The FDA’s Vaccine Advisory Committee is on today. The focus of the meeting, with a number of different experts, is focused on safety. That includes how the FDA’s Center for Biologics Evaluation and Research plans to monitor safety after a vaccine is developed, approved for use, and given to people. A number of different experts are talking about the work and how it will be conducted–the protocols, the plans, where the data will come from, the number of people and agencies who will focus on the work. Scientists and physicians from the Centers for Disease Control (CDC) are also talking about how they plan to investigate different vaccines and determine how different vaccines might be focused, on which populations.
There is also discussion about how vaccines will be rolled out across the country and who is likely to be first on the list to get it. There is also discussion of how providers will be trained, as different vaccines have different requirements, and the initial focus will be to get vaccines to the most vulnerable populations.
Two vaccine makers, Phizer and Moderna, are currently in Phase 3 Clinical Trials, in which they’re giving potential vaccines to thousands of people, and also giving a placebo to others. The Phase 3 Clinical Trials are intended to review not just safety of potential vaccines but also effectiveness against COVID-19. Both drug makers are expected to request Emer
The Center for Biologics Evaluation and Research (CBER) is one Center within the Food and Drug Administration, an Agency within the United States Government’s Department of Health and Human Services (HHS).
CBER’s mission is to protect and enhance the public health through the regulation of biological and related products including blood, vaccines, allergenics, tissues, and cellular and gene therapies. Biologics, in contrast to drugs that are chemically synthesized, are derived from living sources (such as humans, animals, and microorganisms), are not easily identified or characterized, and many are manufactured using biotechnology.
The meeting is available online, right now and available later on the FDA’s You Tube channel: