By MIKE STOBBE – AP Medical Writer
NEW YORK (AP) — A government advisory group on Tuesday approved a second brand of COVID-19 vaccine for school-aged children and teens.
Outside Food and Drug Administration experts voted unanimously that Moderna’s vaccine is safe and effective enough to give to children ages 6 to 17. If the FDA agrees, it would become the second option for these children, joining Pfizer’s vaccine.
The same panel of FDA experts will meet on Wednesday to review medium-sized plans from Moderna and Pfizer for the little ones, those under 5 years old.
Moderna’s COVID-19 vaccine has long been available for adults in the United States and elsewhere and more than three dozen countries also offer it to older children. If the FDA clears Moderna’s vaccine for adolescents and young children, the Centers for Disease Control and Prevention will then decide whether to formally recommend the shots.
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The Massachusetts company is seeking authorization for two doses and plans to offer a recall later. Tuesday’s vote was for just two doses – full strength for 12-17 and half doses for 6-11.
“The data confirms that the benefits outweigh the risks for these two doses, in these two age groups,” said CDC panel member Dr. Melinda Wharton.
“I think this will give families an important option” and may be especially important for families who live in areas where the spread of the coronavirus is increasing, said fellow panelist Dr. Ofer Levy of Boston Children’s Hospital.
The FDA withheld Moderna’s teen vaccine for months as it investigated a rare side effect, heart inflammation. This is especially a risk for teenagers and young men, and it can also happen with the Pfizer vaccine. Moderna has come under additional scrutiny as his shots are at a much higher dose.
In their review, FDA scientists said there were no confirmed cases of heart inflammation in Moderna’s childhood studies. But experts say the studies may have had too few participants for a rare side effect like this to appear.
“This clearly needs to be watched closely in the future as we expand the use of the vaccine,” said panel member Dr. Mark Sawyer, University of California San Diego School of Medicine.
As for other side effects, FDA officials said nothing of concern was reported — mostly sore arms, headaches, and fatigue.
The FDA analysis concluded that two doses of Moderna are effective in preventing symptomatic COVID-19 illness in adolescents and young children, with anti-virus antibody levels comparable to those developed in young adults.
The vaccine’s effectiveness was estimated at 93% for adolescents and 77% for young children, according to the FDA analysis. However, the research was done when earlier versions of the coronavirus were causing most infections in the United States, before more contagious versions emerged. It’s also based on a limited number of COVID-19 cases, which makes estimates a bit rough.
A booster injection has been added to the studies and data is expected around next month, Moderna officials said. Booster shots are now recommended for children vaccinated with Pfizer shots, as well as for all adults.
A member of the panel, Dr. Paul Offit, noted that the effectiveness of the vaccine has decreased against new variants of the coronavirus. Offit, of Children’s Hospital of Philadelphia, said he supports Moderna’s proposals only because he expects a third dose to be offered, which he says is needed before anyone is considered fully vaccinated.
The demand for even two Moderna blueprints is unclear. Teenagers became eligible a year ago for Pfizer’s vaccine, which uses the same technology, and only 60% received two doses. Shooting for young children began in November; about 29% have been fully vaccinated, according to the CDC.
If the FDA allows injections of Moderna for teens and school children, a CDC spokesperson said the agency is not expected to review the vaccine until the end of the month.
The Associated Press Health and Science Department is supported by the Howard Hughes Medical Institute Department of Science Education. The AP is solely responsible for all content.
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