FDA to approve Moderna Vaccine in the US

By: Sumaya Hussein (husseinsumaya1@gmail.com)

Thumbnail photo courtesy of Getty Images

Food and Drug Administration (FDA) say that Moderna’s vaccine is safe and 95% effective, clearing the way for US emergency authorization.


This comes one day after Americans across the country began receiving doses of the Pfizer vaccine.
Once approved by the FDA vaccine panel, Moderna will become the second coronavirus vaccine to be allowed in the US and shipments could begin within 24 hours.

A patient receiving a dose of the Moderna Vaccine. Photo courtesy of New York Times

Moderna’s data was released by the FDA on Tuesday, ahead of the vaccine panel’s meeting to discuss the drug on Friday. The 54-page document said there were “no specific safety concerns” and that serious adverse reactions were rare. The data also suggests that its vaccine begins to prevent asymptomatic infections after the first dose. This is highly effective because this helps significantly slow the spread of the coronavirus. FDA analysts found that the Moderna vaccine was effective “across age groups, gender, racial and ethnic groups, and participants with underlying conditions”. In addition, the research “suggested benefit of the vaccine in preventing severe Covid-19.”


The issues of effectiveness against severe disease have been raised about the studies of vaccines for Covid. The Moderna study found 30 cases of severe disease in the control group, versus zero in the vaccine group.

The FDA found no specific safety concerns that would preclude its authorization of the vaccine. Most common side effects included injection-site pain, fatigue, headache and chills.
Severe adverse reactions were rare but occurred more frequently after the second dose of the vaccine than after the first.


For instance, about 9.1% of vaccine recipients had an injection site reaction that was classified as “grade 3,”. This the FDA defines as severe of medically significant, but not immediately life-threatening. In comparison, fewer than 1% of the control group had grade 3 injection-site reactions.
Some 16.5% of vaccine recipients had systemic adverse reactions – such as fever and fatigue- with the severity of at least grade 3 and 3.7% among the control group. Severe fatigue was more common after the second dose after the first. The FDA last week authorized emergency use of the vaccine from Pfizer and BioNTech, which began distribution this week.


Unlike the Pfizer vaccine, Moderna’s does not require ultra-cold storage during shipping. Instead, it requires temperatures of around -20C for shipping – similar to a regular freezer. The Pfizer vaccine requires temperatures closer to -70C, making transport logistics much more difficult.

A shipment of the Pfizer vaccine delivered to US on Monday. Photo courtesy of Wall Street Journal.


The primary goal of the studies of both Pfizer’s and Moderna’s vaccines was to measure whether they prevented symptomatic COVID-19 disease, including severe disease.
However, people can still become infected affected and transmit the virus without showing any symptoms.

A Pfizer executive said last week that the company was studying whether its vaccine protects against asymptomatic Covid-19 and hope to complete the analysis early next year.

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