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FDA deemed Moderna’s vaccine candidate “highly effective,” so the agency may grant an emergency use authorization later this week.
Moderna’s experimental COVID-19 vaccine is “highly effective”, FDA said, which will likely lead to an official Emergency Use Authorization (EUA) approval by the agency very soon.
In addition, the Department of Health and Human Services (HHS) and the Department of Defense (DoD) will purchase an additional 100 million doses of Moderna’s mRNA-1273 vaccine, HHS said in a press release.
“If authorized by the FDA for emergency use as outlined in agency guidance, doses of the vaccine will begin shipping immediately. The vaccine would be provided at no cost to Americans,” HHS said.
FDA granted EUA to Pfizer-BioNTech’s COVID-19 vaccine on December 11, and the vaccine has already been administered to some healthcare professionals.
Meanwhile, the agency released numerous documents on Moderna’s 30,000-person clinical study along with the agency’s own analysismahead of its advisory committee review of the vaccine candidate on Thursday.
Moderna found that the vaccine was 94.1% effective in protecting people against COVID-19, and new documents suggest that the vaccine begins to prevent asymptotic infections after the first dose. After the first dose, there were about two-thirds fewer cases of asymptomatic coronavirus infections among those who received the vaccine than among those who received a placebo, The Wall Street Journalreported.
In addition, the research suggested benefit of the vaccine in preventing severe COVID-19.
The FDA found no specific safety concerns that would preclude its authorization of the vaccine, The Wall Street Journal reported. Severe adverse reactions were rare but occurred more frequently after the second dose of the vaccine than after the first dose.