With the start of the new school year and a large number of cases clearly associated with the Delta mutation, there are many reasonable questions about vaccinating children against COVID-19.
Doctors of the Therapeutic Clinic of the Medical School of the Athens National University. Capodistria Stavroula Easter (Associate Professor of Endocrinology, Επίκουρη Καθηγήτρια Ενδοκρινολογίας), Theodore Psaltopulu (professor of preventive and curative medicine, Καθηγήτρια Θεραπευτικής-Προληπτικής Ιατρικής) and Thanos Dimopoulos (Professor EKPA, Καθηγητής Θεραπευτικής-Αιματολογίας-Ογκολογίας και Πρύτανης ΕΚΠΑ) gave their expert opinion.
Last month, the US FDA granted full approval to use the Pfizer vaccine for young people over the age of 16. This was based on 6 month clinical data.
The vaccine was already approved for emergency use last December based on a shorter, two-month clinical trial. Likewise, Pfizer and Moderna vaccines are currently approved for children over 12 years of age by the FDA (US) and EMA (Europe). Both vaccines are mRNA, which means that they do not contain the viral portion, but contain only a “set of information” to “train human cells” to produce a protein that activates the immune system to produce protective antibodies.
A Pfizer spokesman said data on vaccine use for children aged 5 to 11 is expected within the next month. Vaccine use data for children 2 to 5 years of age will be available shortly thereafter.
For children 6 months to 2 years of age, Pfizer said they will receive vaccine safety and efficacy data in November 2021.
Moderna also announced that it has completed enrollment in a clinical trial for children ages 6 to 11, while conducting research to select the most appropriate dose for even younger age groups.
US regulators, for their part, have said that children participating in clinical trials of COVID-19 vaccines must be monitored for at least 2 months, suggesting a faster emergency approval process is pending before full approval. The FDA also announced that every effort will be made to complete the analysis of the findings as soon as possible, probably within a few weeks.
Vaccines are the most important response in the fight against a pandemic. However, until the entire population, including children, is reached, additional precautions will be required in the coming months, such as the use of masks, distancing and possibly, in some cases, isolation (quarantine).