The guidelines stipulate that a COVID-19 vaccine must be at least 50 percent effective to be eligible for both traditional and emergency use FDA approval.
The framework also leaves it up to drugmakers to submit vaccines for approval, making it difficult for a third party to pursue an emergency use approval using trial data. This strengthens the sentiment behind nine major drugmakers’ Sept. 8 pledge to uphold their commitment to the scientific process during the vaccine race.
FDA Commissioner Stephen Hahn, MD, emailed all 17,000 employees earlier in September to affirm the agency’s adherence to the scientific process during vaccine review, according to Bloomberg. He also said the agency has “not lost sight of [its] responsibility to ensure [its] decisions related to all medical products, including COVID-19 vaccines, are based on science and data,” in a Sept. 8 tweet.
The FDA and pharmaceutical industry’s recent attempts to assure the public about their adherence to the scientific process address the public’s growing concern that the vaccine approval process is too politics-driven.
During a Sept. 7 news conference, President Donald Trump repeated his declaration that a vaccine will be ready by Election Day, saying, “The faster the better.” However, Moderna, considered by most to be one of the drugmakers furthest along with its vaccine development, told Bloomberg that gaining approval by Thanksgiving is its best-case scenario.
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