FDA staff weigh in on 2 COVID vaccines for kids ahead of advisory meetings

This week the Food and Drug Administration (FDA) will consider key recommendations that would give older kids a second COVID-19 vaccine—Moderna—for the primary series and open vaccination up for the first time to the youngest kids.Ahead of 2 days of meeting this week, FDA staff released in-depth analyses, which said the vaccines were safe and effective.In international developments, European health officials today warned that COVID-19 cases will likely rise in the coming weeks as the BA.4 and BA.5 subvariants become more dominant across the continent.Busy week for vaccine advisory groupsTomorrow, the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) will consider emergency use of Moderna's vaccine in kids ages 6 through 17.The vaccine would be administered as two 100-microgram doses, the same as for adults, in adolescents ages 12 through 17 and given as two 50-microgram doses in children ages 6 through 11.

For youngsters ages 6 months to 5 years, the dosage is 25 micrograms.Then the next day, VRBPAC will consider amending emergency use authorizations for both the Moderna and Pfizer-BioNTech vaccines, allowing them be used in children ages 6 months to 5 years, an eagerly anticipated move that opens up vaccination to the youngest Americans. (The Pfizer vaccine is already approved for emergency use for kids 5 years and older.)In a staff analysis of the data published on Jun 10 ahead of the meeting, FDA staff said the Moderna vaccine prompted a similar immune response in children ages 6 months through 17 years as it did in adult trials.

They said the side effect profiles were similar for children and adults, though fever was more often reported in younger children.Both mRNA vaccines have been