In December 2020 both Pfizer- BioNTech’s and Moderna’s COVID-19 vaccines were approved by the Food and Drugs Administration (FDA), while the Pfizer Vaccine was approved by the European Medicines Agency (EMA) in December 2020 and Moderna’s vaccine in January 2021. In particular, the Pfizer-BioNTech COVID-19 vaccine has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent COVID-19. Having two approved vaccines is a huge step forward in our fight against coronavirus, however, children would be left waiting till late 2021 as they are not part of the latest vaccines’ trials.
Pfizer’s vaccine has been authorized for ages 16 and up. Moderna’s vaccine is currently authorized for ages 18 and up. Children’s immune systems are very different from adults’, and their immune responses can be different at different ages, from infancy through the teenage years. So, the research that has been done on the COVID-19 vaccine for ages 16 and up needs to be repeated in children of younger ages.
Both Pfizer and Moderna planned to begin new vaccine trials including children as young as age 12. If they’re successful, the data will need to go through FDA and EMA review, followed by the time it takes for production and distribution. This process can take a while, especially for very young ages, which are usually tested last.
Moderna has started dosing adolescent participants in a phase 2/3 trial evaluating vaccine candidate mRNA-1273, planning to enroll 3,000 U.S. volunteers aged 12 to 17. The randomized, controlled study, conducted in partnership with the Biomedical Advanced Research and Development Authority, will evaluate the vaccine’s safety, efficacy and reactogenicity in healthy adolescents via a two-dose regimen administered 28 days apart. Waiting for positive results from the above-mentioned studies, we hope that new trials on children under 12 years old will be soon carried out.
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