COVID-19 Vaccine FAQs 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 3/5/21 To see how to get vaccinated, please go to covid.ri.gov/vaccination Rhode Island Vaccination Timeline Rhode Island Vaccination data If you are eligible to get vaccinated, the best vaccine for you is the one that is available to you first. The COVID-19 vaccine is safe, highly effective against serious illness, and prevents you from being infected with COVID-19. Get vaccinated when it’s available to you. A person 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. Because there still may be a small chance you can become infected and spread the virus to others, once you’ve gotten any COVID-19 vaccine, please continue to wear your mask and watch your distance around anyone you don’t live with. Getting Vaccinated in Rhode Island How do I get vaccinated for COVID-19? Updated 3/3/21 Similar to COVID-19 testing in Rhode Island, there are different ways to get vaccinated in Rhode Island. The three main ways that people can get vaccinated are: State vaccination sites, designated 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. Please go to covid.ri.gov/vaccination to learn how to get a vaccine at a state-run site, a local pharmacy, or at a local or regional vaccine site. Please note: To get vaccinated in Rhode Island, you must live in Rhode Island, work in Rhode Island, or go to school in Rhode Island. How do I register to get vaccinated? Updated 3/3/21 Eligible Rhode Islanders can schedule an appointment online at www.vaccinateRI.org. If you need help scheduling an appointment, call the automated phone line at 844-930-1779. The phone line is available in English and Spanish. A person may schedule and consent to vaccination, online or on the phone, for someone else with verbal approval. Appointments will be limited and you must have an appointment to get vaccinated. You cannot just walk in get vaccinated. This video by the Rhode Island National Guard goes over how to register for a vaccination appointment: https://fb.watch/3-L0Kz56XS/ What information do I need for registration? Updated 2/17/21 At vaccinateRI.org, you will first pick the vaccination site you want to go to. Then, you will attest that you meet the eligibility criteria for vaccine. Next, you will enter personal and contact information, health insurance information (for those who have health insurance. If you do not have health insurance, you can skip this section), and information about your health. You can then search for an appointment slot. It may be that there are no appointments available. If that happens, don’t worry. More appointments will be added. You will have to check back and go through the process again. Please note that this system does not work well with the Cox email server. If you have an @cox.net email address, it might be a good idea to instead use a text-enabled cell phone number for your contact information. How do I register to get vaccinated if I don’t have a computer? Updated 2/17/21 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 assist you with your vaccination appointment. Also, friends or family can help you make an appointment. A person may schedule and consent to vaccination, online or on the phone, for someone else with verbal approval. Does Rhode Island have a vaccine waitlist? Updated 2/17/21 Rhode Islanders who are not yet eligible for vaccination can add their contact information to a Vaccine Information Notification List to get updates as eligibility opens to new groups. Enrolling in this list does not guarantee an appointment for vaccination. To enroll in the Vaccine Information Notification List, visit portal.ri.gov. What happens at my COVID-19 vaccination appointment? Updated 3/3/21 Please show up at your assigned time. Appointments have been spaced out to avoid crowding. If you have registered, there is vaccine for you. You do not need to worry about the clinic running out. 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. What happens after my COVID-19 vaccination appointment? Updated 3/3/21 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. 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. If you have any symptoms of COVID-19 following vaccination, stay home, call a healthcare provider, and get tested. Because there still may be a small chance you can become infected and spread the virus to others, once you’ve gotten any COVID-19 vaccine, please continue to wear your mask and watch your distance around anyone you don’t live with. What to expect after you get your vaccine (English only): https://youtu.be/EILCpte7GSw (CDC video) What to expect after you get your vaccine (English only): https://youtu.be/EILCpte7GSw (CDC video) How can I check my vaccination record? Updated 3/3/21 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 for help. I got vaccinated and now have symptoms of COVID-19. What do I do? Updated 2/11/21 After vaccination, people should continue to follow guidance around prevention, testing, quarantine, and isolation. People are likely to experience symptoms after receiving an mRNA 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., abdominal 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. Is there a cost or co-pay for COVID-19 vaccine? Updated 2/17/21 No. COVID-19 vaccines will be provided at no cost. Those who administer vaccines may charge insurance companies a fee for giving the someone the shot, but they will not charge the person being 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. How is Rhode Island making decisions about who is eligible for COVID-19 vaccine? Updated 1/26/21 Rhode Island does not yet receive enough vaccine to give to everyone at once. The State’s planning is informed by the National Academies of Medicine, Engineering, and Science’s Framework for Equitable Allocation of COVID-19 vaccine; recommendations by the Advisory Committee on Immunization Practices (ACIP) and the Rhode Island COVID-19 Vaccine Subcommittee; new information from CDC and other partners about the availability and safety of various COVID-19 vaccines; and consultation with industry leaders, subject matter experts, and community partners. Equity is a top priority that will continue to inform our vaccine planning. Rhode Island’s COVID-19 Vaccine Subcommittee meets regularly. To receive updates on meetings and meeting minutes, please follow this link to the Secretary of State’s Open Meeting website. Click on the orange box that says “email” to register your email address for automatic updates. How long does it take to give people COVID-19 vaccine after Rhode Island receives vaccine supplies? Updated 1/19/21 Rhode Island administers 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. Are doses of COVID-19 vaccine being thrown away or wasted? Vaccines are not going to waste in Rhode Island. Each vaccination site has systems in place to bring people from eligible populations to receive any remaining doses from an opened vial. Is it mandatory to get the COVID-19 vaccine? Updated 3/3/21 The Federal government does not mandate vaccination for individuals. 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 Rhode Island Department of Health does not mandate or require people to be vaccinated. This is voluntary. The COVID-19 vaccine is safe, highly effective against serious illness, and prevents you from being infected with COVID-19. How are people who are unable to leave home getting vaccinated? Updated 2/25/2021 If you are unable to leave home to receive COVID-19 vaccination or are the healthcare provider or family caregiver of someone who is homebound, please inform RIDOH through the following form: http://bit.ly/homeboundvax. The form is available in English, Spanish, and Portuguese and will be used for planning purposes. RIDOH will have an option for vaccination in homebound individuals in the near future. 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 in Rhode Island, work in Rhode Island, 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. Can I choose which COVID-19 vaccine I receive? Updated 3/3/21 The best vaccine is the first one available to you. In general, only one vaccine may be available through a healthcare professional or vaccination clinic. Please talk to a healthcare provider if you have specific questions or concerns about one COVID-19 vaccine versus another. I missed my appointment for the second dose of the COVID-19 vaccine. What should I do? Updated 2/11/21 If you received your first dose through your employer and missed your second-dose appointment, please contact them directly to schedule a second-dose appointment. If you miss your second-dose appointment and did not enroll directly through your employer, please contact [email protected] and ask to reschedule your second dose appointment. Guidance from the CDC states that the second dose should be administered 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 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 six weeks (42 days) after the first dose. There are currently limited data on efficacy of mRNA COVID-19 vaccines administered beyond this window. Despite lack of efficacy data, when unavoidable delays occur, the second dose may be administered beyond the six-week window and there is no need to restart the series. COVID-19 Vaccine Safety Will I get sick from the vaccine? Updated 3/3/20 No. Vaccines do not cause 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. People may feel some soreness in their upper arms, some aches, 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. 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? 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. Are COVID-19 vaccines safe for children? Updated 3/3/21 The Pfizer vaccine has been authorized for people 16 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 children ages 12 and older. They hope to have results by late summer 2021. COVID-19 Vaccine and Contraindications Can I get a COVID-19 vaccine if I have allergies? Updated 3/3/21 If you have allergies that are not related to vaccines (e.g., food allergies, pet allergies, latex allergies), the CDC recommends that you receive 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 receive a COVID-19 vaccine. If you have had an allergic reaction to polyethylene glycol (PEG) or polysorbate, CDC recommends that you do not get an mRNA COVID-19 vaccine. This is because PEG is in mRNA COVID-19 vaccines. Polysorbate is not in mRNA COVID-19 vaccines, but it is closely related to PEG. If you have had a severe allergic reaction to any of the ingredients in the Janssen COVID-19 vaccine, CDC recommends that you do not get the Janssen vaccine. Janssen vaccine ingredients include: citric acid monohydrate, trisodium citrate dihydrate, ethanol, 2-hydroxypropyl-β-cyclodextrin (HBCD), polysorbate-80, and sodium chloride. 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. For more information, please see CDC’s recommendations for people with allergies: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/allergic-reaction.html and https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html?CDC_AA_refVal=https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/clinical-considerations.html Can I receive the COVID-19 vaccine if I am pregnant or breastfeeding? Updated 3/3/21 Pregnant and breastfeeding women can be vaccinated if they choose, after they have had the opportunity to discuss risks and benefits with their healthcare providers. This recommendation applies to Pfizer, Moderna, and Janssen COVID-19 vaccines. Experts believe that mRNA vaccines are unlikely to pose a risk for people who are pregnant. There is a global vaccine trial to evaluate the safety and effectiveness of the Pfizer-BioNTech COVID-19 vaccine in healthy pregnant women over the age of 18. On February 18, 2021, Pfizer Inc. and BioNTech SE announced that the first participants in their Phase 2/3 vaccine trial have received their first doses of the vaccine. Visit ClinicalTrials.gov to learn more. There are no data on the safety of COVID-19 vaccines in women who are breastfeeding or on the effects of mRNA vaccines on the breastfed infant or on milk production/excretion. mRNA vaccines are not thought to be a risk to the breastfeeding infant. For more, see CDC’s page on COVID-19 vaccination considerations for people who are pregnant. Can I get the COVID-19 vaccine if I already had COVID-19? Updated 1/4/21 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. 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 get the COVID-19 vaccine if I just received a different vaccine (e.g., Shingrix)? Updated 12/17/20 People who have received any other vaccine should wait until 14 days have passed to receive the COVID-19 vaccine. 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. Vaccine and COVID-19 Prevention Do I still need to wear a mask after I’ve been vaccinated? Updated 2/25/2021 Yes, you will need to wear a mask after being vaccinated. The COVID-19 vaccine is safe, highly effective against serious illness, and prevents you from being infected with COVID-19. Get vaccinated when it's available to you. Because there may still be a small chance you can become infected and spread the virus to others, once you've gotten any COVID-19 vaccine, please continue to wear your mask and watch your distance around anyone you don't live with. Do I still need to practice social distancing? Updated 2/25/21 Yes, you still need to practice social distancing after vaccination. Because there still may be a small chance you can become infected and spread the virus to others, once you’ve gotten any COVID-19 vaccine, please continue to wear your mask and 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 2/25/21 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 50 states or the District of Columbia (DC) or from a hot spot within the 50 states or DC, you do not need to quarantine if: You’ve gotten a final dose of a COVID-19 vaccine at least 14 days before your last exposure or out-of-state travel that is either FDA approved or received an Emergency Use Authorization (EUA) and It’s been less than 90 days since your final vaccine dose 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. If you have symptoms of COVID-19, isolate at home and get tested. Vaccinated close contacts and travelers should still get a COVID-19 test between 5 and 10 days after their last exposure or out-of-state travel. Vaccinated hospitalized patients and long-term care facility residents must still quarantine for 14 day 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 seek guidance from 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 1/11/21 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. 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 1/4/21 Vaccinated persons should continue to follow all current guidance to protect themselves and others, including following CDC travel guidance. International Travelers: Not all countries have started vaccinating their populations, so continue to follow COVID-19 guidelines such as mask wearing and social distancing when you travel. Different governments across the world are likely to have different protocols for travelers to prove their vaccination status and to test and/or quarantine if they been not been vaccinated, so check the guidelines of the country you plan to visit before traveling. Domestic Travelers: Quarantine restrictions and rules will continue to vary depending on which state you are traveling to. To learn more about the current restrictions that are in place, check with the health department of the state you are traveling to. 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 2/25/21 Yes, you must continue to participate in surveillance testing even after being vaccinated. Because there still may be a small chance you can become infected and spread the virus to others, once you’ve gotten any COVID-19 vaccine, please continue to wear your mask and watch your distance around anyone you don’t live with. Please also continue to take part in required and optional testing at your workplace and elsewhere. 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. For more on EUAs, visit the FDA web pages on 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. Is the Janssen vaccine (Johnson & Johnson) less effective than the Moderna and Pfizer vaccines? Updated 3/4/21 All three vaccines are safe; highly effective at preventing serious illness, hospitalizations, and death; and reduce the risk of being infected. All three vaccines will help protect you from getting different variants of COVID-19. If you are eligible to get vaccinated, the best vaccine for you is the one that is available to you first. Comparing the results from the Pfizer and Moderna trials to the results from the Janssen trials is like doing an apples and oranges comparison. This is because the vaccines were tested at different times, in different places, with different groups of people. Further, different strains of the coronavirus were more present than others, depending on where the trials were done. For example, the Janssen vaccine was tested in multiple countries, including South Africa, where the dominant strain is more contagious. The vaccines will continue to be studied over time, so we will have more comparable data in the future. 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 to COVID-19? Updated 1/19/21 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. Vaccination is the best protection, and it is safe. 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.