Moderna Incs COVID-19 vaccine is set for regulatory authorization this week as U.S. Food and Drug Administration staff associates have not raised any new major concerns regarding it in documents that were released on Tuesday.

The FDA reviewers said that a two-dose regimen of Modernas vaccine was very effective in preventing the confirmed cases of COVID-19. They did not raise any specific safety issues while using the vaccine in adults above the age of 18 years. The remarks were made in documents prepared for Thursdays meeting by outside experts, who were going to discuss endorsing a U.S. emergency use authorization (EUA) for the Moderna vaccine. The FDA usually follows the advice of the panel, nonetheless not required to do so.

Modernas is the second vaccine that the FDA has considered, after one from Pfizer Inc. and Germanys BioNTech, which was authorized last week. Hospitals have started giving the Pfizer vaccine shots on Monday and the United States is hoping that the Moderna vaccine will fulfill its promise to immunize 20 million people by this month end.

The FDA stated that some protection for trial participants after the first dose of Modernas vaccine was observed and it was given in two shots, with 28 days gap between immunizations, however there is not adequate information on its longer-term protection. The vaccine efficacy was 80.2% in participants who received one dose at the time of the interim analysis based on data collected till 7th November.

They stated that serious side effects in the vaccine trial signified the medical events occuring in the general population at a similar incidence as seen in the study. The FDA has flagged the possibility of the vaccine contributing to Bells palsy, which is a type of facial paralysis and reported by participants in the Pfizer trial.

Moderna had reported four cases of Bells palsy, which includes three in people who took the vaccine shot and 1 person in the placebo group. The company later said that the three cases had resolved on itself.

The FDA said that even though the trial participants with Bells palsy had predisposing factors, the possible contribution of the vaccine to the manifestations of such events of facial palsy cannot be ruled out. Pfizer also reported six cases of Bells palsy, 4 people in the vaccine arm.

Source: ET Healthworld