The White House is preventing the Food and Drug Administration from issuing guidelines on the emergency authorization of a potential coronavirus vaccine, specifically objecting to a provision that would require vaccine trial participants to be followed for two months after receiving a final dose. The move would make an emergency release authorization of a vaccine essentially impossible before Election Day. In response, the FDA is seeking other means to ensure a vaccine would meet its approval guidelines, including possibly sharing the standards with a group of outside experts. “The public must have full faith in the scientific process and the rigor of FDA’s regulatory oversight if we are to end the pandemic,” a biotech trade industry association wrote in a letter to Trump’s health secretary. Approval now seems highly unlikely, per a White House official, underscoring the long simmering tensions between the Trump administration and federal agencies over the vaccine approval process.
Read it at The New York TimesCongress
White House Blocks New FDA Guidelines That Would Likely Prevent Vaccine Approval Before Election Day: NYT
RUSH IT OUT
A contested provision would require vaccine trial participants to be followed for two months after they receive a final dose.
Trending Now