Wednesday, December 07, 2022

FDA advisors consider Moderna’s COVID shots for older children

NEW YORK ( Associated Press) – A government advisory panel meeting Tuesday to recommend a second brand of COVID-19 vaccine for school children and adolescents.

Outside experts from the Food and Drug Administration will vote on whether Moderna’s vaccine is safe and effective to give to children ages 6 to 17. If the panel supports the shot and the FDA agrees, it would become a second option for children joining Pfizer’s vaccine. ,

The same expert panel will meet on Wednesday to consider both Moderna and Pfizer’s aggregate-size shots for the youngest children under the age of 5.

Moderna’s COVID-19 vaccine has long been available to adults in the US and elsewhere, and dozens of countries offer it to children as well. In the US, children 12 to 17 years of age will receive two full-strength doses; Ages 6 to 11 will get a half-size dose.

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.

Read more: Moderna says new COVID-19 vaccine protects against Omicron

In a call with reporters earlier this week, Georgetown University’s Dr. “If this is happening, there are not enough people in clinical trials to find the problem,” Jesse Goodman said.

As for other side effects, FDA officials said nothing alarming had been 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 the FDA analysis, the vaccine’s effectiveness was estimated at 93 percent for the 12-17 group and 77 percent for the younger group. However, the research was done at a time when earlier versions of the coronavirus were causing most US infections, and it’s not clear how well they work against more recent versions. It is also based on a limited number of COVID-19 cases, making the estimate a bit rough.

The FDA review said it is likely that a booster shot will be needed, as is now recommended for vaccinated children, along with shots from Pfizer, as well as for all adults.

How much demand for Moderna’s shots will be, it is not clear. Teens became eligible for Pfizer’s vaccine a year ago, which uses the same technology, and only 60 percent have received two doses. Shots for young children began in November; According to the Centers for Disease Control and Prevention, about 29 percent have been fully vaccinated.

If the FDA authorizes Moderna shots for teens and schoolchildren, the matter moves forward to the CDC, which makes recommendations about vaccinations to doctors and the public. A CDC spokesman said the agency is not expected to take questions until later this month.

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