The Covid-19 vaccine jointly developed by Pfizer and BioNTech is now fully FDA approved Preventing respiratory diseases, making secondary injection therapy the first method to reach this milestone.
The approval announced on Monday was announced eight months after the vaccine became the first vaccine to be authorized for emergency use. This type of authorization is a temporary order that continues during an emergency. The pandemic is still ongoing, but based on the review of additional clinical trial data, it is hoped that those who have not yet been vaccinated will eventually be vaccinated.
“Although millions of people have been safely vaccinated against COVID-19, we recognize that for some people, FDA-approved vaccines may now inject more confidence in vaccination,” FDA Acting Commissioner Janet Woodcock Said in the FDA announcement. “Today’s milestone brings us one step closer to changing the course of this epidemic in the United States”
The full approval of the messenger RNA vaccine covers people 16 years and older, just like Initial authorization Done. According to the emergency use authorization granted in May, the vaccine is allowed to be used in adolescents between 12 and 15 years of age. The approved vaccine will be marketed under the name “Comirnaty” and will have the same formula as the approved vaccine, and will be administered on the same schedule-two intramuscular injections three weeks apart.Approval from Federal health officials have developed a plan to provide a third injection, a booster, eight months after the second injection of an individual who has been vaccinated..
The initial authorization was based on a review of data that showed that in a placebo-controlled clinical trial involving more than 36,000 people aged 16 years and older, the vaccine was 95% effective in preventing Covid-19. In order to obtain full approval, the FDA requires these companies to provide the latest safety and efficacy data from participants in subsequent clinical trials over a longer period of time. The FDA’s approval of Cormirnaty is based on effectiveness data, which includes another 4,000 people, divided into vaccinated people and placebo people. Among these results, the data shows that the vaccine is 91% effective in preventing Covid-19.
In the months after the Pfizer/BioNTech vaccine was first approved, the FDA stated that it closely monitored reports of inflammation in and around the heart of some vaccinated people. The agency said that its review of these reports found an increased risk of such problems, especially in the first week after the second dose. Compared with women and older men, men under 40 have a higher risk, and men between 12 and 17 have the highest risk.
According to the FDA, data indicate that most people’s symptoms have been relieved, but some people need intensive care. The label of the vaccine includes warnings about these potential problems. There are no long-term data on these risks. The FDA said that since receiving the second dose, more than half of clinical trial participants have been followed for at least four months. Approximately 12,000 study participants have been followed for at least six months.
The initial authorization of the vaccine was obtained on the recommendation of an independent FDA advisory committee. The FDA apparently did not find that the observed cardiac risk was severe enough to require further inspection by the same advisory team.inside Ratification When sent to BioNTech, the agency stated that another meeting was not needed because the application “did not raise controversial issues that could have benefited from discussions in the advisory committee.”
However, the FDA is still interested in learning more about the potential problems that vaccines may cause to the heart. The approval letter stated that the analysis of adverse events reported so far and the system that monitors such issues after the vaccine is marketed are not sufficient to assess unknown cardiac risks. Therefore, the agency requested Pfizer and BioNTech to conduct post-marketing studies to evaluate the long-term outcome of people who develop myocarditis (i.e., inflammation of the heart muscle) after vaccination.
According to the FDA letter, Pfizer and BioNTech are already preparing for this cardiac study, and the final clinical trial agreement will be submitted to the FDA on August 31. Although not a requirement for approval, the FDA also stated that these companies have committed to conducting additional safety studies, including evaluating the results of pregnant women and their babies after being vaccinated during pregnancy.
Two other Covid vaccines that have received emergency authorization so far are from Moderna and Johnson & Johnson. Moderna, the developer of mRNA vaccines such as Comirnaty, started Rolling submission in May for full FDA approval.
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