Instant Report

Date: 31-Aug-2021

Pfizer BioNTech Covid-19 Vaccine First To Be Given Full FDA Approval

Pfizer’s Covid-19 vaccine, which was co-developed with BioNTech, will now be marketed as Comirnaty for the prevention of Covid-19 in those aged 16 years and older.

The Pfizer-BioNTech Covid-19 vaccine was first given Emergency Use Authorisation (EUA) by the FDA in December 2020 after data emerged showing the vaccine was 90% effective against Covid-19.

To support its recent decision, the FDA has reviewed updated data from the clinical trial, which included a longer duration of follow-ups in a larger clinical trial population. In doing so, the FDA analysed effectiveness data from around 20,000 vaccine and 20,000 placebo recipients aged 16 and older who did not have evidence of a Covid-19 infection within a week of receiving the second dose.

Some clinical trial participants receiving Comirnaty did experience side effects including pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, and fever. Post-authorisation data also show that patients may be at increased risks of myocarditis and pericarditis within seven days of receiving a second dose. For males under 40 years of age, the risk is higher, according to the FDA, with the highest risk in those aged 12 through 17 years of age.

Comirnaty will still be available under EUA for those aged 12 through 15 and for the administration of a third dose in certain immunocompromised individuals.

Acting FDA Commissioner Janet Woodcock said: “The FDA’s approval of this vaccine is a milestone as we continue to battle the Covid-19 pandemic. While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorisation, as the first FDA-approved Covid-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product. 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.”

“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 own analyses of Comirnaty’s safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities,” added Peter Marks, director of FDA’s Center for Biologics Evaluation and Research. “We have not lost sight that the Covid-19 public health crisis continues in the US and that the public is counting on safe and effective vaccines. 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."