FDA data says Moderna’s COVID-19 vaccine is safe and effective

Ahead of a meeting to discuss the potential approval of the COVID-19 vaccine from Moderna (NSDQ:MRNA), FDA data says the candidate is safe and effective.

Cambridge, Mass.-based Moderna filed for emergency use authorization in November, having conducted a Phase 3 study, known as the COVE study, that enrolled more than 30,000 U.S. participants, with 196 confirmed cases of COVID-19. Data analysis indicated a vaccine efficacy of 94.1%. All of the 30 severe cases in the study involved people in the placebo group; none of the severe cases received Moderna’s mRNA-1273 vaccine.

Moderna’s FDA advisory meeting for EUA follows last week’s advisory meeting which resulted in EUA for the vaccine made by Pfizer and BioNTech, which had its U.S. rollout begin yesterday.

The findings by the FDA ahead of the advisory meeting look set to lead to EUA for Moderna’s mRNA-1273 vaccine by the end of the week, according to a report in The New York Times, meaning a second COVID-19 vaccine could be made available to Americans as early as next week.

According to The New York Times report, about 6 million doses could be distributed beginning next week, supplementing the Pfizer/BioNTech vaccine which several healthcare workers began receiving yesterday.

Moderna reports that the most common solicited adverse reactions from its mRNA-1273 vaccine include injection site pain, fatigue, myalgia, arthralgia, headache, and erythema/redness at the injection site.

The company, however, seems to have the upper hand in terms of its vaccines’ storage requirements. Moderna’s candidate is stable for 30 days between 2° and 8° C. Pfizer currently specifies that its vaccine candidate should be stored at –70° C.