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FILE PHOTO: In this illustration taken on October 31, 2020, vials with a decal that reads “COVID-19 / Coronavirus Vaccine / Injection Only” and a medical syringe are seen in front of the Moderna logo displayed. REUTERS / Dado Ruvic / Illustration.
BENGALURU – Moderna Inc’s COVID-19 vaccine appeared to be scheduled for regulatory clearance this week after staff members from the US Food and Drug Administration raised no major new concerns about it in documents released Tuesday.
FDA reviewers said that a two-dose regimen of Moderna’s vaccine was very effective in preventing confirmed cases of COVID-19 and did not pose any specific safety concerns with the use of the vaccine in adults 18 years of age and older.
The comments were made in papers prepared for Thursday’s meeting of outside experts, who will discuss whether to back a US emergency use authorization for the Moderna takeover.
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 considered, behind one from Germany’s Pfizer Inc. and BioNTech, which was licensed last week.
Hospitals began giving Pfizer injections 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 there appeared to be some protection for trial participants after the first dose of Moderna’s vaccine, which is given in two injections, with 28 days between inoculations, but there was not enough information about longer-term protection.
He said the vaccine’s efficacy was 80.2% in participants who only received one dose at the time of interim analysis, which was based on data collected through Nov. 7.
They said that serious side effects in the vaccine trial represented medical events that occur in the general population with a frequency similar to that seen in the study.
The FDA pointed to 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 received the vaccine and 1 in the placebo group. The company said three of the cases had been resolved.
Although the FDA said that trial participants with Bell’s palsy had predisposing factors, the “potential contribution of the vaccine to the manifestations of these events of facial paralysis cannot be ruled out.”
Pfizer reported six cases of Bell’s palsy, including 4 in the vaccine arm, which it said was a typical rate for the general population.
Moderna shares, which have increased nearly eightfold this year to Monday’s closing price, were up 1.8% before the bell.
/ MUF
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