Will COVID-19 Vaccines for Children be Available by Year-End?
The FDA is trying to make available a safe and effective COVID-19 vaccine for use in children below 12 years of age as soon as possible.
As schools have started to re-open following the lifting of restrictions in place for more than a year amid the pandemic, COVID-19 vaccines for children below 12 years of age has become the talk of the town. Amid the noise, the FDA last week announced that COVID-19 vaccines for children will be clinically validated before getting an authorization/approval. Although the FDA did not mention any specific timeline for the availability of a vaccine for children below 12 years of age with a few companies already developing one, we expect a COVID-19 vaccine to be available by the end of 2021.
The FDA stated that it will review clinical data on prospective vaccines for younger kids as fast as possible, once a complete regulatory application gets filed but assured that safety will remain the top priority. The regulatory applications need to have at least two months follow-up data on half of the study participants, following administration of a vaccine in children for proper safety monitoring.
However, the regulatory authority has cautioned that vaccines for children may need a different dosage or different strength formulations compared to those authorized for adults currently. The FDA stated that as children are still developing, thorough and robust clinical studies of adequate size are critical for the evaluation of the safety and immune response of a COVID-19 vaccine for them.
Pediatric COVID-19 Vaccine Progress
The leading COVID-19 vaccine-makers — Moderna MRNA, and Pfizer PFE, and BioNTech BNTX — are already progressing with their clinical studies evaluating their marketed COVID-19 vaccines in a pediatric population.
Pfizer/BioNtech’s Comirnaty is the only COVID-19 vaccine to receive “full” approval from the FDA for immunization of individuals who are 16 years of age or older. The vaccine is also authorized for emergency use in individuals as young as 12 years. No other vaccine is authorized/approved for use in adolescents. In March, the companies initiated dosing in a multi-phase study to evaluate Comirnaty’s initial two-dose regimen in children aged six months to 11 years. We expect the companies to have gathered a significant amount of data from their pediatric study over more than five months of study. Per a Reuters article, data on immunization with Comirnaty in 5-11 years aged children will be filed over the next few weeks to regulatory authorities around the world with an emergency use authorization (EUA) request following suit. An authorization request for the children below five years is likely by the end of this year, the report claimed.
Moderna’s mRNA-1273 is currently authorized for use in adults and the company is seeking authorization for use in adolescents in the United States. The company is also seeking a “full” FDA approval for vaccination of adults against COVID-19. Meanwhile, the company has completed enrollment in the clinical study evaluating 50-microgram dose of its COVID-19 vaccine in children aged 5-11 years. The company is currently working on evaluating the best dosage of its COVID-19 vaccine to be used in children aged six months or higher. Moderna is likely to have enough data for requesting an EUA for use in children aged 5-11 years over the coming weeks.
Another contender in the COVID-19 vaccine race, AstraZeneca had started evaluating its COVID-19 vaccine in children early this year but the study was reportedly halted later as rare blood clot cases cropped up following immunization with the vaccine in adults. However, the vaccine is yet to gain an EUA in the United States. J&J JNJ is currently evaluating its COVID-19 vaccine in adolescents but a study on children is yet to be announced. Although Novavax is yet to receive an authorization for its COVID-19 vaccine candidate even for adults, it is developing the candidate for adolescents and adults. The vaccine holds promise as it demonstrated an efficacy rate above 90%. However, a pediatric study is yet to start. The majority of other COVID-19 vaccine candidates under development are currently being evaluated for adults.
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