The federal Food and Drug Administration has granted full approval of the Pfizer-BioNTech COVID-19 vaccine for people age 16 and older. This is the first vaccine to receive traditional approval, and health officials hope the move will encourage more people to get vaccinated.
Previously, the Pfizer-BioNTech vaccine had been granted emergency use authorization by the FDA.
"I've heard from some folks who were waiting until 'full approval' from the FDA to get a COVID vaccine," San Francisco Mayor London Breed wrote on Twitter August 23. "Well, today that happened with the Pfizer vaccine. Appointments are widely available and you can go get your shot today!"
Addressing the nation on Monday, President Joe Biden offered the same message.
"Let me say this loudly and clearly: if you're one of the millions of Americans who said that they will not get the shot until it has the full and final approval of the FDA, it has now happened," he said. "The moment you've been waiting for is here. It's time for you to go get your vaccination."
Safety and effectiveness
The Pfizer-BioNTech vaccine received FDA emergency use authorization for people 16 or older on December 11, 2020. It was later authorized for teens ages 12 to 15; the younger age group remains covered by the EUA. The Moderna vaccine received its EUA a week after the Pfizer vaccine and many expect full approval soon. The single-shot Johnson & Johnson vaccine was granted EUA in late February.
Health officials emphasized that although the Pfizer-BioNTech vaccine received unusually speedy authorization in the face of the growing COVID crisis, the agency did not cut corners in evaluating its safety and efficacy.
"The FDA's approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic," acting FDA Commissioner Dr. Janet Woodcock said in a statement. "[T]he 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."
The Pfizer-BioNTech vaccine, which has been given the brand name Comirnaty, employs a novel messenger RNA (mRNA) technology that uses lipid nanoparticles to deliver genetic blueprints for the SARS-CoV-2 coronavirus spike protein. When injected into a muscle, cells produce the protein, triggering an immune response. The mRNA degrades quickly in the body and it does not alter human genes.
In a phase 3 clinical trial, more than 43,000 adults were randomly assigned to receive either two doses of the vaccine or a placebo spaced three weeks apart. The vaccine was 95% effective at reducing the risk of symptomatic COVID-19 after the second dose. The vaccine was also found to be safe and generally well tolerated, with most participants reporting only mild side effects such as injection site soreness and flu-like symptoms.
Although vaccine effectiveness has declined somewhat against the more transmissible SARS-CoV-2 Delta variant, it still provides good protection against serious COVID outcomes. While the vaccine remains around 80% to 90% effective at preventing symptomatic illness and death, its efficacy against any infection has fallen to around 60% in some studies.
This decline informed the Biden administration's recent announcement that it plans to make booster doses of the Pfizer and Moderna vaccines available to all adults eight months after their last dose. This is separate from the recent FDA and Centers for Disease Control and Prevention decision that moderately to severely immunocompromised people — including organ transplant recipients, people being treated for cancer and people with advanced or untreated HIV — are eligible for a third dose of these vaccines now.
More vaccine mandates
Officials are hopeful that full approval will encourage more people to get vaccinated. A Kaiser Family Foundation poll found that around a third of people who have not yet gotten a vaccine were more likely to do so if it had full FDA approval.
"While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated," Woodcock said.
The full approval will also make it easier for cities, hospitals, businesses, schools, and airlines to require vaccination. San Francisco did not wait for the FDA and has already mandated vaccines for city workers, teachers, and people who wish to enter indoor restaurants, bars, gyms and entertainment venues.
A growing number of national companies, universities, and public school systems are requiring staff and patrons to get vaccinated. The Pentagon announced Monday that active-duty members of the military will need to receive vaccines, though it did not give a deadline.
Full approval generally allows physicians to prescribe medications and vaccines off-label as they see fit. This could mean, for example, that a doctor could prescribe a Pfizer-BioNTech dose for a person who received the J&J vaccine. Earlier this month, Zuckerberg San Francisco General Hospital and the San Francisco Department of Public Health began offering a supplemental Pfizer-BioNTech or Moderna dose to people in this situation.
Although many parents are eager to get their children vaccinated as soon as possible, the CDC cautioned that they should not seek off-label use of the Pfizer-BioNTech vaccine for kids under 12 before the shot is authorized for this age group. Pfizer is currently testing a lower dose of the vaccine for children and is expected to request FDA authorization this fall.
In the meantime, health officials urge all adults to get vaccinated without delay.
"For weeks we have watched cases go up at an alarming pace among individuals who are not vaccinated while the vaccinated are largely protected," California Department of Public Health director Dr. Tomás Aragón said in a statement. "If you are not vaccinated, let this be the milestone that gets you there."
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