Moderna to File for FDA Approval

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Posted: Nov 30, 2020 10:25 AM
Moderna to File for FDA Approval

Source: AP Photo/Hans Pennink

Dr. Anthony Fauci is among the health experts who warned us that we could see an uptick in COVID cases after Thanksgiving travel. So the latest development on the vaccine front is extremely welcome news. A few weeks after Pfizer requested an emergency approval from the FDA on the vaccine candidate they've been developing with BioNTech, Moderna has followed suit. Moderna's candidate proved to be over 94 percent effective in clinical trials and they are ready to take the next step. President Trump urged the agency to act speedily.

Moderna's candidate has been described as "truly remarkable." 

As Science Magazine reported:

"Only 11 people who received two doses of the vaccine developed COVID-19 symptoms after being infected with the pandemic coronavirus, versus 185 symptomatic cases in a placebo group. That is an efficacy of 94.1%, the company says, far above what many vaccine scientists were expecting just a few weeks ago."

Moreover, Moderna’s candidate had "100% efficacy against severe disease."

Last month the FDA announced that they are meeting on Dec. 10 to at least discuss the Pfizer request. 

“The FDA recognizes that transparency and dialogue are critical for the public to have confidence in COVID-19 vaccines. I want to assure the American people that the FDA’s process and evaluation of the data for a potential COVID-19 vaccine will be as open and transparent as possible,” said FDA Commissioner Stephen M. Hahn, M.D. “The FDA has been preparing for the review of EUAs for COVID-19 vaccines for several months and stands ready to do so as soon as an EUA request is submitted.  While we cannot predict how long the FDA’s review will take, the FDA will review the request as expeditiously as possible, while still doing so in a thorough and science-based manner, so that we can help make available a vaccine that the American people deserve as soon as possible. A discussion about the safety and effectiveness of Pfizer and BioNTech’s vaccine with this committee, made up of outside scientific and public health experts from around the country, will help ensure clear public understanding of the scientific data and information that the FDA will evaluate in order to make a decision about whether to authorize a vaccine for emergency use for the prevention of COVID-19.”