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Pfizer-BioNTech becomes the first FDA-approved COVID-19 vaccine

Pfizer and BioNTech’s vaccine is the first to be approved by the FDA for the prevention of COVID-19 in people aged 16 years and older.

Gloved hand holding a vial labelled 'COVID-19 Vaccine' with Pfizer and BioNTech logos [Credit: malazzama / Shutterstock.com].

[Credit: malazzama / Shutterstock.com].

The US Food and Drug Administration (FDA) has approved the first COVID-19 vaccine. The vaccine, developed by Pfizer and BioNTech, will be marketed as Comirnaty® and is intended for the prevention of COVID-19 in individuals aged 16 years and older.

The vaccine also continues to be available under emergency use authorisation (EUA) for individuals 12 to 15 years of age and for the administration of a third dose in certain immunocompromised individuals.

“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic,” said Acting FDA Commissioner Janet Woodcock. “While millions of people have already safely received COVID-19 vaccines, we recognise that for some, the FDA approval of a vaccine may now instil additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the US.”

Comirnaty contains messenger RNA (mRNA) which is only present in the body for a short time. It has the same formulation as the EUA vaccine and is administered as a series of two doses, three weeks apart. 

The first EUA was issued 11 December 2020 for individuals 16 years of age and older and based on data from a randomised, controlled, blinded ongoing clinical trial of thousands of individuals. To support the FDA’s approval decision today, the FDA reviewed updated data from the clinical trial which supported the EUA and included a longer duration of follow-up in a larger clinical trial population. 

The FDA agency analysed 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 percent 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 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.

Additionally, the FDA conducted a rigorous evaluation of the post-authorisation safety surveillance data pertaining to myocarditis and pericarditis following administration of the 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, though some individuals required intensive care support.

“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine,” said Peter Marks at the FDA. “We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnaty’s safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities…The public and 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 US.”

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