FDA panel endorses Moderna coronavirus vaccine for emergency use

FDA panel endorses Moderna coronavirus vaccine for emergency use

Pending approval of Moderna coronavirus vaccine is ‘only good news’: Doctor

Former HHS Chief Medical Officer Dr. Vanila Singh discusses the FDA’s pending approval of Moderna’s coronavirus vaccine and whether or not the vaccine should be mandatory.

A U.S. Food and Drug Administration advisory panel voted Thursday to endorse Moderna’s coronavirus vaccine for emergency use, clearing a major hurdle toward final regulatory approval of a second treatment to combat the deadly pandemic.

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The advisory panel, comprised of outside experts on infectious diseases, voted 20-0 to recommend the Moderna vaccine as effective in the prevention of COVID-19. One member of the panel abstained. The vote was the last step before senior FDA officials decide whether to approve the vaccine for mass distribution.

FDA AUTHORIZES PFIZER VACCINE FOR MASS DISTRIBUTION

Shipments of the Moderna vaccine would begin within hours of the FDA’s decision, which could come by as early as Friday. U.S. officials have pledged to prioritize frontline health care workers and high-risk patients in the initial days of the country’s historic vaccination campaign.

The advisory panel was asked to consider whether "the benefits of the Moderna COVID-19 vaccine outweigh its risks for use in individuals 18 years of age and older?" based on available evidence.  Members debated on a potential change to the wording of their recommendation but ultimately decided to vote on the question as originally posed.

Moderna is expected to release an initial shipment of six million doses shortly after the FDA’s decision. The FDA is not required to follow the advisory panel’s recommendation. However, the agency is expected to follow through on the endorsement with fast approval.

MODERNA COVID-19 VACCINE GIVEN 'FAVORABLE SAFETY PROFILE'

Based on data from clinical trials, the FDA determined the Moderna vaccine to be 94% effective and did not result in any major side effects. Trial patients reported symptoms often associated with vaccinations, such as fever, fatigue and muscle aches.

Last week, the Pfizer-BioNTech coronavirus vaccine became the first of its kind to receive an emergency use authorization. The first vaccinations were administered on Monday. A small number of patients have experienced allergic reactions after receiving the shot.

Both the Pfizer-BioNTech and the Moderna vaccines required two shots to be administrated over a period of several weeks. Both vaccines will be available in limited quantities in the early days of the distribution campaign.

Unlike Pfizer’s version, the Moderna vaccine can be stored at regular freezer temperatures. Recommendations call for the Pfizer vaccine to be stored at minus 70 degrees Celsius.

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Dr. Moncef Slaoui, chief adviser for Operation Warp Speed, predicted that 100 million Americans could be vaccinated by the end of February.

More than 309,000 Americans have died from COVID-19 since the pandemic began. More than 17.1 million cases have been reported in the U.S. alone.

The Associated Press contributed to this report.

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