When will the vaccines be approved?
Pfizer and Moderna submitted applications to the FDA for emergency use authorization at the end of November, while AstraZeneca has yet to apply.
The FDA’s career scientists and physicians are reviewing clinical trial data and performing evaluations of the drug’s chemistry, manufacturing, and safety controls information to ensure the quality and consistency of the manufacturing and distribution process.
The FDA’s advisory panel is scheduled to meet to discuss the safety and effectiveness of the Pfizer-BioNTech vaccine application on Dec. 10th. President Trump is reportedly frustrated by the delay, as the United Kingdom announced their approval of the drug and has ordered 40 million doses.
Additionally, several states including New York, have formed advisory committees to independently determine if the vaccination meets their safety and efficacy standards. The federal government is less than enthusiastic at the response.
“Any delay that the state wants to impose will be a delay in getting its citizens — its most vulnerable citizens — vaccines,” said Paul Mango of the U.S. Department of Health and Human Services. “We think it is actually counterproductive for them to talk about this.”
