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The US Food and Drug Administration (FDA) granted emergency approval of the corona vaccine from Pfizer and Biontech. According to President Trump, the first vaccinations should now take place within 24 hours.
The US Food and Drug Administration (FDA) granted emergency approval to the corona vaccine from Mainz-based pharmaceutical company Biontech and its US partner Pfizer. FDA chief scientist Denise Hinton announced in a letter to Pfizer that night. The companies submitted the corresponding application to the FDA in November. They were the first Western manufacturers to publish promising study results and apply for emergency approval from the FDA.
The president of the United States, Donald Trump, announced that the first vaccines would be given “in less than 24 hours”. In a speech posted on Twitter, Trump said delivery of the vaccine “to all states and postal districts” has already begun. Official approval was expected after an independent FDA vaccination commission recommended emergency approval for the vaccine Thursday night. As early as Tuesday, the pharmaceutical agency announced that it classified the vaccine as safe and effective.
In numerical terms, the United States is the country most affected by the Crown crisis. On Friday, Johns Hopkins University reported a new record with nearly 235,000 new infections in one day. Almost 2,600 people died in 24 hours from or with the coronavirus.
95 percent fewer illnesses
Canada, Mexico, Bahrain and Saudi Arabia, among others, have since given approvals for 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.
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. 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.
Since then, the Pfizer study has been published in the renowned “New England Journal of Medicine.” 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.
