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FDA panel backs Pfizer and Moderna Shots for kids 5 and under

FDA backs Pfizer, Moderna for kids 5 and underBy Robin Foster Health Day Reporter

THURSDAY June 16, 2022

A U.S. Food and Drug Administration advisory panel voted unanimously on Wednesday to recommend emergency use of both the Pfizer and Modern COVID-19 vaccines for the nation’s youngest children.

Approvals don’t come too soon: more than two years into the pandemic, children under 5 still don’t have a vaccine available to them.

“I know that the mortality rate from COVID and young children may not be extremely high,” said Dr. Jay Portnoy, professor of pediatrics at Children’s Mercy Hospital in Kansas City, Mo., during the interview. meeting, The New York Times reported. But, “it’s absolutely terrifying for parents to have their child sick” or hospitalized, he noted.

“There are so many parents desperate to get this vaccine,” he added, “and I think we owe it to them to give them the choice.”

The group’s recommendations will now go to the FDA, which is expected to approve the vaccines for use this week. On Friday and Saturday, an advisory group from the US Centers for Disease Control and Prevention plans to vote on whether to approve the firings. The final step in the approval process will come when CDC Director Dr. Rochelle Walensky gives the green light to the shots.

On Wednesday, regulators and company officials spent much of the morning discussing side effects caused by vaccines, the vast majority of which were mild and tolerated by children in clinical trials: irritability and crying, drowsiness , fatigue and loss of appetite. A smaller number of these children had fevers, most of which did not become severe, theTime reported.

In younger age groups, fevers of all kinds can be more dangerous, a fact that has prompted vaccine makers to calculate the dosage correctly. Pfizer chose a dose at only one-tenth the strength of the adult dose, given in three doses; the first two are given three weeks apart, with the third coming at least eight weeks after the second. Moderna used a quarter of the strength of its adult dose, given as two injections, four weeks apart.

Challenges remain: Perhaps the most critical is that none of the vaccines have been tested against the subvariants currently circulating in the United States. Clinical trials were largely conducted when the Omicron variant was dominant last winter. Since then the BA.2 sub-variant has claimed this title. And two new subvariants, BA.4 and BA.5, could soon fuel most cases in this country. From June 11BA.5 accounted for 13.3% of all COVID-19 cases, while BA.4 fueled 8.3% of cases.

Both vaccines appear to be significantly less effective against symptomatic infection than adult vaccines when introduced, primarily because Omicron and its subvariants were much more able to evade vaccine defenses against infection than were was the original virus.

Still, the need to protect young children from COVID-19 is great, the FDA’s lead vaccine regulator, Dr. Peter Marks, said at the panel meeting. Time reported. He added that 442 children had died from COVID, a rate he said “compares quite terribly” to pediatric deaths during a major flu outbreak in 2009 and 2010.

Children are also vulnerable to a rare complication of COVID called multisystem inflammatory syndrome in children (MIS-C), which causes severe inflammation throughout the body.

Given the decline in protection seen in adult recipients and the rapid evolution of the virus, regulators have said children who receive the vaccines are likely to need a booster shot. This would mean that Pfizer’s vaccine could end in four doses, while Moderna’s could be three.

After two doses, Pfizer’s vaccine was only about 28% efficient to prevent symptomatic infection in children aged 6 months to 4 years. Pfizer suggested the vaccine was 80% effective after a third dose, but the finding was based on just 10 cases out of a subset of the 1,678 trial participants. On Wednesday, the small number of cases on which this conclusion was based involved both panel members and regulators.

Dr. Doran Fink, a federal vaccine regulator, called Pfizer’s efficacy data preliminary. “We consider it imprecise and potentially unstable,” he said. “The exact efficacy of the vaccine after the third dose requires additional data.”

Meanwhile, Moderna discovered that its vaccine was 51% efficient in the prevention of symptomatic infections in children aged 6 months to 2 years, and 37% effective in children aged 2 to 5 years. These results appear consistent with those reported in adult studies conducted during the Omicron era, the FDA said. Yet vaccination continues to provide strong protection against serious illnesses that lead to hospitalization and death.

If the FDA and CDC approve the injections in the coming days, health officials said the federal government would be ready to ship doses next week.

At a press conference earlier this month, White House COVID-19 coordinator Ashish Jha said the federal government has an initial supply of 10 million doses of pediatric vaccines and states could start placing orders.

“We hope that within a few weeks every parent who wants their child vaccinated will be able to get an appointment,” Jha said.

The White House wants states to prioritize doses for young children in high-traffic places like children’s hospitals, and offer appointments outside of regular working hours so it’s easier for parents to have their children vaccinated, Associated Press reported.

Pharmacies and states have already ordered millions of doses of the Pfizer and Moderna COVID vaccines for children under 5, the Biden administration said last week.

But there are still uncertainties about adoption. Only 1 in 5 parents of young children said they would get their children vaccinated immediately, according to a recent investigation found.

More information

Visit the United States Centers for Disease Control and Prevention to learn more about COVID vaccines for children.

THE SOURCE: The New York Times; Associated Press

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source: www.medicinenet.com

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