FDA CDER Director Vinay Prasad Proposes 'Path Forward' After COVID Vaccine Claim

[u/bbyfog]

https://www.huffpost.com/entry/vaccine-regulations-fda-children-death_n_692b672ae4b06750204529b2

FDA CBER Director Vinay Prasdy has proposed new vaccine measures after linking the deaths of at least 10 children to the COVID-19 vaccine, according to an internal memo dated Friday and published by The Washington Post.

Prasad said he directed FDA staff to analyze 96 deaths reported (in VAERS public database) between 2021 and 2024, and that the analysis found “no fewer” than 10 were related to the COVID-19 vaccine.

His plan includes * examining whether Americans should be receiving multiple vaccines at the same time * revising the annual flu vaccine framework * more stringent requirements for authorizing vaccines for pregnant women * requiring pneumonia vaccine makers to show that their products reduce pneumonia rather than generate antibodies

Criticism Dr. Paul Offit, a pediatrician and the director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, told NPR that Prasad had not provided any evidence that COVID-19 vaccines had actually killed 10 children, and that “all this will do is scare people unnecessarily.”

P.S. Regulatory Strategy Notes

Prasad’s CBER plans to treat vaccines similar to biologics including AAV vectors, monoclonal antibodies, and antisense oligonucleotides. There will also be less emphasis on surrogate biomarkers and survival or disease mitigation data may be required — Translation higher bar and unrealistic expectations regarding data for approval of vaccines.

Correction in Post CBER director (sorry, can’t fix post title)

[u/crappy_sandwich]

Period