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FDA advisers consider Moderna’s COVID shots for older kids

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FDA advisers consider Moderna’s COVID shots for older kids

FDA advisers consider Moderna's COVID shots for older kids
A vial of the Moderna COVID-19 vaccine is displayed on a counter at a pharmacy in Portland, Ore. on Dec. 27, 2021. A government advisory panel met Tuesday, June 14, 2022, to decide whether to recommend a second brand of COVID-19 vaccine for school-age children and teens. The Food and Drug Administration’s outside experts will vote on whether Moderna’s vaccine is safe and effective enough to give kids ages 6 to 17. If the panel endorses the shot and the FDA agrees, it would become the second option for those children, joining Pfizer’s vaccine.Credit: AP Photo/Jenny Kane, File

A government advisory panel met Tuesday to decide whether to recommend a second brand of COVID-19 vaccine for school-age children and teens.

The Food and Drug Administration’s outside experts will vote on whether Moderna’s vaccine is safe and effective enough to give kids ages 6 to 17. If the panel endorses the shot and the FDA agrees, it would become the second option for those children, joining Pfizer’s vaccine.

The same expert panel will meet Wednesday to consider tot-sized shots from Moderna and Pfizer for the littlest kids, those under 5.

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Moderna’s COVID-19 vaccine has long been available for adults in the U.S. and elsewhere and dozens of countries offer it to children, too. In the U.S., children ages 12 to 17 would get two full-strength doses; ages 6 to 11 would get half-sized doses.

The FDA held up Moderna’s teen vaccine for months while it investigated a rare side effect, heart inflammation. That’s mostly a risk for teen boys and young men, and also can occur with the Pfizer vaccine. Moderna got extra scrutiny because its shots are a far higher dose..

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In their review, FDA scientists said there were no confirmed cases of the heart inflammation in Moderna’s kid studies. But experts say the studies may have had too few participants for a rare side effect like that to appear.

“It’s just not enough people in the clinical trials to detect” the problem if it’s occurring, said Dr. Jesse Goodman of Georgetown University, a former FDA vaccine chief, in a call with reporters earlier this week.

The FDA analysis concluded that two doses of Moderna are effective in preventing symptomatic COVID-19 illness in teens and younger kids, with the levels of virus-fighting antibodies comparable to those developed in young adults.

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Vaccine effectiveness was estimated at 93% for the 12-17 group, and 77% for the younger group. However, the research was done when earlier versions of the coronavirus were causing most U.S. infections, and it’s not clear how well they work against more recent variants.

The FDA review said it was likely a booster shot would be needed, as is now recommended for children vaccinated with Pfizer’s shots, as well as for all adults.

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How much demand there will be for Moderna’s shots isn’t clear. Teens became eligible a year ago for Pfizer’s vaccine, which uses the same technology, and only 60% have gotten two doses. Shots for younger kids started in November; about 29% have been vaccinated, according to the Centers for Disease Control and Prevention.

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



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FDA advisers consider Moderna’s COVID shots for older kids (2022, June 14)
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Statement from Agriculture Secretary Tom Vilsack on Passage of Keep Kids Fed Act

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Statement from Agriculture Secretary Tom Vilsack on Passage of Keep Kids Fed Act

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WASHINGTON, June 24, 2022 – “I am pleased to see that Congress has taken action to provide much needed support to help USDA’s child nutrition programs serve nutritious meals to America’s children. Throughout the pandemic, the school nutrition professionals who feed our children faced enormous challenges, which persist today, and they desperately need additional resources and continued flexibilities. The deal passed by Congress will ease some of the uncertainty and provide partial relief to our schools, summer sites and child care feeding programs. As I have said before, it is important to note that schools across the country will still face ongoing challenges and at USDA we will continue to use every tool at our disposal to ensure kids get the nutritious meals they need and deserve.”

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Statement from Agriculture Secretary Tom Vilsack on Supreme Court Ruling in Dobbs v. Jackson Women’s Health Organization

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Statement from Agriculture Secretary Tom Vilsack on Supreme Court Ruling in Dobbs v. Jackson Women’s Health Organization

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WASHINGTON, June 24, 2022 – “There is no question that today’s Supreme Court decision will have a devastating impact on the health and autonomy of women in America. Yesterday, the right to privacy was secure, with fifty years of precedent behind it. Today, six Supreme Court Justices took that right away for millions, and jeopardized it for all Americans. I’m particularly concerned about what this will mean for women and families in rural America. Yesterday, their health care options were limited. Today, the hurdles they face in accessing reproductive care have grown taller. The Department stands ready to explore the tools at our disposal to support them.”

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470 illnesses and potential liver function issues reports linked to Daily Harvest product

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470 illnesses and potential liver function issues reports linked to Daily Harvest product

Daily Harvest has received approximately 470 reports of illness or adverse reactions to their products, specifically their “French Lentil + Leek Crumbles.”

In response to consumer reports of gastrointestinal illness and potential liver function issues, Daily Harvest has recalled all French Lentil + Leek Crumbles.

From April 28 to June 17, 2022, approximately 28,000 units of the recalled product were distributed to consumers in the United States through online sales and direct delivery, as well as through retail sales at the Daily Harvest store in Chicago, IL, and a “pop-up” store in Los Angeles, CA. 

Samples were also provided to a small number of consumers. Daily Harvest directly notified by email those consumers who were shipped the affected product, and other consumers for whom the company had contact information, and consumers were issued a credit for the recalled product.

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Recalled product:

French Lentil + Leek Crumbles is a frozen product packaged in a 12oz white pouch with the words “Daily Harvest” at the top, a large “CRUMBLES” immediately below the top and the words “French Lentil + Leek” in bold. All lot codes of the French Lentil + Leek Crumbles are affected.

The company says that no other Daily Harvest products are affected or part of this recall.

Consumers who may still have the recalled product in their freezers should immediately dispose of it. 

(To sign up for a free subscription to Food Safety News, click here)

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