Pfizer vaccine is officially approved by FDA
Until this date It was used as an emergency shortcut
The US Drug Authority FDA approved on Monday Pfizer’s vaccine against Covid-19 for use in people from 16 years of age. It is therefore officially on the market in the US, under the name Corminaty. Since December 11, the vaccine has been approved in the US for emergency use during the pandemic – just like The Vaccines of Moderna and Janssen. This allows the FDA to allow unapproved drugs in an emergency situation, such as a life-threatening disease for which there are not yet approved alternatives.
The FDA hopes that with this approval more vaccine doubts will become convinced of the safety and effectiveness of the drug, and dare to take the shot now. So far, around 51 percent of Americans have been fully vaccinated. Especially in the southern states, a stream of Covid-19 patients engulfs hospitals and intensive care units.
The FDA first approved emergency use based on the first results of a large clinical study of several thousand people, which is still ongoing. For full approval, the FDA reviewed the completed data from that study. The information on the effectiveness and safety of the product is now based on at least 20,000 vaccinees compared with the same number of unvaccinated. About 12,000 vaccinees have now been followed for six months.
In this study, the vaccine protected 91 percent against Covid-19. The FDA also describes a rare but increased risk of inflammation of the heart muscle or lining of the heart (myocarditis or pericarditis). This is particularly common in men under 40 years of age in the first week after the second injection. The highest risk was seen by the FDA in boys between the ages of 12 and 17.
Even after approval, the FDA will continue to monitor the safety of the product, and the manufacturer will also have to carry out research into side effects and use during pregnancy.