FDA Ties Coronavirus Jabs to Pediatric Deaths – RedState
The fallout from the COVID-19 debacle of 2020 continues to rain down. In the latest episode, the Food and Drug Administration (FDA) found evidence linking coronavirus vaccines to up to 10 child deaths, and the federal agency is responding by stepping up new vaccine approval regulations.
The nation’s top vaccine regulator laid out a tougher approach to federal vaccine approvals on Friday, citing his team’s conclusion that coronavirus vaccines 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 request of Health and Human Services Secretary Robert F. Kennedy Jr. We should note that at least part of the new approach is not just about how vaccines are administered, but also about how they are developed. COVID-19 vaccines have been the subject of much debate due to the speed of their development and 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 would rethink its framework for annual flu shots, examine whether Americans should receive multiple shots at the same time and require vaccine makers to submit significantly more data to prove the safety and value of their products. For example, Prasad said pneumonia vaccine makers must demonstrate that their products reduce pneumonia, rather than simply generating antibodies to fight infections.
It’s a bit confusing. Vaccines work by tricking the immune system into generating antibodies. This is how they reduce infections. They train your immune system to fight an infection by recognizing and targeting specific pathogens.
Learn more: Trump issues ultimatum to big pharma on COVID vaccine amid CDC drama
COVID Purge Now Overturned: Trump Orders Reinstatement of Veterans’ Education Benefits
The new regulations will, however, have a negative effect on vaccine development times.
Collectively, Prasad’s plans would transform the FDA’s decades-old vaccine approval process by requiring drug companies to conduct much 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 the FDA’s internal operations or comment on developments. This approach could also have a chilling effect on the development of new vaccines, because manufacturers will have to undertake extensive new studies when seeking most new approvals — even to expand the population that can get vaccinated, they said.
There is a strong case for more extensive testing. The link between COVID-19 vaccines and child deaths is one, but not the only one. Certainly, each vaccine, each drug, each therapy carries its own risks and possible side effects. Every vaccine, every drug, every therapy ever developed in the future will also carry its own risks and possible side effects. A new pharmaceutical product can cost the company developing it hundreds of millions of dollars in research and development before a dose is delivered.
Learn more: Government and Big Pharma Should Be Banned from Calling COVID Vaccines “Vaccines”
Latest COVID Data Offers Another Factual Rejection of COVID Vaccine Effectiveness Narrative
There must be a balance, risk/benefit assessment in the development of not only pharmaceuticals, but also biotechnology, medical devices, combination products or any other products used in healthcare delivery. I should know; this is the world I lived and worked in for 30 years.
In many ways, these industries are over-regulated. But with the COVID-19 debacle in hindsight, a closer look at this risk/benefit analysis is required.
Editor’s note: Do you like RedState’s conservative reporting that attacks the radical left and woke media? Support our work so we can continue to bring you the truth.
Join RedState VIP and use promo code STRUGGLE to benefit from 60% off your VIP subscription!
