Full FDA Approval of a COVID-19 Vaccine: What You Should Know
The three COVID-19 vaccines authorized for use in the U.S. are safe and effective in helping prevent serious disease or death due to the coronavirus. These vaccines were granted an emergency use authorization, or EUA, by the Food and Drug Administration (FDA). The Pfizer/BioNTech COVID-19 vaccine received full approval by the FDA on Aug. 23, 2021.
Lisa Maragakis, M.D., M.P.H., senior director of infection prevention, and Gabor Kelen, M.D., director of the Johns Hopkins Office of Critical Event Preparedness and Response, explain what that means.
What does full FDA approval of a COVID-19 vaccine mean?
Review for full FDA approval is a normal step in the process of making a vaccine available for the public. One of the COVID-19 vaccines (Pfizer) has full approval, and the FDA may grant full approval for others in the future.
Full FDA approval takes place when enough data demonstrate that the vaccines are safe and effective for most people who receive them, and when the FDA has had an opportunity to review and approve the whole vaccine manufacturing process and facilities. After many months of studies and more than 165 million people having received a COVID-19 vaccine, the FDA has a lot of information on how safe and effective the COVID-19 vaccines are in protecting people, how well they work to prevent severe coronavirus disease, and how the vaccines are safely and consistently manufactured.
COVID Vaccines: Emergency Use Authorization vs. Approval
Not every vaccine is granted an emergency use authorization before full approval. The FDA authorized three COVID-19 vaccines to answer an urgent need to protect people from the coronavirus pandemic, which was (and continues to be) a public health emergency.
When it was clear in 2020 that COVID-19 was a rapidly spreading, dangerous disease, the FDA worked with vaccine manufacturers, independent laboratories, academic research centers and nonprofit organizations to quickly gather and interpret large amounts of data on the vaccines.
The data showed that the vaccines were very effective in preventing severe COVID-19 and the risks of serious side effects was extremely low. Based on these findings, the FDA granted the EUA so people could be vaccinated earlier in the approval process and be protected from serious effects of COVID-19.
Full approval is granted when, over time, the FDA has amassed even more scientific evidence to support use of the COVID-19 vaccines, showing that the benefits of the vaccine are greater than its risks, and that the vaccines can be manufactured reliably, safely and with consistent quality.
Using Data to Approve COVID-19 Vaccines
As of August 2021, hundreds of millions of COVID-19 vaccine doses have been given to people in countries all over the world.
People who get the vaccines are encouraged to report any problems, including any severe side effects. A cooperative effort between the U.S. Centers for Disease Control and Prevention (CDC) and the FDA, the Vaccine Adverse Event Reporting System (VAERS) collects and analyzes reports from people who received a vaccination and who experienced an adverse event, such as a severe side effect, after getting the shot.
As a result, we now have even more evidence that all three of the FDA-authorized COVID-19 vaccines are safe for most people who receive them, and that all three work well to prevent severe coronavirus disease.
Like other fully approved vaccines used to help prevent illnesses, the FDA-authorized COVID-19 vaccines can cause temporary aches, pains and fever in some people, but the risk of serious side effects is extremely low.
FDA and the Vaccine Review ProcessFor over a century, FDA-authorized and approved vaccines have prevented potentially serious diseases such as measles, influenza and whooping cough. Vaccinations have helped reduce and prevent deadly outbreaks of smallpox and polio. The approval system for vaccines uses scientific data and exacting standards to ensure safe and effective vaccines. These review process includes:
- Clinical trials. The FDA requires rigorous testing of vaccines through a series of clinical trials to make sure they work and are safe before authorizing or approving them for the public. The laboratories that conduct the trials are independent from the vaccine companies and the government, so the information they convey to the FDA for its approval process is not biased.
- Risks and benefits. FDA approval of a vaccine involves careful assessment of risks and benefits. Before approval can happen, the clinical trials and other data used by the agency must demonstrate that the benefits of a vaccine are greater than its risks for those who will be vaccinated.
- Continual monitoring. After authorization or approval, monitoring continues: The FDA continues to examine data for adverse effects among the people receiving the vaccine. If any problems are linked to a vaccine, the FDA may pause the administration of that vaccine to do more studies and ensure that the problem does not outweigh the vaccine’s benefit.
- Manufacturing guidelines. The FDA also sets strict guidelines for vaccine manufacturers and requires that they test the vaccine doses in batches (lots) to ensure the quality and effectiveness of the vaccines remain consistent and reliable.
Learn more about COVID-19 vaccine safety and side effects.
Get information and updates from Johns Hopkins Medicine.
Published on August 23, 2021