The US Food and Drug Administration (FDA) on Monday finally approved the coronavirus vaccine developed by the US company Pfizer and its German partner BioNTech. About it reported in the press release of the regulator.
Pfizer is the first COVID-19 vaccine to receive final FDA approval. Prior to that – in December 2020 – Pfizer’s vaccine was fast tracked for emergency use by the FDA. Vaccines from Moderna and Johnson & Johnson later received similar approval.
“Today the FDA approved the first COVID-19 vaccine. The drug was known as [вакцина от] COVID-19 Pfizer / BioNTech, will now be marketed as Comirnaty [в качестве препарата] for the prevention of COVID-19 for persons aged 16 and over, ”it was reported.
As noted in the press release, as part of the previously issued authorization for the use of this vaccine in emergency situations, it will continue to be available to people aged 12 to 15 years. Permission to use a booster dose of the drug for immunocompromised persons will also continue to be valid.
“Our scientific and medical experts have done an incredibly thorough and thoughtful evaluation of this vaccine. We looked at scientific evidence and analyzed hundreds of thousands of pages of information to evaluate the safety and effectiveness of Comirnaty, ”said Peter Marks, director of the FDA’s Center for Biological Evaluation and Research. He stressed that the production lines producing the vaccine have also been thoroughly tested.
“The public and the medical community can rest assured that although we quickly approved this vaccine, it fully meets our high standards for vaccines in the United States,” concluded Peter Marks.
When deciding whether to approve the vaccine, the results of a study involving 40,000 people aged 16 and over were taken into account. Half of them received not the drug itself, but a placebo. The effectiveness of the vaccine is estimated at 91%. More than half of the participants in clinical trials were under medical supervision for four months or longer after taking the second dose.
The most common side effects reported by clinical trial participants were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, and fever. There was also an increased risk of myocarditis and pericarditis (inflammation in the heart muscle and the lining of the heart), especially within seven days after receiving the second dose of the drug. This risk is most at risk for men under 40, especially young men between the ages of 12 and 17. In some cases, patients with such inflammation required intensive care. There are no data on the long-term consequences of such violations.
The vaccine is effective in preventing COVID-19 and potentially serious outcomes including hospitalizations and death. In addition, the FDA has thoroughly evaluated post-marketing safety surveillance data for myocarditis and pericarditis following administration of Pfizer-BioNTech COVID-19 vaccine and determined that the data showed an increased risk, especially within seven days after the second dose. The observed risk is higher among men under the age of 40 compared to women and older men. The observed risk is highest in men between 12 and 17 years of age. Available short-term data suggest that symptoms have resolved in most people. However, some people required intensive care. No information is yet available on potential long-term health effects. The prescribing information for Comirnaty includes a warning about these risks.