Moderna Confirms COVID-19 Vaccine Is Safe and Over 94% Effective, Files for FDA Emergency Use Authorization

By Wu Bin | Cailianshe

On Monday (November 30) Eastern Time, Moderna further updated its COVID-19 vaccine data, confirming the vaccine is safe and more than 94% effective. Moderna plans to apply for Emergency Use Authorization from the FDA later on Monday.

(Source: Moderna)

Moderna’s latest efficacy analysis evaluated 30,000 participants in its Phase 3 clinical trial, identifying 196 confirmed cases, with 185 observed in the placebo group and 11 in the vaccinated group, yielding a vaccine efficacy of 94.1%.

The Moderna vaccine also appears to prevent severe COVID-19; no cases of severe disease occurred in the vaccinated group, whereas all 30 severe cases were in the placebo group, which also reported one death.

Meanwhile, the vaccine also demonstrated good tolerability, with no serious adverse events reported. The most common side effects were fatigue, myalgia, headache, and injection site pain. Furthermore, the vaccine showed consistent efficacy across different age groups, races, and genders. Among the 196 confirmed cases, there were 33 adults aged 65 years or older and 42 individuals from ethnic minority groups.

Moderna previously released the first interim efficacy analysis of its Phase 3 clinical trial on November 16. Based on 95 confirmed cases, 90 were observed in the placebo group and 5 in the mRNA-1273 group, yielding a vaccine efficacy rate of 94.5%.

Applied for Emergency Use Authorization from the FDA on Monday

Moderna Plans to Apply for FDA Emergency Use Authorization on Monday, Becoming the Second Pharmaceutical Company to Do So; Pfizer Applied for Emergency Use Authorization on November 20, and Some Americans Are Expected to Receive the First Dose of the Moderna Vaccine Within Weeks.

The FDA’s review of the Moderna vaccine is expected to take several weeks, with an advisory committee meeting potentially scheduled for December 17 to evaluate the vaccine.

U.S. Secretary of Health and Human Services Alex Azar stated that the FDA would act “as soon as possible” to authorize the emergency use of the Pfizer and Moderna vaccines, with approximately 40 million doses expected to be available by the end of the year.

However, the efficacy of vaccines still needs to be verified through practice. Public health officials and medical experts emphasize that it is currently unclear how long immunity provided by vaccines will last, and whether or for how long people will need booster shots.