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FDA panel recommends approving Moderna COVID-19 vaccine

By Mark Moore

December 17, 2020 | 5:05pm

A coronavirus vaccine developed by drugmaker Moderna was recommended for use by a Food and Drug Administration panel of experts on Thursday — just days after the first doses of Pfizer’s shot began rolling out across the country and into people’s arms on Monday.

In a 20-0 vote, the Vaccines and Related Biological Products Advisory Committee agreed that the vaccine should be made available to help battle the coronavirus, which has killed more than 307,000 Americans.

The FDA is expected to quickly give the green light for emergency use authorization of the shot, following the panel’s recommendation that the benefits of Moderna’s vaccine outweighed the risks for those 18 and up.

The recommendation followed seven hours of debate over the vaccine’s safety and effectiveness, including parsing through details of Moderna’s study and follow-up plans.

“The evidence that has been studied in great detail on this vaccine highly outweighs any of the issues we’ve seen,” said Dr. Hayley Gans of Stanford University Medical Center.

On Tuesday, the FDA issued a report that Moderna’s two-shot regimen was confirmed in a clinical trial to be 94 percent effective — and was particularly effective against severe disease.

It has not caused major safety problems, the report said.

Like Pfizer’s vaccine, side effects of Moderna’s include fever, fatigue and muscle aches.

Both vaccines use similar technology and each require two doses administered several weeks apart. Still, experts cautioned that the shots are not identical. 

“I would not necessarily assume” that any reactions would be the same, said Moderna chief medical officer, Dr. Tal Zaks.

The review by experts on infectious diseases, epidemiology and immunology, took on added significance after a health worker in Alaska was hospitalized after having a serious allergic reaction to Pfizer’s COVID-19 vaccine.

The person, believed to have suffered an anaphylactic reaction similar to two patients in the UK, became ill on Tuesday.

The Trump administration has secured nearly 6 million doses of Moderna’s vaccine for immediate release, Heath and Human Services head Alex Azar said on Wednesday.

The shots would first go to health workers and to people in nursing homes.

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Sandra Lindsay, a nurse at Long Island Jewish Medical Center, is inoculated with the Pfizer-BioNTech COVID-19 vaccine.

AP

Azar also said another 2 million doses of Pfizer’s vaccine, given the OK by the FDA last Friday, have been allocated for release next week.

“As of today, shipments of vaccine will have been delivered to every delivery site identified by public health jurisdictions for our first wave of shipments,” the Health and Human Services secretary said at an Operation Warp Speed press conference.

The federal government has also ordered a total of 200 million Moderna doses to date, the company said last week, with about 20 million expected to be delivered by the end of December.

The remainder would come in the first quarter of 2021.

With Post wires

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