FDA NEWS UPDATE: Today, the FDA’s Vaccines and Related Biological Products Committee (VRBPAC) greenlit the use of booster doses for: ages 65+, those at high risk for severe COVID-19, and those at high risk for occupational exposure (such as frontline healthcare workers). This is only for Pfizer’s COVID vaccine and does not apply to those who got Moderna or Johnson & Johnson.
While the advisory panel voted to expand the emergency use authorization (EUA) on Pfizer’s COVID-19 mRNA vaccine to include an additional dose for these specific groups, the experts opted NOT to approve boosters for everyone 16 and up at this time. They did not believe there is enough safety data yet to show that the benefits of boosters outweigh potential risks in other groups.
It is now up to CDC’s independent advisory committee (ACIP) to meet and make an official recommendation, which is expected to happen next week. Our system works like this: first, the FDA advisory panel votes - which happened today. Next, the FDA will decide whether to follow VRBPAC’s recommendation, which is likely to happen in the coming days. Once the FDA decides IF boosters can be made available based on the data, then the ACIP decides who SHOULD get the newly authorized booster. The CDC then reviews ACIP’s recommendations and makes the final decision on who should get the boosters and when.
It’s important to remember that the primary 2 doses of COVID-19 mRNA vaccines AND the J&J vaccine continue to provide very good protection against severe illness. This update does NOT mean that COVID-19 vaccines don’t work.
It also doesn’t mean that other people won’t need boosters in the future. VRBPAC experts simply need more information about the benefits and risks of a booster dose in other people before making a decision. Boosters are a tool we have to try to stay ahead of the virus. As we learn more about the COVID-19 virus and variants, we will continue to need to change how we respond to protect ourselves and our communities. We’ll share more information as it becomes available.
COVID-19 vaccines remain the best tool we have against this pandemic. Mask up, vax up.