The US Food and Drug Adminstration on Friday granted the Pfizer-BioNTech Covid-19 vaccine an emergency use authorization, paving the way for its imminent rollout across the country.
“I am authorizing the emergency use of Pfizer-BioNTech COVID-19 Vaccine for the prevention of Covid-19,” Denise Hinton, the agency’s chief scientist wrote in a letter to a Pfizer executive.
Shots for health workers and nursing home residents are expected to begin in the coming days after the FDA authorized an emergency rollout of what promises to be a strongly protective vaccine from Pfizer Inc. and its German partner BioNTech.
While the FDA decision came only after public review of data from a huge ongoing study, it has also been dogged by intense political pressure from the Trump administration, which has accused the agency of being too slow and even threatened to remove FDA chief Stephen Hahn if a ruling did not come Friday.
The move sets off what will be the largest vaccination campaign in US history — but it also has global ramifications because it’s a role model to many other countries facing the same decision.
The US is considering a second vaccine, made by Moderna Inc., that could roll out in another week. In early January, Johnson & Johnson expects to learn if its vaccine is working in final testing.
About 3 million doses of the Pfizer-BioNTech vaccine are expected in the first shipments around the country, according to officials with Operation Warp Speed, the Trump administration’s vaccine development program. A similar amount is to be held in reserve for those recipients’ second dose.
A Centers for Disease Control and Prevention advisory committee is poised to recommend who’s first in line. Expected to follow health workers and nursing homes are other essential workers, older adults and people at high risk because of other health problems. U.S. authorities don’t expect enough for the general population before spring, and that’s assuming there are no manufacturing glitches.
In a still unfinished study of nearly 44,000 people, the FDA found the vaccine was safe and more than 90% effective across recipients of different ages, including older adults, races and those with health problems that put them at high risk from the coronavirus.
Emergency use means the vaccine still is experimental. Most important for would-be recipients to know:
- Some protection begins after the first dose, but it takes a second dose three weeks later for full protection. It’s unclear how long protection lasts.
- The vaccine protects against COVID-19 illness, but no one yet knows if it can stop the silent, symptomless spread that accounts for roughly half of all cases. The ongoing study will attempt to answer that but for now, the vaccinated still will need to wear a mask and keep their distance.
- Expect a sore arm and some flu-like symptoms such as fever, fatigue, headache and chills after the second dose. While uncomfortable, those reactions only last about a day. “That’s just your immune system working. It’s a good thing,” Offit said.
- Authorities are investigating several allergic reactions reported in Britain by people with a history of severe allergies. Offit said it is routine in the U.S. for the vaccinated to stick around for a half-hour so they could get prompt treatment if such reactions appear.
If emergency use of Moderna’s vaccine also is authorized, the U.S. expects to vaccinate 20 million people by the end of December. They hope to have enough for another 30 million people in January and 50 million in February.