FDA endorses safety and efficacy of Moderna’s COVID-19 vaccine

A coronavirus vaccine manufactured by Moderna is on the verge of authorization after Food and Drug Administration (FDA) scientists found it to be safe and 94 percent effective at preventing severe cases of COVID-19.

The evidence will be discussed during a panel meeting of independent experts on Thursday. Based on the track taken by the vaccine manufactured by Pfizer and BioNTech, the FDA could grant emergency use authorization for the Moderna vaccine as soon as Friday. 

The vaccine was effective across all races and genders, the FDA found, similar to the Pfizer vaccine. Both Pfizer and Moderna developed their vaccines using experimental mRNA technology, and both rely on two doses to be effective — Moderna’s must be taken 28 days apart, while Pfizer’s are given 21 days apart.

Moderna is asking for authorization in people ages 18 and over, while Pfizer’s vaccine was cleared for people as young as 16. The lack of data among 16 and 17-year-olds led some of the members of the agency’s Vaccines and Related Biological Products Advisory Committee to vote against Pfizer’s authorization.

Side effects included chills, injection site soreness, fever, headache and fatigue, but most did not last longer than a day, the agency found. The FDA said there appears to be some protection against COVID-19 following one dose; however, there wasn’t enough information about longer-term protection beyond 28 days after a single dose.

The anticipated authorization would give America two different vaccines against COVID-19. The Trump administration’s Operation Warp Speed has invested $4.1 billion in federal funds in the development and distribution of Moderna’s vaccine.

The federal government signed a deal last summer to deliver a total of 100 million doses in the first quarter of 2021. Last week the administration announced that it had purchased another 100 million doses from Moderna for the second quarter.

Between Moderna and the vaccine from Pfizer/BioNTech, health officials said they expect to deliver enough doses to vaccinate 20 million people with the first dose by the end of the year.

Moderna’s vaccine is anticipated to create fewer logistical challenges, as it does not require the same ultra-cold storage of Pfizer’s vaccine. It can remain stable for up to 30 days at the same temperature as a standard refrigerator.

Gen. Gustave Perna, the CEO of Operation Warp Speed, on Monday said the administration plans to ship 6 million doses out to 3,285 locations across the country in the first week of the vaccine’s authorization.

The results from Moderna’s clinical trial were decisive. There were 196 cases of COVID-19, with all but 11 in the placebo group. There were 30 cases of severe COVID-19 and one death, also all in the placebo group.

One potential issue that could come up during Thursday’s meeting is the vaccine appears to be 86 percent effective, slightly less than the overall effectiveness of the previously approved Pfizer vaccine.