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SILVER SPRING, Maryland: Moderna’s COVID-19 vaccine appeared slated for regulatory clearance this week after staff at the U.S. Food and Drug Administration endorsed it as safe and effective in documents released Tuesday.
The coronavirus pandemic has killed more than 300,000 people in the US, and the government is counting on the Moderna vaccine to help deliver on its promise to inoculate 20 million this month.
The FDA will make a decision on issuing the so-called emergency use authorization for Moderna vaccine after a panel of outside advisers meets Thursday. The FDA generally follows the advice of the panel, but is not required to do so.
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Moderna’s is the second vaccine the FDA has considered, behind one from Pfizer. and BioNTech from Germany, which was licensed last week. US hospitals began administering the Pfizer injections on Monday.
The New York Times, citing unidentified sources, reported that the FDA’s decision on Moderna’s vaccine would be on Friday. The FDA did not immediately respond to a request for comment on the NYT report.
FDA staff members said in documents prepared for that meeting 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. .
Moderna published data in documents supporting earlier claims that the vaccine can prevent some asymptomatic COVID-19 infections.
He said 38 trial participants in the placebo arm of his trial tested positive for COVID-19 without showing symptoms at the time of their second dose, nearly triple the number in the vaccine arm of the trial.
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Both Moderna and Pfizer designed their late-stage trials to show that their vaccines were capable of preventing major 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 vaccinated people infecting unvaccinated ones, further slowing the spread of the disease.
SUCCESSFUL ONE SHOT?
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 percent in participants who only received one dose at the time of interim analysis, which was based on data collected through Nov. 7.
But the FDA said it couldn’t draw a conclusion because the number of participants and observation time were limited and there was no single-dose arm in the 30,000-person trial.
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Moderna said that trial participants, half of whom received a placebo, can request to find out if they had a placebo or the vaccine so they can receive the vaccine or another vaccine potentially available outside of the trial.
FDA staff 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 one in the placebo group. The company said three of the cases had been resolved.
Although the FDA said that Bell’s palsy trial participants had predisposing factors, “the potential contribution of the vaccine to the manifestations of these facial paralysis events cannot be ruled out.”
Pfizer reported six cases of Bell’s palsy, including four in the vaccine arm, which it said was a typical rate for the general population.
Thirteen people who participated in the trial died, six who received the vaccine and seven who received the placebo.
The death rate during the trial was in line with death rates in the general population for patients of this age, according to the papers. There was only one death related to COVID-19, a patient who received the placebo.
Moderna shares, which have increased nearly eightfold this year through Monday’s close, were up 1.8% before the bell.
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