Centers for Disease Control and Prevention endorses Pfizer-BioNTech jab, less than two months after firms presented positive study results
Following FDA's authorization for emergency use late last week, the CDC Advisory Committee on Immunization Practices’ (ACIP) has recommended that a pediatric Pfizer-BioNTech Covid-19 vaccine be given to children ages 5 to 11. CDC Director Rochelle P. Walensky, MD, MPH, endorsed the ACIP’s recommendation.
This covers approximately 28 million children in the US, and providers can start vaccinating them as soon as possible.
The CDC says that Covid-19 shots have undergone—and will continue to undergo—"the most intensive safety monitoring in US history.” Vaccinating children will help protect them from getting Covid and lowers their risk of severe disease, hospitalizations, or developing long-term Covid-19 complications, the organization adds.
“Together, with science leading the charge, we have taken another important step forward in our nation’s fight against the virus that causes Covid-19,” notes Dr. Walensky. “ … As a mom, I encourage parents with questions to talk to their pediatrician, school nurse or local pharmacist to learn more about the vaccine and the importance of getting their children vaccinated.”
The news comes less than months after Phase 2/3 trial results from Pfizer-BioNTech demonstrated a “favorable safety profile and robust neutralizing antibody responses” in this age group, who were administered the Covid vaccine’s two-dose regimen of 10 µg that is given 21 days apart.
Understanding the FDA's Exemption for DSCSA Compliance
November 12th 2024In the quest for achieving full traceability, the exemption applies to certain trading partners under the Act, and postpones enforcement of final compliance requirements while acknowledging progress and ongoing challenges.