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Saturday, July 2, 2022

FDA advisors back Moderna’s COVID-19 vaccine for older children

A government advisory panel on Tuesday endorsed a second brand of COVID-19 vaccine for school children and adolescents.

Outside experts from the Food and Drug Administration voted unanimously that Moderna’s vaccine is safe and effective to give to children between the ages of 6 and 17. If the FDA agrees, it would become a second option for children joining Pfizer’s vaccine.
The same FDA expert panel will meet on Wednesday to consider Moderna’s and Pfizer’s total-size shots for children under the age of 5.

Moderna’s COVID-19 vaccine has long been available to adults in the US and elsewhere, and more than three dozen countries offer it to older children. If the FDA authorizes Moderna’s vaccine for teens and young children, the Centers for Disease Control and Prevention will decide whether to formally recommend the shots.

The Massachusetts company is seeking approval for two doses and plans to offer a booster later. Tuesday’s vote was for only two doses — full strength doses for 12-17 and half-size doses for 6-11.

“The data support that the benefits for both of these supplements outweigh the risks in these two age groups,” said CDC’s Dr. Melinda Wharton, a member of the panel.

“I believe this will provide families with an important alternative” and may be especially important for families who live in areas where the coronavirus is spreading, said another panel member, Boston Children’s Hospital. K Dr. Ofer Levy said.

The FDA withheld Moderna’s teen vaccine for months while it investigated a rare side effect, heart inflammation. This is a risk for most teenage boys and young men, and can happen with the Pfizer vaccine as well. Moderna got additional scrutiny because its shots are far higher doses.

In their review, FDA scientists noted that there were no confirmed cases of heartburn in Moderna’s child study. But experts say it may be too few participants in studies for such a rare side effect to appear.

“This clearly needs to move forward as we expand the use of the vaccine,” said Dr. Mark Sawyer, a panel member at the University of California, San Diego’s Medical School.

As for the other side effects, FDA officials said nothing worrisome was reported — primarily sore throat, headache and fatigue.

An FDA analysis concluded that two doses of Moderna are effective in preventing symptomatic COVID-19 disease in adolescents and young children with levels of virus-fighting antibodies compared to those developed in young adults.

According to an FDA analysis, the vaccine’s effectiveness was estimated at 93% for adolescents and 77% for young children. However, the research was done when earlier versions of the coronavirus were causing most US infections before more infectious versions emerged. It is also based on a limited number of COVID-19 cases, making the estimate a bit rough.

Moderna officials said a booster shot has been added to the studies, and the data is expected next month. Booster shots are now recommended for Pfizer vaccinated children, as well as for all adults.

How much demand for even two shots of Moderna will be unclear. Teens became eligible for Pfizer’s vaccine a year ago, which uses the same technology, and only 60% have received two doses. Shots for young children began in November; According to the CDC, about 29% have been fully vaccinated.

This article is republished from – Voa News – Read the – original article.

World Nation News Desk
World Nation News Deskhttps://worldnationnews.com/
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