Moderna Becomes Second Firm to Seek COVID-19 Vaccine Authorization

Moderna on Monday submitted a request for FDA Emergency Use Authorization (EUA) for its coronavirus vaccine, mRNA-1273, making it just the second company to date that’s taken a candidate far enough to file an application for emergency clearance.

The Cambridge, Mass. drugmaker announced the filing on the same day that its late-stage trial’s primary efficacy analysis showed the mRNA-based vaccine demonstrated a 94.1 percent efficacy rate and an astounding 100 percent effectiveness against severe coronavirus. The analysis, which evaluated 196 cases of infection, confirmed the high efficacy seen in the phase 3 trial’s first interim analysis (DID, Nov. 17), Moderna CEO Stéphane Bancel said.

The FDA’s advisory committee on vaccines will meet on Dec. 10 to discuss Pfizer’s vaccine candidate, the first coronavirus vaccine to be reviewed by the agency for emergency clearance. The panel will meet a week later, on Dec. 17, to discuss the Moderna vaccine.

HHS Secretary Alex Azar said he believes that Pfizer’s and Moderna’s vaccine candidates could earn EUAs before Christmas, meaning that high-risk patients in the U.S. may begin receiving vaccinations by year’s end (DID, Nov. 19).

Under the U.S. government’s distribution strategy, a vaccine would be ready to go within 24 hours of being granted emergency authorization. The government expects to have approximately 40 million doses of the two vaccines for allocation by the end of the year, with production ramping up in 2021.

Moderna is on schedule to produce 500 million to 1 billion doses of its vaccine for global use in 2021, the company said.

The drugmaker’s vaccine is already being evaluated under rolling review by other regulators, including the European Medicines Agency, Health Canada, Switzerland’s SwissMedic and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).

The UK government over the weekend announced that it has secured an additional 2 million doses of Moderna’s vaccine, adding on to the 5 million doses it previously acquired. Britain’s Secretary of State for Health and Social Care, Matt Hancock, said the country is ready to deploy a vaccine should one receive regulatory approval. — James Miessler