Responding to early data
As Dr. Fryhofer put it, the medical community has been learning in “real time” about how COVID vaccines work and how to use them.
The EUA granted on May 17 for booster shots for children ages 5 to 11 was based on an analysis of immune response data in a subset of children from an ongoing randomized placebo-controlled trial, the FDA said.
Antibody responses were evaluated in 67 study participants who received a booster dose 7 to 9 months after completing a two-dose primary series of the Pfizer-BioNTech COVID-19 Vaccine. The EUA for the booster shot was intended to respond to emerging data that suggest that vaccine effectiveness against COVID-19 wanes after the second dose of the vaccine, the FDA said.
CDC seeks help tracking vaccine complications
At the ACIP meeting, a top CDC vaccine-safety official, Tom Shimabukuro, MD, MPH, MBA, asked physicians to make sure their patients know about the agency’s V-Safe program for gathering reports from the public about their experiences with COVID vaccines. This is intended to help the CDC monitor for side effects of these medications.
“We need your help,” he said during a presentation about adverse events reported to date in children ages 5 to 11 who took the Pfizer vaccine.
About 18.1 million doses of Pfizer-BioNTech vaccine have been administered to children ages 5 to 11 years in the United States so far. Most of the reports of adverse events following vaccination were not serious, he said. But there were 20 reports of myocarditis verified to meet CDC case definition among children ages 5 to 11 years.
One case involved a death with histopathologic evidence of myocarditis on autopsy. The CDC continues to assist with case review, he said.
A version of this article first appeared on Medscape.com.