FDA Approve Pfizer Jab For Children Ages 5 to 11 Despite Lack of Data

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

While the committee endorsed the shot in a 17-0 vote, one FDA panellist, 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.”

Despite the uncertainties surrounding the side-effects discussed in the video attached and the unsettling claims made by Dr. Eric Rubin they continued to vote 17-0

In the video, 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.

While 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.

Yet further in, after his statements, you can clearly hear Dr. James Hildreth state, 

“One of the things that’s really been impactful for me is to learn that the prevalence in children might already be 42%. Which means that 30 million of the 72 million children in our country they have some form of immunity to the virus already.”

Dr. Hildreth Continues,

“The other thing is that I was disappointed that the number of minorities in the Pfizer study by such a small percentage of the total because they bear the brunt of disease and hospitalizations. And it just seemed to me that in some ways, we’re vaccinating children to protect the adults. And it should be the other way around”.

“That if 30 million children already have some form of immunity, they’ve made their contribution to herd immunity already, and our focus should be to get the adults vaccinated to protect the children”.

So this is a really tough one for me, but I do believe that children at highest risk need to be vaccinated. But vaccinating all of the children to, to achieve that. Just seems a bit that much for me, so I’m having some challenges with this. But those are those are my thoughts…

Dr. Rubin was not the only speaker who conveyed some troubling messages.

Dr. Fiona Havers of the CDC admitted there are no studies on the long-term outcomes of the vaccine in children (1:03:22), as there is no information available on the vaccinated children’s chances of reinfection (1:05:44).

Dr. Matthew Oster, a pediatric cardiologist, commenting on the data available on vaccinated adolescents, outlined the higher chances of young male vaccine recipients having higher chances of developing heart inflammation than their unvaccinated peers (1:11:26). In females, the risk of developing myocarditis following vaccination was lower than in males, yet still exceeded the “background incidence.” At the same time, the chances of adolescents developing myocarditis because of COVID were significantly lower compared to them developing the condition due to vaccination (1:20:13).

As of October 21, the COVID-19 death rate in children ages 5-11 represented 0.03 percent of all COVID-19 deaths in the United States, 0.008 percent of total COVID-19 cases, and 0.0005 percent of deaths among the entire U.S. population. The age group of 0-17 years made up for 0.0000002 percent deaths by total COVID-19 cases, according to the CDC data that was presented during the discussion (4:43:49).

The safety data on the Pfizer shot for children, based on “at least two months of follow-ups,” showed, according to the FDA (2:20:01), that no recipients developed any of the “adverse events of special interest,” including myocarditis/pericarditis, anaphylaxis, Bell’s palsy, and appendicitis.

Should you take the time to watch the full video, you will notice the uncertainty of the data and the persistence to push for approval.

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