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White House Blocks New FDA Guidelines That Would Likely Prevent Vaccine Approval Before Election Day: NYT

A contested provision would require vaccine trial participants to be followed for two months after they receive a final dose.

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.