FDA authorizes 2nd COVID-19 vaccine, giving Moderna green light to ship doses to states

December 18, 2020December 18, 2020 WKXA

pinkomelet/iStockBy ANNE FLAHERTY, ABC News

(WASHINGTON) — The U.S. Food and Drug Administration has authorized use of a second COVID-19 vaccine for people age of 18 and over, a move that will trigger the shipment of millions more doses to hospitals and nursing homes next week.

Like its competitor Pfizer, the Moderna vaccine was believed to be both safe and highly effective. After tracking some 30,000 volunteers, Moderna estimated it as 94% effective in preventing COVID-19 illness with few serious side effects.

“With the availability of two vaccines now for the prevention of COVID-19, the FDA has taken another crucial step in the fight against this global pandemic that is causing vast numbers of hospitalizations and deaths in the United States each day,” said FDA Commissioner Dr. Stephen M. Hahn.

The Moderna vaccine though does not require the same ultra-cold storage, making it more user-friendly, particularly in rural areas that might be less equipped.

The authorization comes after federal advisers — an independent group of infectious disease experts, doctors and scientists — agreed overwhelmingly on Thursday that the benefits of the Moderna vaccine outweighed any potential risks based on trial data. The vote was 20-0 with one abstention.

As with volunteers who took the Pfizer vaccine, fatigue, headaches and swelling at the injection site were noted.

Unknown still is whether the vaccine stops transmission. The study only looked at whether people became serious ill.

Also unclear is the potential for allergic reactions. A few incidents have been reported following shots of the Pfizer vaccine.

At Thursday’s meeting on Moderna, Dr. Doran Fink, a senior vaccine official at the FDA, said researchers didn’t have all the information. But he noted that “these cases underscore the need to be vigilant during the early stage of the campaign” and communicate those findings to the public.

Fink said the FDA was working with Pfizer to further revise fact sheets and warnings to health care providers to make clear that any facility administering it “should ensure that medical treatment for managing serious allergic reactions is immediately available.” He said the FDA plans to do the same for Moderna.

“I have never been more hopeful that we will eventually turn the corner on this pandemic,” said Rich Besser, a former director of the Centers for Disease Control and Prevention and head of the Robert Wood Johnson Foundation.

The 5.9 million doses shipped from Moderna would be in addition to the 6.4 million doses provided by Pfizer-BioNTech.

Dr. Anthony Fauci, the nation’s top infectious disease expert, said Wednesday that people shouldn’t be concerned about having to choose between Moderna and Pfizer. An internal assessment by the FDA already found that the Moderna data showed the benefits likely outweigh the risks.