The U.S. Food and Drug Administration ( FDA ) has approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty, for the prevention of COVID-19 disease in individuals 16 years of age and older.
The vaccine also continues to be available under emergency use authorization ( EUA ), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.
Since Dec. 11, 2020, the Pfizer-BioNTech COVID-19 Vaccine has been available under EUA in individuals 16 years of age and older, and the authorization was expanded to include those 12 through 15 years of age on May 10, 2021.
EUAs can be used by the FDA during public health emergencies to provide access to medical products that may be effective in preventing, diagnosing, or treating a disease, provided that the FDA determines that the known and potential benefits of a product, when used to prevent, diagnose, or treat the disease, outweigh the known and potential risks of the product.
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 has the same formulation as the EUA vaccine and is administered as a series of two doses, three weeks apart.
FDA evaluation of safety and effectiveness data for approval for 16 years of age and older
The first EUA, issued Dec. 11, for the Pfizer-BioNTech COVID-19 Vaccine for individuals 16 years of age and older was based on safety and effectiveness data from a randomized, controlled, blinded ongoing clinical trial of thousands of individuals.
To support the approval decision, the FDA has reviewed updated data from the clinical trial which supported the EUA and has included a longer duration of follow-up in a larger clinical trial population.
Specifically, in the FDA’s review for approval, the Agency has 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 have received the vaccine and 22,000 people who have 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 for at least four months after the second dose. Overall, approximately 12,000 recipients have been followed for at least 6 months.
The most commonly reported side effects by those clinical trial participants who have received Comirnaty were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, and fever.
The vaccine is effective in preventing COVID-19 and potentially serious outcomes including hospitalization and death.
Additionally, the FDA has conducted a rigorous evaluation of the post-authorization safety surveillance data pertaining to myocarditis and pericarditis following administration of the Pfizer-BioNTech COVID-19 Vaccine and has determined that the data demonstrate increased risks, particularly within the seven days following the second dose.
The observed 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.
Information is not yet available about potential long-term health outcomes.
The Comirnaty Prescribing Information includes a warning about these risks. ( Xagena )
Source: FDA, 2021