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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, according to a person familiar with the decision but not authorized to discuss it publicly.
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.
The state of Indiana is set to receive more than 55,000 doses of the COVID-19 vaccine next week, but officials said earlier this week it won’t be nearly enough to vaccinate all 400,000 of the state’s health care workers.
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.
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.
“I don’t think you would have found a scientist on this planet that would have predicted this 11 months ago,” said Dr. Paul Offit, a vaccine expert at Children’s Hospital of Philadelphia who advises the FDA.
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.
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.
President Donald 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.
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The vaccine cannot be available to the public soon enough. Our lives have been on hold and our businesses have suffered enough.
All you Trump-haters will note that this was accomplished through Trump’s Operation Warp Speed, co-operating with and encouraging private enterprise…and as a result, projected and promised, will be available in limited quantities by the end of the year. And for that, he gets run out of office by a dementia-compromised lifetime politician whose modest accomplishments can be measured on one hand with fingers left over; a man who has done nothing of significance in 47 years of slurping at the public trough and running his mouth when it isn’t slurping.
No, he got run out of office by over 81,283,495 voters who felt having a mentally deranged, lying, cheating, narcissist in the White House was no longer a good idea. Trump sunk himself. Had he even once shown he was anything close to a decent human being, who could put his inflamed ego to the side for even a few minutes, and let the professionals handle the Pandemic, there is no way a do nothing old man like Biden would have won.
Bob P, you’re delusional. Just like Trump. What if this Pfizer vaccine were found to have serious, life-altering side effects. Trump didn’t do the research. Armies of scientists and brave volunteers made this happen. Trump’s harsh, punitive and cold-blooded goons in the White House are only pushing the FDA this hard so that buffoon can say “he” brought the vaccine. Right…and Al Gore invented the internet. As for the election, Donald Trump didn’t lose to Joe Biden. He lost to himself – the arrogant, childish, faux-savior of the Middle Class, revenge-seeking Trump that cannot get out of his own way.
OK, you terminal Trump-haters: Exactly what should Trump’s administration have done with the pandemic? Please, no more rants about his being a narcissist or anything, just YOUR specifics as to what YOU, in all your endowed brilliance as armchair quarterbacks, think SHOULD have been done that was different than what WAS done. (I’m not holding my breath waiting for a cognizant answer…)
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Easy. He should not have tried to discredit every single medical professional that said something he didn’t like. He should have been honest from the beginning as to the seriousness of the Virus, instead of continually acting like it was no big deal in February and March. When in fact he knew at the end of January (proven later by tapes of him speaking with Bob Woodward) that the virus was very deadly, is transmitted in the air, and that children were not immune. He should have let states do what they felt was best for them instead of threatening every Governor that did something he didn’t like. He should not have turned it into a political issue, it is a medical issue. He lied daily about it. It’s a media and Democrat hoax trying to hurt me. Summer will kill it. Ingesting bleach will kill it. It will be gone by Sept. It will be gone the day after the election. We are rounding the the corner. He cared more about the stock market staying up, then the infection rates going down. In summation, all he had to do was keep his mouth shut and let the people he had assigned to handle it, actually handle it. But his ego wouldn’t let him.
And save your self righteous act. You are no different with your Biden-hate and “dementia-compromised” rant. Trump would have four more years if he wasn’t everything I said in my first response. I mean really, look who beat him. Most people didn’t vote for Biden. They voted against Trump. And that is solidly Trump’s fault. He had the country rocking. But then proved he was totally incapable of handling a national crisis, almost criminally so. That cost him the election. And, stuck us with Biden.