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After weeks of anticipation, FDA has granted full approval for the Pfizer/BioNTech anti-COVID 19 vaccine, raising hopes that this action will help overcome the vaccine hesitancy that has plagued efforts to broadly immunize the U.S. population. The decision announced Aug. 23, 2021 was no surprise,1 as staff in the Center for Biologics Evaluation and Research (CBER) have been working overtime to review extensive clinical data contained in thousands of documents as quickly as possible. Consequently, FDA fully assessed the Pfizer BLA (biologics license application) in 40% of the time allotted for this process, producing a decision that hopefully will “give people confidence to get vaccinated,” said CBER director Peter Marks at a press conference. FDA acting commissioner Janet Woodcock termed the approval decision “a pivotal moment” in the fight against the pandemic, noting that the BLA should make the public “confident that this vaccine meets the FDA’s gold standards for safety, effectiveness and manufacturing quality that we require for an approved product.”
The approved vaccine now carries the brand name Comirnaty, devised for the manufacturers by the Brand Institute to convey a sense of “community” and “immunization.” FDA notes that the manufacturers now may promote the vaccine according to its rules, efforts that hopefully will further encourage vaccination in the U.S. and elsewhere. Such uptake may be advanced by vaccination mandates from federal, state and local government agencies. President Biden remarked that the BLA should be a signal to both public and private employers to move forward with vaccine requirements. The Pentagon has announced plans to mandate vaccination for military forces, both active duty and reserve units, while hospitals and nursing homes look to require such protection for all staffers.
The manufacturers note that Comirnaty has been administered to more than 1 billion patients around the world.2 Production is slated to increase from 1.2 billion vaccine doses so far to three billion this year and four billion doses in 2022, according to the manufacturers. The partners also plan to seek licensure of a third, or booster, dose via a supplemental BLA, and to extend full approval to individuals over 12 years of age. Patients age 12 to 16 still can obtain the vaccine under the emergency use authorization (EUA) that remains in effect, as can immunocompromised individuals seeking a third booster shot to protect against the delta variant.
The BLA package submitted in May 2021 included longer-term follow-up data from its Phase III clinical trial plus extensive information on manufacturing and facilities. We didn’t “just look at data summaries,” commented Marks. He explained that the task of evaluating the Pfizer/BioNTech BLA involved reviewing hundreds of thousands of pages of reports, including four months of follow-up data on half of the 40,000 clinical trial participants. Staff also visited sites where the clinical trials were conducted to ensure that the information was collected accurately and met all standards. FDA wanted to ensure “that we saw all adverse events,” Marks said, adding that FDA also did a full benefit-risk assessment based on real world data for the hundreds of millions of patients that have received the vaccine over the past year.
The BLA review process also involved visiting numerous manufacturing facilities to ensure quality production. The manufacturers noted in a press release that there is no change in the formulation for Comirnaty, and that providers may continue to use already distributed product obtained under the EUA.
The FDA approval letter for Comirnaty also specifies a number of post-approval studies and commitments to further assess product safety and efficacy.3 These include additional studies on the risks for myocarditis and pericarditis after receiving Comirnaty, a side effect that has been seen and assessed by FDA, notably in younger male patients. The companies also will create a registry to monitor the vaccine’s impact on pregnant women and infants.
FDA’s action represents the agency’s first approval of a vaccine using messenger RNA technology, a move expected to further bolster R&D on therapies and preventives in this area. Further evidence of the vaccine’s safety and efficacy will hopefully encourage broader public vaccination and begin to rein in the now-resurgent COVID pandemic.