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www.fdanews.com/articles/202341-modernas-covid-19-vaccine-effective-after-six-months-phase-3-trial-data-shows

Moderna’s COVID-19 Vaccine Effective After Six Months, Phase 3 Trial Data Shows

April 14, 2021

New data from Moderna’s phase 3 COVID-19 vaccine trial have shown that the U.S. drugmaker’s two-dose inoculation remains highly effective against the virus six months after the second shot, including for severe infection, the company said Tuesday.

According to updated preliminary data from its late-stage trial, Moderna’s vaccine, mRNA-1273, proved more than 90 percent effective against COVID-19 infection and more than 95 percent effective against severe COVID-19 approximately six months after patients were given their second dose.

The new data, which span more than 900 cases of coronavirus and more than 100 cases of severe COVID, are consistent with previous trial updates, the company said. The phase 3 trial remains ongoing and more updates will come as the year continues, including findings on the vaccine’s effectiveness against asymptomatic COVID-19.

Though Moderna didn’t specify when it might file for a biologics license application (BLA) with the FDA for its vaccine — which is currently only authorized for emergency use — the fact that it appears to have met the agency’s six-month requirement for additional trial data suggests the company could be close to doing so.

Moderna added that its two variant-specific booster vaccine hopefuls, mRNA-1273.351, a candidate aimed at the South African mutation, and mRNA-1273.211, a combination of the original vaccine and the 351 candidate, were able to increase neutralizing titers against viral variants of concern in preclinical studies.

The drugmaker said that it has shipped a total of 132 million doses globally as of April 12 and remains on track to meeting its supply commitment with the U.S., pledging 100 million doses by the end of May and an additional 100 million doses by the end of July. — James Miessler