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July 28, 2021

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Pediatric COVID-19 Vaccines – What We Know

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On behalf of the Emerging Infectious Disease Task Force

There are many questions about when vaccines will be available for children. Here is what we know as of July 2021.

Pfizer-BioNtech

Pfizer-BioNTech initiated a global study of their COVID-19 vaccine dosing the first healthy children (11 years to six months of age) in March 2021. This is a dose escalation study – two doses 21 days apart.  They are looking at three groups:

  • Children ages five to 11 years
  • Children two to five years
  • Children six months to two years

Children younger than six months of age may be evaluated, once an acceptable safety profile has been established.

The study is looking at safety and immunogenicity of the Pfizer vaccine. Because vaccine effectiveness has already been established in those who are 16 to 25 years old, a comparison with that group (called immunobridging) can be used to establish vaccine effectiveness. This accelerates the process without sacrificing safety. The Pfizer study will enroll about 4,500 children six months to 11 years old in the United States, Finland, Poland and Spain at more than 90 clinical trial sites.

According to Pfizer-BioNtech “If safety and immunogenicity is confirmed, and pending authorization or approval from regulators, we hope to submit the vaccine for potential Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) sometime in the September-October timeframe for children five to 11, and soon after for six months to five years.”

Moderna

Children have started receiving doses of the Moderna mRNA vaccine as part of a study called “KidCOVE”. The company plans to enroll 6,750 children ages six months through 11 years. The two-part study will begin by testing different dose levels, then move into a randomized, placebo-controlled expansion study to evaluate vaccine safety and effectiveness. Moderna plans to use the immunobridging method to determine effectiveness the same as Pfizer is doing.

The second age group in the study will be recruiting later for children between the ages of two years to less than six years old. Finally, the third, and last group to start, will be for children ages six months to less than two years old. Given the typical time frame for vaccine safety and effectiveness trials (even with the immunobridging method) we would not expect a vaccine for children from Moderna before December or later. 

Janssen (Johnson and Johnson)

The randomized, double-blind, placebo-controlled Phase 2a study by Janssen for their COVID-19 vaccine has been ongoing since September 2020.  It was initially designed to look for vaccine reactions, safety, and immunogenicity in healthy adults ages 18 to 65 using a single dose. That study has now expanded to include adolescents 12 to 17 years of age as of a month ago. Don’t expect anything for younger ages from Janssen until 2022.

References

Pfizer Studies in additional populations

https://www.pfizer.com/science/coronavirus/vaccine/additional-population-studies

Moderna KidCOVE study site

https://connect.trialscope.com/studies/0e8fc8e6-5782-46fd-8b03-0994a5ad8b41

Janssen Study

https://clinicaltrials.gov/ct2/show/NCT04535453