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

Doses of the vaccine are expected to be shipped next week.

December 18, 2020, 10:03 PM

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 within days.

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 vaccine was developed with assistance from the National Institute of Allergy and Infectious Diseases, led by Dr. Anthony Fauci. He has said there is no real difference between the Moderna and Pfizer vaccines, which rely on similar technology.

"It is my hope that all Americans will protect themselves by getting vaccinated when the vaccine becomes available to them. That is how our country will begin to heal and move forward," he said in a statement.

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.

"I am proud of what the Moderna team has achieved in collaboration with our partners. We were able to create and manufacture the Moderna COVID-19 Vaccine in 11 months from sequence to authorization, while advancing clinical development with a Phase 1, Phase 2 and pivotal Phase 3 study of 30,000 participants," Moderna CEO Stéphane Bancel said in a statement following the authorization. "We remain focused on scaling up manufacturing to help us protect as many people as we can from this terrible disease."

Volunteer Melissa Harting receives an injection of a possible COVID-19 vaccine, developed by the National Institutes of Health and Moderna Inc., in Binghamton, N.Y., July 27, 2020.
Hans Pennink/AP, FILE

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.

A man stands outside an entrance to a Moderna, Inc., building, Monday, May 18, 2020, in Cambridge, Mass.
Bill Sikes/AP, File

"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 will be in addition to the 6.4 million doses provided by Pfizer-BioNTech.

President Donald Trump, who had incorrectly tweeted earlier in the day that the Moderna vaccine had been "approved," tweeted after the EUA was granted, "Congratulations, the Moderna vaccine is now available!"

President-elect Joe Biden, who is set to receive Pfizer's vaccine on Monday, praised the FDA's authorization for the Moderna COVID-19 vaccine.

“Today’s emergency use authorization by the Food & Drug Administration of the Moderna COVID-19 vaccine is another milestone in our battle to overcome the crisis our country is facing today," Biden said in a statement. "The authorization of two vaccines, Pfizer-BioNTech and now Moderna, assures us that brighter days lie ahead."