Source: Health Policy Institute of Ohio
On November 20, Pfizer Inc., announced that it will apply to U.S. health regulators for emergency use authorization (EUA) of its COVID-19 vaccine, the first such application in a major step toward providing protection against the new coronavirus (Source: “Pfizer Files COVID-19 Vaccine Application to U.S. FDA,” Reuters, November 20, 2020).
The application to the U.S. Food and Drug Administration (FDA) comes just days after Pfizer reported final trial results that showed the vaccine was 95% effective in preventing COVID-19 with no major safety concerns.
“We literally could be weeks away from the authorization of a 95% effective vaccine,” U.S. Health Secretary Alex Azar said.
The companies expect the FDA to grant the EUA by mid-December and said they will begin shipping doses almost immediately. Pfizer has said it expects to have 50 million vaccine doses ready this year, enough to protect 25 million people.
Moderna Inc., is expected to be the next company to seek a U.S. emergency use nod for a COVID-19 vaccine. An initial analysis of data from its late-stage trial showed the vaccine was 94.5% effective. Final results and safety data are expected in the coming days or weeks. The next late-stage data is expected to come from AstraZeneca Plc., which is working with the University of Oxford, in November or December. Johnson & Johnson said it expects to have data needed to seek U.S. authorization for its experimental vaccine by February.