Just this past Tuesday, the Food and Drug Administration endorsed the emergency use and authorization of the Moderna coronavirus vaccine. This move is a crucial step in achieving formal clearance for the vaccine’s administration to the public, which we could see as early as this coming week.
The recent staff report was written to brief the Vaccines and Related Biological Products Advisory Committee, a subsidiary of the FDA. The committee is set to meet this Thursday to reviews the emergency use authorization request from the Moderna company.
Just this past Thursday, Pfizer’s vaccine was recommended for emergency use by a group of third-party medical advisors. The FDA approved the request the next day. Now, the committee must decide whether or not to accept the same request for Moderna’s Coronavirus vaccine.
While it isn’t mandatory that the FDA follow the recommendations of the committee, it typically does.
According to the FDA’s briefing on the applicable safety data and clinical trial results, it was determined that the trials were “consistent with the recommendations set forth in FDA’s Guidance on Emergency Use Authorization for Vaccines to Prevent COVID-19.”
“FDA has determined that the Sponsor has provided adequate information to ensure the vaccine’s quality and consistency for authorization of the product under an EUA,” it said.
Thanks to that statement alone, Moderna stock shot up by 1.5%.
Paul Offit, one of the committee’s voting members, said that the documents regarding the two vaccines were “enormously encouraging.” This past week, Offit voted in favor of Pfizer’s vaccine and believes that Moderna’s will be just as effective.
Moderna is now asking for the FDA to approve the vaccine for use in people 18 and over. Pfizer’s vaccine, on the other hand, was approved for those over 16. With insufficient data regarding the teen population, a few of the advisory committee members decide to vote against the release of Pfizer’s vaccine this past week.
The FDA is recommending that the company tracks Bell’s Palsy cases if the vaccine is released to the public. Bell’s Palsy is a condition that causes weakness or sudden freezing of the facial muscles.
The agency noted that four cases of Bell’s Palsy arose among the 30,000 trial participants, including three in the vaccine group and one in the placebo group.
“Currently available information is insufficient to determine a causal relationship with the vaccine,” said the agency.
Offit was in agreement with the FDA on monitoring Bell’s Palsy cases, saying that he was “not dismissing that yet.”
When Merck’s data was submitted after the rotavirus vaccine trial, five cases of Kawasaki disease arose in the vaccine group without any in the placebo group. According to Merck, that was a better example of something “statistically significant.”
The FDA noted that some of the most common side effects of the Moderna’s Coronavirus vaccine included headache, fatigue, muscle pain, and chills. Many trial participants said that while the symptoms were uncomfortable, they often went away within a day, making it far better than actually contracting coronavirus.
