[ad_1]
A Covid vaccine was first approved in the US on Friday night. President Trump announced that the first vaccination would take place in 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. The FDA announced Friday 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.
An application has also been submitted to the European Medicines Agency EMA for approval of the corona vaccine in the EU, a decision on this is still pending. There are no emergency approvals in the EU; instead, the results of vaccine studies are continuously monitored. In early December, the UK pharmaceutical regulatory authority issued an emergency approval for the preparation of Pfizer-Biontech. 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 vaccine approval in the EU is expected in late December or early January.
Long-term efficacy data must be submitted later
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. Since then, the 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 now in the case of the Pfizer Biontech vaccine, is intended to meet urgent medical needs. In the United States, applicants may be granted 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.
Trump: governors decide on vaccination
After the first emergency approval for a corona vaccine in the US, US President-elect Donald Trump promised his compatriots the first vaccines this weekend. “The first vaccine will be administered in less than 24 hours,” Trump announced in a video he posted on Twitter late Friday.
Your government has already started shipping the vaccine to every state in the US Your governors would decide who gets vaccinated there first.
Trump said vaccines are free for all Americans. Watching the vaccine develop in record time, he said, “This is one of the greatest scientific achievements in history.” The vaccine will save millions of lives “and end the pandemic once and for all.” Trump presented the development as a success for his administration, which is not true. More recently, it emerged that the US government had rejected several offers from Pfizer to reserve more doses of the vaccine for free. For example, the US should only be able to immunize 50 million people with the Pfizer Biontech vaccine by the summer. It will not be possible to order more later, since in the meantime Pfizer has entered into binding contracts with other countries, and production is running at full speed.
The pandemic remains out of control in the United States. By Wednesday, the death toll in a single day had surpassed 3,000 for the first time. According to statistics from Johns Hopkins University, the number of new registered infections was more than 200,000 in recent days.
(WHAT / dpa / Red.)
