FDA Backs Pfizer, Moderna for Kids 5 and Under

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FDA Backs Pfizer, Moderna for Kids 5 and UnderBy Robin Foster HealthDay Reporter

THURSDAY, June 16, 2022

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

The approvals come not a moment too soon: More than two years into the pandemic, children younger than 5 still have no vaccine available to them.

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

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

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

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

In younger age groups, fevers of any kind can be more dangerous, a fact that pressured vaccine makers to calculate dosing correctly. Pfizer chose a dose at just a tenth the strength of the adult dosing, given in three shots; the first two are administered three weeks apart, with the third coming at least eight weeks after the second. Moderna used a quarter the strength of its adult dosing, administered in two shots, four weeks apart.

Challenges remain: Perhaps most critical is that neither vaccine has been tested against the subvariants that are now circulating in the United States. The clinical trials were largely conducted when the Omicron variant was dominant last winter. Since then, the BA.2 subvariant has claimed that title. And two newer subvariants, BA.4 and BA.5, could soon fuel most cases in this country. As of June 11, BA.5 accounted for 13.3% of all COVID-19 cases, while BA.4 fueled 8.3% of cases.

Both vaccines appear significantly less effective against symptomatic infection than the adult vaccines when they were first introduced, mostly because Omicron and its subvariants have been far more able to dodge the vaccines‘ defenses against infection than the original virus was.

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

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

Given the waning of protection observed among adult recipients and the virus’s rapid evolution, regulators have said children who would get the vaccines would likely require a booster shot. That would mean Pfizer’s vaccine could wind up as four doses, while Moderna’s could be three.

After two doses, Pfizer’s vaccine was only about 28 percent effective at preventing symptomatic infection in children aged 6 months through 4 years old. Pfizer has suggested the vaccine was 80 percent effective after a third dose, but the finding was based on only 10 cases out of a subset of the 1,678 trial participants. The tiny number of cases on which that finding was based concerned both panel members and regulators on Wednesday.

Dr. Doran Fink, a senior federal vaccine regulator, called Pfizer’s efficacy data preliminary. “We consider it to be imprecise and potentially unstable,” he said. “Exactly what the vaccine efficacy is after dose three needs further data.”

Meanwhile, Moderna found its vaccine to be 51 percent effective in preventing symptomatic infection in children 6 months to 2 years old, and 37 percent effective in children ages 2 through 5. Those results appear consistent with those reported in adult studies conducted during the Omicron era, the FDA said. Still, immunization continues to offer strong protection against severe disease that leads to hospitalization and death.

If the FDA and the CDC approve the shots in the next few days, health officials have said the federal government will be ready to ship doses out next week.

During a media briefing 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.

“Our expectation is that within weeks every parent who wants their child to get vaccinated will be able to get an appointment,” Jha said.

The White House wants states to prioritize the doses for young children to high-traffic locations such as children’s hospitals, and to offer appointments outside regular work hours so it’s easier for parents to get their children vaccinated, the Associated Press reported.

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

But there’s still uncertainty about uptake. Only 1 in 5 parents of young children said they would get their kids vaccinated immediately, a recent survey found.

More information

Visit the U.S. Centers for Disease Control and Prevention for more on COVID vaccines for kids.

SOURCE: The New York Times; Associated Press

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