Moderna’s COVID-19 Vaccine Bags FDA’s Emergency Use Authorization, Inoculations to Start on Monday

December 18th, 2020 – The Food and Drug Administration (FDA) authorized Moderna’s COVID-19 vaccine for emergency use on Friday in adults 18 years and older, making it the second vaccine after Pfizer and BioNTech’s to receive the FDA’s blessing. This news brings hope to millions in the country which witnessed more than 17 million infection cases and over three hundred thousand deaths in the past year.

“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 a statement by FDA Commissioner Stephen M. Hahn, M.D.

The authorization, which is the first for Moderna, came after a panel of experts sat together on Thursday to address the vaccine’s safety and efficacy issues. After a daylong discussion on the topics ranging from vaccine-mediated anaphylactic reactions to unblinding of the trials, the FDA advisory panel voted unanimously in favor of the vaccine’s emergency approval. This decision was reviewed by the FDA for granting emergency approval.

“I would anticipate that we likely will see shots in the arm by the very early part of next week,” Dr. Anthony Fauci told NBC’s Today show earlier today. “I would hope Monday or Tuesday.”

Moderna’s vaccine is similar to Pfizer’s in its composition. Both are mRNA vaccines made using the DNA sequence of the spike protein of the virus. In terms of efficacy and safety, both are equally good. But if asked which one works better against serious COVID-19 infections, then it is definitely Moderna’s vaccine. Moderna’s vaccine shows the efficacy of 94.1 % in young adults and 86.4% in older adults (>65 years) after two doses taken 28 days apart. But it shows 100% efficacy in preventing severe COVID-19 infection, unlike Pfizer’s vaccine.

While the safety of Moderna’s vaccine is as good as Pfizer’s with mild reactions including headaches and sore arms seen in most of the trial patients, what remains to determine is whether it will work equally well in the real world. Pfizer’s vaccine showed no signs of anaphylactic reactions in the trial. However, two people in the first batch of vaccination in the UK and two in the states got severe allergic reactions following a single dose of the vaccine. Within a few days of emergency authorization approval, Moderna’s vaccine will be available for people with high priority. It will become clear in a matter of days whether the vaccine has any allergy-related side effects.

Moderna’s vaccine is a product of efforts made by hundreds of scientists over the past year. Fauci’s Institute, the National Institute of Health, was also instrumental in developing the Moderna vaccine. After China released the sequence of the virus, Moderna was the first one ready with the vaccine. As the company progressed with the trials, it received enormous support from the government’s Operation Warp Speed to accelerate the development of the vaccine. Nearly $2.5 billion in federal funds were spent by the government to support Moderna’s vaccine development program. But in return, Moderna promised 100 million doses to the US government for about $1.5 billion in August this year. Of which, 20 million will be supplied by the end of this year.

The FDA’s emergency authorization approves the federal government’s plan of distributing roughly 5.9 million doses of Moderna’s vaccine to 64 states, territories, and major cities across the nation next week. The Centers for Disease Control and Prevention has provided states with an outline that clarifies who will get the vaccine first. The vaccine will first be given to healthcare workers and nursing homes, however, states can distribute the vaccine as they see fit.

By Ruchi Jhonsa, Ph.D.

Related Article: FDA Panel Recommends Moderna’s COVID-19 Vaccine for Emergency Use Authorization

References

1. https://www.fda.gov/media/144434/download
2. https://www.fda.gov/news-events/press-announcements/fda-takes-additional-action-fight-against-covid-19-issuing-emergency-use-authorization-second-covid

Author

Ruchi Jhonsa