The CDC’s Advisory Committee on Immunization Practices is holding a public meeting to discuss whether to recommend Pfizer/BioNTech’s Covid-19 vaccine for use in youth as young as 12. The US Food and Drug Administration extended its emergency use authorization for the vaccine in 12-15-year-olds Monday.
ACIP is being asked: “Should vaccination with Pfizer-BioNTech COVID-19 vaccine (2-doses, IM) be recommended for persons 12-15 years of age under an Emergency Use Authorization?”
In slides prepared for presentation Wednesday, Dr. Sara Oliver of the CDC’s National Center for Immunization and Respiratory Diseases said the vaccine would provide large benefits to younger teens and pre-teens, with small harms.
“Adolescents 12–17 years of age are at risk of severe illness from COVID-19,” the written presentation reads. “COVID-19 in adolescents may also indirectly impact others’ health,” it added.
“Adults living in a household with a child engaged in full-time in-person school had an increase in odds of reporting COVID-19 like illness, loss of taste/smell, or positive SARS-CoV-2 test within previous 14 days.”
The CDC estimates more than 22 million children ages 5 to 17 have been infected with coronavirus, Oliver said. In the 12-17 age group, 127 have died.
Oliver also noted that 3,742 cases of multisystem inflammatory syndrome in children, or MIS-C, have been reported. It’s a rare but serious complication of coronavirus infection that affects multiple organs. It affects minorities disproportionately; 63% of reported cases have been among Black and Latino children.
“The clinical trial for the Pfizer-BioNTech COVID-19 vaccine demonstrated efficacy against symptomatic, laboratory-confirmed COVID-19. The efficacy was 100%,” Oliver’s presentation reads.
Adverse events were very rare and no serious adverse events were linked to the vaccine. None of the 2,200 12-15-year-olds in the clinical trial suffered a severe allergic reaction known as anaphylaxis.
A vote is scheduled for 245 p.m. ET and the CDC is expected to sign off on the recommendations quickly afterwards.
While most states will wait for the CDC go-ahead, some states allowed the vaccination of the younger adolescents starting Tuesday — among them, Georgia and some districts of North Carolina.
Pfizer said last week it expects to submit for emergency use authorization for its Covid-19 vaccine for children ages 2 to 11 in September. Its vaccine safety and efficacy study in children ages 6 months to 11 years old is ongoing.
The FDA also scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee for June 10 to discuss the potential extension of EUA to children under 12.
This story is developing and will be updated throughout the day.Source link