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The United States gave the final go-ahead to the Pfizer / BioNTech Covid-19 vaccine last night.
Jabs for healthcare workers and nursing home residents are expected to begin in the next few days after the Food and Drug Administration (FDA) authorized an emergency release of the vaccine.
It came hours after White House Chief of Staff Mark Meadows lobbied FDA Chief Stephen Hahn to grant an emergency use authorization for Pfizer’s vaccine at the end of the day or faces a possible dismissal, according to two administration officials.
Meadows spoke with Dr. Hahn by phone on Friday and told him his job was in jeopardy if the emergency use authorization was not issued by Saturday, according to a senior Trump administration official who spoke to The Associated Press on condition. of anonymity.
It is understood that the ultimatum came at the order of President Donald Trump.
The threat marked the latest attempt by the Trump administration to override government scientists working to combat the deadly pandemic.
Even with an FDA decision expected in a few hours, Trump and his deputies proved unwilling to let regulators work on their careful review, which includes drafting safety warning labels and instructions for physicians.
Dr. Hahn questioned these characterizations of his conversation with Meadows as “false”.
But Trump tweeted directly to Dr. Hahn early Friday, complaining that the FDA “is still a big, old, slow turtle.” Trump has publicly criticized the pace of the FDA’s vaccine review process.
“Get the vaccines out of the dam NOW, Dr. Hahn,” Trump tweeted.
“Stop playing and start saving lives.”
Initial doses of the approved vaccine in the US are scarce and rationed as the country joins Britain and several other nations in the fight to vaccinate as many people as possible ahead of a long winter and somber.
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.
The move sets off what will be the largest vaccination campaign in US history, but it also has global ramifications as 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.
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Other vaccine
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.
Both China and Russia did not wait for end-stage testing before starting vaccines with some homegrown injections.
Trump said Friday night that Pfizer had “exceeded the gold standard for safety” in a video statement that hailed 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 nationwide, 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.
The government is still deciding final recommendations, but health care and nursing home workers 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.
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