We have created a list of common questions about the COVID-19 vaccines based on current knowledge and understanding. These questions will continue to evolve with time, so we encourage you to check back frequently for the most up-to-date information.
Common Questions about COVID-19 Vaccines
- What does it mean that the Pfizer COVID-19 vaccine has received full approval from the Food and Drug Administration (FDA)?
Receiving full approval means the Pfizer vaccine now carries the FDA's strongest endorsement of safety and effectiveness. This is based on thorough research and comprehensive data review over many, many months.
- What did the approval process involve?
Full FDA approval only occurs when enough data demonstrate that the vaccines are safe and effective for the majority of people who receive them. After many months of studies and hundreds of millions having received a COVID-19 vaccine, the FDA has substantial information on how safe and effective the COVID-19 vaccines are in protecting people, how well they prevent severe disease, and how the vaccines are safely and consistently manufactured.
- What data did the FDA review?
The Pfizer-BioNTech COVID-19 vaccine underwent the FDA’s standard process for reviewing the quality, safety and effectiveness of medical products. The FDA evaluates data and information included in the manufacturer’s submission of a biologics license application (BLA). The agency also conducts its own analyses of the information in the BLA to make sure the vaccine is safe and effective and meets the FDA’s standards for approval.
The FDA stated the BLA submitted by Pfizer “builds on the extensive data and information previously submitted that supported the EUA, such as pre-clinical and clinical data and information, as well as details of the manufacturing process, vaccine testing results to ensure vaccine quality, and inspections of the sites where the vaccine is made.”
- Is the Pfizer COVID-19 vaccine considered safer than the other two vaccines still under emergency use authorization?
Like the Pfizer vaccine, both of the currently FDA-authorized COVID-19 vaccines (single-dose Johnson & Johnson/Janssen and two-dose Moderna) have been proven safe and effective based on extensive research. Pfizer was the first COVID-19 vaccine manufacturer to complete the arduous application and rigorous inspection process for full approval.
- Does FDA approval of the Pfizer vaccine apply to everyone 12 years old and up?
No. At this time, the vaccine has received full FDA approval for individuals who are 16 years and older. The vaccine is still under emergency use authorization (EUA) for those who are 12-15 years old until Pfizer files its application for this specific age group. The vaccine is also still under EUA for the third dose for immunocompromised individuals.
- Is Bourbon Community Hospital planning to require the vaccine for healthcare workers since Pfizer has received full approval?
We are carefully evaluating our next steps in light of the FDA’s decision to grant full approval for the Pfizer COVID-19 vaccine. At this time, we are still strongly encouraging and supporting all of our staff and our community to become fully vaccinated. We are hopeful that the FDA’s decision will help reduce vaccine hesitancy among unvaccinated individuals and encourage them to roll up their sleeves to protect themselves and those around them from COVID-19.
- When will the other currently available COVID-19 vaccines be approved?
Moderna has applied for full approval, and its vaccine is still being evaluated. Johnson & Johnson has indicated that it will likely apply for full approval later this year.
- Will the name of the Pfizer COVID-19 vaccine change with the FDA approval?
Comirnaty will be the brand name of the Pfizer mRNA COVID-19 vaccine. It will likely not be commercially available until 2022. Until more information is available, the Pfizer vaccine doses will continue to be distributed to states using the existing process.
- Once Comirnaty is commercially available, will individuals have to pay for the vaccine?
Cost and pricing information is not yet available for the FDA-approved product.
- Who is currently eligible for the COVID-19 vaccine? When will it be available to the general public?
We are in the process of distributing the vaccine in accordance with prioritization guidance from the Centers for Disease Control and Prevention (CDC), the federal government and our state health departments. We encourage everyone in our community to get vaccinated once the vaccine is more widely available to our community members, hopefully in the coming months. #VaccineHero
- The vaccine was produced very quickly. How do I know it is safe?
The U.S. vaccine safety system ensures that all vaccines are as safe as possible. Safety is the top priority while federal partners work to make the COVID-19 vaccines. Despite what the name may suggest, “Operation Warp Speed” does not mean that manufacturers were able to skip steps or cut corners in the vaccine development process. Instead, after development of the vaccine, manufacturers took a secured risk and overlapped the study, manufacturing and distribution phases. The FDA committed to giving these vaccinations priority (not rushed) review at all phases of the studies, which helped speed up the overall process. Ongoing monitoring of vaccine effectiveness and side effect reports will continue to be evaluated by the FDA and the manufacturers.
- If I get the COVID-19 vaccine, should I still wear a mask?
Yes. For several reasons, a mask and other proven methods of preventing COVID-19 (hand hygiene and social distancing) are still important even after receiving the vaccine. It typically takes a few weeks for the body to build immunity after vaccination. That means it is possible that a person could be infected with the virus that causes COVID-19 just before or just after vaccination. This is because the vaccine has not had enough time to provide protection. Also, while the vaccines protect you from becoming ill, it is not yet known if the vaccines prevent you from spreading the virus if infected.
In addition, while COVID-19 vaccines are highly effective, there is a small percentage of people who might not be protected while the virus continues to spread – including those with compromised immune systems due to cancer and cancer treatments and those who are unable to be vaccinated due to severe allergic reactions to vaccine ingredients.
Masks also help protect against new strains of the virus, for which vaccine effectiveness is still unclear. For these reasons, it is important to continue practicing safety measures like wearing masks until vaccines are widely administered and the virus is no longer spreading.
- If I have already had COVID-19 and recovered, should I still get the COVID-19 vaccine when it is available?
Yes, at this time the vaccine is recommended even if you previously tested positive for COVID-19. Due to the severe health risks associated with COVID-19 and the fact that re-infection with COVID-19 is possible, individuals who have previously been infected with COVID-19 should proceed with getting the vaccine. However, due to limited vaccine supply at this time, you may be asked to wait to get the vaccine if you had COVID-19 within the previous 90 days, as the likelihood of reinfection during this time period is likely low.
- Can you contract COVID-19 by getting the vaccine?
No. The vaccine is NOT a live vaccine, and it is NOT possible to contract COVID-19 from receiving the vaccine. Some people experience side effects from the vaccine, such as headache, muscle pain, or fever – but that does not mean you have COVID-19. It means your body is working to build the necessary immunity against the virus, which is a good thing.
- What are the possible side effects/adverse events from the COVID-19 vaccine?
The most common adverse reactions reported have been fatigue, headache, fever/chills and joint pain. This means your body is working to build the necessary immunity against the virus.
- Can the COVID-19 vaccine be administered to children?
The COVID-19 vaccine is not indicated for children younger than 16 years old at this time.
- Can the COVID-19 vaccine be administered to pregnant women?
The American College of Obstetricians and Gynecologists (ACOG) recommends that COVID-19 vaccines should not be withheld from pregnant individuals. It is important to note that the COVID-19 vaccines currently available have not been tested in pregnant women, so there is no safety data specific to use in pregnancy. Pregnant women should make an informed decision after discussing with their healthcare provider.
- How many doses are required? If multiple, when do I get another dose?
The dose regimen for full vaccination will depend on the type of vaccine you receive. For both the Pfizer and Moderna vaccine, two doses are required. The second dose of the Pfizer vaccine should be administered 21 days after the first dose. The second dose of the Moderna vaccine should be administered 28 days after the first dose. It is very important to note that the second dose must be from the same manufacturer as the first dose.
Other types of vaccines may only require one dose.
- What should I do if I am unable to get the second dose exactly 21 days (Pfizer) or 28 days (Moderna) after the first dose?
While it is recommended that you receive the second dose as soon as feasible after day 21 or day 28, we understand that it might not be possible to receive it on the desired date. This could be due to multiple reasons. Please keep the following in mind if you cannot receive the second vaccine dose on the desired date:
- You must receive the second dose from the same manufacturer as the first dose.
- Get the second dose as soon as possible after the desired date has passed, as it is better to get the second dose late than not at all. You will still experience the same efficacy in the long run, although you may not see the full effect of the immunity until a few weeks after the second dose.
- How long after receiving my full dose regimen until it is considered effective?
Similar to the flu vaccine, 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. This is because the vaccine has not had enough time to provide protection. As a general rule, the vaccine is considered effective about two weeks after your full dose regimen, according to the manufacturers. If you are receiving the Pfizer or Moderna vaccines, which require two doses, there is evidence that the first dose will begin providing some immunity, but it is still very important to receive the second dose for optimal results.
- Can I choose which vaccine I get?
We do not recommend waiting for a specific manufacturer. All authorized COVID-19 vaccines have been proven effective in reducing the risk of becoming infected with the SARS-CoV-2 virus that causes COVID-19, decreasing the likelihood of having a severe case of the illness and reducing hospitalizations and deaths due to COVID-19 disease. It is recommended that you receive the first vaccine made available to you. Early defense is better than no defense against COVID-19.
- If receiving a two-dose regimen, should those who experience significant side effects from their first COVID-19 vaccine dose expect significant or worse side effects with the second dose? What about those who were previously COVID-19-positive?
Based on data from the Pfizer and Moderna vaccines, there appears to be an increased incidence of experiencing certain side effects from the second dose of the COVID-19 vaccine compared to the first dose (e.g., fever, fatigue, headache, chills, muscle pain, and joint pain). This does not mean that all vaccine recipients will experience these side effects with the first or second dose. A full list of the reported side effects comparing Dose 1 and Dose 2 may be found within the Pfizer BioNTech EUA Fact Sheet and the Moderna EUA Fact Sheet.
At this time, we do not have definitive data to state whether vaccine side effects are worse in patients who were previously positive for COVID-19.
- How long will I need to be observed after I get the vaccine?
In general, a 30-minute observation period is recommended for anyone with a history of severe allergic reactions (due to any cause), and a 15-minute observation period is recommended for all other individuals.
- Will the COVID-19 vaccine result in a false positive COVID-19 test?
No, COVID-19 vaccination will not cause a false positive COVID-19 viral test. Per CDC guidance, the immunity response from a COVID-19 vaccine could possibly result in a positive antibody test, which indicates previous infection and potential protection against the virus.
- If I become COVID-19-positive following my first dose of the vaccine, should I take the second dose?
Per CDC guidance, you may receive the vaccine (either dose) following resolution of symptoms, if any, and completion of the quarantine period.
- What ingredients are included in the COVID-19 vaccines?
Ingredients for authorized COVID-19 vaccines can be found via this CDC link. Individuals with allergies to any of the vaccine components should discuss concerns with their healthcare provider before receiving the vaccine.