U.S. drug regulators have rejected a request to revoke emergency authorization for Pfizer’s COVID-19 vaccine for 12- to 15-year-olds.
“Petitioner has provided no basis to demonstrate that the EUA should be revoked,” Dr. Peter Marks, a top Food and Drug Administration (FDA) official, wrote in a June 17 letter, which was made public on July 21.
He was responding to the Informed Consent Action Network, which in May urged the FDA in a citizen petition to revoke the emergency use authorization (EUA) for the shot, asserting that data has emerged since the EUA was issued in May 2021 shows the benefits of the vaccine do not outweigh the risks.
That data includes research estimating Pfizer’s shot provides just 51 percent protection against the Omicron variant of SARS-CoV-2, which causes COVID-19, after six weeks; a study backed by the Centers for Disease Control and Prevention that found the vaccine less effective against severe disease; and another study that effectiveness against Omicron-associated emergency department and urgent care visits was just 45- to 51-percent.
Researchers performing the second study found that the benefit of being vaccinated amounted to spending “an average of one half day less sick in bed,” the action network noted.
The waning effectiveness drove U.S. authorities to clear and recommend booster shots for children as young as 5.
The effects of the boosters, though, also quickly wane, research has indicated.
“This dramatic waning in efficacy of Pfizer’s COVID-19 vaccine, the need for more doses, and the extremely limited benefit only further emphasize the necessity of revoking the EUA for children ages 12–15,” petitioners stated.
EUAs have a lower bar than approvals. They’re made possible because the Trump administration declared an emergency over COVID-19, and that declaration has been extended by the Biden administration.
Under an EUA, regulators can authorize a product for diagnosing, treating, or preventing COVID-19 if, based on the available evidence, “it is reasonable to believe that the product may be effective.” EUAs can be revised or revoked if regulators decide certain circumstances have changed, such as new evidence that tilts the earlier determination.
Although children are much less likely to experience severe illness or die with COVID-19 than adults, the emergency declaration remaining in place means that the FDA continues to have the authority to keep the EUA in place for 12- to 15-year-olds, Marks said in his response.
“FDA is not aware of any data that change the conclusion that SARS-CoV-2 can cause a serious or life-threatening disease or condition, including in individuals 12–15 years of age, nor has Petitioner demonstrated that to be the case,” he said.
“Post-authorization data regarding the Pfizer-BioNTech COVID-19 Vaccine continues to support that the vaccine prevents severe consequences of COVID-19,” Marks said. “Finally, a vaccine does not need to be 100% effective in preventing the target disease to meet the licensure or EUA standard. It is expected that some vaccinated individuals will contract the target disease despite having been vaccinated against it.”
While there are signs that the vaccine is performing worse against newer variants, the known and potential benefits still outweigh the known and potential risks, Marks claimed, pointing to a study from Israel that found the Pfizer vaccine was 43 percent effective in preventing symptomatic COVID-19 and a September 2021 paper that concluded increases in COVID-19 metrics were unrelated to vaccination.
“The Petition does not provide evidence showing otherwise,” Marks said.
The adjustment to the EUA for monoclonal antibodies, he said, were based on data showing they were highly unlikely to be effective against Omicron, and “it is appropriate for FDA” to approach the monoclonals and vaccines differently.
“While there are data suggesting a reduction of protection against COVID-19 after the second dose of the PfizerBioNTech COVID-19 Vaccine in all authorized populations, including individuals 12–15 years of age, as explained above, available data indicate that the vaccine has retained some level of effectiveness against all epidemiologically important SARS-CoV-2 variants that have emerged to date, with higher level effectiveness preserved against more serious outcomes,” he said.
The Informed Consent Action Network told The Epoch Times in an email, “It is not surprising that the FDA would not overturn its own decision to authorize this product, especially after it has been widely promoting its use.”