The U.S. Food and Drug Administration (FDA) on Friday formally granted emergency approval for Moderna’s coronavirus vaccine candidate, officially paving the way for widespread distribution of the long-awaited vaccine.
It is the second COVID-19 vaccine to receive such approval in the U.S. A week ago, the FDA granted emergency use approval to one developed by Pfizer and BioNTech. Distribution of that vaccine to health care workers and residents of long-term care facilities began this week.
The FDA’s move came just one day after an advisory panel to the agency voted to endorse the product.
The vote was 20-0. One committee member abstained.
The committee was charged with voting on the following question: “Based on the totality of scientific evidence available, do the benefits of the Moderna COVID-19 Vaccine outweigh its risk for use in individuals 18 years of age and older?”
The highly anticipated meeting included members of the FDA’s Center for Biologics Evaluation and Research advisory committee, outside vaccine experts and Moderna representatives.
Although significant, the committee’s vote in favor of emergency use authorization (EUA) was not final — the vote had to go before FDA officials, as it did Friday before widespread distribution could commence.
A similar process ensued after a panel of independent experts advising the Centers for Disease Control and Prevention (CDC) recently voted that health care workers and residents of long-term care facilities should be the first to receive the long-awaited coronavirus vaccine. That decision required approval from CDC Director Dr. Robert Redfield.
With formal FDA approval — the first such approval for Moderna — Americans could see an initial 6 million doses distributed next week.
The FDA panel’s vote to approve the company’s EUA was expected, with documents posted ahead of the agency’s scheduled Dec. 17 meeting showing that the candidate met the FDA’s requirements for emergency use.
An FDA committee’s review of Moderna’s coronavirus vaccine emergency use authorization application found “no specific safety concerns” in subgroup analyses by age, race, ethnicity, medical comorbidities, or prior SARS-CoV-2 infection, potentially paving the way for a second COVID-19 jab to enter the scene.
The panel also found that the vaccine reduced the risk of confirmed COVID-19 – including severe cases – occurring at least 14 days after the second dose.
The committee was careful to note that there wasn’t enough data to evaluate the duration of protection in relation to the vaccine, effectiveness in certain high-risk populations such as immunocompromised individuals, effectiveness in individuals who have previously been infected with SARS-CoV-2, or effectiveness in pediatric populations. There also wasn’t enough data for the committee to evaluate future vaccine effectiveness in relation to changes in the virus, effectiveness against asymptomatic infection, and effectiveness against long-term effects of COVID-19, effectiveness against mortality, or effectiveness against transmission of SARS-CoV-2.
Not unlike Pfizer and BioNTech’s vaccine, the Moderna jab did elicit non-serious adverse reactions such as pain at the injection site, fatigue, headache, muscle pain, joint pain and chills. The reactions were characterized as generally mild to moderate.
The FDA did consider three serious adverse reactions, including nausea and vomiting, and facial swelling. An incident of Bell’s palsy also occurred in a vaccine recipient, “for which a causal relationship to vaccination cannot be concluded at this time.”
From an accessibility standpoint, the Moderna vaccine, which proved more than 90% effective in late-stage clinical trials and requires two doses given weeks apart, does not require ultra-cold storage requirements as the Pfizer-BioNTech jab does.
A third candidate, from Johnson & Johnson, which would require just one dose, is working its way through the pipeline. Behind that is a candidate from AstraZeneca and Oxford University.
U.S. health experts are hoping a combination of vaccines will ultimately enable the country to conquer the outbreak.
Fox News’ Alexandria Hein, Kayla Rivas, and the Associated Press contributed to this report.
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