On Oct. 12, 2022, the U.S. Food and Drug Administration (FDA) granted an Emergency Use Authorization (EUA) of the COVID bivalent booster versions of messenger RNA (mRNA) Comirnaty and Spikevax biologics developed by Pfizer/BioNTech and Moderna/NIAID for children as young as five or six years old, respectively. The FDA’s decision on Aug. 31 to grant Pfizer an EUA to distribute the bivalent booster shot to adults was made without using direct data on the effectiveness of the Pfizer bivalent booster shots in humans, only data from testing on eight mice.1 2 3 4 5
The FDA’s rationale for approving the bivalent booster for children on Oct. 12 was summarized by Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research:
Since children have gone back to school in person and people are resuming pre-pandemic behaviors and activities, there is the potential for increased risk of exposure to the virus that causes COVID-19. Vaccination remains the most effective measure to prevent the severe consequences of COVID-19, including hospitalization and death.2
CDC Officials Recommend COVID Bivalent Booster for Young Children Before ACIP Vote
These experimental “bivalent formulations” of the COVID shots contain the original strain of the SARS-CoV-2 virus and a newer mutated form of the spike protein found in the BA.4 and BA.5 variants of the Omicron strain,. The bivalent booster was first approved for use as a single booster dose for adults, replacing the monovalent booster shot.2 5 6
Within hours after the FDA decision on Oct. 12 to grant an EUA for children as young as five to receive the new booster shot, the U.S. Centers for Disease Control and Prevention (CDC) moved to recommend the bivalent shots for young children without waiting for a vote and recommendation from its Advisory Committee on Immunization Practices (ACIP).4 7
Children will now receive the new COVID bivalent booster shot instead of the monovalent version.
Pfizer said it could begin shipping up to six million children-sized doses of its COVID bivalent booster within a week of authorization, in addition to the doses for adults it is currently delivering. Some U.S. pharmacies planned to start administering the bivalent boosters to children this week, assuming no delays in shipments of the product.4 9 10 11 12
No Trial Data on New COVID Bivalent Booster Shots in Children
According to the FDA, only individuals who have received initial doses of the original-formula versions of the COVID shots qualify for the updated bivalent booster and they must wait at least two months following completion of primary or booster vaccination before getting the bivalent booster.2 9
At the end of August, federal health officials promised the new COVID bivalent booster shot would be ready to roll out to every adult by Labor Day, even though there was no effectiveness data from human clinical trials. CDC director Rachel Walensky, MD reportedly said there was no time to wait for human clinical trial data before granting the companies an EUA to distribute the bivalent booster shot to adults, a move that drew criticism from some doctors.13
Johns Hopkins medical professor Marty Markary, MD said, “Americans deserve to see the data.” Vinay Prasad, MD, MPH expressed concern about potential safety issues, tweeting, “The sequence inside mRNA vax has everything to do with myocarditis. Make a new seq (bivalent) & shove it in a vax. You might lower myocarditis. You might raise it. If you only give it to mice, and/or 65+, you have no idea about young men. You are flying blind. Total incompetence.”14
When the FDA approved an EUA on Oct, 12 for companies to distribute the bivalent booster shot for children as young as five years old, the agency admitted that the safety and effectiveness data for children was based on an adult clinical study of a COVID booster dose that contained a component of the original strain of SARS-CoV-2 and a component of Omicron lineage BA.1 (but not BA.4 and BA.5 which are in the new booster).15 FDA officials defended their decision…
For each of the bivalent COVID-19 vaccines authorized today, the FDA relied on immune response and safety data that it had previously evaluated from a clinical study in adults of a booster dose of a bivalent COVID-19 vaccine that contained a component of the original strain of SARS-CoV-2 and a component of omicron lineage BA.1. The FDA considers such data as relevant and supportive of vaccines containing a component of the omicron variant BA.4 and BA.5 lineages. In addition, the FDA has evaluated and considered immune response and safety data from clinical studies of the monovalent mRNA COVID-19 vaccines, including as a booster dose in pediatric age groups. These data and real-world experience with the monovalent mRNA COVID-19 vaccines, which have been administered to millions of people, including young children, support the EUA of the bivalent COVID-19 vaccines in younger age groups.15
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1 Kimball S. FDA authorizes Covid omicron booster shots for kids as young as 5 years old. CNBC Oct. 12, 2022.
2 Press Release. Coronavirus (COVID-19) Update: FDA Authorizes Moderna and Pfizer-BioNTech Bivalent COVID-19 Vaccines for Use as a Booster Dose in Younger Age Groups. Food and Drug Administration Oct. 12, 2022.
3 Radcliffe S. FDA Authorizes Bivalent COVID-19 Booster Shots For Kids Over Age 5. Healthline Oct. 12, 2022.
4 Scribner H. CDC, FDA authorize COVID-19 Omicron booster shots for kids. Axios Oct. 12, 2022.
5 Cáceres M. Safety and Effectiveness of New COVID Bivalent Boosters Based on a Study of Eight Mice? The Vaccine Reaction Sept. 12, 2022.
6 Press Release. Coronavirus (COVID-19) Update: FDA Authorizes Moderna, Pfizer-BioNTech Bivalent COVID-19 Vaccines for Use as a Booster Dose. U.S. Food and Drug Administration Aug. 31, 2022.
7 Kimball S. CDC recommends Covid omicron booster shots for kids as young as 5 years old. CNBC Oct. 12, 2022.
8 Associated Press. FDA approves Omicron-specific boosters for kids as young as 5. PBS Oct. 12, 2022.
9 CBS Chicago Team. New bivalent booster shots available for kids as young as 5 at Chicago clinics, pharmacies, and more. CBS News Chicago Oct. 17, 2022.
10 NBC 5 Chicago. Chicago’s Top Doc Says New Bivalent Shots For Kids as Young As 5 Could Start Monday. Oct. 13, 2022.
11 NBC 5 Chicago. Illinois Coronavirus Updates: COVID Boosters for Kids, Predicting a Surge. Oct. 17, 2022.
12 Stinson S. Santa Clara County health officials plan to roll out booster shots for kids. KRON 4 Oct. 17, 2022.
13 Krieger LM. Q&A: The new COVID vaccine booster is coming: Should you get it? The Mercury News Aug. 26, 2022.
14 Piper G. Eight boosted mice: Critics pan FDA for preelection Omicron jab approval based on irrelevant data. Just the News Aug. 31, 2022.
15 FDA. Coronavirus (COVID-19) Update: FDA Authorizes Moderna and Pfizer-BioNTech Bivalent COVID-19 Vaccines for Use as a Booster Dose in Younger Age Groups. Oct. 12, 2022.