FDA Gives Green Light On Another Round Of Boosters

(JustPatriots.com)- Older Americans as well as those who are immunocompromised are now eligible to receive a second booster shot of the COVID-19 vaccine.
The Food and Drug Administration gave approval for fourth doses of vaccines produced by both Moderna and Pfizer for all Americans who are least 50 years old. Certain people who have a compromised immune system are also eligible for the fifth dose, even if they aren’t 50 years old.
Earlier this week, the Centers for Disease Control and Prevention gave their stamp on the FDA’s approval, paving the way for these groups of people to get a second COVID-19 booster if they want.
In addition to the fifth booster approval, the CDC recommended that any person — regardless of age — who got two doses of the vaccine produced by Johnson & Johnson go and get a third shot with either the Moderna or Pfizer vaccine.
People who got an initial shot of the J&J vaccine followed by a second shot from either Moderna or Pfizer aren’t yet eligible for a third shot, unless they are 50 years old or older or have a compromised immune system.
No matter what the person’s situation, they aren’t eligible to receive this next booster until they are at least four months removed from the last shot they received.
Both the CDC and the FDA made these decisions in a very rare way: They didn’t call a meeting of their committees that advise on vaccines.
The vaccine advisory committee for the FDA isn’t scheduled to meet until April 6, at which time they plan to discuss the future of all booster shots in America. At that meeting, the advisers are expected to have a broader discussion regarding boosters, but don’t plan to hold a vote on giving any recommendation.
Some health experts have questioned whether this second booster shot is even necessary, as there isn’t a lot of real-world data that supports it just yet. Some others simply didn’t like the process by which this booster was approved.
One member of the FDA’s vaccine committee, Dr. Paul Offit, didn’t like that an open meeting wasn’t held so that the public could hear the experts weighing all the data before making an official recommendation.
While any recommendation the advisory committee makes isn’t binding, it helps the public get information in a transparent way. As Offit opined about the booster shot’s authorization:
“It’s just sort of fait accompli. So, is this the way it works? We talk endlessly about how we follow the science. It doesn’t seem to work out that way.”
But the leader of the office at the FDA that’s responsible for vaccine efficacy and safety, Dr. Peter Marks, said this decision was “relatively straightforward” and therefore didn’t require a full meeting of the advisory board. He explained:
“This fourth booster dose is something that evidence that we have now from Israel suggests that by getting this, one can reduce the risk of hospitalization and death in this population of older individuals.”