FDA Rejects Request to Revoke Emergency Authorization of Pfizer’s Vaccine for Some Children

The United States Food and Drug Administration has rejected a request to revoke emergency authorization for Pfizer’s COVID-19 vaccine for 12-15 year old children.

“Petitioner has provided no basis to demonstrate that the EUA should be revoked,” Dr. Peter Marks, a top FDA official, wrote in a letter from June 16, which was made public on July 21.

The letter was a response to the Informed Consent Action Network, which urged the organization in May to revoke the emergency use authorization for the vaccine, claiming that data has emerged since the EUA was issued in May 2021 showing that the benefits of the vaccine do not outweigh the risks of the experimental drug.

Included in this data was research estimating Pfizer’s shot provides just 51 percent protection against the Omicron variant of COVID-19 after six weeks. 

Another study showed that effectiveness against Omicron-associated emergency room and urgent care visits was just 45- to 51-percent.

Yet another study, backed by the Centers for Disease Control and Prevention, found the vaccine less effective against severe disease. The researchers behind this study found that the benefit of being vaccinated amounted to spending “an average of one half day less sick in bed.”

The lessening effectiveness has prompted the government to authorize booster shots for everyone ages 5 and up, but further research, also from the CDC, has shown that the booster’s effectiveness is short lived.

“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.

The petitioners also cited examples in which the FDA had effectively revoked EUAs for monoclonal antibodies because they were ineffective against newer variants.

Although children are significantly less likely to experience severe illness or die with COVID-19 than adults, the emergency declaration set by the Trump administration, and extended by the Biden administration until at least October 13, 2022, that remains 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.”

Marks claimed that 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. He pointed 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 to support his decision.

“The Petition does not provide evidence showing otherwise,” Marks said.

The adjustment to the EUA for monoclonal antibodies, he said, was based on data showing they were highly unlikely to be effective against Omicron.

“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 said in a statement, “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.”