The U.S. Food and Drug Administration (FDA) 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. Spokesperson Dr. Mark Heinz from the FDA in a Saturday morning webcast with journalist said, “our review took weeks as apposes to months under a normal review process.”
When ask by a journalist about the integrity of the manufacturing facilities that are producing the vaccines, Dr. Heinz responded, “because this is an emergency use authorization, onsite inspections were not conducted.”
There were some expressed concerns by journalists as to the affects of the vaccines on teenagers, to which the FDA responded that actual affects on teenagers won’t be know for months until they can accumulate sufficient data to extrapolate some analysts.
Shots for health workers and nursing home residents could begin in less than 24 hours 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.
“The FDA’s authorization for emergency use of the first COVID-19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world,” Dr. Stephen M. Hahn, FDA commissioner, said in a statement.
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.
“Vaccines will help bring this pandemic to an end, which is all the more reason to double down on the public health measures we need to stay safe in the coming months,” Health and Human Services Secretary Alex Azar said in a statement late Friday. “As Americans get vaccinated, we need to continue taking steps like washing our hands, social distancing, and wearing face coverings to protect ourselves, our loved ones, and our communities.”
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. Why was the UK first to authorize Pfizer’s coronavirus vaccine?
The move sets off what will be the largest vaccination campaign in U.S. history. The vaccine will be delivered through two doses to each person that are three weeks apart, the FDA said.
It also has global ramifications because it’s a role model to many other countries facing the same decision.
The world desperately needs multiple vaccines for enough to go around, and the Pfizer-BioNTech shot is the first based on rigorous scientific testing to emerge from that worldwide race — a record-setting scientific achievement that shaved years off the usual process.
President Donald Trump called it a medical miracle.
“Efforts to speed vaccine development have not sacrificed scientific standards or the integrity of our vaccine evaluation process,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement Friday.
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.
Pfizer CEO Albert Bourla said the first doses will be shipped immediately, using three Pfizer manufacturing sites that include St. Louis, Missouri, Andover, Massachusetts and Kalamazoo, Michigan. The company also said in a statement that its Pleasant Prairie, Wisconsin site is among the other facilities also being used.Play Video
The U.S. 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.
Europe is set to make its own decision on the Pfizer-BioNTech and Moderna shots later this month, an important step as some other candidates that multiple countries were anxiously awaiting have hit roadblocks. Friday, Sanofi and GSK announced a months-long delay after early tests showed their vaccine didn’t work well enough in older adults.
And China and Russia didn’t wait for final-stage tests before beginning vaccinations with some homegrown shots.
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. What does COVID-19 vaccine effectiveness mean?
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.
Getting shots into arms is the big challenge, especially as a new poll from The Associated Press-NORC Center for Public Affairs Research found only half of Americans want the vaccine when it’s their turn. About a quarter say they won’t get it and the rest aren’t sure.
Political interference has complicated health authorities’ message that the testing was rigorous and cut no corners.
Trump bashed the FDA, again, Friday for taking too long, complaining that the agency “is still a big, old slow turtle.” One of his deputies even pressed Hahn to clear the shots by the end of the day or face possible firing, two administration officials said.
The FDA is unique in analyzing drugmakers’ raw data, a process that takes longer than many other countries’ regulatory reviews. In addition, the FDA insisted that large COVID-19 vaccine studies track at least half the participants for two months to look for side effects, a time period when historically any vaccine problems appear.