Published June 7, 2022
On June 7, 2022, EPPC Fellow David Gortler submitted a comment to the Food and Drug Administration for a public advisory meeting of the Vaccines and Related Biological Products Advisory Committee, which will consider two topics: (1) amend the Emergency Use Authorization (EUA) of the Moderna COVID-19 mRNA vaccine to include the administration of a primary series to infants, children, and adolescents 6 months through 17 years of age; and (2) to amend the EUA of the Pfizer-BioNTech COVID-19 mRNA vaccine to include the administration of a primary series to infants and children 6 months through 4 years of age.
In the comment, Dr. Gortler argues that Advisory Committee should not grant either COVID-19 vaccine EUA request. “There is no emergency requiring the use of the truncated EUA approval process for COVID-19 vaccines for children. Infants, children, and adolescents all have a decreased benefit from COVID-19 vaccination, but a greater safety risk. Many have already had COVID and have the benefits of naturally acquired immunity. The Committee should follow the data not politics and reject the EUA proposals. Our children deserve no less.”