Pfizer’s vaccine
FDA approves emergency use
WASHINGTON — The U.S. gave the final go-ahead Friday to the nation’s first COVID-19 vaccine, marking what could be the beginning of the end of an outbreak that has killed nearly 300,000 Americans.
Shots for health workers and nursing home residents are expected to begin in the coming days after the Food and Drug Administration authorized an emergency rollout of what promises to be a strongly protective vaccine from Pfizer Inc. and its German partner BioNTech.
Initial doses are scarce and rationed as the U.S. joins Britain and several other countries in scrambling to vaccinate as many people as possible ahead of a long, grim winter. It will take months of work to tamp down the coronavirus that has surged to catastrophic levels in recent weeks and already claimed 1.5 million lives globally.
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 U.S. history — but it also has global ramifications because it’s a role model to many other countries facing the same decision.
It offers the ability “in this situation where the pandemic is out of control, to bring hope to the people,” Dr. Ugur Sahin, CEO of BioNTech, told The Associated Press.
In a still unfinished study of nearly 44,000 people, the FDA found the vaccine was safe and more than 90 percent effective across recipients of different ages, including older adults, races and those with health problems that put them at high risk from the coronavirus. It’s authorized for people age 16 and up.
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 health workers with a history of severe allergies. The FDA said people must have treatments for allergic reactions on hand before they are administered the COVID-19 vaccine, and not give it to those with a known history of severe allergic reactions to any of its ingredients.
¯ Every vaccine recipient must be given an FDA-written fact sheet about the vaccine and its known risks and benefits.
¯ FDA didn’t forbid the vaccine’s use in pregnant women but noted there isn’t enough evidence to determine its safety in that group.
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.