FDA moves to authorize COVID vaccines for infants

Citing 'gaps and inequalities,' health regulators believe that the risk of an adverse reaction to the novel injection are not outweighed by the perceived benefit.

FDA moves to authorize COVID vaccines for infants
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It’s official, Pfizer-BioNTech has received FDA Emergency Use Authorization (EUA) for children aged six months through four years. Moderna, who only had previous authorization for youth aged 12 and up, also expanded their EUA to include infants aged six months to 11 years old.

Pre-existing EUA’s cover every other demographic thereafter.

The Vaccines and Related Biological Products Advisory Committee, a branch of the Food and Drug Administration (FDA), delegated over two days to discuss the risk versus benefit of the EUA for the two manufacturers.

In my previous report, I speculated that Health Canada will not be far behind. Also in that report, I pointed out some of the potential logical fallacies around the emergency nature of this injection for children and summarized key points of data for adverse events.

At the onset of the first day of deliberations, process was called into question.

One voting member asked why, after such a long period of time, were these companies seeking authorization under emergency use when they could seek full licence approval. The response was that the sponsors (Pfizer and Moderna) have not submitted the six months worth of follow-up data — a requirement needed to seek full licensure.

Dr. Peter Marks confirms that because they “can’t predict when there will be an end to the emergency declaration, it’s perfectly reasonable to have these under emergency use authorization.”

Much of the delegation was dedicated to the sponsors, Pfizer and Moderna, to represent their own safety data.

During day two of the nearly eight-hour meeting, there was an “Open Public Hearing” where members of the public expressed their opinions on the matter.

Accounts ranged from fanatical parents suffering from unfounded fear who are still isolating their children, to tearful accounts of people who have suffered adverse reactions and others who question the validity of the alleged “emergency” for children.

Dissenters from the COVID norms included Dr. Katarina Lindley, Congressman Louie Gohmert, a vaccine-injured mother and another concerned citizen.

Childhood vaccine proponent Dr. Paul Offit, criticized for previous conflicts of interest, wanted to “air his concerns”:

Chief medical officer at the National Center for Immunizations and Respiratory Diseases, Amanda Cohn, is concerned about the previously misleading claims touted by the sponsors and governing health bodies:

Voting member Dr. Mark Sawyer, infectious disease specialist at Rady’s Children’s Hospital, thinks that the novel injections will help hysterical parents “liberate” their isolated children:

https://twitter.com/tamaraugo/status/1537541323212918784?s=21

In the closing statements from the first meeting day, chief of pediatric infectious diseases at Tufts Children’s Hospital, a hospital that had never responded to vaccine reactions until now, Dr. Cody Meissener expresses concern over the minimal safety data and does not want to see mandates imposed for the age group:

Dr. Meissener also expressed previous concerns over ensuring parents are fully informed that a COVID infection poses very little risk to younger demographics.

Despite all of the concerns and harrowing personal accounts, Dr. Peter Marks, from the FDA Center for Biologics Evaluation and Research, says that they will continue to monitor the vaccines as they are deployed before “reminding the public that there seems to be a lot of misinformation around misunderstanding VAERS,” citing “experts that pride themselves and work day and night to ensure that they understand the safety profile of these vaccines.”

Roll out the shots first and review the follow-up data later. That seems to be the name of the game at the FDA with continued knee jerk reactions under the guise of emergency use authorization.

Coronavirus United States Protect Kids COVID Vaccines FDA news
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