Moderna to apply for emergency FDA approval for coronavirus vaccine

moderna fda approval coronavirus vaccine
Photo via Yuri Samoilov/Flickr (yuri.samoilov.online) (CC BY 2.0)

Moderna will apply for emergency Food and Drug Administration approval for its coronavirus vaccine on Nov. 30. Should Moderna get FDA approval, it’s possible that select Americans could be receiving the first of two required vaccine doses as soon as Dec. 21.

According to the New York Times, Moderna’s application comes after its new release of data from a 30,000-person clinical trial, showing 94.1% effectiveness against COVID-19. The study also showed the vaccine is 100% effective at preventing severe disease from COVID-19.

Moderna’s chief executive, Stéphane Bancel, noted that the company will be able to produce 20 million doses of the vaccine by the end of the year and is poised to produce as many as 1 billion doses in 2021. Moderna’s vaccine requires two doses, spaced a month apart.

According to CNN, both FDA and Moderna representatives marveled at the vaccine’s efficacy rate. Moderna chief medical officer Tal Zaks reportedly said, upon seeing the updated study data over the weekend, that “it was the first time I allowed myself to cry. We have a full expectation to change the course of this pandemic.”

CNN also reported specifics from the trials, including:

  • Among the approximately 15,000 people who received the vaccine, 11 developed COVID-19.
  • Among the approximately 15,000 people who received the placebo, 185 developed COVID-19.
  • None of the 11 people who received the vaccine became severely ill, but 30 of the 185 who received the placebo became severely ill, and one of them died.
  • The vaccine had similar efficacy rates for elderly people and for people of different races.

NPR reported that inoculation can result in symptoms ranging from soreness at the injection site to achiness or even fever and flu-like symptoms. One researcher involved in the trials, Dr. Carlos del Rio of Atlanta’s Emory University, likened symptoms to those experienced by people taking the shingles vaccine. “You feel terrible for a day or two but then you’re fine,” he noted, adding that education will be needed to assure people that the vaccine has not made them sick.

Moderna is the second company to seek emergency approval from the FDA for the two-dose vaccine; Pfizer put in its application on Nov. 20. According to CNN, the government agency is expected to meet on both the Moderna and Pfizer applications in early December. Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, indicated that both vaccines would start being distributed in the latter part of December.

On Dec. 1, the FDA is set to meet to determine who will be among the first to get the vaccine. It’s expected that essential workers—including healthcare workers and police officers, as well as residents in nursing homes—will be first in line for the vaccine. Both Moderna and Pfizer’s vaccines require storage in ultra-cold temperatures, so that will factor into distribution plans, especially with a dry ice shortage.

Moderna is also making a similar application to the European Medicines Agency for distribution throughout the continent.

Read more on the coronavirus vaccine:

Sources: New York Times, CNN, NPR

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