FDA – Not sure about kids vaccines

The Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee met on Tuesday to discuss Pfizer-BioNTech COVID-19 vaccine for children five through 11 years of age (full recording is available here).

While the committee endorsed the shot in a 17-0 vote, one FDA panelist, Dr. Eric Rubin, made some unsettling remarks in regard to vaccines’ safety, saying, verbatim, “We’re never gonna learn about how safe the vaccine is until we start giving it. That’s the way it goes.”  Dr. Rubin noted,

This is a much tougher one, I think, than we had expected coming into it. The data show that this vaccine works and it’s pretty safe.… And yet, we’re worried about a side effect that we can’t measure yet, but it’s probably realAnd we see a benefit that isn’t the same as it is in older patients. 

Dr. Rubin further stated:

It’s a very, sort of, personal choice. If I had a child who was a transplant recipient, I would really want to be able to use a vaccine. And there are certain kids who probably should be vaccinated. The question of how broadly to use I think is a substantial one. And I know it’s not a question, and I know we’re kind of punting that to ACIP [Advisory Committee on Immunization Practices of the CDC].

But I do think that it’s a relatively close call…. It really is going to be a question of what the prevailing conditions are. But we’re never going to learn about how safe this vaccine is unless we start giving it. That’s just the way it goes. That’s how we found out about rare complications of other vaccines like coronavirus vaccine. And I do think we should vote to approve it.

Dr. Rubin did not argue that the committee should issue a limited endorsement for the jab, and recommend it only to immunocompromised children or those having known co-morbidities to COVID, such as obesity or diabetes. While admitting that the benefits of vaccination for young children are not as great compared to those in older people, and that the long-term safety will only be learned after the vaccination begins, he still fully endorsed it.

Story continues at: Kids Vaccine


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