FDA, CDC, NIH, & WHO Stockpile Vaccines for Global 2024-25 H5N1 Flu Pandemic

The FDA stated that they will provide FULL FDA approval for the H5N1 vaccines if a public health emergency is declared without receiving safety or efficacy data from clinical trials.

October 23, 2024: On October 10, 2024, members of the WHO, FDA, CDC, NIH, as well as U.S. infectious disease pediatricians, held a 6.5 hour meeting to discuss the current status and further development of vaccines for an emerging 2024-2025 H5N1 global flu pandemic. According to the WHO, the H5N1 flu has a case fatality rate of 52%.

Jerry Weir, PhD, of the FDA’s Center for Biologics Evaluation Research (CBER) clearly stated multiple times that the FDA will provide full FDA approval for H5N1 (or other H5 strands) flu vaccines if a public health emergency is declared without receiving safety or efficacy data from clinical trials.

“The scenario assumes that any strain changes recommenced by VRBPAC would be implemented during a declared pandemic, but would not require clinical data prior to the approval… In any case during the pandemic we would use the strain change and the safety, immunogenicity and even effectiveness data will come post-approval.”

- Jerry Weir, PhD, Director CBER/FDA

Full FDA Vaccine License Approval Allows for Mass Mandates

Full FDA approval (vs emergency use authorization) of US BioPharma biological license applications (BLA) will allow federal and state governments, as well as employers, to mandate the H5N1 vaccines for adults and children alike.

Take a listen to this 2.5 minute video of Jerry Weir and Dr. Paul Offit from the October 10, 2024 H5N1 pandemic meeting.