FDA affirms safety and effectiveness of Moderna’s COVID-19 vaccine


Zach Gilbert

The FDA has officially supported Moderna’s coronavirus vaccine, attesting to its safety and effectiveness against preventing illness from and spread of COVID-19. Photo courtesy of Joseph Prezioso/AFP via Getty Images.

The Food and Drug Administration (FDA) officially supported the use of the COVID-19 vaccine from biotechnology company Moderna on Dec. 15, affirming its safety and effectiveness.

According to the FDA’s analysis, Moderna’s COVID-19 vaccine is 94% effective at preventing illness caused by COVID-19, and it additionally seems to assist in staving off the spread of coronavirus as well. While the FDA noted that just one dose of Moderna’s vaccine could help to stop the spread of COVID-19 (with “asymptomatic infection [being] reduced by 63% after the first shot”), it is still expected that two doses will be required for comprehensive protection.

The Vaccines and Related Biological Products Advisory Committee – which operates independent of the FDA – also authorized Pfizer’s COVID-19 vaccine on Dec. 10.

“This is great news, as this now brings us to two products with high levels of efficacy,” said Rupali Limaye, an associate scientist at Johns Hopkins Bloomberg School of Public Health, to the New York Times.

On Monday, Dec. 14, Army Gen. Gustava Perna, the chief operating officer of Operation Warp Speed (which is handling distribution of COVID-19 vaccines) estimated that nearly 6 million doses of the Moderna vaccine could be shipped out to 3,285 locations across America, pending the FDA’s authorization.

The FDA’s review found that the Moderna vaccine may come with minor side effects – including headache, fever and fatigue – but, ultimately, though these experiences may be unpleasant initially, they are not detrimentally dangerous by any means.

The news of the FDA’s support of the Moderna vaccine is uplifting to many Americans, especially as it was announced that over 300,000 individuals have died from COVID-19 since the start of the pandemic. This total has now exceeded the number of Americans who died in combat during World War II, which was 291,557. The University of Washington’s Institute for Health Metrics and Evaluation predicts that more than 460,000 Americans will have died of COVID-19 by March 1.

“The way the number of infections has been growing so fast, it’s hard to believe we won’t be at half a million deaths,” said Dr. John Swartzberg, a professor emeritus of infectious diseases and vaccinology at the University of California-Berkeley, when interviewed by USA Today.

Though it remains to be seen how long it will take to inoculate all 330 million Americans, the government has signed deals with both Moderna and Pfizer to purchase 200 million doses of the vaccines in the first quarter of 2021. These vaccines will be available free of charge.

Because the Pfizer vaccine requires extreme cold storage, the Moderna vaccine is actually easier to ship, store and handle for medical professionals across the country. 

“Moderna is the one that I would take out to rural areas and community health centers and private doctors’ offices.” Dr. Barry R. Bloom, a professor of public health at Harvard, indicated when interviewed by the New York Times, who also noted that the Pfizer vaccine would be most helpful in traditional hospitals.