The U.S. Food and Drug Administration’s (FDA) vaccine advisory committee met this week to discuss requests to amend the Emergency Use Authorization (EUA) of the Moderna and Pfizer-BioNTech COVID-19 mRNA vaccines.
Moderna asked for its EUA to include the administration of a primary series of the vaccine to infants, children and adolescents ages 6 months through 17 years. Pfizer-BioNTech asked that its EUA include the administration of a primary series to infants and children 6 months old through age 4. Vaccinations and/or boosters in these age groups are unnecessary.
However, based on the Vaccines and Related Biological Products Advisory Committee’s (VRBPAC) extended history of ignoring fundamental aspects of immunology, drug safety and epidemiology — occurring as recently as last week with its approval of the Novavax COVID-19 vaccine — it was always a foregone conclusion that the committee would approve these proposals despite the significant risk to children and noteworthy lack of effectiveness.