Following Briefing, Clyburn Vows to Hold FDA to Its Commitment to Review Coronavirus Vaccines for Young Children as Expeditiously as Science Allows
Washington, D.C. (May 9, 2022) – Today, Rep. James E. Clyburn, Chairman of the Select Subcommittee on the Coronavirus Crisis, issued the following statement after a staff briefing by Dr. Peter Marks, Director for the Center of Biologics Evaluation and Research at the Food and Drug Administration (FDA), on the status of coronavirus vaccine candidates for young children that took place on the afternoon of May 6. The briefing followed Chairman Clyburn’s April 25 letter to FDA Commissioner Dr. Robert M. Califf after reports emerged that the agency was considering delaying its review of the first coronavirus vaccine for children under six years old.
“Parents of young children across America have been waiting for more than two years for the peace of mind that a safe and effective coronavirus vaccine provides. They deserve to know that FDA is doing everything in its power to review and authorize pediatric vaccines as quickly as the science allows. I appreciate FDA’s commitment to expeditiously conduct its rigorous scientific review of vaccines for young children, and I was pleased to hear that authorization may be possible before the scheduled June meetings.
“I will continue to monitor the process to ensure that the agency follows through on its commitment. If the science does not enable authorization before the announced June dates, I respectfully ask agency officials to provide American parents an explanation of why such a lengthy process has been in the best interests of their children.”
Dr. Marks shared the following information during the briefing:
FDA Will Move Up Advisory Panel’s Deliberations on Vaccines for Young Children if Agency Reviews Are Completed Sooner than Expected
Dr. Marks explained that if FDA is able to complete its reviews of the Moderna or Pfizer pediatric vaccines faster than anticipated, then the agency would move up the meetings of the Vaccines and Related Biological Products Advisory Committee (VRBPAC), currently scheduled in June 2022, saying: “Obviously if we get through reviews faster, then we will send them to committees sooner.” He noted that committee members have reserved earlier dates, enabling FDA to potentially “move dates up even by a week for any of these reviews.”
Dr. Marks said that FDA will not compromise its rigorous scientific standards in conducting its review, saying, “We will move as fast as we can to get this done, but when it gets done, it will get done right with the proper evaluation of these vaccines,” but committed to move as swiftly as the science allows, saying: “We see case counts rising, we feel urgency, we will move as fast as we can on reviews.”
FDA Denied Reports that Its Review of Moderna’s Vaccine Will Be Delayed and Provided Information on the Process It Will Follow in Reviewing and Authorizing Coronavirus Vaccines for Young Children
Dr. Marks denied reports that FDA will postpone the review of Moderna’s vaccine for young children so that it can be considered at the same time as Pfizer’s vaccine, saying: “We’re not going to delay one or the other vaccines in order to take them together.” However, he acknowledged that if the vaccine reviews end up being completed within a short time—such as a week—then they may be considered by VRBPAC together.
Dr. Marks explained that reviewing vaccines for young children involves more “complexity” than the review of adult vaccines, and the agency’s review process may require more time as a result. He stated that FDA has to take a “very close look” at the side effect profile of vaccines for young children because common side effects from vaccinations—such as fevers—that are not typically associated with adverse outcomes in adults can, in rare cases, cause severe conditions in young children.
Dr. Marks also said that the emergence of new variants—including Delta and Omicron—has made the process of reviewing vaccines more complex and time consuming. He acknowledged that it “was a little simpler for the original submissions in late 2020 when we didn’t have the variants and tons of immunogenicity data to go through,” which has made review and authorization of the vaccines for young kids “reasonably complicated.”
FDA Will Not Withhold Authorization Based Exclusively on Vaccine Efficacy at Preventing Symptomatic Infection
Dr. Marks explained that FDA would not withhold authorization for a pediatric vaccine solely because it did not reach a 50% efficacy threshold at blocking symptomatic infection—a requirement that had been previously listed in FDA guidance. The vaccines currently authorized in the United States have proven to be less effective at preventing symptomatic infection from the Omicron variant—as compared to the original strain—but still remain effective at reducing the risk of severe disease.
Dr. Marks confirmed, “If these vaccines seem to be mirroring efficacy in adults and just seem to be less effective against Omicron like they are for adults, we will probably still authorize.” He further stated that FDA would “look carefully at all data” when assessing the vaccines—including the efficacy against severe disease—and made clear that “the goal here is to get some protection in sooner rather than later.”
FDA Highlighted the Ongoing Importance of Vaccines in the Fight Against the Coronavirus
Dr. Marks said: “At the end of the day, we want people to have confidence in getting vaccinated.” He reiterated the importance of vaccinations to protect children against the coronavirus, stating: “We need to get more kids vaccinated, not just in the younger than 5 age range, but also older than 5.”