U.S. Food and Drug Administration (FDA) reviewers said in a briefing document released late Friday that Moderna's COVID-19 vaccine for children under 5 years old is safe and effective. It is reported that the FDA is about to hold a meeting on granting emergency use authorization after releasing the document.
The document states: "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 FDA's Vaccines and Related Biological Products Advisory Committee is scheduled to A meeting is scheduled for next week to decide whether the agency should approve Moderna's application for emergency use authorization for children 6 months to 5 years old and for children 6 to 17 years old. Pfizer and partner BioNTech's application for authorization of their 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.
The New York Times noted in a report on the briefing document that Moderna's low-dose pediatric vaccine was found to be 51% effective in preventing symptomatic infection in children 6 months to 2 years old, and 2 to 5 years old. 37% effective in children aged 10 years. 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, just like adults already do.
The New York Times reported that FDA reviewers said the Moderna vaccine for children did not produce inflammation of the heart muscle and surrounding tissue -- myocarditis or pericarditis -- a rare side effect that is common with shots of the Moderna or Pfizer vaccines. is a risk for young people.
In addition, according to the " Washington Post " report, this week, the White House said that if they are approved, vaccinations for children under 5 years old could begin as soon as June 21, with an initial supply of 10 million doses.
