First Corona vaccine now approved in the USA

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The drug from German pharmaceutical company Biontech and its U.S. partner Pfizer has become the first Corona vaccine to receive emergency approval in the United States. The vaccine can now be used in people 16 and older, the U.S. Food and Drug Administration (FDA) announced Friday evening (local time). FDA chief Stephen Hahn spoke of a “significant milestone in the fight against this devastating pandemic.”

According to media reports, the White House had previously used threats to push the FDA for immediate emergency approval. According to the report, U.S. President-elect Donald Trump promised his countrymen the first vaccinations this weekend following the approval. “The first vaccine will be administered in less than 24 hours,” Trump announced in a video posted on Twitter. He said his administration has already begun shipping the vaccine. Trump stressed vaccinations are free for all Americans.

Referring to the vaccine’s development in record time, Trump said, “This is one of the greatest scientific achievements in history.” The vaccine, he said, will save millions of lives “and soon end the pandemic once and for all.”

Trump presented the development as a success of his administration, saying the U.S. was “the first country in the world” to produce a proven safe and effective vaccine. However, this is untrue, especially since the U.S. company Pfizer was a partner in the development of the vaccine by the German company Biontech. The drug is already being produced outside the U.S. and is even being used in some countries.

Pfizer and Biontech had submitted an application for emergency approval to the FDA last month. They were the first Western manufacturers to publish promising study results and apply for such approval. An application has also been submitted to the European Medicines Agency (Ema) for approval of the Corona vaccine in the EU, although a decision on this is still pending.

Earlier this month, the UK Medicines Regulatory Agency had already granted emergency approval to the Biontech/Pfizer preparation. This made the UK the first country in the world to release this vaccine. Canada, Bahrain, Saudi Arabia and Mexico have since followed suit. Russian and Chinese vaccines are also already in use.

The White House reportedly pressed FDA chief Hahn with threats Friday for immediate approval of the vaccine, according to consistent media reports. The “Washington Post” reported that White House Chief of Staff Mark Meadows told Hahn to resign if the Biontech/Pfizer vaccine is not approved before the end of the day. The New York Times reported Meadows told Hahn to otherwise consider looking for another job.

Hahn himself, on the other hand, in a statement to U.S. media, spoke of “an untrue account of the phone call with the chief of staff.” He said the FDA was “encouraged” to move quickly on Biontech and Pfizer’s application. The New York Times reported that the agency had scheduled approval for Saturday morning. It was unclear what the benefits of accelerating approval by half a day would be, it said.

Trump himself had increased pressure on the FDA on Friday. He criticized the agency as a “big old slow turtle.” On Twitter, he wrote: “Give the damn vaccines out now, Dr. Hahn. Stop playing games and start saving lives!!!” Trump had pressured the agency several times in the past regarding the approval of Corona vaccines and therapies. He had been sharply criticized for doing so.

Republican Trump lost the U.S. election Nov. 3 to Democrat Joe Biden. Experts also attribute that to Trump’s crisis management in the pandemic, which Americans have given a poor report card to in polls for months. Biden is scheduled to be sworn in on Jan. 20. The Democrat plans to launch a 100-day plan to fight the coronavirus immediately afterward. Part of the program is to administer at least 100 million doses of a vaccine during that period.

The pandemic remains out of control in the United States. On Friday, more than 3300 deaths were reported in a single day, a new record. On Wednesday, the U.S. death toll had surpassed 3000 for the first time. Biden called the peak in coronavirus deaths a “tragic milestone” and said, “That’s more deaths in a single day than we had on 9/11 or Pearl Harbor.” Biden was referring to the Sept. 11, 2001, attacks in New York and Washington and the Japanese attack on Pearl Harbor, Hawaii, in December 1941.

The U.S. government has contractually secured the supply of 100 million vaccine doses from Pfizer/Biontech. U.S. pharmaceutical company Moderna said Friday the U.S. government is buying another 100 million doses of its vaccine candidate. Those doses would be delivered in the second quarter of next year.

Of the first 100 million units already purchased by the U.S., 20 million would be delivered by Moderna this month and the remaining 80 million in the first quarter of 2021. The U.S. would also have the option to buy 300 million more doses from Moderna. The Moderna vaccine still must be approved by the FDA. An advisory committee plans to discuss that next Thursday.

  • hp, Source: kurier.at. picture: pixabay.com
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