COVID-19 Vaccine Committee: Here's How the US FDA Chooses a Vaccine
A vaccine goes to three different stages of human clinical trials to test its safety and effectiveness. Here are some important facts that you should know about how the vaccine is approved.
Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S.
The race for a safe and effective COVID-19 vaccine continues. Different pharmaceutical companies, researchers, scientists, and other groups try to do their best to develop and produce a vaccine for COVID-19 that has already claimed millions of lives worldwide.
This is not the first time the U.S. scrutinizes, filters, selects, and approves a vaccine. But this might be the first time the public will know who is responsible for this and how the process is done.
The public will now know one crucial part of the U.S. Food and Drug Administration's decision-making process over the COVID-19 vaccine. The FDA will hold its first advisory committee meeting on Thursday.
Typically, this committee is composed of a small group of vaccine experts whose main job is to advise the FDA either to use a specific vaccine or not based on different criteria.
There are two main criteria that they prioritize - the safety and effectiveness of a vaccine. The advisory committee meeting will give the public a glimpse of the highly technical discussions over the safety and effectiveness of COVID-19 vaccines.
There are now potential vaccines, but these need to be scrutinized by the experts to avoid the placebo effect. Even though there is not enough data to discuss the COVID-19 potential vaccines, at least this gives the public a sign that the committee is now back on its normalcy.
It also assures everyone that the committee will no longer be vulnerable to any political influence.
According to a published article of ABC News, the FDA will require at least two months of safety data. This means if a potential vaccine is already in its last stage, it will not be immediately approved and it will be subjected to deliberation and discussion by the experts.
Paul Offit, a committee member and a professor of pediatrics from the Children's Hospital of Philadelphia, said the meeting on Thursday is likely to be free-ranging scientific discussions over safety and effectiveness parameters once a pharmaceutical company will ask approval for a vaccine.
The FDA might be questioned with the following:
- What specific criteria will be used to decide whether a COVID-19 vaccine should be given emergency authorization for certain high-risk groups?
- How will follow-up safety data be collected after that?
- What processes should be in place to seek final, full approval?
It is expected that the FDA will depend on the committee in the next few months. Even though the FDA is not obliged to follow the recommendations but typically, the agency follows them. Additionally, none of the FDA employees sit as a member of the committee.
The committee is primarily composed of more than a dozen doctors, statisticians, and academicians whose expertise is on vaccines. At least one person, who is not a doctor or a scientist, and another one from the pharmaceutical industry will sit, but they will only join the discussion and will not be allowed to vote.