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Biontech and Pfizer vaccine receive emergency approval in the US.
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According to various US media outlets, the White House was pressuring the drug agency to get approval for the corona vaccine.
Source: AFP / JOEL SAGET
The US Food and Drug Administration (FDA) granted the vaccine from Mainz-based biotech company BioNTech and its partner Pfizer an emergency approval Friday night. Previously, the White House is said to have urged the FDA chief with threats for immediate emergency approval.
meA corona vaccine has been approved for the first time in the U.S. The U.S. Food and Drug Administration (FDA) granted the vaccine from Mainz-based biotech company BioNTech and its partner Pfizer emergency approval on Friday night. This applies to people over the age of 16, the FDA announced. The first vaccines are expected in the next few days.
According to media reports, the White House is said to have previously urged FDA chief Steven Hahn with threats for immediate emergency approval of the corona vaccine. The Washington Post reported that White House Chief of Staff Mark Meadows asked Hahn on Friday to submit the resignation if the vaccine from Mainz-based company Biontech and its US partner Pfizer was not approved before the end of the day (local time).
The New York Times reported that Meadows had told Hahn that if he didn’t, he should consider looking for another job.
Several US media confirmed the reports. Hahn himself spoke in a statement to the US media, on the other hand, of “a false representation of the telephone conversation with the chief of staff.” The FDA had been “encouraged” to expeditiously process the Biontech and Pfizer application. “The FDA is determined to grant this approval quickly.” The New York Times reported that the agency had originally planned approval for Saturday morning. It is unclear what the benefits are of speeding up approval in half a day.
US President-elect Donald Trump also increased pressure on the FDA on Friday. He criticized the authority as a “big, old, slow tortoise.” He wrote on Twitter: “Give the damn vaccines now, Dr. Gallo. Stop playing games and start saving lives !!!” Trump had repeatedly lobbied the agency in the past to approve corona vaccines and therapies. , and was criticized for it.Trump also sees the rapid development of a corona vaccine as his success.
An FDA advisory committee had ruled Thursday in favor of granting emergency approval of the vaccine for Biontech and Pfizer for people 16 years of age and older. In the meeting held by video link, 17 of the experts voted in favor of admission, 4 voted against. The recommendation of the advisory committee is not binding, but the authority generally follows the recommendations of the experts. It is now the first corona vaccine approved in the United States. The United States government had contractually secured the delivery of 100 million doses of Pfizer / Biontech vaccines.
On Wednesday, the number of deaths in the United States had surpassed 3,000 in a single day for the first time since the pandemic began. According to statistics from Johns Hopkins University, the number of new registered infections was more than 200,000 in recent days. Future US President Joe Biden announced on Tuesday a 100-day program to combat the pandemic, which he plans to implement immediately after taking office on January 20. Part of the plan is to administer at least 100 million doses of a vaccine by that time.
Biden called the high number of coronavirus deaths a “tragic milestone.” “More than 3,000 deaths in a single day, the highest death toll during this pandemic,” he said Friday in Wilmington, Delaware. “That’s more deaths in a single day than we had on September 11 or at Pearl Harbor.” In his comments, Biden referred to the September 11, 2001 attacks in New York and Washington, as well as the Japanese attack on Pearl Harbor. (Hawaii) in December 1941. He again asked the Congress of the United States to end the months of tug of war and decide on a new aid package in the crisis.
Modern pharmaceutical company announced on Friday that the US government was purchasing another 100 million doses of its candidate vaccine. These cans would be delivered in the second quarter of next year. Of the first 100 million units already purchased by the US, 20 million would ship this month, the remaining 80 million in the first quarter of 2021. The US would also have the option to purchase another 300 million cans of Moderna. . The Moderna vaccine has not yet been approved by the FDA.
