FDA Delays Advisory Meeting for COVID-19 Vaccine for Very Young Kids

 | Post date: 2022/02/13 | 

The FDA postponed the Feb. 15 meeting of the Vaccines and Related Biological Products Advisory Committee that was scheduled to discuss the authorization of Pfizer-BioNTech's COVID-19 vaccine for children 6 months through 4 years of age.

According to Peter Marks, MD, PhD, the director of the FDA Center for Biologics Evaluation and Research, the delay was requested by Pfizer-BioNTech, after the agency—which originally thought it could move forward with authorization of a two-dose schedule—requested more data about a third dose, he said.

“Since the early days of the pandemic, we've always followed the science in this ever-changing situation. Given the recent omicron surge and the notable increase in hospitalizations in the youngest children to their highest levels during the pandemic so far, we felt it was our responsibility as a public health agency to act with urgency and consider all available options, including requesting that the company Pfizer provide us with initial data on two doses from its ongoing study,” Dr. Marks said during a media briefing. 

“The goal was to understand if two doses would provide sufficient protection, to move forward with authorizing the use of the vaccine. But at this time, we believe additional information regarding the ongoing evaluation of a third dose should be considered,” he announced. “It makes sense for us to wait until we have the data from the evaluation of a third dose before taking action.”

The trial in children 6 months through 4 years of age is ongoing, and data on the first two 3-mcg doses in this age group are being shared with the FDA on a continuing basis, according to Pfizer. Cases continue to accumulate according to the study protocol, and more data are being generated because rates of infection and illness remain high in children of this age, especially due to the recent omicron surge.

Pfizer-BioNTech said a three-dose schedule may provide a higher level of protection in this age group. “This is also supported by recent observations of three-dose booster data in several other age groups that seems to meaningfully augment neutralizing antibody levels and real-world vaccine protection for omicron compared to the two-dose regimen. The companies expect to have three-dose protection data available in early April,” the companies said in a statement.

The phase 1/2/3 trial initially enrolled 4,500 children 6 months to 11 years of age in the United States, Finland, Poland and Spain at more than 90 clinical trial sites. Additional children have been enrolled in all age groups following study amendments and the trial currently includes approximately 8,300 children. 

The study was designed to evaluate the safety, tolerability and immunogenicity of the Pfizer-BioNTech vaccine in three groups: 

  • ages 5 to 11 years; 
  • ages 24 months to 4 years; and 
  • ages 6 to 24 months. 

Based on the phase 1 dose escalation part of the trial, children ages 5 to 11 years received a two-dose schedule of 10 mcg each, while children younger than 5 years received a 3-mcg dose for each injection in the phase 2/3 study. The trial enrolled children with or without prior evidence of SARS-CoV-2 infection. On Dec. 17, 2021, Pfizer and BioNTech announced the companies would test a third 3-mcg dose given at least two months after the second dose in children under 5 years of age and a third dose of the 10-mcg formulation in children 5 to 11 years of age.

Dr. Marks said he hopes the decision to wait for more data is reassuring to parents and the public. “We take our responsibility for reviewing these vaccines very seriously because we're parents,” Dr. Marks said. “In looking over these data, I think parents can feel reassured that we have set the standard by which we feel that if something does not meet that standard, we can't proceed forward. 

“So, rather than having any issue causing anyone to question the process, I hope this reassures people that the process has a standard, that the process is one that we follow, and we follow the science in making sure that anything that we authorize has the safety and efficacy that people have come to [expect] from our regulatory review of medical product,” Dr. Marks said.

Although it is impossible to predict anything concerning COVID-19, Dr. Marks said, especially in light of recent surges involving more than three-quarters of a million cases per day, and a rise in pediatric cases and hospitalizations caused by omicron, he is hoping that waiting for this information will allow a more expeditious review.  

Dr. Marks added that he empathizes with parents who want the vaccine now for their children. “For the next few months while these additional data are gathered, parents will have to rely on what they've come to do well, which is their using masking procedures. They're making sure that they're vaccinated and taking those types of precautions with their youngest children. We will do our part, obviously, to move as fast as we can when we have the data, but for now we'll have to ask parents to help to continue to do what they've been doing.”

He added that he hopes that waiting will allow decisions to be made on clinical data about actual pediatric infections rather than immune-bridging analyses, which generalize clinical data based on using the vaccine in other age groups.



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