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The United States has given 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 deployment of what promises to be a strongly protective vaccine from Pfizer and its German partner BioNTech.
Frank Augstein / AP
The US regulator approved the Pfizer-BioNTech Covid-19 vaccine.
In a video announcing the approval, US President Donald Trump said the United States had achieved a “medical miracle” and praised the vaccine as “one of the greatest scientific achievements in history.”
“It will save millions of lives and will soon end the pandemic once and for all,” Trump said, adding that the first person will receive it in “less than 24 hours.”
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“The pandemic may have started in China, but we are ending it right here in the United States.”
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 exploded 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 science-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, which could be launched 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.
Bill Sikes / AP
Moderna said it will ask European regulators to allow emergency use of its Covid-19 vaccine, as the results of a new study confirm that the injections offer robust protection.
And China and Russia didn’t wait for end-stage testing before starting vaccines with some homegrown injections.
About 3 million doses of the Pfizer-BioNTech vaccine are expected in the first shipments into the United States, according to officials with Operation Warp Speed, the Trump administration’s vaccine development program. A similar amount will be reserved for the second dose of those recipients.
An advisory committee from the US Centers for Disease Control and Prevention is prepared to recommend who is first in line. Healthcare workers and nursing homes are expected to follow other essential workers, older adults, and people at high risk due to other health problems. The US authorities are not waiting long enough for the general population before spring, and that’s assuming there are no manufacturing problems.
“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 percent effective in recipients of different ages, including older adults, races, and people with health problems that put them at high risk for get the coronavirus.
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 Covid-19 disease, but no one yet knows 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.
- Authorities are investigating a number of allergic reactions reported in Britain by people with a history of severe allergies. Offit said it is routine in the US for vaccinates to stay for half an hour so they can receive immediate treatment if such reactions appear.
If the emergency use of Moderna’s vaccine is also authorized, the US hopes 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 between 120 and 130 million doses a month to reach 1.3 billion doses in 2021.
Putting guns 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 get it and the rest aren’t sure.
Political interference has complicated the message from health authorities that the tests were rigorous and didn’t cut corners.
US President Donald 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 longer 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.
