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Moderna and Pfizer-BioNTech COVID-19 vaccines were approved by FDA for COVID-19 prevention in younger children aged six months.
As reported in the Food and Drug Administration (FDA) publication of 17 June 2022, two vaccines have been approved for preventing coronavirus disease, the Pfizer-BioNTech vaccine and the Modern vaccine in children as young as six months. For Moderna vaccine, the FDA modified the emergency use authorization (EUA) to encompass usage of vaccine in subjects six months through seventeen years of age. This vaccine had been approved for usage in adults eighteen years of age and above.
For Pfizer-BioNTech vaccine, the FDA altered the EUA to incorporate usage of vaccine in subjects six months through four years of age. This vaccine had been approved for usage in subjects five years of age and above.
Efficacy and safety of Moderna COVID-19 Vaccine
For pediatrics 6 months to 5 years of age, 6 years to 11 years, and 12 years of age and above, the study data revealed that immune responses in these age groups were similar to those in adults. Among children 6 months to 23 months, vaccine exhibited 50.6% excellent efficacy in prevention of COVID-19. Among pediatrics 2 to 5 years of age, vaccine was 36.8% effective while in individuals aged 12 to 17 years, the vaccine was 93.3% effective in preventing coronavirus disease.
The most frequently encountered adverse effects were experienced by participants aged from 6 to 11 years and 12 to 17 years which included discomfort, redness, and swelling at the injection site, muscular pain, tiredness, chills, enlarged lymph nodes in underarm, fever, nausea, vomiting, and headache. In males 18 through 24 years of age, the myocarditis/pericarditis risk was noted to be highest.
Efficacy and safety of Pfizer-BioNTech COVID-19 Vaccine
For pediatrics 6 months to 4 years, the study data indicated that immune responses in this age group were comparable to those in older adults. Notably, 80 children (aged 6 to 23 months) and 140 children (aged 2 to 4 years) were compared with 170 persons (aged 16 to 25 years) in terms of their immune responses in the FDA trial, and the results were determined to be comparable, and the immunization was judged effective.
The most frequently reported side effects in clinical trial participants aged 6 to 23 months and 2 to 4 years were irritability, decreased appetite, fever, soreness, swelling and redness at the injected site (also chills, fever, and headache in pediatrics 2 to 4 years old). In males 12 through 17 years of age, myocarditis/pericarditis risk was witnessed to be highest.
As a primary series, Moderna vaccine is given in two doses one month apart to subjects aged 6 months to 17 years. For children of this age group who have have specific kinds of immunocompromise, Moderna vaccine is also approved to offer a third primary series dose at least 1 month following the 2nd dose.
For children aged 6 months to 4 years, Pfizer-BioNTech offers COVID-19 vaccine in three doses as a primary series. The first two doses are given 3 weeks apart, and the 3rd dose is given 8 weeks after the 2nd dose. It is anticipated that these vaccines for younger children will offer protection from the most serious outcomes of coronavirus disease, like hospitalization and death.
US-FDA
Coronavirus (COVID-19) Update: FDA Authorizes Moderna and Pfizer-BioNTech COVID-19 Vaccines for Children Down to 6 Months of Age
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