FDA reviewers say Moderna COVID-19 vaccine is safe and effective for children under 5
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FDA reviewers say Moderna COVID-19 vaccine is safe and effective for children under 5
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FDA reviewers say Moderna COVID-19 vaccine is safe and effective for children under 5.
U.S. Food and Drug Administration (FDA) reviewers noted in a briefing document released late Friday that Moderna’s coronavirus vaccine for children under 5 is safe and effective.
It is reported that the FDA will hold a meeting on granting emergency use authorization after the release of the document.
“Existing data support the effectiveness of the Moderna COVID-19 vaccine in preventing symptomatic COVID-19 in the pediatric age group 6 months to 17 years,” the document states.
The FDA’s Vaccines and Related Biologics Advisory Committee is scheduled to meet next week to decide whether the agency should approve Moderna’s application for emergency use authorization for the vaccine for children 6 months to 5 years old and for children 6 to 17 years old.
Applications from Pfizer and partner BioNTech to authorize the use of its pediatric vaccine for children under 5 years of age will also be considered.
In the United States, children under the age of 5 are still not eligible for the coronavirus vaccine. Older children can get the Pfizer-BioNTech vaccine.
In a report on the briefing document, The New York Times noted that Moderna’s low-dose pediatric vaccine:
- 51% effective in preventing symptomatic infections in children 6 months to 2 years old
- 37% effect on children 2 to 5 years old.
The FDA cautions that estimates of vaccine effectiveness are based on only a few cases of COVID-19.
The agency also said children may need booster shots, as adults already do.
FDA reviewers say Moderna’s vaccine for children did not produce inflammation of the heart muscle and surrounding tissue — myocarditis or pericarditis — a rare side effect in young people who get Moderna or Pfizer’s vaccine, the New York Times reported. is a risk.
Separately, the White House said this week that if they were approved, vaccines for children under 5 could begin as soon as June 21, with 10 million doses initially available, The Washington Post reported.
FDA reviewers say Moderna COVID-19 vaccine is safe and effective for children under 5
(source:internet, reference only)
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