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The Food and Drug Administration (FDA) scheduled a public meeting Friday to review COVID-19 vaccines for the youngest children in the United States
The meetings are scheduled for June 8th, 21st and 22nd, but the dates are not yet final.
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A panel of experts will review applications from vaccine manufacturers Moderna and Pfizer for children’s 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 members of our Advisory Committee,” said Dr. Peter Marks, director of the Center for Biologics Evaluation and Research, said in a statement. “We are providing an indicative timeline for discussing these filings as these meetings will cover a range of topics of significant interest to the general public. The agency is committed to a thorough and transparent process that takes into account input from our independent consultants and provides insight into our review of COVID-19 vaccines. We intend to proceed quickly with all appropriate permits once our work is complete.”
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 will review the data, hold an advisory committee meeting and make a decision as soon as possible once we receive the applications.”
On Thursday, Moderna asked the FDA to approve its vaccine for emergency use in children under 6 years old.
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The biotech said the shot was about 51% effective against the virus in children under the age of 2 and about 37% in children aged 2 to 5.
It added that similar inquiries were ongoing with international regulators, noting that the inquiries are based on a 25-microgram primary series of the vaccine in two doses.
“We are proud to announce that we have initiated our EUA filing for approval of our COVID-19 vaccine for infants,” Moderna CEO Stéphane Bancel said in a statement. “We believe that mRNA-1273 can safely protect these children from SARS-CoV-2, which is so important in our ongoing fight against COVID-19 and is especially welcomed by parents and caregivers.”
Modern has submitted FDA applications for older children, but the FDA has not ruled on it, and it remains unclear if this data will be considered.
In the USA, only children over the age of 5 can currently be vaccinated with the vaccine from competitor Pfizer.
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Pfizer is also expected to announce whether three of its even smaller doses work for the youngest children.
In the USA, only children over the age of 5 can currently be vaccinated with the vaccine from competitor Pfizer.
The Associated Press contributed to this report.