News and Commentary

FDA Releases Data On Moderna COVID-19 Vaccine Before Key Vote

Agency says vaccine about 94% effective for most people
Cropped hand wearing a nitrile glove holding a Covid-19 vaccine vial and a syringe
Javier Zayas Photography / Getty Images

While the Food and Drug Administration (FDA) has issued emergency use authorization for a COVID-19 vaccine made by Pfizer, there’s another one in the pipeline that may be far easier to distribute nationwide.

Pfizer’s two-shot vaccine needs to be stored at -94 degrees Fahrenheit, but the new one can be kept in a normal fridge.

The FDA on Tuesday announced that Moderna’s coronavirus vaccine to be highly effective and fully safe. Moderna has also asked for emergency use authorization, and the FDA’s report puts that request on track for approval.

The FDA’s 54-page report found the Moderna vaccine about 94% effective for most people, but the efficacy rate in people older than 65 was slightly lower at 86.4%. The analysis comes just two days before a meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee expected to recommend emergency approval.

The agency said Moderna’s shot was equal to Pfizer’s across racial, ethnic and gender groups, and that it also performed well in people with medical issues.

The biotech firm on Nov. 30 moved to win emergency use authorization. Moderna said then its data showed their vaccine was 94.1% effective in its late-stage clinical trial, just under Pfizer’s efficacy rate of 95%. The Moderna vaccine was developed in conjunction with the Trump administration’s Operation Warp Speed.

“We believe that our vaccine will provide a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalizations and death,” Moderna CEO Stéphane Bancel said in a statement. Bancel said last week that 20 million doses will be available by the end of the year.

A third vaccine is also in the pipeline. AstraZeneca and Oxford University on Nov. 23 said their jointly created COVID-19 vaccine has proven to be up to 90% effective and the makers claims will be easier to distribute.

“These findings show that we have an effective vaccine that will save many lives,” said Oxford University professor Andrew Pollard, who served as the lead investigator for the drug’s trials. “Because the vaccine can be stored at fridge temperatures, it can be distributed around the world using the normal immunization distribution system. And so our goal … to make sure that we have a vaccine that was accessible everywhere, I think we’ve actually managed to do that.”

The CDC’s Advisory Committee on Immunization Practices (ACIP) on Dec. 2 voted to direct that healthcare workers and residents of long-term care facilities will be the first to get the shots in the initial rollout — once federal regulators authorize use of a vaccine. The recommendation was approved CDC Director Robert Redfield, but governors will eventually have the final say on who gets the vaccine first.

Participants in Moderna’s 30,000-person clinical trial did report some common side effects such as headache, fatigue, muscle aches and pain at the injection site, the FDA said. Pfizer’s shot has caused similar side effects.

Related: IT BEGINS: NYC Nurse Becomes First American To Receive COVID-19 Vaccine

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