OPERATION WARP SPEED PFIZER TRIAL
But it’s unclear when the trial hit that number. If Pfizer hadn’t raised its threshold in response to the FDA’s recommendations, it’s possible it could’ve hit the lower bar of 32 positive cases before the Nov. The FDA has been under pressure from scientists to set tough standards for a vaccine so that Americans will feel it has been rigorously vetted and is safe to use. Food and Drug Administration on what would be acceptable to gain approval. After that, it revised its trial protocols to raise that threshold higher, after consulting with the U.S. 27, a week before Election Day, that it hadn’t met the threshold for positive cases that would’ve allowed it to report the data. and Texas Senator Ted Cruz, questioned the timing of Pfizer’s release of its positive data on Monday, almost a week after the presidential election - with the implication that the information could’ve changed the outcome and tipped the scales toward President Donald Trump, who lost to former Vice President Joe Biden. Some Republicans, including Donald Trump Jr. The Trump administration’s rapid-vaccine operation, led by the Health and Human Services Department, the Defense Department, and other agencies, could well prove to be the reason many Americans get a vaccine in 2021, even if it’s not made by Pfizer. Operation Warp Speed is credited with speeding along several other vaccine programs, including one from Moderna Inc.that uses similar technology to Pfizer’s and could produce trial data later this month. The company has designed reusable containers that can keep the doses at ultracold temperatures, and is organizing trucks and flights to move them. While most vaccine front-runners that have been tapped by Warp Speed will distribute their doses through a government partnership with McKesson Corp., Pfizer is handling its own delivery of its products. gets to decide who gets the vaccine first, and will work with the company on logistical support.
The Trump administration agreed in July to pay almost $2 billion for 100 million doses, with an option to acquire as many as 500 million more, once that clearance comes.Īs part of that agreement, the U.S. did, meanwhile, was commit to buying hundreds of millions of vaccines in advance to ensure Americans were among the first in line if it clinches an emergency-use authorization or approval from the FDA.
OPERATION WARP SPEED PFIZER FREE
Subscribe to The Capsule, a weekly brief monitoring advances in health care and biopharma, delivered free to your inbox. Berlin gave the German company $445 million in an agreement in September to help accelerate the vaccine by building out manufacturing and development capacity in its home market.
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