On Oct. 20, 2021, the Biden administration outlined plans to begin giving COVID-19 vaccinations to children between five and 11 years old. Pending the results of reviews of the plan by the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) over the next two weeks, an estimated 28 million children could be affected.1 2
“We’re completing the operational planning to ensure vaccinations for kids ages 5 to 11 are available, easy and convenient. We’re going to be ready, pending the FDA and CDC decision,” White House Coronavirus Response Coordinator Jeff Zients said. “Kids have different needs than adults and our operational planning is geared to meet those specific needs, including by offering vaccinations in settings that parents and kids are familiar with and trust.”1 2
According to the White House, more than 25,000 primary health care providers and tens of thousands of pharmacies will be available to administer COVID shots to elementary school children. The Federal Emergency Management Agency (FEMA) will reportedly also fund and support the establishment of hundreds of vaccination clinics in schools, community health centers and rural health clinics throughout the country.1 2
Pfizer, BioNTech Seek Emergency Use Authorization to Distribute COVID Shots to Younger Children
On Oct. 7, Pfizer, Inc. and BioNTech SE submitted a request to the FDA to grant Emergency Use Authorization (EUA) to distribute their messenger RNA (mRNA) COVID biologic, BNT162b2 (or “Comirnaty”), to children between five and 11 years old. That product is currently only approved for people 12 years and older.2 3 Pfizer stated:
With new cases in children in the U.S. continuing to be at a high level, this submission is an important step in our ongoing effort against COVID-19. We’re committed to working with the FDA with the ultimate goal of helping protect children against this serious public health threat.3
Effects of Lower Dose Pfizer/BioNTech COVID Shot for Younger Children Reportedly Similar to Older People
Based on a clinical trial earlier this year involving 2,268 kindergartners and elementary school-aged kids, Pfizer and BioNTech said on Sept. 20 that the BNT162b2 is “safe, well tolerated, and showed robust neutralizing antibody responses.”5 6 7
The young children in the trial ages five to 11 years old were administered two doses of the biologic 21 days apart, which is the same regimen used for those 12 years and older. The dosage, however, was much smaller—10 μg (micrograms) rather than the 30 μg given to older children and adults.5 6 7
The side effects were reportedly comparable to those experienced by people 16-25 years of age who received the higher dose biologic. However, according to the Associated Press, the “study isn’t large enough to detect any extremely rare side effects, such as the heart inflammation that sometimes occurs after the second dose, mostly in young men.”5
On Oct. 26 at the FDA’s Vaccines & Related Biological Products Advisory Committee (VRBPAC), Pfizer presented a briefing document that contained more information on clinical trials of Comirnaty in young children.8 That document indicated that the primary clinical trials Pfizer conducted on children ages five to 11 years old included about 3,100 children who got the COVID shot and were followed up for between two weeks and two months.
Dr. Ugur Sahin, CEO and co-founder of BioNTech said:
The safety profile and immunogenicity data in children aged 5 to 11 years vaccinated at a lower dose are consistent with those we have observed with our vaccine in other older populations at a higher dose.7
The Associated Press also reported that the results of the trial were published in a press release issued by Pfizer and BioNTech, not in a peer-reviewed scientific journal. “The study still is ongoing,” noted the news agency, “and there haven’t yet been enough COVID-19 cases to compare rates between the vaccinated and those given a placebo something that might offer additional evidence.”5
FDA and CDC May Soon Approve Pfizer/BioNTech COVID Shot for Children 5-11 Years
Still, there are some indications that the FDA and CDC may soon approve the Pfizer/BioNTech COVID shot for children 5-11 years old. “Depending on how long the FDA takes to review the application, whether it’s a four-week review or a six-week review, you could have a vaccine available to children as early as probably by the end of October,” said former FDA commissioner Scott Gottlieb, MD, who serves on Pfizer’s board of directors.9
Pfizer and BioNTech are currently conducting trials for their COVID shot on children 2-4 years of age, as well as children as young as six months. Trial results for the first group may be available “before the end of the year,” said Pfizer CEO Albert Bourla.10
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1 Diamond J, Collins K, Sullivan K. White House details plan to roll out Covid-19 vaccines for children ages 5 to 11. CNN Oct. 20, 2021.
2 Miller Z, Tanner L. White House details plans to vaccinate 28M children age 5-11. Associated Press Oct. 20, 2021.
3 Burke M, Chuck E. Pfizer asks FDA for emergency authorization for its Covid vaccine for kids ages 5-11. NBC News Oct. 7, 2021.
4 CBS Baltimore. Pfizer To Request Emergency Approval For Vaccines For Children Aged 12 And Under. Oct. 8, 2021.
5 AP. Pfizer vaccine safe for children aged 5-11, show clinical trial results. Business Standard Sept. 20, 2021.
6 Elbaum R. Pfizer says its Covid vaccine is safe and effective for children ages 5 to 11. NBC News Sept. 20, 2021.
7 Pfizer, BioNTech. Pfizer and BioNTech Announce Positive Topline Results From Pivotal Trial of COVID-19 Vaccine in Children 5 to 11 Years. Business Wire Sept. 20, 2021.
8 U.S Food and Drug Administration. FDA Briefing Document on EUA amendment request for Pfizer BioNTech COVID-19 vaccine for use in children 5 through 11 years of age. Vaccines and Related Biological Products Advisory Committee Oct. 26, 2021.
9 Lovelace B. Pfizer says its Covid vaccine is safe and generates robust immune response in kids ages 5 to 11. CNBC Sept. 20, 2021.
10 Zhang S. Vaccine Data for Kids Under 5 Are Coming ‘Before the End of the Year’. The Atlantic Sept. 28, 2021.