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Sunday, June 26, 2022

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

MIKE STOBBE. By

NEW YORK ( Associated Press) – 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 as well. 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 outweigh the risks of both of these supplements in both of these 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.

“It clearly needs to be watched closely to expand the use of the vaccine as we move forward,” 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.

A member of the panel, Dr. Paul Offit, said that there has been a decline in the effectiveness of the vaccine against new forms of the coronavirus. Offit, of the Children’s Hospital of Philadelphia, said he supported Moderna’s proposals only because he expects a third dose to be offered, which he says needs to be done before someone is fully vaccinated.

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.

If the FDA authorizes Moderna shots for teens and schoolchildren, a CDC spokesperson said the agency is not expected to review the vaccine until later this month.

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The Associated Press Department of Health and Science receives support from the Howard Hughes Medical Institute’s Department of Science Education. Associated Press is solely responsible for all content.

World Nation News Desk
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