Strict New Rules Ahead: FDA Ties Coronavirus Jabs to Pediatric Deaths

The fallout from the 2020 COVID-19 debacle is still raining down. In the latest episode, the Food and Drug Administration (FDA) has now found evidence linking the coronavirus vaccines to as many as 10 child deaths, and the federal agency is responding by ramping up new vaccine approval regulations.

The nation’s top vaccine regulator on Friday laid out a stricter approach for federal vaccine approvals, citing his team’s conclusion that coronavirus vaccines had contributed to the deaths of at least 10 children, according to an internal Food and Drug Administration email obtained by The Washington Post.

At least part of this was done at the urging of the Secretary of Health and Human Services, Robert F. Kennedy Jr. We should note that at least part of the new approach is not just on how vaccines are delivered, but how they are developed. The COVID-19 vaccines were subject of much debate due to the speed of their development and their initial use under an Emergency Use Authorization, or EUA.

Vinay Prasad, an FDA official whose approach to vaccine policy has been championed by Health Secretary Robert F. Kennedy Jr., told agency officials that the FDA will rethink its framework for annual flu shots, examine whether Americans should be receiving multiple vaccines at the same time and require vaccine makers to show far more data to prove the safety and value of their products. For instance, Prasad said that pneumonia vaccine makers must demonstrate that their products reduce pneumonia, rather than just generate antibodies to fight infections.

That's a trifle confusing. Vaccines work by provoking the immune system to generate antibodies. That's how they reduce infections. They train your immune system to fight an infection by recognizing and targeting specific pathogens.

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The new regulations will, however, have an adverse effect on the timelines for vaccine development.

Collectively, Prasad’s plans would transform the FDA’s decades-old process of approving vaccines by compelling pharmaceutical companies to run far larger studies, likely slowing them down, said current and former agency staff and outside public health experts, some of whom spoke on the condition of anonymity to discuss internal FDA operations or comment on a developing situation. The approach could also have a chilling effect on the development of novel vaccines, because manufacturers will need to undertake sweeping new studies when seeking most new approvals — even for expanding the population who can get the shot, they said.

There's a strong argument to be made for more extensive testing. The COVID-19 vaccines being linked to the deaths of children is one, but not the only one. Granted, every vaccine, every medicine, every therapy has its own risks and possible side effects. Every vaccine, every medicine, every therapy ever developed in the future will likewise come with its own risks and possible side effects. A new pharmaceutical can cost the company developing it hundreds of millions of dollars in research and development before one dose is delivered.

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There has to be a balance, a risk/benefit assessment in the development of not only pharma products but also biotechnology, medical devices, combination products, or anything else used in the delivery of healthcare. I should know; this is the world I lived and worked in for 30 years.

In many ways, these industries are over-regulated. But in hindsight of the COVID-19 debacle, a good, hard look at that risk/benefit analysis is in order.

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