Administration Food and Drug Administration (FDA, for its English acronym) the endorse as safe and effective in documents released Tuesday.
The coronavirus pandemic has killed more than 300,000 people in the United States, and the government is counting on the Moderna vaccine to help deliver on its promise to inoculate 20 million Americans this month.
The FDA’s decision on the emergency use authorization of Moderna’s vaccine will be made after a panel of outside advisers meets Thursday . The FDA generally follows the advice of the panel, but is not required to do so.
Moderna’s is the second vaccine the FDA has evaluated after Pfizer Inc and Germany’s BioNTech, which was licensed last week. American hospitals began administering the Pfizer vaccines on Monday.
The New York Times, citing unidentified sources, reported that the FDA’s decision on Moderna’s vaccine would be made on Friday. The FDA did not immediately respond to a request for comment on the newspaper’s story.
FDA staff said that a two-dose regimen of Moderna’s vaccine was highly effective in preventing confirmed cases of COVID-19 and did not pose any specific safety concerns in adults 18 and older. For its part, Moderna published data in documents that supported previous claims that the vaccine can prevent some asymptomatic COVID-19 infections .
The company said 38 participants in the placebo portion of its trial tested positive for COVID-19 without showing symptoms at the time of their second dose, nearly triple the number in the vaccine segment.
Both Moderna and Pfizer designed their trials in the final phase to show that their vaccines were capable of preventing more significant forms of COVID-19 , in the hope that the injections could prevent hospitalizations and deaths.
But prevention of asymptomatic infection is also important and could reduce the chances of the vaccinated infecting the unvaccinated, further slowing the spread of the disease.
The FDA said there appeared to be some protection for trial participants after the first dose of Moderna’s vaccine, which is given in two doses, with 28 days between inoculations, but that it did not have enough information about long-term protection. term.
He further noted that the efficacy of the vaccine was 80.2% in participants who received only one dose at the time of the interim analysis , which was based on data collected through November 7. But the FDA said it could not reach a conclusion because the number of participants and the observation time were limited and there was no single-dose segment in the 30,000-person trial.