First COVID-19 Vaccine Approved in the USA
The U.S. Food and Drug Administration (FDA) announced today it Approved the first COVID-19 preventive vaccine for individuals 16 years of age and older.
The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine and will now be marketed as Comirnaty.
The Comirnaty vaccine is effective in preventing COVID-19, and potentially serious outcomes, including hospitalization and death, says the FDA.
The FDA Approval was granted to Germany-based BioNTech Manufacturing GmbH.
Also, the FDA clarified the Comirnaty vaccine continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of the third vaccine dose in specific immunocompromised individuals.
Since December 2020, Comirnaty has been available under EUA in individuals 16 years of age and older, and the FDA Authorization was expanded to include those 12 through 15 years of age on May 10, 2021.
The FDA evaluates data and information included in the manufacturer’s submission of a biologics license application (BLA) for all vaccines. A BLA is a comprehensive document that is submitted to the agency, providing precise requirements.
For Comirnaty, the BLA builds on the extensive data and information previously submitted that supported the EUA, such as preclinical and clinical data and information, and details of the manufacturing process, vaccine testing results ensure vaccine quality and inspections of the sites where the vaccine is made.
The FDA conducts its analyses of the information in the BLA to make sure the vaccine is safe and effective and meets the FDA’s standards for approval.
Comirnaty contains messenger RNA (mRNA), a kind of genetic material.
The mRNA is used by the body to make a mimic of one of the proteins in the virus that causes COVID-19. The result of a person receiving this vaccine is that their immune system will ultimately react defensively to the virus that causes COVID-19.
The mRNA in Comirnaty is only present in the body for a short time and is not incorporated into - nor does it alter - an individual’s genetic material. Comirnaty is administered as a series of two doses, three weeks apart.
“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine. We evaluated scientific data and information included in hundreds of thousands of pages, conducted our analyses of Comirnaty’s safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities,” stated Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research, in today’s press statement.
“We have not lost sight that the COVID-19 public health crisis continues in the U.S. and that the public is counting on safe and effective vaccines.”
“The public and the medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S."
Specifically, in the FDA’s review for Comirnaty’s Approval, the agency analyzed effectiveness data from approximately 20,000 vaccine and 20,000 placebo recipients ages 16 and older who did not have evidence of the COVID-19 virus infection within a week of receiving the second dose.
The safety of Comirnaty was evaluated in approximately 22,000 people who received the vaccine and 22,000 people who received a placebo 16 years of age and older.
Based on results from the clinical trial, the vaccine was 91% effective in preventing COVID-19 disease.
More than half of the clinical trial participants were followed for safety outcomes at least four months after the second dose. Overall, approximately 12,000 recipients have been followed for at least six months.
The most commonly reported side effects by those clinical trial participants who received Comirnaty were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, and fever, says the FDA.
Additionally, the FDA conducted a rigorous evaluation of the post-authorization safety surveillance data about myocarditis and pericarditis following the Pfizer-BioNTech COVID-19 vaccine administration and has determined that the data demonstrate increased risks, particularly within the seven days following the second dose.
The observed heart-health risk is higher among males under 40 years of age compared to females and older males.
The observed risk is highest in males 12 through 17 years of age.
Available data from short-term follow-up suggest that most individuals have had resolution of symptoms. However, some individuals required intensive care support.
In addition, information is not yet available about potential long-term heart-health outcomes.
On August 11, 2021, 'within the Vaccine Adverse Event Reporting System, ‘ the CDC and FDA confirmed 762 reports of myocarditis or pericarditis.
Among persons with reported myocarditis after mRNA vaccination, the median age was 26 years, with symptom onset intervals of 3 days after vaccination. The CDC and its partners are investigating these reports to assess whether there is a relationship to COVID-19 vaccination.
Previously, during the CDC's vaccine committee meeting on June 23, 2021, Tom Shimabukuro, M.D., Vaccine Safety Team, presented 'Early safety data of myocarditis or pericarditis among Pfizer-BioNTech vaccination in persons aged 12–15 years old.'
As of August 11, 2021, the UK's Medicines and Healthcare products Regulatory Agency had received 182 reports of myocarditis and 153 reports of pericarditis following use of the Pfizer-BioNTech vaccine, as well as three reports for viral pericarditis and one report each of infective pericarditis, non-infective endocarditis and streptococcal endocarditis.
Furthermore, as of July 29, 2021, the European Medicine Agency reported a total of 244,807 cases of suspected side effects with Comirnaty from EU/EEA countries, with 4,198 of these cases reported a fatal outcome. By the same date, about 330 million doses of Comirnaty had been given to people in the EU/EEA. Healthcare professionals and vaccinated individuals are encouraged to report to their national competent authorities all suspected side effects individuals may have experienced after receiving a vaccine even if it is unclear whether the vaccine was the cause.
Although not FDA requirements, the company has committed to additional long-term, post-marketing safety studies, known as phase four clinical research. These studies will further assess the risks of myocarditis and pericarditis following vaccination with Comirnaty.
And the post-marketing studies will include conducting a pregnancy registry study to evaluate pregnancy and infant outcomes after receipt of Comirnaty during pregnancy.
The Maryland-based FDA is an agency within the U.S. Department of Health and Human Services.
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