Pfizer asks FDA for emergency use of COVID-19 vaccine

If the agency signs off, some people could start receiving it within weeks.

A passerby outside Pfizer headquarters in New York on Monday.Ted Shaffrey/Associated Press

Pfizer and its German partner BioNTech on Friday applied to the Food and Drug Administration to allow emergency use of their experimental COVID-19 vaccine, saying that people at high risk for exposure to the disease or most vulnerable to it could start getting shots “by the middle to the end of December.”

The partners are the first drugmakers to seek “emergency use authorization” for a vaccine to help end the pandemic that has killed more than 1.3 million people globally, including over 250,000 Americans.

“Our work to deliver a safe and effective vaccine has never been more urgent, as we continue to see an alarming rise in the number of cases of COVID-19 globally,” said Albert Bourla, chief executive of Pfizer, whose company released data Wednesday from a late-stage clinical trial suggesting that the vaccine appeared to be 95 percent effective at preventing the disease.

“Filing in the US represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world, and we now have a more complete picture of both the efficacy and safety profile of our vaccine, giving us confidence in its potential,” he added.

The FDA will review data on the safety and effectiveness of the vaccine and also consult an outside panel of vaccine experts, a process that could take weeks. The companies said they “will be ready to distribute the vaccine within hours after authorization.”

BioNTech, a biotechnology company in the German city of Mainz that created the vaccine and formed a partnership with Pfizer to test and manufacture it, is working with the drug giant on applications to other regulatory agencies around the world.

Pfizer has said it expects to produce up to 50 million doses this year worldwide, enough for 25 million people, given that the regimen requires two doses three weeks apart.

Initial doses are likely to go to people at high risk for catching COVID-19, such as health care workers, and those most likely to suffer severe cases of the disease, including the elderly and people with underlying health conditions.

If approved by the FDA, the vaccine isn’t expected to be available to most Americans until the spring or summer of 2021.

Cambridge-based biotech Moderna has said it also plans to seek an emergency use authorization “in the coming weeks.” It released interim results Monday from its own late-stage trial suggesting that its two-dose vaccine was 94.5 percent effective, roughly the same as the one developed by Pfizer and BioNTech.

Both vaccines rely on synthetic messenger RNA, an ingenious variation on the natural substance that directs protein production in cells throughout the body. The vaccines contain custom-made messenger molecules that instruct cells to create a part of the coronavirus. That stimulates the immune system to make antibodies to fend off the disease if people encounter the actual virus. No mRNA vaccine has ever been approved.

If the FDA approves Pfizer’s emergency use request, attention will quickly turn to how the vaccine is distributed. It must be stored at minus 94 degrees Fahrenheit, colder than any other vaccine in development. Pfizer plans to ship the vaccine in special boxes of 1,000 to 5,000 doses that are stuffed with dry ice and equipped with GPS-enabled sensors. Pfizer’s vaccine can be stored in conventional freezers for up to five days, or in the special coolers for up to 15 days.

Moderna’s vaccine also must be kept in a freezer for long-term storage, but at minus 4 degrees Fahrenheit. The 10-year-old company said Monday that its vaccine could be stored at standard refrigerator temperatures of 36 to 46 degrees for up to 30 days, which could make it easier to store than the Pfizer vaccine.

Pfizer, a 171-year-old Fortune 500 powerhouse, has about 2,400 employees in Massachusetts, including 1,400 at an Andover manufacturing plant that is helping to make the vaccine.

There are a dozen coronavirus vaccine candidates in late-stage trials worldwide that use a variety of approaches, and no company could produce enough of one to protect the world’s 7.8 billion people. The Pfizer and Moderna vaccines have been the only ones to report any results from late-stage trials.