time as another vaccine, your healthcare provider may give you the shots in the same arm or in different arms or legs, depending on which vaccine(s) you are getting. Can I get the COVID-19 vaccine when fasting for personal or religious reasons, such as Ramadan? Yes, you can still get the COVID-19 vaccine when fasting for religious reasons, such as Ramadan, or personal reasons, such as intermittent fasting. The vaccine will be just as effective when fasting. Many religious leaders and groups also say the vaccine does not break a religious fast. Vaccine and COVID-19 Prevention Do the vaccines work? Updated 6/9/21 Yes. COVID-19 vaccination reduces the risk of COVID-19 and its potentially severe complications. All COVID-19 vaccines currently authorized for use in the US helped protect people against COVID-19, including severe illness, in clinical trial settings. So far, studies that have looked at how COVID-19 vaccines work in real-world settings (vaccine effectiveness studies) have shown that these vaccines are working well. Vaccine effectiveness studies provide growing evidence that mRNA COVID-19 vaccines (Pfizer-BioNTech and Moderna) offer similar protection in real-world conditions as they have in clinical trial settings, reducing the risk of COVID-19, including severe illness, among people who are fully vaccinated by 90 percent or more. Most vaccine effectiveness data now available are related to mRNA vaccines. In addition to providing protection against COVID-19, there is increasing evidence that COVID-19 vaccines also provide protection against COVID-19 infections without symptoms (asymptomatic infections). COVID-19 vaccination can reduce the spread of disease overall, helping protect people around you. How long does it take for the COVID-19 vaccines to provide immunity (protection)? Updated 3/11/2021 People are considered fully vaccinated two or more weeks after they have received the second dose of a two-dose series (for Pfizer and Moderna vaccines) or two or more weeks after they have received the single dose of the Johnson & Johnson (Janssen) vaccine. If I received one dose of a two-dose vaccination series, can I be exempt from mask mandates? Those who received one dose of a two-dose vaccination series are not considered fully vaccinated and are not exempt from the mask mandate at this time. I’m not fully vaccinated. What does the CDC mask guidance mean for me? The guidance on wearing masks has not changed for unvaccinated people or partially vaccinated people, who should continue to wear a mask and maintain social distance, particularly when indoors or in crowded outdoor settings. To protect their friends, family, and community, unvaccinated people age 2 and older should wear a well-fitted mask in public settings and when around people who don’t live in their household. Unvaccinated people do not need to wear a mask outdoors if they practice social distancing or when they are at small outdoor gatherings where all other guests are fully vaccinated. Do I still need to wear a mask after I’ve been fully vaccinated? Updated 6/2/2021 If you’re fully vaccinated, you can go back to doing most of the things you did before the pandemic, including no longer wearing a mask, with some exceptions. Even if you’re fully vaccinated, you must still wear a mask in certain places. Fully vaccinated means you’ve gotten all recommended doses of a COVID-19 vaccine authorized by the United States Food and Drug Administration (FDA) or World Health Organization (WHO) and more than 14 days have passed since the final dose. Continue to watch your distance around anyone you don’t live with. Do I need to quarantine if I have been fully vaccinated and am later identified as a close contact of someone who tested positive for COVID-19? Updated 5/3/2021 If you’ve been in close contact with someone who tested positive for COVID-19 or you’ve recently arrived in Rhode Island from outside the United States (US) and US territories or from a hot spot within the United States and US territories, you do not need to quarantine if: You’ve gotten a final dose of a COVID-19 vaccine, that is authorized by either the US Food and Drug Administration (FDA) or World Health Organization (WHO), at least 14 days before your last exposure or out-of-state travel and You haven’t had symptoms of COVID-19 since your last exposure or out-of-state travel. Always watch for symptoms for a full 14 days. Fully vaccinated travelers do not need to get a COVID-19 test after domestic out-of-state travel. Vaccinated travelers are encouraged to get a COVID-19 test between 3-5 days after travel outside the United States. All air passengers coming to the United States, including U.S. citizens and fully vaccinated people, are required to have a negative COVID-19 test result no more than 3 days before travel or documentation of recovery from COVID-19 in the past three months before they board a flight. Vaccinated hospitalized patients and long-term care facility residents must still quarantine for 14 days. Nothing changes with isolation: If you have symptoms of COVID-19, isolate at home and get tested. If you test positive for COVID-19, you must still isolate for 10 days after your symptoms start or after your test date if you have no symptoms. Do I need to isolate if I test positive on a respiratory specimen (nasal swab) after I am vaccinated? Updated 1/4/21 Yes, you must isolate if you test positive for COVID-19 whether or not you have received a vaccine. The COVID-19 vaccine does not in any way interfere with PCR or rapid testing from a respiratory specimen. If you test positive after receiving the vaccine, please contact your/a healthcare provider. Do I get better protection against another COVID-19 infection from COVID-19 vaccines or from getting and recovering from COVID-19? Updated 6/10/21 The protection someone gains from having an infection (called “natural immunity”) is different by disease and by person. Because this is a new virus, we don’t know how long natural immunity might last. Early evidence suggests that it may not last very long. Some people can also get post-COVID conditions, such as “long COVID.” Post-COVID symptoms vary by person but can include a range of new, returning, or ongoing health problems lasting weeks or even months after first being infected. You can experience post-COVID conditions even if you did not have symptoms. Also, we don’t yet know how long immunity lasts from vaccination, because these vaccines are new and we are still collecting data over time. Both natural immunity and vaccine-induced immunity are important aspects of COVID-19 that experts are learning more about. The CDC will keep the public informed as new evidence becomes available. Can I travel without quarantining if I have been fully vaccinated? Updated 6/24/21 Vaccinated persons should continue to follow all current guidance to protect themselves and others, including following CDC travel guidance. I am an international student and received a COVID-19 vaccine authorized by the WHO but not by the FDA. Do I need to get vaccinated again in the US? People who completed a COVID-19 vaccination series with a vaccine that has been authorized for emergency use by the World Health Organization (WHO) do not need any additional doses with an FDA-authorized COVID-19 vaccine. People who are partially vaccinated with a COVID-19 vaccine series authorized for emergency use by WHO may be offered an FDA-authorized COVID-19 vaccine series. Is Novavax still undergoing clinical trials? 9/21/2021 Yes. Novavax is conducting late-stage clinical trials for NVX-CoV2373, the recombinant protein vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. You can find an update of clinical trial enrollment and progress toward diversity demographics on Novavax’s website. Has Novavax received emergency use authorization (EUA) by the World Health Organization (WHO)? 9/21/2021 No, the vaccine does not yet have an Emergency Use Listed (EUL) by WHO. So far, WHO has approved the 7 COVID-19 vaccines: Moderna Pfizer-BioNTech Johnson & Johnson (Janssen) Oxford/AstraZeneca Serum Institute of India Sinopharm Sinovac I am an international student and received a COVID-19 vaccine that has not been authorized by the FDA or by the WHO. Do I still need to get vaccinated in the US? People who completed or partially completed a COVID-19 vaccine series with a vaccine that is not authorized by FDA or not authorized for emergency use by WHO may be offered an FDA-authorized COVID-19 vaccine series. COVID-19 Vaccine and Testing Do I need to get tested for COVID-19 before receiving a COVID-19 vaccine? Updated 3/3/21 No, you do not need to get tested for COVID-19 before receiving a COVID-19 vaccine. If you are exhibiting symptoms of COVID-19 or are currently infected with COVID-19, you should not get vaccine until after you have completed your quarantine or isolation requirements. This recommendation applies to people who develop COVID-19 infection before receiving any doses and those who develop COVID-19 infection after the first dose (of a vaccine requiring two doses) but before the second dose. If you were scheduled to receive a COVID-19 vaccine while you are still in isolation or quarantine, you will need to cancel or reschedule for after you have completed isolation. After ending quarantine or isolation, you do not need to wait for any specific length of time before getting the COVID-19 vaccine. You may choose to delay vaccination for up to 90 days after infection. This is because you will likely have a short-term immunity to COVID-19 after infection (it is rare that people become infected again with COVID-19 in the 90 days following their first infection). I received a COVID-19 vaccine dose and then tested positive for COVID-19. What does this mean? If you test positive for COVID-19 on a respiratory specimen (nasal swab), you have COVID-19 infection and must isolate whether or not you have received a vaccine. There are two types of tests for COVID-19: viral tests and antibody tests. Viral tests (i.e., PCR or rapid antigen tests), such as nasal swab test, test for current infection. Neither the recently authorized and recommended vaccines nor the other COVID-19 vaccines currently in trials in the United States cause positive viral test results. Antibody tests check the blood for antibodies to the virus that causes COVID-19. If your body develops an immune response following a COVID-19 vaccine—which is the goal of vaccination—an antibody test may come back positive. Positive antibody test results also indicate that you may have previously been exposed to the virus causing COVID-19. A positive antibody test result does not necessarily mean you have protective immunity. There is no way to tell whether a positive antibody test is from a previous infection or from vaccination. Experts are looking at how COVID-19 vaccination may affect antibody testing results. Do I need to participate in routine surveillance testing for my employment if I have been vaccinated? Updated 5/12/21 Fully vaccinated asymptomatic people without an exposure may not need routine screening testing. However, people with symptoms of COVID-19 should get tested for COVID-19 even if fully vaccinated. Organizations may choose to include fully vaccinated people in their screening testing program. When an outbreak is occurring, RIDOH may recommend testing of fully vaccinated people as a component of outbreak control. COVID-19 Vaccine and Treatment Should I get the COVID-19 vaccine if I received monoclonal antibody treatment for COVID-19? Updated 12/17/20 The CDC advises waiting 90 days after monoclonal antibody or convalescent plasma treatment before receiving COVID-19 vaccine. COVID-19 Vaccine Authorization and Approval How do vaccines get approved? Vaccines go through three phases of clinical trial. Each phase tests for safety and effectiveness across an increasing number of test volunteers. In Phase 1, vaccines are tested by approximately 20 to 100 people. In Phase 2, vaccines are tested by several hundred volunteers. In Phase 3, vaccines are tested by thousands of volunteers. The US Food and Drug Administration (FDA) will only approve a vaccine if it is safe, effective, and if its benefits outweigh its risks. What is an Emergency Use Authorization? Updated 3/3/21 Emergency Use Authorization (EUA) is an authority that allows the FDA to make certain medical products (e.g., vaccines, treatments) available during public health emergencies. It also can allow the use of medical products that have been approved, but for use in a different way than originally intended. An EUA lasts for the length of an emergency. A regular FDA approval lasts forever, unless a safety or efficacy issue comes up that needs further review. The FDA has authorized COVID-19 vaccines made by Pfizer, Moderna, and Janssen for emergency use. What criteria are needed to issue an EUA? To issue an EUA: The known and potential benefits of a drug, device, or test must outweigh the risks. The drug, device, or test must meet certain thresholds for safety and effectiveness. People must be in urgent need of care. How do we know that drugs, devices, or tests that have received EUAs are safe? The FDA released guidance for vaccine manufacturers considering requests for an EUA. This guidance explains the criteria that need to be met before any vaccine for COVID-19 will receive an EUA. To meet criteria, manufacturers will use data from a Phase 3 clinical trial. The vaccine’s potential and known benefits must outweigh the potential and known risks. In addition, the vaccine must be at least 50% effective and must meet certain safety standards among a sufficiently large group of volunteers. The FDA will also consult with an independent advisory committee before issuing an EUA for a COVID-19 vaccine. Granting an EUA does not mean that vaccine clinical trials will stop. Data can continue to be collected through trials even if an EUA is granted. Learn more about Emergency Use Authorization and FAQs on Emergency Use Authorizations (EUAs) for Devices - COVID-19. Is the COVID-19 vaccine development and approval process different from a typical vaccine development and approval process? The COVID-19 vaccines are being held to the same standards as other vaccines to make sure they are safe. No steps involving safety have been skipped. There are some differences in other processes that have made COVID-19 vaccines available much faster than a typical vaccine. Importantly, there has been much collaboration across the scientific community to develop a vaccine. This is a global pandemic. As a result, a lot of time and resources from across the globe have gone into developing several COVID-19 vaccines. Further, researchers had a head start on vaccine development because of research already done on similar coronaviruses. This includes the viruses that caused Middle East Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS). Also, the government began producing doses of certain COVID19 vaccines when they reached Phase 3 trials. This way, when these vaccines were determined to be safe and effective, people could get them immediately. COVID-19 Vaccine: Addressing Misinformation There is a lot of information about COVID-19 vaccines. It can be difficult to know which sources of information to trust. Here are some suggestions for where and how you can look for accurate and trustworthy vaccine information. Does the vaccine contain a microchip? Updated 1/11/21 No. There is no vaccine microchip, and the vaccine will not track people or gather personal information into a database. This myth started after comments made by Bill Gates from the Bill & Melinda Gates Foundation about a digital certificate of vaccine records. The technology he was referencing is not a microchip, has not been implemented in any manner, and is not tied to the development, testing, or distribution of COVID-19 vaccines. Can mRNA vaccines change your DNA? Updated 3/3/21 No. The COVID-19 vaccines that use messenger RNA (mRNA) (Pfizer and Moderna), will not change your DNA. Messenger RNA vaccines work by instructing cells in the body how to make a protein that triggers an immune response, according to CDC. Messenger RNA injected into your body does not enter the cell nucleus, which is where DNA is kept. The mRNA do not interact with DNA in any way. Human cells break down and get rid of the mRNA soon after they have finished using the instructions. Will the vaccine give you COVID-19? Updated 1/11/21 No. None of the COVID-19 vaccines currently in development or in use in the United States contain the live virus that causes COVID-19. The goal for each of the vaccines is to teach our immune system how to recognize and fight the virus that causes COVID-19. Sometimes this process can cause symptoms, such as fever. These symptoms are normal and are a sign that the body is building immunity. It typically takes a few weeks for the body to build immunity after vaccination. That means it’s possible a person could be infected with the virus that causes COVID-19 just before or just after vaccination and get sick, but this is not because they got the vaccine. This is because the vaccine has not had enough time to provide protection. Is it better to get natural immunity than get vaccinated for COVID-19? Updated 6/10/21 No. It is unclear how long immunity lasts after natural infection after recovering from COVID-19. However, people who get COVID-19 can have serious illnesses, and some have debilitating symptoms that persist for months. This is known as “long COVID,” which can happen to anyone who has had COVID-19 even if the illness was mild. Vaccination is the best protection. Will the flu vaccine protect me from COVID-19? Updated 1/11/21 No. Getting a flu vaccine will not protect against COVID-19; however, flu vaccination has many other important benefits. Flu vaccines have been shown to reduce the risk of flu illness, hospitalization, and death. Getting a flu vaccine this season will be more important than ever, not only to reduce your risk from flu but also to help conserve potentially scarce healthcare resources. Can I get the COVID-19 vaccine if I am Catholic? Updated 3/3/21 Yes. In a March 2 statement, chairmen of the U.S. Conference of Catholic Bishops’ Committee on Doctrine and the Committee on Pro-Life Activities state that it is morally acceptable to receive COVID-19 vaccines. For more information on this, please see: Moral Considerations Regarding the New COVID-19 Vaccines (United States Conference of Catholic Bishops) Answers to Key Ethical Questions About COVID-19 Vaccines (United States Conference of Catholic Bishops) Note of the Vatican Covid-19 Commission in collaboration with the Pontifical Academy for Life “Vaccine for all. 20 points for a fairer and healthier world” (Vatican Covid-19 Commission in collaboration with the Pontifical Academy for Life) Will the COVID-19 vaccine cause me to test positive for COVID-19? Updated 1/11/21 No. Neither the recently authorized and recommended vaccines nor the other COVID-19 vaccines currently in clinical trials in the US cause you to test positive on viral tests (for example a nasal swab), which are used to see if you have a current infection. If your body develops an immune response, which is the goal of vaccination, there is a possibility you may test positive on some antibody tests. Antibody tests indicate you had a previous infection and that you may have some level of protection against the virus. Experts are currently looking at how COVID-19 vaccination may affect antibody testing results. Will the COVID-19 vaccine cause infertility? Updated 1/22/21 No, the COVID-19 vaccines do not cause infertility. There is no evidence that COVID-19 vaccine causes increased risk of infertility, first or second trimester loss, stillbirth, or congenital anomalies of any kind. Several national medical organizations have put out statements that say as much, such as this statement from the American Society for Reproductive Medicine. CDC has also shared information on vaccines during pregnancy here. Can the COVID-19 vaccine affect my menstrual cycle? No. Many things can affect your menstrual cycle, such as stress, changes in diet or exercise, and infection. Being near someone who got the COVID-19 vaccine cannot affect your menstrual cycle, too. FAQ Archives Does Rhode Island have a waiting list or a pre-registration tool? Updated 4/29/2021 Because vaccine is more and more accessible now, we are phasing out our vaccine pre-registration system, which is known as the Vaccine Interest Notification List (VINL). Anyone who signs up between now and May 2, will get an appointment, but we are going to stop pre-registrations on May 3. People can sign up at portal.ri.gov or by calling 844-930-1779. When will all Rhode Islanders be eligible for COVID-19 vaccination? Updated 4/29/21 We opened eligibility to the last age group on our timeline (people 16 to 39 years of age) on April 19. There are no COVID-19 vaccines approved or authorized in the United States for people under the age of 16. This does not mean that everyone will be able to get an appointment by April 19. This is when we opened eligibility for everyone. Appointments are booking two and three weeks out. Soon, every Rhode Islander will be eligible to make an appointment for a first dose of COVID-19. We are grateful for everyone’s patience during this time. How long does it take to give people COVID-19 vaccine after Rhode Island receives vaccine supplies? Updated 1/19/21 Rhode Island gives vaccine at roughly the same rate that the State receives vaccine. But there are several steps between receiving vaccine doses in Rhode Island and getting vaccine into someone’s arm. Those steps, such as recording and allocating specific doses or organizations which are vaccinating, distributing and transport of vaccine from a centralized site, ensuring accountability and logging of each dose and scheduling people for shots, take a few days. For this reason, there will always be a small difference between the number of doses we have received and the number of doses that have been administered. How do I know if I live in a ZIP code prioritized for vaccination? Updated 4/26/2021 As of April 19, people age 16 and older are eligible for the COVID-19 vaccine in Rhode Island. Many Rhode Islanders living in specific geographies have experienced higher rates of COVID-19 infections, hospitalizations, and deaths throughout the pandemic. Such differences are directly connected to the settings in which some communities of color are more likely to live and work every day, and to systems of structural racism and discrimination that have historically undermined the health and well-being of these communities. RIDOH believes reaching high vaccination rates across all individuals and communities regardless of ZIP code is key to saving lives and achieving broader population immunity. Rhode Island’s Hard-Hit Community Vaccination Strategy aims to ensure equitable vaccine access by distributing vaccine more quickly and deliberately in the hardest-hit ZIP codes. This includes focused efforts to expand access to and uptake of vaccine among communities of color at highest risk of hospitalization and death. Given the current limitations on vaccine supply, focused strategies are necessary to ensure vaccine access for the most vulnerable members of the hardest-hit areas in the state. The Hard-Hit Community Vaccination Strategy previously applied to the following ZIP codes in Central Falls, Pawtucket, and Providence: 02863, 02860, 02861, 02904, 02905, 02907, 02908, and 02909. People who are 16 years of age and older, who live in one of eight hardest hit ZIP codes covering parts of Providence, Cranston, North Providence and all of Pawtucket and Central Falls, can register for vaccination appointments at State-run vaccination sites and participating pharmacy locations. These ZIP codes are: 02863, 02860, 02861, 02904, 02905, 02907, 02908, and 02909. Starting April 9, eligibility opened for residents age 16 and older in Woonsocket. On April 12, eligibility opened for certain ZIP codes in Pawtucket, West Warwick, Providence, Cranston, North Providence, East Providence, and Johnston. These ZIP codes are 02893, 02906, 02910, 02920, 02911, 02914, and 02919. Learn about Rhode Island's Hard-Hit Community Vaccination Strategy. If I am a resident of Rhode Island in the summer but another state in the winter, where do I get the COVID-19 vaccine? Updated 3/3/21 To get vaccinated in Rhode Island, you must live, work, or go to school in Rhode Island. If you received a vaccine that requires two doses (e.g., Pfizer or Moderna), you should receive both doses in the same state and at the same location. This is because the second dose will be shipped automatically to the healthcare provider or location that gave you the first dose. Which underlying conditions will qualify me for a COVID-19 vaccine? Updated 4/1/2021 People with conditions such as diabetes, lung disease, heart disease, kidney disease, and weakened immune systems are eligible for vaccine since they are at higher risk for becoming hospitalized if they get COVID-19. See the full list of qualifying underlying conditions in Rhode Island. The list is available in Spanish here and Portuguese. Will I need a note from a doctor saying I have an underlying condition? Updated 3/11/2021 No. People must agree that they are age 16 or older and have one or more qualifying underlying medical condition(s) before making a vaccine appointment online or over the phone. They do not need a note from a medical provider. If people have questions about whether their underlying medical condition(s) qualify, they should contact their primary care provider. Are doses of COVID-19 vaccine being thrown away or wasted? Updated 5/14/21 RIDOH is committed to providing vaccine to any eligible individuals who wish to be vaccinated. While the State has maintained extremely low percent waste to date (0.1%), given the shifting demand for vaccine among smaller groups, it is possible that the amount of vaccine waste could increase. RIDOH has determined that the need to vaccinate anyone who wishes to get vaccinated outweighs the potential for increase in vaccine waste. Vaccination sites should strive to avoid excessive waste and not exceed 30% on a given order but also take every opportunity to administer vaccine, even if it results in wasted doses. Why did I receive a reminder to schedule my second dose appointment when I am fully vaccinated? You may receive this notification because your vaccination series needs to be updated in your Rhode Island Adult and Child Immunization Registry (RICAIR) record. Please complete the form in the PDF below, attach a picture of your CDC vaccine card if possible and send your completed form to this address, [email protected]. We apologize for the inconvenience and any confusion this may have caused. https://health.ri.gov/forms/records/COVID-Immunization-Record-Correction-Request.pdf Johnson & Johnson (Janssen) Pause Why did Rhode Island pause administration of the Johnson & Johnson (Janssen) COVID-19 vaccine? On April 13, Rhode Island paused the administration of Johnson & Johnson (Janssen) COVID-19 vaccine per federal recommendations. The pause was put in place after six cases of a rare and severe blood clot were reported in people after receiving the Johnson & Johnson vaccine. The cases were in women between the ages of 18 and 48. The rare blood clot reported is called thrombosis with thrombocytopenia (TTS). Thrombosis occurs when a blood clot blocks blood flow in your vessels. Thrombocytopenia is a condition in which someone has low platelets. Platelets are cells that help the blood clot. Platelets help us stop bleeding. TTS is when someone experiences blood clots and also has low platelets. You may also hear or see “cerebral venous sinus thrombosis” or CVST. This describes a blood clot that happens in the brain and is a medical emergency. The cases of blood clots identified through the Vaccine Adverse Events Reporting System (VAERS) were blood clots that occurred in the brain and in combination with low platelets. These clots occurred between 6 and 13 days after receiving the Johnson & Johnson COVID-19 vaccine. The CDC and FDA recommended a pause out of an abundance of caution. What did we learn from the pause? This pause in the use of the Johnson & Johnson vaccine means that the vaccine safety monitoring system is working. Through the Vaccine Adverse Event System (VAERS), a “signal” was detected after only six reported cases of a rare and severe type of blood clot. As of April 23, 15 cases have been identified in women between the ages of 18 and 59. For women 18 to 49, these events occurred at a rate of about 7 cases per 1 million vaccinated women. For women age 50 and older, these events occurred at a rate of about 0.9 cases per 1 million vaccinated women. For men age 18 to 49, these events occurred at a rate of 1 per 1 million vaccinated men. There were no such events for vaccinated men age 50 and older. These are rare events. What did CDC and FDA decide during the pause? On April 23, the CDC and the FDA authorized healthcare providers to resume use of the Johnson & Johnson vaccine. After the pause, FDA and CDC determined that the Johnson & Johnson vaccine is safe and effective in preventing COVID-19. A review of all the available data suggests the vaccine’s known and potential benefits outweigh its known and potential risks, and the chance of this rare blood clot occurring is very low, yet serious. Use of Johnson & Johnson vaccine can resume with a new warning label regarding blood clots. Are there any restrictions on who should receive the Johnson & Johnson vaccine? The ACIP did not recommend any restrictions on who should receive the Johnson & Johnson vaccine. However, the vaccine label now includes a warning about the rare risk of blood clots. Providers should use this vaccine with caution in patients at increased of clotting and consider the Moderna or Pfizer vaccines which are not known to have this risk. Additionally, the Johnson & Johnson vaccine has only been authorized for use in people ages 18 and older. I am a vaccine administrator. Can I begin administering Johnson & Johnson again? Yes. If you have Johnson & Johnson vaccine on hand from before the pause, you may begin administering the vaccine as long as the vials were properly stored, and no vials were punctured. Can I receive the Johnson & Johnson vaccine now? Yes. Rhode Island announced on April 26 that it would begin administering Johnson & Johnson again and that appointments would be available for the Johnson & Johnson vaccine that week. What if I got the Johnson & Johnson vaccine before the pause? If you received the Johnson & Johnson vaccine within the last month and develop any of the following symptoms within three weeks of receiving your shot, you should immediately contact your doctor or seek medical treatment: severe headache, blurred vision, fainting, seizures, abdominal pain, leg pain or shortness of breath. Mild fever, mild headache, fatigue, and joint or muscle pain after vaccination are routine and typically go away within two to three days. As of April 23, 2021, more than eight million doses of the Johnson & Johnson vaccine had been given in the United States. Experts identified 15 reports of women who got the vaccine and later developed thrombosis with thrombocytopenia syndrome. This is an extremely rare event. The great majority of people who have received the Johnson & Johnson vaccine have not experienced any harmful side effects. According to the CDC, if you received your shot over a month ago, your risk is very low, and you do not need to take any specific action. If you have concerns, consult your doctor. What will happen next for the Johnson & Johnson vaccine in Rhode Island? Rhode Island healthcare providers have information and guidance about thrombosis with thrombocytopenia and the appropriate medical treatment. Updated clinical guidance will continue to be provided. Healthcare providers should ensure patients understand the risk of any vaccine and have all their questions answered prior to any vaccine administration. Patients do have a choice of which COVID-19 vaccine they receive, and State-run vaccination sites will do their best to have as many vaccine options available as possible. The Johnson and Johnson vaccine label now includes a warning about the rare risk of blood clots. Providers should use this vaccine with caution in patients at increased of clotting and consider the Moderna or Pfizer vaccines which are not known to have this risk. Appointments for Johnson & Johnson will again be available on www.vaccinateRI.org this week (week of April 26, 2021), as well as through other channels. There are important advantages to the Johnson & Johnson COVID-19 vaccine. In addition to protecting you against COVID-19, the Johnson & Johnson vaccine can be transported and stored under regular refrigeration and only requires one dose. If I am offered the Johnson & Johnson vaccine, should I wait for Moderna or Pfizer? The COVID-19 vaccines are an important tool in stopping the spread of COVID-19 and getting vaccinated is one of several things you can do to protect yourself and your household. The odds of developing a severe COVID-19 infection are higher than the odds of developing serious side effects from the vaccine. However, the Johnson and Johnson vaccine label now includes a warning about the rare risk of blood clots. Providers should use this vaccine with caution in patients at increased of clotting and consider the Moderna or Pfizer vaccines which are not known to have this risk. If you have additional questions about which vaccine is best for you, check with your provider. Teachers, School Staff, and Licensed Child Care Providers How can a teacher, school staff person, or child care worker get vaccinated? Updated 3/30/2021 Pre-kindergarten to grade 12 teachers, school staff, and child care workers at centers and family child care sites licensed by the Rhode Island Department of Human Services (DHS) are being vaccinated at municipal vaccination clinics. Some clinics are serving more than one community. School leaders and licensed child care providers are working directly with municipalities to schedule staff for vaccination. Your school or child care facility will share more information with you about how to make an appointment. As of March 30, pre-kindergarten to grade 12 teachers, school staff, and child care workers are eligible to schedule vaccination appointments at State-run vaccination clinics if they have not yet gotten a first dose of vaccine at a municipal site or at a local pharmacy. All pre-kindergarten to grade 12 teachers, child care workers, and staff members should get the second dose of vaccine where they got the first dose (if they are getting the two-dose series of Pfizer-BioNTech or Moderna COVID-19 vaccine). Will I have to pay for the vaccine? All vaccines are free of charge regardless of immigration status and health insurance. Are vaccines required of school or child care staff? Not at this time; however, all staff are strongly encouraged to participate in this opportunity. If I have staff who have already received a vaccine, or are eligible through a different mechanism (such as age) do I need to report their vaccinations to RIDOH or DHS? No. You should maintain these records as required (determined) by your HR department. Does RIDOH and/or DHS need documentation of our staff’s completed vaccinations? No. You should maintain these records as required (determined) by your HR department. COVID-19 Vaccine FAQs for Healthcare Providers and Professionals About COVID-19 Vaccines How does the Johnson & Johnson (Janssen) COVID-19 vaccine differ from the Pfizer-BioNTech and Moderna vaccines? Updated 3/11/2021 The Johnson & Johnson COVID-19 vaccine uses an adenovirus type 26 (Ad26) vector to deliver a piece of the DNA that is used to make the distinctive “spike” protein of the SARS-CoV-2 virus, whereas the Pifzer-BioNTech and Moderna vaccines use messenger RNA (mRNA). While adenoviruses are a group of viruses that are relatively common, Ad26, which can cause cold symptoms and conjunctivitis, has been modified for the vaccine so that it cannot replicate in the human body to cause illness. After a person receives this vaccine, the body can temporarily make the spike protein, which does not cause disease but triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2. The Johnson & Johnson COVID-19 vaccine is administered intramuscularly as a single dose (0.5 mL). The mRNA vaccines require a two-dose series. The Johnson & Johnson vaccine does not need to be stored at extremely low temperatures like the Pfizer-BioNTech vaccine. It can be kept safely in a refrigerator. What kind of severe symptoms should I watch out for in patients who have recently gotten vaccinated for COVID-19? Updated 6/24/2021 Please monitor patients for the following symptoms after vaccination, as they require prompt medical attention: Chest pain; shortness of breath; feelings of having a fast-beating, fluttering, or pounding heart Severe or persistent headaches or blurred vision; shortness of breath; chest pain; leg swelling; persistent abdominal pain; easy bruising or tiny blood spots under the skin beyond the injection site Please review the CDC Health Alert: Cases of Cerebral Venous Sinus Thrombosis with Thrombocytopenia after Receipt of the Johnson & Johnson COVID-19 Vaccine Please review CDC’s Clinical Considerations: Myocarditis and Pericarditis after Receipt of mRNA COVID-19 Vaccines Among Adolescents and Young Adults If you have any questions about symptoms or reactions after a COVID-19 vaccine, please contact a physician. What should I do if a patient has a thrombotic event and thrombocytopenia after getting the Johnson & Johnson vaccine? Updated 4/14/2021 In patients with a thrombotic event and thrombocytopenia after the Johnson & Johnson COVID-19 vaccine, evaluate initially with a screening PF4 enzyme-linked immunosorbent (ELISA) assay as would be performed for autoimmune HIT. Consultation with a hematologist is strongly recommended. Do not treat patients with thrombotic events and thrombocytopenia following receipt of Johnson & Johnson COVID-19 vaccine with heparin, unless HIT testing is negative. If HIT testing is positive or unable to be performed in patient with thrombotic events and thrombocytopenia following receipt of Johnson & Johnson COVID-19 vaccine, non-heparin anticoagulants and high-dose intravenous immune globulin should be strongly considered. Report adverse events to VAERS, including serious and life-threatening adverse events and deaths in patients following receipt of COVID-19 vaccines as required under the Emergency Use Authorizations for COVID-19 vaccines. Read the full CDC Health Alert. Vaccine storage and handling How can I tell the difference between 14- and 10-dose vials of Moderna vaccine? Updated 5/27/21 Starting in June, some vaccination providers will begin receiving 14-dose vials of Moderna vaccine. The labeling for the 14-dose cartons and vials is very similar to the labeling for the 10-dose cartons and vials, but the 14-dose cartons and vials have a blue band. See the differences between the 14- and 10-dose cartons and vials on the DailyMed website (scroll to the “Package/Label Display Panel” sections at the bottom of the page). Does the vaccine need to be kept in a different container once it reaches a distribution site, or can the boxes be put in a freezer or refrigerator? (Updated 2.17.2021) The vaccine does not need to be kept in a different container once it reaches a distribution site. The CDC recommends that vaccines and diluents be stored in their original packaging with lids closed until ready for administration. Note that, upon arrival, shipments of refrigerated and frozen vaccine should be immediately examined for signs of damage, for indication of a temperature excursion during transit, and to guarantee receipt of the appropriate vaccine types and quantities. (Source: CDC) What should I know ahead of time about planning for a power outage? Emergencies such as equipment failures, power outages, severe weather conditions, or natural disasters usually happen without warning and may compromise storage conditions. Because of the limited supply of the COVID-19 vaccines, especially during early US vaccination efforts, it is critical that COVID-19 vaccination providers have plans in place for emergency situations. Some key issues to remember include: Vaccines may remain inside a nonfunctioning unit as long as appropriate temperatures are maintained. Monitor your Digital Data Logger (DDL) to determine when additional action should be taken. Having an on-site generator(s) prevents the need to transport vaccines to an alternative storage facility during a power outage. Emergency situations can arise outside of normal business hours, so your office staff as well your facility’s building manager and/or security staff, if appropriate, should understand how to implement your emergency operation plans or access your facility if necessary. Ensure your facility has the resources on hand to safely pack vaccines for transport during emergencies. (Source: CDC) Response added 1.11.2021 Can the Pfizer-BioNTech COVID-19 vaccine be stored in the same freezer unit used for the storage of other vaccines, such as Varicella and MMRV (which are stored at -58°F to 5°F)? (Updated 3.4.2021) On February 25, 2021, the US Food and Drug Administration (FDA) announced that it is allowing undiluted frozen vials of Pfizer-BioNTech COVID-19 Vaccine to be transported and stored at conventional temperatures commonly found in pharmaceutical freezers (-25°C to -15°C; -13°F to 5°F) for a period of two weeks. This reflects an alternative to the recommended storage of undiluted vials in an ultra-low temperature freezer between -80°C to -60°C (-112°F to -76°F). Storage between -60°C and -25°C (-76°F and -13°F) is considered an excursion from the recommended storage condition, and any time vials are stored within this range should be counted against the 2 weeks allowed for storage at -25°C to -15°C (-13°F to 5°F). The data loggers RIDOH supplies for temperature monitoring are set up to alarm when the routine frozen vaccines go out of range—not the tight range for Pfizer-BioNTech COVID-19 Vaccine. If a site plans to use a freezer solely for storing Pfizer-BioNTech COVID-19 Vaccine, they must adjust the settings on their datalogger so it will alarm when temperatures go out of the -13°F to 5°F range. RIDOH can supply a datalogger for sites that do not have one for a separate freezer. For more storage information related to the Pfizer-BioNTech COVID-19 vaccine, read the Fact Sheet for Healthcare Providers. Can sites that do not have ultra-low cold storage receive redistributed frozen vaccine? (Updated 3.4.2021) CDC does allow the transport of frozen vaccine when packed appropriately, so sites that do not have ultra-low cold storage can receive redistributed frozen vaccine. How long can thawed, undiluted Pfizer-BioNTech COVID-19 vaccine be stored in the refrigerator? Updated 5/20/21 The FDA has authorized undiluted, thawed Pfizer-BioNTech COVID-19 vaccine vials to be stored in the refrigerator at 2°C to 8°C (35°F to 46°F) for up to one month. Previous guidance stated that thawed, undiluted vaccine vials could be stored in the refrigerator for up to five days. For more information, please read the Fact Sheet for Healthcare Providers Administering Vaccine. Can Pfizer-BioNTech COVID-19 vaccine be stored in the refrigerator first and then frozen (-20°C) for a total of 45 days or does it have to be frozen first? Updated 5/20/21 Do not refreeze COVID-19 vaccines. The Pfizer-BioNTech vaccine can be stored in the freezer for two weeks and then the refrigerator for another 31 days (in that order). For Pfizer-BioNTech vaccine already in refrigerators, does the 30-day timeline apply? Updated 5/20/21 Yes—vaccine may be refrigerated for a total of 30 days. COVID-19 Vaccine Eligibility and Distribution Are primary care practices able to administer COVID-19 vaccines? Updated 6/3/21 Primary care providers (PCPs) in Rhode Island have been getting COVID-19 vaccine and are vaccinating in their offices. RIDOH continues to onboard other clinics and PCPs, including larger family medicine and pediatric practices. RIDOH is working through a list of all practices enrolled in Rhode Island State-Supplied Vaccine (SSV) program. Practices will be contacted directly to determine interest and begin the process of onboarding. Practices do not need to contact RIDOH unless they are being engaged through the survey follow up. Administering COVID-19 vaccine How do I sign up to administer the COVID-19 vaccine? Updated 6/24/21 All organizations and providers who want to administer the COVID-19 vaccine must be enrolled as State-Supplied Vaccine (SSV) providers for the 7/1/2021 - 6/30/2022 program year. If you are not currently enrolled in the SSV program learn more about enrolling in the SSV Program. If you are already enrolled in the SSV program and would like to enroll as a COVID-19 vaccine provider, contact your Immunization Program representative. If you are not currently enrolled in the SSV program, contact Heidi Wallace. Learn more about enrolling in the SSV Program. Can I administer COVID-19 vaccine at or around the same time as other vaccinations? Updated 5/20/21 Yes. According to CDC, COVID-19 vaccines and other vaccines may now be administered without regard to timing. This includes simultaneous administration of COVID-19 vaccines and other vaccines on the same day as well as coadministration within 14 days. It is unknown whether reactogenicity of COVID-19 vaccine is increased with coadministration, including with other vaccines known to be more reactogenic, such as adjuvanted vaccines or live vaccines. When deciding whether to coadminister other vaccine(s) with COVID-19 vaccines, providers should consider the following: Whether the patient is behind or at risk of becoming behind on recommended vaccines Their risk of vaccine-preventable disease (e.g., during an outbreak or occupational exposures) The reactogenicity profile of the vaccines If multiple vaccines are administered at a single visit, administer each injection in a different injection site. For adolescents and adults, the deltoid muscle can be used for more than one intramuscular injection. Best practices for multiple injections include: Label each syringe with the name and the dosage (amount) of the vaccine, lot number, the initials of the preparer, and the exact beyond-use time, if applicable. Separate injection sites by 1 inch or more, if possible. Administer the COVID-19 vaccines and vaccines that may be more likely to cause a local reaction (e.g., tetanus-toxoid-containing and adjuvanted vaccines) in different limbs, if possible. For more information, visit CDC’s Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Authorized in the United States. Are there ‘high-risk vaccination sites’ in Rhode Island? Updated 3/25/2021 People who are otherwise eligible to be vaccinated can be vaccinated in most hospitals. RIDOH has offered all of the hospitals vaccine to help support vaccinating individuals in alignment with the State eligibility criteria. If their doctor feels that a hospital is where a patient should be vaccinated, then the physician should call a hospital with which they have a relationship to discuss. For vaccines requiring two doses, if there is a delay in timing of the second dose, at what point does the vaccination have to start over? Updated 2/25/2021 The second dose should be administered as close to the recommended interval as possible. However, if it is not feasible to adhere to the recommended interval, the second dose of Pfizer-BioNTech and Moderna COVID-19 vaccines may be scheduled for administration up to 6 weeks (42 days) after the first dose. There are currently limited data on efficacy of mRNA COVID-19 vaccines administered beyond this window. If the second dose is administered beyond these intervals, there is no need to restart the series. Does v-safe document which vaccine a patient received? Yes. The patient is prompted to enter this information into v-safe when setting up the program. For more, see: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/vsafe.html Response added 1.11.2021 Are mRNA vaccines interchangeable? Can patients receive a second dose of a different vaccine? (Updated 3.4.2021) The current mRNA COVID-19 vaccines are not interchangeable with each other or with other COVID-19 vaccine products. The safety and efficacy of mixing these vaccines has not been evaluated. Per the CDC, in exceptional situations in which the first-dose vaccine product cannot be determined or is no longer available, any mRNA COVID-19 vaccine may be administered at a minimum of 28 days between doses. There are no data available to support using the Janssen COVID-19 vaccine to complete a vaccination series initiated with another COVID-19 Vaccine. Who can vaccine providers contact for technical assistance? (Updated 2.16.2021) RIDOH has established a provider-only Help Desk to assist with technical issues related to provider standup, PrepMod support (online clinic management and appointment scheduling system), onboarding providers, and staff inquiries. For inquiries related to PrepMod or data reporting requirements, please call the COVID-19 Vaccine Provider Help Desk Phone: 888-662-4341 Hours Monday – Friday: 7:30 a.m. – 7 p.m. Saturday – Sunday: 8:30 a.m. – 4:30 p.m. Email: [email protected] How do I prevent, report, and manage mRNA COVID-19 vaccination administration errors? CDC has issued guidance for clinicians if there are errors in vaccine administration related to site/route, age, vaccine intervals, mixed series, dosage, storage/handling, and diluents. For all vaccine administration errors: Inform the recipient of the vaccine administration error. Consult with the state immunization program and/or Immunization Information System (IIS) to determine how the dose should be entered into the IIS, both as an administered dose and to account for inventory. Report the error to the Vaccine Adverse Event Reporting System (VAERS), unless otherwise indicated in the table. Providers are required to report all COVID-19 vaccine administration errors—even those not associated with an adverse event — to the VAERS. To file an electronic report, please see the VAERS website. Determine how the error occurred and implement strategies to prevent it from happening again. A discussion on strategies to prevent errors can be found in the Vaccine Administration chapter of the Epidemiology and Prevention of Vaccine-Preventable Diseases (Pink Book). Additional resources can be found on CDC’s vaccine administration web page, including a job aid for preventing errors. See Appendix A. vaccine administration errors and deviations for full details: https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-consider… COVID-19 Vaccines and COVID-19 variants Can healthcare providers help patients access COVID-19 vaccine records? Updated 4/8/2021 Yes. Patients may contact your office if they have been unable to access their COVID-19 vaccination record at https://portal.ri.gov/VaccineRecord/s/. When a patient looks up their COVID-19 vaccine record, an accurate cell phone or email address is required for authentication. They must also enter their name, date of birth, and zip code to access the record. Providers can help patients by updating cell phone, email address, and other information in RICAIR web on the demographics page. Patient privacy is better protected this way because providers can more accurately verify their patients' identity when updating information. Providers who do not currently have access to RICAIR or need help in updating demographics can request assistance by emailing [email protected]. Patients can also submit a data correction form to RICAIR here. COVID-19 Variants and Vaccines How many COVID-19 variants are circulating? Updated 6/17/21 There are multiple COVID-19 variants circulating around the world. CDC and WHO are tracking this development. To learn about COVID-19 variants in Rhode Island, please see the COVID-19 Variants web page. These variants seem to spread more easily and quickly than other variants, which may lead to more cases of COVID-19. An increase in the number of cases will put more strain on healthcare resources, lead to more hospitalizations, and potentially more deaths. For this reason, we must continue to practice protective measures. For more information, check out CDC’s website: https://www.cdc.gov/coronavirus/2019-ncov/variants/variant.html. Are the existing COVID-19 vaccines effective against COVID-19 variants? Updated 6/17/21 The COVID-19 vaccine is highly protective against variants, including the Delta variant. For the bestprotection, you need to be fully vaccinated—meaning two weeks have passed since you’ve gotten the second dose of a two-dose series (Moderna, Pfizer-BioNTech) or a single dose of a one-dose series (Johnson & Johnson). Should I be concerned about the COVID-19 variants? Updated 6/17/21 While variants tend to spread easily and quickly and may lead to more serious cases of COVID-19, the good news is that the COVID-19 vaccine is protective against variants, including the Delta variant. To get this protection, you need to be fully vaccinated. If you’re not yet fully vaccinated, getting vaccinated, wearing a mask, and weekly testing are more important than ever to stop the variant from spreading and to protect the progress we’ve made. COVID-19 Vaccines and Contraindications Can a patient who had an initial reaction to the first dose of an mRNA COVID-19 vaccine get the second dose? 4/1/2021 Please review the information about vaccine contraindications and precautions to assist you in your discussions about COVID-19 vaccination in patients who had an initial reaction to a vaccine dose: CDC interim clinical considerations for COVID-19 vaccines. If, after reviewing this information, you feel that additional advice would be helpful for a specific patient scenario, you can consult with an allergist-immunologist, and/or the clinical safety line from CDC: Healthcare personnel or health departments in the United States can request a consultation from the Clinical Immunization Safety Assessment COVIDvax project about an individual patient residing in the United States for a complex COVID-19 vaccine safety question not readily addressed by CDC guidance. This request can be made through CDC-INFO by calling 800-CDC-INFO (800-232-4636), or submitting a request via CDC-INFO webform. Please also note that adverse events that occur in a recipient following COVID-19 vaccination should be reported to VAERS. Vaccination providers are required by the FDA to report the following that occur after COVID-19 vaccination under EUA: Vaccine administration errors Serious adverse events Cases of Multisystem Inflammatory Syndrome Cases of COVID-19 that result in hospitalization or death Reporting is encouraged for any other clinically significant adverse event, even if it is uncertain whether the vaccine caused the event. Information on how to submit a report to VAERS is available at https://vaers.hhs.gov or by calling 1-800-822-7967. Who can I contact with questions about vaccine reactions? Updated 4/15/2021 For timely consults, providers can call Lifespan’s Infectious Disease (ID) Consult Line at 401-474-7622. This line is for providers only. For patient referrals, providers or clinic staff can call 401-793-2020 to set up an appointment for an outpatient visit for a patient to see a physician. How should clinicians manage anaphylaxis after mRNA COVID-19 vaccination? Updated 2.25.2021 Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of mRNA COVID-19 vaccine. For more information on anaphylaxis management, visit CDC’s interim considerations for the management of anaphylaxis following COVID-19 vaccination and laboratory evaluation of persons who experience anaphylaxis after vaccination. Should patients with a history of Guillain-Barré Syndrome avoid the COVID-19 vaccine? To date, no cases of Guillain-Barré syndrome (GBS) have been reported following vaccination among participants in the Pfizer-BioNTech or Moderna COVID-19 vaccines clinical trials. With few exceptions, ACIP’s general best practice guidelines for immunization does not include history of GBS as a contraindication or precaution to vaccination. Persons with a history of GBS may receive an mRNA COVID-19 vaccine unless they have a contraindication to vaccination. Any occurrence of GBS following mRNA COVID-19 vaccination should be reported to the Vaccine Adverse Event Reporting System (VAERS). Response added 1.11.2021 Can patients with a history of MIS-C or MIS-A get the COVID-19 vaccine? Updated 6/4/21 Current evidence suggests that the risk of SARS-CoV-2 reinfection is low in the months after initial infection but may increase with time due to waning immunity. Thus, people with a history of Multisystem inflammatory syndrome in children (MIS-C) or adults (MIS-A) should consider delaying vaccination until they have recovered from illness and for 90 days after the date of diagnosis of MIS-C or MIS-A, recognizing that the risk of reinfection and, therefore, the benefit from vaccination, might increase with time following initial infection. For more information, visit CDC’s Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Authorized in the United States. What are the signs of myocarditis I should look for in patients? Myocarditis is the inflammation of the heart muscle, and pericarditis is the inflammation of the lining outside the heart. In both cases, the body's immune system is causing inflammation in response to an infection or some other trigger. While myocarditis can be serious, it is frequently mild and self-limited. Symptoms to look for in patients can include abnormal heart rhythms, shortness of breath, or chest pain. Healthcare providers should consider myocarditis in an evaluation of chest pain after vaccination and report all cases to the Vaccine Adverse Event Reporting System (VAERS) [cdc.gov]. There have been a small number of cases of myocarditis and pericarditis among people after getting the mRNA COVID-19 vaccines (Pfizer-BioNTech or Moderna vaccines). The CDC are closely monitoring myocarditis/pericarditis in the VAERS and the Vaccine Safety Datalink (VSD) [cdc.gov]. The CDC continues to recommend that everyone age 12 or older get vaccinated. Myocarditis can be caused by several different things including infections, medications, toxins (like alcohol) and autoimmune disorders. In fact, the most common cause of myocarditis is viral infection in general. If a patient has a mammogram scheduled, should they postpone their COVID-19 vaccination or vice versa? Updated 3/18/2021 According to CDC, some experts recommend getting a mammogram before being vaccinated or waiting four to six weeks after getting vaccinated. There have been some reports of patients developing swollen lymph nodes under the arm in which they received their COVID-19 vaccine. The swelling is a normal sign that the body is building protection against COVID-19. However, because breast cancer can present with lymph nodes that are swollen under the arm, patients may be concerned that a COVID-19 vaccination would cause a false reading on a mammogram. Patients should let the mammogram technologist know if they’ve recently gotten the vaccine and which arm it was administered in. If a doctor sees swollen lymph nodes, they will conduct further analyses to make sure it is related to the vaccine and not to breast cancer. If a patient has tested positive for SARS-CoV-2 should they receive the COVID-19 vaccine? Updated 4/20/2021 People should get vaccinated once they have recovered from COVID-19 and completed their isolation period. Getting vaccinated is a safer way to build protection than getting infected with COVID-19. According to CDC, the risk of severe illness and death from COVID-19 outweighs any benefit of natural immunity. Can COVID-19 vaccines be administered to patients with a history of dermal filler use? Updated 2.17.2021 The mRNA COVID-19 vaccines can be administered to persons who have received injectable dermal fillers who have no contraindications to vaccination. No additional precautions are needed. However, these persons should contact their healthcare provider for evaluation if they experience swelling at or near the site of dermal filler following vaccination. Infrequently, persons who have received dermal fillers might experience swelling at or near the site of filler injection (usually face or lips) following administration of a dose of an mRNA COVID-19 vaccine. This appears to be temporary and can resolve with medical treatment, including corticosteroid therapy. Can cancer patients receive the COVID-19 vaccine? Updated 2.17.2021 The National Comprehensive Cancer Network (NCCN) has recently formed a COVID-19 Vaccine Committee including top hematology and oncology experts with expertise in infectious diseases, vaccination development, medical ethics, and health information technology. This committee has established recommendations that can help cancer care providers make informed decisions on how to protect their patients from the ongoing COVID-19 pandemic, based on available evidence plus expert consensus. Can immunocompromised patients receive the COVID-19 vaccine? Updated 6/10/21 Yes. People who are immunocompromised should be vaccinated against SARS-CoV2, as there are no conditions that cause anyone to be immunocompromised, or medications that weaken the immune system, that are a contraindication to vaccination. While there is not enough data to determine optimal timing of COVID-19 vaccination among people who are planning to receive immunosuppressive therapies, general best practices for immunocompromised people suggest COVID-19 vaccination should be completed at least two weeks before starting immunosuppressive therapies. When it is not possible to administer a complete COVID-19 vaccine series in advance, people receiving immunosuppressive therapy can still get the COVID-19 vaccine. Healthcare providers should consider the person’s risks related to their underlying condition when making decisions about delaying immunosuppressive therapy to complete COVID-19 vaccination. Vaccine efficacy in people with compromised immune systems is not fully understood, so it’s uncertain if they’ll have the same protective response as people with normally functioning immune systems. Routine testing for antibodies to a COVID-19 vaccine is not recommended. Please review RIDOH’s Guidance for Vaccination and Mask Wearing in People with Compromised Immune Systems. What should clinicians do if a patient who has been fully vaccinated later develops COVID-19? Updated 3/11/2021 For vaccinated people who later experience COVID-19, prior receipt of a COVID-19 vaccine should not affect treatment decisions (including use of monoclonal antibodies, convalescent plasma, antiviral treatment, or corticosteroid administration) or timing of such treatments. If a person is fully vaccinated (i.e., ≥2 weeks after completion of a two-dose mRNA series or single dose of Johnson & Johnson vaccine) and tests positive for SARS-CoV-2, healthcare providers and local health departments are encouraged to request the specimen be held and to report the case to their state health department immediately. CDC will work with the state health department to collect information about the case. In addition, information about these cases should be reported to VAERS. How should I talk to patients about vaccination if they have already had COVID-19? Updated 5/6/2021 People who have tested positive for COVID-19 and have recovered should still get vaccinated. Experts do not yet know how long you are protected after having COVID-19. Vaccines help protect you from getting COVID-19 again and will also protect you against variants. Every shot gets us closer to ending the pandemic. Vaccine appointments are now widely available for people age 16 and older. If someone has received 2 doses (not placebo) in a clinical trial, are they considered fully vaccinated? 9/21/2021 For people who received the full series of an active COVID-19 vaccine candidate as part of a US-based clinical trial of a COVID-19 vaccine that is neither authorized by FDA nor listed for emergency use by WHO: If a participant in a US-based clinical trial has been documented to have received the full series of an "active" (not placebo) COVID-19 vaccine candidate, and vaccine efficacy has been independently confirmed (e.g., by a data and safety monitoring board), the participant can be considered fully vaccinated 2 weeks after they completed the vaccine series. Currently, the Novavax COVID-19 vaccine meets these criteria. This does not imply that the vaccine has been authorized by FDA or is recommended by CDC or ACIP.