COVID vaccines for America’s youngest children: FDA sets June meetings 2022-04-30 10:29:02

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The Food and Drug Administration (FDA) scheduled a public review meeting on Friday COVID-19 Vaccines For the youngest children in the United States

Meetings are scheduled for June 8, 21 and 22, but the dates are not final.

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A panel of experts will review applications from pediatric vaccine manufacturers Moderna and Pfizer.

“As we continue to address the ongoing COVID-19 pandemic, there are a number of anticipated requests and scientific questions that will benefit from discussion with members of our advisory committee,” Dr. Peter Marks, director of the Center for Biological Evaluation and Research, said in statment. “We are providing a tentative timetable for discussing these requests, as these meetings will cover a number of topics of great interest to the general public. The agency is committed to a comprehensive and transparent process that takes into account the input of our independent consultants and provides insight into our review of COVID-19 vaccines. We intend to move quickly with any appropriate authorizations Once our work is done.”

More details will be provided as each company completes its application, the agency said.

“There will be no delay,” FDA commissioner Robert Califf said. reporters Friday. “We will review the data, hold an advisory committee meeting and make a decision as soon as possible once we have the applications.”

Thursday, Modern request The US Food and Drug Administration authorizes the vaccine for emergency use in children under 6 years of age.

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The Biotechnology The company said the vaccine was 51% effective against the virus in children under the age of two and about 37% effective in children aged two to five.

She added that similar requests are underway with international regulatory authorities, noting that the requests are based on two basic doses of the vaccine of 25 micrograms.

“We are proud to share that we have begun submitting our EUA for a license to a COVID-19 vaccine for young children,” Moderna CEO Stefan Bancel said in a statement. “We believe that mRNA-1273 will be able to safely protect these children from SARS-CoV-2, which is very important in our ongoing fight against COVID-19 and will be particularly welcomed by parents and caregivers.”

Modern has submitted FDA applications for older children, but the Food and Drug Administration has not judged them and it remains unclear if this data is being studied.

Currently, only children 5 years of age or older can be vaccinated in the United States with competing company Pfizer’s vaccine.

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Pfizer is also expected to announce whether three doses smaller than its own work for young children.

Currently, only children 5 years of age or older can be vaccinated in the United States with competing company Pfizer’s vaccine.

The Associated Press contributed to this report.

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