The Pfizer-BioNTech vaccine is safe and also generated a robust neutralizing antibody response in children aged 5 to 11 years, according to results of phase 2 and 3 trials released earlier this week.

The vaccine was tested in 2268 children aged 5 to 11 years and the doses used were 10µg, which is smaller than the 30µg dose used for those aged 12 years and older.  The two doses were administered at a gap of 3 weeks.

The SARS-CoV-2 neutralizing antibody geometric mean titer at one month after the second dose was found to be 1197.6 (95% confidence interval [CI, 1106.1, 1296.6]), which was comparable to the titer of 1146.5 (95% CI: 1045.5, 1257.2) obtained with the 30µg dose in persons aged 16 to 25 years, which served as the control group, demonstrating non-inferiority. The vaccine was also well tolerated and no between-group differences were observed with regard to the side effects.

While these results are encouraging, the data is yet to be peer reviewed or published. The data will be submitted to the FDA, European Medicines Agency (EMA) and other regulatory agencies, said Pfizer.

Currently, the Pfizer-BioNTech COVID-19 vaccine has been granted full approval for individuals aged ≥16 years. But it is still available for use in adolescents 12-15 years under an emergency use authorization. Recently, a third (booster) dose of the Pfizer-BioNTech vaccine has been granted emergency use approval for immunocompromised individuals. An FDA expert panel has also recommended approval of emergency use authorization (EUA) for a booster dose of the vaccine for individuals ≥65 years and those at high risk of severe COVID-19. However, the FDA is yet to rule on this.

References

1. American Academy of Pediatric news, Sept. 20, 21. https://www.aappublications.org/news/2021/09/20/pfizer-covid-vaccine-children-092021.
2. Pfizer Press release,  Sept. 20, 21. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-positive-topline-results