Moderna's COVID-19 vaccine shows 'no specific safety concerns', says US FDA

The US Food and Drug Administration on Tuesday issued a positively-worded briefing document about the Moderna Covid-19 vaccine ahead of a meeting by experts on whether to grant it emergency approval.

The FDA was upbeat on the vaccine, saying there were "no specific safety concerns identified that would preclude issuance of an EUA (emergency use authorization" and confirmed an overall efficacy of 94.1 per cent.

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The comments were made in documents prepared for Thursday's meeting of outside experts, who will discuss whether to endorse a U.S. emergency use authorization (EUA) for the Moderna shot.

The FDA typically follows the advice of the panel, but is not required to do so. Modernais the second vaccine the FDA has considered, behind one from Pfizer Inc. and Germany's BioNTech, which was authorized last week.

Hospitals began giving the Pfizer shots on Monday and the United States is counting on the Moderna vaccine to fulfill its promise to inoculate 20 million people this month.

One dose protection

The FDA said that there appeared to be some protection for trial participants after the first dose of Moderna's vaccine, which is given in two shots, with 28 days between inoculations, but there was not enough information on longer term protection.

It said that vaccine efficacy was 80.2 per centin participants who only received one dose at the time of the interim analysis, which was based on data collected as of November7.

They said that serious side effects in the trial of the vaccine represented medical events that occur in the general population at a similar frequency as observed in the study.

The FDA did flag the possibility that the vaccine was contributing to Bell's palsy, a type of facial paralysis also reported by participants in the Pfizer trial.

Moderna reported four cases of Bell's palsy, including three among people who had the vaccine and 1 in the placebo group. The company said that three of the cases had resolved itself.

Although the FDA said that the trial participants with Bell's palsy had predisposing factors, the "potential contribution of the vaccine to the manifestations of these events of facial palsy cannot be ruled out".

Pfizer reported six cases of Bell's palsy, including 4 in the vaccine arm, which it said was a rate typical of the general population.

Moderna shares, which have risen nearly eight-fold this year up to Monday's closing price, were up 1.8 per centbefore the bell.