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COVID vaccines for America's youngest kids: FDA sets June meetings

HealthCOVID vaccines for America's youngest kids: FDA sets June meetings


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The Food and Drug Administration (FDA) on Friday scheduled public meeting to review COVID-19 vaccines for the youngest children in the U.S.

The meetings are slated for June 8, 21 and 22, but the dates are not final.

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A panel of experts will review applications from vaccine-makers Moderna and Pfizer for child vaccines. 

“As we continue to address the ongoing COVID-19 pandemic, there are a number of anticipated submissions and scientific questions that will benefit from discussion with our advisory committee members,” Dr. Peter Marks, director of the Center for Biologics Evaluation and Research, said in a statement. “We are providing a tentative schedule for discussion of these submissions, as these meetings will cover a number of topics that are of great interest to the general public. The agency is committed to a thorough and transparent process that considers the input of our independent advisors and provides insight into our review of the COVID-19 vaccines. We intend to move quickly with any authorizations that are appropriate once our work is completed.”

The agency said more details will be provided as each company completes its application.

“There will be no delays,” FDA Commissioner Robert Califf told reporters on Friday. “We’ll review the data, hold an advisory committee meeting and make a decision as quickly as possible once we get the applications.”

On Thursday, Moderna asked the FDA to authorize its vaccine for emergency use in children under 6 years of age. 

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The biotech company said the shot was about 51% effective against the virus for kids under 2 years old and about 37% effective in kids ages 2 to 5.

It added that similar requests are underway with international regulatory authorities, noting that the requests are based on a 25-microgram two-dose primary series of the vaccine. 

“We are proud to share that we have initiated our EUA submission for authorization for our COVID-19 vaccine for young children,” Moderna CEO Stéphane Bancel said in a statement. “We believe mRNA-1273 will be able to safely protect these children against SARS-CoV-2, which is so important in our continued fight against COVID-19 and will be especially welcomed by parents and caregivers.”

Modern has filed FDA applications for older kids, but the FDA has not ruled on them and it remains unclear if that data will be under consideration.

Right now, only children ages 5 or older can be vaccinated in the U.S., using rival Pfizer’s vaccine.

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Pfizer is also expected to announce if three of its even smaller-dose shots work for the youngest children.

Right now, only children ages 5 or older can be vaccinated in the U.S., using rival Pfizer’s vaccine.

The Associated Press contributed to this report.

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