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reThe US pharmaceutical agency FDA granted emergency approval to the corona vaccine from Mainz-based pharmaceutical company Biontech and its US partner Pfizer. The FDA announced Friday night (local time). The agency had already announced Tuesday that it classified the vaccine as safe and effective.
The companies submitted an application for approval to the FDA in November. They were the first Western manufacturers to publish promising study results and apply for emergency approval from the FDA. An application has also been submitted to the European Medicines Agency (Ema) for the approval of the corona vaccine in the EU, a decision on this is still pending.
US President Donald Trump announced that the first vaccines would be given “in less than 24 hours.” In a speech posted on Twitter, Trump said his administration had already started shipping the vaccine to all states. Its governors would decide who gets vaccinated first. He is proud to say that the vaccine is free to all Americans.
Trump praised the vaccine as a result of “Operation Warp Speed.” In fact, however, it was developed without any funding from the US government.
Trump put massive pressure on the FDA on Friday to issue the emergency approval immediately. FDA chief Stephen Hahn should get “the damn vaccines out NOW,” Trump wrote on Twitter. According to multiple media reports, Trump’s chief of staff, Mark Meadows, asked Hahn to resign immediately if approval was not granted on Friday. The authority’s decision was originally expected by the weekend.
Republican Trump lost the election to Democrat Joe Biden on November 3. Experts also attribute this to Trump’s crisis management of the pandemic, which Americans have been giving poor grades in polls for months. Biden is due to be sworn in on January 20. Immediately afterwards, the Democrat wants to start a 100-day plan to combat the corona virus. Part of the program is to administer at least 100 million doses of a vaccine within this period.
The pandemic remains out of control in the United States. By Wednesday, the number of deaths in a single day had exceeded 3,000 for the first time. Calling the number of deaths from coronavirus a “tragic milestone,” Biden said: “There are more deaths in a single day than we had on September 11 or at Pearl Harbor.” Biden was referring to the attacks of September 11, 2001 in New York and Washington, as well as the Japanese attack on Pearl Harbor (Hawaii) in December 1941. According to statistics from Johns Hopkins University, the number of new infections recorded in the country it was more than 200,000 in recent days.
Already approved in several countries
In early December, the UK Pharmaceuticals Regulatory Authority granted emergency readiness approval for Biontech / Pfizer. Britain became the first state in the world to approve the vaccine. Meanwhile, Canada, Bahrain and Saudi Arabia, among others, have approved the vaccine.
Pfizer / Biontech’s so-called mRNA vaccine is about 95 percent effective based on an extensive series of tests, as announced by the manufacturers. This means that 95 percent fewer illnesses occurred among subjects in the vaccinated group than among subjects in the control group. Meanwhile, the study has also been published in the renowned “New England Journal of Medicine” (NEJM).
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According to the manufacturer, the vaccine works equally well in all age groups and other demographic differences and shows virtually no serious side effects. The tests had examined protection against Covid 19 disease.
Conditional approval, as is the current case for the Biontech vaccine, is intended to meet urgent medical needs. Applicants may obtain conditional approval in the interest of public health if the benefits outweigh the risk posed by less data than is normally required. Missing data, for example on long-term efficacy or on certain subgroups, should be submitted as soon as possible.
After the emergency approval in the United States, the head of Biontech, Ugur Sahin, now sees the biggest task in expanding production. “We have to solve this manufacturing challenge,” Sahin told Reuters. “It is very clear that more cans are needed. And we are concerned with the question of how we can produce more cans. “
Biontech and Pfizer had announced that they would make up to 50 million doses of vaccines this year and up to 1.3 billion next year.
