FDA Declares MODERNA Jab “Safe and Effective” Ahead of Approval Committee

US opens COVID vaccine to little kids, shots begin next week - OPB

Reviewers at the Food and Drug Administration (FDA) said in briefing documents that Moderna’s COVID-19 vaccine is both effective and safe for children under 6 years old.

The analysis comes ahead of several advisory committee meetings next week to weigh giving approval to Moderna’s and Pfizer’s vaccines for young children.

“Available data support the effectiveness of the Moderna COVID-19 Vaccine in preventing symptomatic COVID-19 in pediatric age groups from 6 months through 17 years of age,” staff at the FDA wrote.

The FDA staff noted that rates of adverse reactions were found to be similar between young adults and those aged between 12 and 17 years old.

“In children 6 months through 11 years of age, rates of solicited local and systemic adverse reactions were generally lower compared to those observed in adolescents and in previous clinical trials with young adults, with the exception of fever which was reported more frequently in the younger age groups compared to adolescents and adults,” FDA staff said.

So far, children aged 5 years and older can only receive the Pfizer vaccine, and no vaccine has been authorized for children under 5 years old.

An FDA advisory committee is set to meet Wednesday to weigh allowing Moderna’s vaccine for children between the ages of 6 months and 5 years old and Pfizer’s vaccine for children under 5.

If the advisory committee recommends approval the vaccines for young children, approval from the Centers for Disease Control and Prevention and FDA authorization could follow soon after.

The advisory committee will also meet Tuesday to discuss changing emergency use authorization for the Moderna vaccine so children and adolescents aged 6 to 17 years can receive it.


Source: thehill.com/policy/healthcare/3519696-fda-says-moderna-covid-vaccine-safe-and-effective-for-young-children/

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