Pfizer applies for emergency U.S. approval

Regulators plan to take three weeks to review vaccine before outside panel of experts meets on Dec. 10

Drugmaker Pfizer said Friday that it had submitted an application to the U.S. Food and Drug Administration to authorize its coronavirus vaccine for emergency use, setting in motion an accelerated regulatory process that could allow the first Americans to get a vaccine by the middle of December.

Pfizer and its German partner, BioNTech, announced Wednesday that the vaccine was safe and 95 per cent effective and that it also worked well in older people and in preventing severe COVID-19.

Another front-runner, Moderna, said Monday that its vaccine, which uses similar technology, was 94.5 per cent effective and that the company also expected to apply soon for emergency authorization.

If the two vaccines are authorized for emergency use, federal and company officials have said there could be enough doses to immunize about 20 million Americans before the end of the year, a group that would most likely include health-care workers and nursing home residents. There are an estimated 17 million to 20 million healthcare workers in the United States, and about one million people living in nursing homes.

Both Pfizer and Moderna have arranged deals with the government so that the vaccines will be free to Americans and distributed according to plans worked out between the federal government and the states. CVS and Walgreens also have federal deals to begin immunizing nursing home residents. On Tuesday, Alex Azar, the secretary of the Department of Health and Human Services, said that 99 per cent of the country’s nursing homes had signed up to be part of the program.

Regulators at the FDA plan to take about three weeks to review Pfizer’s vaccine before an outside panel of experts meets to review the application the second week of December. That meeting has been scheduled for Dec. 10.

Inside the FDA, Pfizer’s application will be reviewed by the agency’s Center for Biologics Evaluation and Research, which has organized large teams of medical and compliance officers, public health researchers and statisticians to dig into thousands of pages of data about the safety and effectiveness for each vaccine.