The United States gave the final go-ahead to the country’s first COVID-19 vaccine, marking what could be the beginning of the end of an outbreak that has killed nearly 300,000 Americans.
Vaccines for healthcare workers and nursing home residents are expected to begin in the next few days after the Food and Drug Administration authorized an emergency launch of what promises to be a strongly protective vaccine from Pfizer Inc. and its German partner BioNTech.
Starting doses are meager and rationed as the United States joins Britain and several other countries in the fight to vaccinate as many people as possible ahead of a long and bleak winter. It will take months of work to control the coronavirus that has skyrocketed to catastrophic levels in recent weeks and has already claimed 1.5 million lives worldwide.
While the FDA’s decision came only after public review of data from an ongoing large study, it has also been haunted by intense political pressure from the Trump administration, which has accused the agency of being too slow and He 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 is a role model for 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 people,” Dr. Ugur Sahin, BioNTech CEO, told The Associated Press.
The world desperately needs multiple vaccines to make enough, and the Pfizer-BioNTech injection is the first rigorous, scientifically-based injection to emerge from that global race – a record-setting scientific achievement that cut years off the usual process.
“I don’t think I would have found a scientist on this planet who 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 United States is considering a second vaccine, made by Moderna Inc., which could launch in another week. In early January, Johnson & Johnson hopes to find out if its vaccine is working in final tests.
Europe is ready to make its own decision on the Pfizer-BioNTech and Moderna takeovers later this month, an important step as some other candidates that several countries eagerly awaited have run into roadblocks. On Friday, Sanofi and GSK announced a delay of months after the first tests showed that their vaccine did not work well enough in older adults.
And China and Russia didn’t wait for end-stage testing before starting vaccines with some homegrown injections.
President Donald Trump said Friday night that Pfizer had “exceeded the gold standard for safety” in a video statement praising the vaccine as “one of the greatest scientific achievements in history.”
About 3 million doses of the Pfizer-BioNTech vaccine are expected in the first shipments across the country, according to officials with Operation Warp Speed, the Trump administration’s vaccine development program. A similar amount will be kept in reserve for the second dose of those recipients.
The government is still working on final recommendations, but health workers and nursing homes are expected to follow other essential workers, older adults and people at high risk due to other health problems. US officials aren’t waiting long enough for the general population before spring, and that’s assuming no manufacturing flaws.
“We would need at least until March, April, to have an impact on the pandemic,” said Sahin of BioNTech. But he predicted that protecting the most vulnerable could start to take a toll on hospitals and deaths sooner.
In an unfinished study of nearly 44,000 people, the FDA found the vaccine to be safe and more than 90% effective in recipients of different ages, including older adults, races, and people with health problems that put them at high risk for contracting the coronavirus. It is authorized for people over 16 years of age.
Emergency use means the vaccine is still experimental. The most important thing for potential recipients is to know:
– Some protection begins after the first dose, but a second dose is needed three weeks later for full protection. It is not clear how long the protection lasts.
—The vaccine protects against the COVID-19 disease, but no one knows yet if it can stop the silent and asymptomatic spread that accounts for about half of all cases. The ongoing study will attempt to answer that, but for now, those vaccinated will still need to wear a mask and keep their distance.
—Expect arm pain 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 is just your immune system working. It’s a good thing, ”Offit said.
—The authorities are investigating several allergic reactions reported in Britain by healthcare workers with a history of severe allergies. The FDA said that people should have treatments for allergic reactions on hand before they are given the COVID-19 vaccine, and not give it to those with a known history of severe allergic reactions to any of its ingredients.
—Every recipient of the vaccine should receive a fact sheet written by the FDA about the vaccine and its known risks and benefits.
—The FDA did not ban the use of the vaccine in pregnant women, but noted that there is not enough evidence to determine its safety in that group.
If the emergency use of Moderna’s vaccine is also authorized, the United States 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.
Globally, Sahin said production should increase sharply in February, with Pfizer and BioNTech projecting 120 million to 130 million doses per month to reach 1.3 billion doses in 2021.
Bringing injections to arms is the big challenge, especially since a new poll from The Associated Press-NORC Public Affairs Research Center found that only half of Americans want the vaccine when it’s their turn. About a quarter say they won’t make it, and the rest aren’t sure.
Political interference has complicated the message from health authorities that the tests were rigorous and did not cut corners.
Trump again criticized the FDA on Friday for taking too long, complaining that the agency “is still a big, old, slow turtle.” One of his aides even pressured Hahn to clear the shots at the end of the day or he would face possible firing, two administration officials said.
The FDA is unique in analyzing raw data from drug manufacturers, a process that takes more time than regulatory reviews in many other countries. In addition, the FDA insisted that large studies of the COVID-19 vaccine track at least half of the participants for two months to look for side effects, a period of time in which historically any problems with the vaccine appear.