On 17 May 2022, the Food and Drug Administration (FDA) modified the emergency use authorization (EUA) for a single booster dose of vaccine to be received by children (5-11 years of age) following the completion of primary series vaccination. This dose is effective in the prevention of most severe consequences of coronavirus disease in children five years of age and older.

On 3rd January, FDA approved usage of a single booster dose of vaccine for administration to children (12 through 15 years of age) after accomplishing primary vaccination.  FDA has approved the COVID-19 vaccine for children five years and older and has authorized Comirnaty (COVID-19 mRNA Vaccine) to employ in people sixteen years and older.

Data in support of efficacy

On the basis of FDA’s assessment of immune response data in a subgroup of children from the randomized placebo-controlled study, the EUA for the booster dose (for children 5-11 years old) was granted. This study assisted the October 2021 approval of the coronavirus vaccine primary series in children 5-11 years old.

Assessment of antibody responses was done in 67 volunteers who were administered a booster dose 7-9 months after accomplishing a 2-dose primary series of SARS-CoV-2 vaccine. In comparison with prior to booster dose, the level of antibodies against the coronavirus was elevated one month after the booster dose.

FDA assessment of safety

In around 400 children (who were administered a booster dose of vaccine at least 5 months following the completion of a 2-dose primary series), the safety of a single booster dose of the coronavirus vaccine was evaluated. Fever, chills, joint or muscle pain, headache, fatigue, swelling at the site of injection, redness, and pain were found to be the commonly reported adverse effects.