Moderna announced final results for the Phase III trial of their vaccine candidate. mRNS-1273. The shot demonstrated 94% efficacy against Covid-19 and 100% against the severe form of the disease.
The final readout was based on 196 cases of Covid-19 that had developed in study volunteers. The placebo arm of the trial saw 185 cases and the vaccination arm 11. Of 11 severe cases, all occurred in volunteers who had received the placebo. The company said that efficacy did not vary across race, gender, age, or ethnicity. Of the 196 people who came down with Covid-19, 33 were older adults, 29 identified as Latinx or Hispanic, six were Black, four were Asian American, and three identified as multiracial.
Moderna said it will file today with the FDA for an Emergency Use Authorization for its shot. The FDA has advised the company that its outside advisory committee, known as the VRBPAC, will probably meet on December 17 to consider the application — one week after it gathers to weigh the Pfizer / BioNTech vaccine candidate. Moderna is also applying to regulators in Europe, Britain, Canada, and elsewhere in the world.
While Pfizer has said it can have 25 million doses available in 2020, and Moderna 15 million, there is uncertainty about who will be first in line for the shots. Stat News reports that cracks have opened between the White House and the DCD’s outside advisory panel, which has traditionally set the priorities for distribution. The CDC’s panel, which will meet tomorrow, favors giving the first shots to health care workers; the White House prefers that seniors and those with pre-existing conditions go to the head of the line.
Also, the head of the CDC and the FDA’s point man on drug approval have publicly disagreed on when exactly FDA approval might come. The CDC’s Dr. Robert Redfield said it could be a matter of days after the VRBPAC meets to consider Pfizer’s shot on December 10; Dr. Peter Marks, head of the FDA’s Center for Biologics Evaluation and Research, has signaled to expect approval within a couple of weeks.
Here is some of the coverage this morning.