The Food and Drug Administration announced Monday that it has granted full approval to Pfizer and BioNTech for their COVID-19 vaccine to be given to Americans as young as 16, even though several safety and efficacy studies will not be completed for years. The approval appears to only cover the first two doses of the vaccine, with subsequent boosters covered by the emergency use authorization.
The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.
The Pfizer vaccine—now called Comirnaty—is the first COVID-19 vaccine to receive FDA approval. Health officials are hoping the rushed authorization of the vaccine will encourage more unvaccinated people to get the jab.
“I am hopeful this approval will help increase confidence in our vaccine,” Pfizer CEO Albert Bourla said in a statement. “Vaccination remains the best tool we have to help protect lives.”
In a statement from the White House, Joe Biden stayed on message, telling vaccine skeptics “it’s time for you to get your vaccination, and get it today.”
The FDA said in a statement that “based on results from the clinical trial, the vaccine was 91% effective in preventing COVID-19 disease.”
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.
Specifically, in the FDA’s review for approval, the agency analyzed 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.
There was no mention in the FDA’s statement of how many boosters might be required after the vaccine’s effectiveness wears off.
The FDA approval came with the condition that Pfizer submit study results in the years to come analyzing the safety and effectiveness of the vaccine in infants, children, teenagers, and young adults, as well as pregnant women.
In its approval letter to BioNTech, the FDA mandated Pfizer to submit several study results evaluating the occurrence of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the heart’s surrounding membrane) following administration of the vaccine.
The final results of a study “entitled “A Non-Interventional Post-Approval Safety Study of the Pfizer-BioNTech COVID-19 mRNA Vaccine in the United States,” to evaluate the occurrence of myocarditis and pericarditis following administration of COMIRNATY is due October 31, 2025.
The final results of another study evaluating the occurrence of myocarditis and pericarditis following administration of the vaccine is due on September 30, 2024.
A natural history study of myocarditis and pericarditis following administration of COMIRNATY is also due on September 30, 2024.
A “prospective cohort study with at least 5 years of follow-up for potential long-term sequelae of myocarditis after vaccination (in collaboration with Pediatric Heart Network)” is not expected to be completed until Dec. 31, 2026.
Two more studies measure the incidence subclinical myocarditis following administration of the second dose of COMIRNATY in children and young adults. Results of those studies are not due until May 31, 2024, and December 31, 2022 respectively.
According to the CDC, as of July 16, 2021, there were 9,246 adverse events in U.S. adolescents aged 12–17 reported in the Vaccine Adverse Event Reporting System (VAERS) after receipt of Pfizer-BioNTech vaccine.
As of July 16, 2021, approximately 8.9 million U.S. adolescents aged 12–17 years had received Pfizer-BioNTech vaccine.* VAERS received 9,246 reports after Pfizer-BioNTech vaccination in this age group; 90.7% of these were for nonserious adverse events and 9.3% were for serious adverse events, including myocarditis (4.3%).
According to some medical experts, VAERS greatly undercounts the incidents of adverse events.
New analysis from the Journal of the American Medical Association (JAMA) found a rate of 1.8 cases of per 100,000 people for pericarditis and 1 in 100,000 for myocarditis. That’s a combined rate that’s more five times higher than thought: 2.8 people per 100,000 rather than 1/2 per 100,000.
The FDA has also requested results of a “post approval” study evaluating the safety of the vaccine on “Pregnancy and Infant Outcomes” by June 30, 2025.
Although no Covid vaccines have yet been authorized for use in children under 12, approvals are expected later this fall or winter.
During a town hall on CNN, last month, Joe Biden attempted to articulate his frustration with the FDA’s approval process, saying “why can’t the experts say we know that this virus is in fact it’s going to be, or—excuse me—we know why all the drugs approved are not temporarily approved and but permanently approved.” He predicted that vaccine approval was imminent. “That’s underway too. I expect that to occur quickly” he said.
Biden took a victory lap on Twitter Monday morning over the FDA’s final approval of the Pfizer vaccine.
“The FDA has officially approved the Pfizer COVID-19 vaccine,” he said. “While all three COVID vaccines have met FDA’s strict standards for emergency use, this FDA approval should give added confidence that this vaccine is safe and effective. If you’re not vaccinated yet, now is the time.”
The FDA has officially approved the Pfizer COVID-19 vaccine. While all three COVID vaccines have met FDA's strict standards for emergency use, this FDA approval should give added confidence that this vaccine is safe and effective.
If you're not vaccinated yet, now is the time. https://t.co/XaxFdWHbRc
— President Biden (@POTUS) August 23, 2021
Biden, whose public standing has been in freefall since his botched handling of the withdrawal from Afghanistan, was scheduled to deliver remarks on the approval of the Pfizer vaccine at the South Court Auditorium of the Eisenhower Executive Office Building at the White House at 1:30 ET.
“If you’re one of the millions of Americans who said that they will not get the shot when-until it gets full and final approval of the FDA, it has now happened,” Biden said when he appeared at 2:00. “The moment you’ve been waiting for is here. It’s time for you to get your vaccination, and get it today.”
Biden also called on U.S. companies to mandate the #COVID19 vaccine for employees.
“Today I’m calling on more country—on more companies I should say—in the private sector—to step up the vaccine requirements that will reach millions more people,” he said. “If you’re a business leader, a nonprofit leader, a state or local leader, who has been waiting for full FDA approval to require vaccinations, I call on you now to do that. Require it.”
The FDA’s approval of the Pfizer vaccine, and Biden’s full-throated support of vaccine mandates comes amid increasing concerns that the vaccines are causing a dangerous reaction known as antibody dependent enhancement (ADE) which actually exacerbates the virus.
Top vaccine scientist Dr. Robert Malone said in a bombshell interview last month on Steve Bannon’s WarRoom podcast that a recent report by NBC News on Tuesday claimed data was showing that vaccinated people “could be carrying higher levels of virus than previously understood” and possibly infecting others, indicating that a worst case scenario could be unfolding.
“This is precisely what one would see if antibody dependent enhancement was happening,” Malone said. “What is antibody dependent enhancement? Briefly, it’s that the vaccine causes the virus to become more infectious than would happen in the absence of vaccination, would cause the virus to replicate at higher levels than in the absence of infection.”
“This is the vaccinologist’s worst nightmare. It happened with the respiratory syncytial virus and in the ‘60s and caused more child deaths in vaccine recipients than unvaccinated. It happened with Dengvaxia, the dengue vaccine,” Malone continued.
“And it’s happened with virtually every other coronavirus vaccine development program, certainly in humans, known in history, and it’s what the vaccinologists like myself have been warning about since the outset, is the risk of antibody dependent enhancement,” he said.
Malone told Bannon that ADE seemed most apparent in people injected with Pfizer’s vaccine. “So, we now know that the Pfizer protection is waning at six months,” he said. “And what the data seem to suggest is those who have received Pfizer, which is probably the least immunogenic of the three in terms of durability, length of protection, people that are now in the waning phase of the immune response to the Pfizer vaccine seem to be getting infected.”
“Notice they keep talking about Pfizer and not about the other two. So, this suggests this is exactly what you would anticipate, is the window of greatest susceptibility to antibody dependent enhancement is in this long tapering phase as the vaccine response declines,” he added.
“If the data are consistent with [antibody dependent enhancement], we have to stop the vaccine campaign,” Malone stressed. “We have to pivot to expediting as much as possible drug treatments, which have been largely blocked and suppressed at the FDA level, particularly for repurposed drugs.”