The decision does not come as a surprise. In the struggle with the corona pandemic, the USA is taking a big step. The country with thousands of deaths and hundreds of thousands of infections a day now has a vaccine. Most recently, the White House had put massive pressure on the agency. In the fight against the corona pandemic, the USA now has an approved vaccine. The US drug agency FDA has given the vaccine from the German company Biontech and its partner Pfizer an emergency approval. This applies to people aged 16 and over, the FDA announced. The US government has already secured 100 million vaccine doses worth around $ 1.95 billion. There is also the option to purchase an additional 500 million cans. US President Donald Trump has announced that vaccinations will start within 24 hours. A conditional approval as now granted is intended to satisfy urgent medical needs. Missing data, for example on long-term effectiveness or on certain subgroups, must be submitted as soon as possible. An application has also been made to the European Medicines Agency (Ema) for approval of the corona vaccine in the EU; a decision on this is still pending. At the beginning of December, the British regulatory authority for pharmaceuticals had granted the Biontech / Pfizer preparation emergency approval.

The decision in the US follows the FDA’s expert hearing. On Thursday, an advisory committee of the authority had spoken out in favor of granting emergency approval of the vaccine for people aged 16 and over. At the meeting held via video link, 17 of the experts voted for admission, 4 voted against. The recommendation of the advisory committee is not binding, but the authority usually follows the recommendations of the experts.

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At the same time, according to media reports from the White House, the FDA chief, Steven Hahn, has threatened to press for immediate emergency approval of a corona vaccine. The Washington Post reported that Chief of Staff Mark Meadows had asked Hahn to submit the resignation if the vaccine was not approved on Friday (local time). The New York Times reported that Meadows had told Hahn that if he did not, he should consider looking for another job. Several US media confirmed the reports. Admission will now take place on late Friday (local time). Hahn himself spoke in a statement to the US media about “an untrue representation of the phone call with the chief of staff”. The FDA was “encouraged” to process the application quickly. “The FDA is determined to get this approval swiftly.” The “New York Times” reported that the authority had originally planned the approval for Saturday morning. It is unclear what the advantages of accelerating approval by half a day.

“Big, Old, Slow Turtle”

The elected US President Donald Trump had also increased the pressure on the FDA. 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 repeatedly exerted political pressure on the agency in the past with regard to the approval of corona vaccines and therapies and was sharply criticized for this. Trump also sees the rapid development of a corona vaccine as his success. On Wednesday, the number of deaths in the United States had exceeded 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 infections registered was more than 200,000 in the past few days.

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The so-called mRNA vaccine from Pfizer / Biontech has an effectiveness of around 95 percent according to extensive test series, as the manufacturers had announced. This means that 95 percent fewer diseases occurred among the subjects in the vaccinated group than among the subjects in the control group. The study has since been published in the renowned “New England Journal of Medicine” (NEJM). According to the manufacturer, the vaccine works equally well across all age groups and other demographic differences and shows practically no serious side effects. The tests examined the protection against Covid-19 disease.

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