The COVID-19 virus and its variants (currently dominated by Delta) continues to rage around the globe. As world leaders and health officials strive to spread the vaccine more quickly than the virus can circulate, the US Food and Drug Administration (FDA) continues reviewing information on vaccines and treatment development and keeping an eye out for unauthorized products.
First vaccine approved
The FDA approved the Pfizer-BioNTech COVID-19 vaccine, making it the first to receive the agency’s full approval; vaccines from Moderna and Johnson and Johnson remain under an emergency use authorization (EUA). The approved vaccine (from here on in marketed under the name Comirnaty) is approved for people 16 years and older and remains under a EUA for patients aged 12 to 15 years, and for boosters in immunocompromised people.
“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 in a statement. “While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, 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.”
Pfizer-BioNTech booster discussion
While the vaccine has not received full approval for boosters, the FDA has announced a virtual meeting (scheduled September 17, 8:30 am to 3:45 pm EST) of its Vaccines and Related Biological Products Advisory Committee. Members are slated to discuss the matter of additional doses of COVID-19 vaccines and specifically to discuss the Pfizer-BioNTech supplemental Biologics License Application for the administration of a third “booster” dose of Comirnaty in individuals 16 years of age and older.
“The process for authorizing or approving the use of a booster dose of a COVID-19 vaccine involves each vaccine manufacturer submitting data pertaining to safety and effectiveness to the agency to support this use,” said Peter Marks, director of the FDA’s Center for Biologics Research and Evaluation. “The FDA is evaluating data submitted by Pfizer-BioNTech in a supplemental Biologics License Application for its COVID-19 vaccine and will discuss it with the agency’s advisory committee to inform our decision-making; should the data received from other manufacturers raise unique questions that would benefit from the committee’s input, the agency intends to consider additional public discussions.”
Weighing vaccines for children
Acting commissioner Woodcock issued a statement on the FDA’s review of vaccines for children. She indicated that the agency plans to make a timely yet careful decision on approving the shots for children, who have been returning to schools in recent weeks.
“As schools around the country are re-opening for in-person learning and families are returning to their busy school year schedules, we know many parents are anxious about the pandemic and protecting their children,” she said. “Many parents have questions about COVID-19 and when vaccines will be available for children younger than 12 years of age.
“As regulators, we recognize we have an important task ahead of us that will require us to act expeditiously while undertaking an extremely meticulous and thoughtful review once we receive requests to authorize a COVID-19 vaccine for emergency use or submissions for approval of a COVID-19 vaccine for this population,” she added.
Woodcock outlined the steps the agency plans to take in ensuring the safety and efficacy of vaccines for younger Americans:
- Monitoring pediatric vaccine trials; a number are already ongoing, while others currently are enrolling patients
- Reviewing data and analyses from these trials as they become available
- Fielding completed EUA and approval requests carefully and independently
Stern trial warning
Kaleido Biosciences received a warning letter from the FDA for failure to comply with federal laws and regulations, including laws and regulations to protect individuals participating in clinical trials, during the clinical investigation of an investigational drug to mitigate and treat COVID-19. The FDA states that sponsors seeking to develop therapies for COVID-19, or any other disease or condition, must fully comply with FDA rules covering trials of investigational drugs or face stern rebuke.
Unauthorized COVID-19 products
No consumer products for the prevention, mitigation, or cure of COVID-19 have received approval from the FDA. The agency issued a joint letter with the Federal Trade Commission to Mahita LLC (dba PushMyCart) for selling unapproved products with unproven COVID-19 claims.