FDA Advisory Committee Backs Pfizer Vaccine in 5-11 Year-olds

An advisory committee with the Food and Drug Administration voted by a majority today to support use of the Pfizer-BioNTech COVID-19 vaccine in children 5-11 years of age.

Seventeen out of a total 18 members voted yes, and there was a single abstention to the question that was the focus of the meeting: “Based on the totality of scientific evidence available, do the benefits of the Pfizer-BioNTech COVID-19 vaccine when administered as a two dose series (10 μg each dose, three weeks apart) outweigh its risks in children 5-11 years of age?”

This marks the start of the authorization process, with formal backing still needed by the FDA. The process continues on Nov. 2 and 3, when an advisory committee with the Centers for Disease Control and Prevention is scheduled to meet to discuss clinical recommendations.

Prior to the vote, Committee member Oveta Fuller said, “I’m reminded that we have had vaccines for children before… We cannot see the effects of COVID-19 so dramatically on children–and it weighs to question, is it worth the risk. But I certainly believe in hindsight when we look back on this decision, giving parents the option to make that decision for themselves, will be something that in history we will be glad that we were able to do. And to look at the risk/benefit ratio, and say that the benefits of this option far outweigh the known risks–we can’t see the disease… we certainly can’t anticipate all the risks ahead, but we have systems in place that can help us do that.”

Member Dr. Amanda Cohn explained her vote noting that COVID-19 is the eighth leading cause of death for kids in this age group in the past year. “Use of this vaccine will prevent death, will prevent ICU admissions, and will prevent significant long-term adverse outcomes in children,” she said.

To date, there have been 45 million COVID-19 cases in the US–the majority of them in adults. Dr. Fiona Havers, a medical officer with the CDC said that of that number, there have been 1.9 million cases in the 5-11 age group. She said that from Jan. 1, 2020 to Oct. 16, 2021, there were 94 COVID-19 related deaths in children 5-11, accounting for 1.7% of all deaths in this age group.

Dr. Havers also discussed multisystem inflammatory syndrome or MIS-C in children, described as “a severe hyperinflammatory syndrome occurring 2-6 weeks after acute SARS-CoV-2 infection, resulting in a wide range of manifestations and complications.” According to studies cited, the median age is nine years old, with 39% of cases in children 6-11 years old. Of those impacted, 60-70% of patients are admitted to the ICU and 1-2% die. Dr. Havers notes there have been 5,217 cases of MIS-C reported to national surveillance as of Oct. 4, 2021.

The state Department of Health estimates there are 119,473 children 5-11 living in Hawaiʻi, which is roughly 8.4% of the state’s population.  

The federal government is expected to distribute the first waves of vaccine directly to states and DOH has already pre-ordered the full allotment allocated to Hawaiʻi—41,700 doses. This first allocation covers 35% of the keiki population between 5 and 11 years old.

The full FDA panel discussion from Oct. 26, and vote are available for viewing here.