Vaccine for younger children 'unlikely' before mid to late 2022
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A COVID-19 vaccine for young children is “unlikely” to be available before mid or even late 2022, an expert said.
Pfizer and BioNTech announced last week that they were evaluating the addition of a third 3 µg dose of their vaccine for children aged 6 months to 5 years after the two-dose series failed to produce the expected level of protection in study participants aged 2 to 5 years, although protection in participants aged 6 to 24 months matched that seen in adolescents and young adults.
If the three-dose series is successful, the companies said they would submit data to the FDA for an emergency use authorization “in the first half of 2022.”
“Hopefully, that'll make up for the fact that it didn't get an adequate response with two doses for that older group within that population,” Paul A. Offit, MD, director of the Vaccine Education Center at the Children's Hospital of Philadelphia, told Healio.
“We learn as we go,” Offit said. “The good news is they're going to have to generate data that conclusively proves that their vaccine is safe and effective in a group of, no doubt, thousands of children.”
A version of the Pfizer-BioNTech vaccine for children aged 5 to 11 years was authorized for emergency use by the FDA on Oct. 29. Uptake has been slow, however, and a delay in the development of the shot for children aged 6 months to 5 years was widely described as a setback.
“I think it's unlikely that we're going to have a vaccine for that younger age group before the middle to end of next year,” Offit said.
References:
Pfizer and BioNTech provide update on ongoing studies Of COVID-19 vaccine. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-provide-update-ongoing-studies-covid-19. Published Dec. 17, 2021. Accessed Dec. 21, 2021.
Perspective
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Leonard R. Krilov, MD, FAAP, FIDSA, FPIDS
As the COVID-19 pandemic continues, it is clear vaccination is a critical component in protecting individuals and controlling the spread of the virus. With the recently identified and rapidly spreading omicron variant, a booster dose in adults appears to provide significantly improved protection against severe infection.
As we are making progress in vaccinating adults, children constitute an increasing proportion of new cases. From Dec. 9 to 16, almost 170,000 cases were reported in children, accounting for almost one-quarter of the weekly cases. Presently, Pfizer’s messenger RNA COVID-19 vaccine is approved for children aged as young as 5 years, but the uptake in the most recently approved 5- to 11-year-old age range has been slow to date.
The next planned step forward is to expand COVID-19 vaccination to children aged 6 months to 5 years. Pfizer’s clinical trial in this age range employed a 3 µg dose (1/10 of the adult dose). Although there were no safety concerns identified, the interim data from this study suggest that this regimen did not produce antibody levels comparable to those seen in teenagers and adults for the 2-, 3- and 4-year-olds in the study. As a result, the study is being revised to add a third dose of 3 µg at this age. Additionally, a third dose is being evaluated for children aged 5 to 11 years and 12 to 17 years in separate studies.
Unfortunately, these findings will lead to a delay in the availability of COVID-19 vaccination for younger children. On the brighter side, if the third dose proves successful, it may lead to better protection, including against the omicron variant for these children.
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