Pfizer starting COVID-19 antiviral pill trials for children 'a very big deal,' experts say

Pfizer announced on Wednesday that it has started clinical trials that could lead to the antiviral pill Paxlovid being available for children ages six and up to reduce the severity and duration of COVID-19 infections.

Medical experts on Long Island said the pill being shown to be safe and effective for children could be an important step toward ending the pandemic.

"If this medication has good dosing information for children, that puts us so much further ahead moving from pandemic to just background information," said Dr. Sharon Nachman, chief of the division of pediatric diseases at Stony Brook Children's Hospital.

"It’s a very big deal, because we need to be able to have drugs available to treat children who get COVID," she said.

It is such an important potential development that Stony Brook itself is taking part in the trial, Nachman added.

The FDA in December granted an emergency use authorization allowing for the pill to be administered to people who test positive and are at risk for severe disease, while being aged 12 and older and weighing at least 88 pounds. But previous clinical trials had focused on adults, according to Pfizer.

Pfizer said the new phases of the study will involve about 140 children ages 6 to 17. Test subjects are being divided into two groups to determine the appropriate dosage: one group weighs 88 pounds or more; the other is between 44 and 88 pounds.

The company said in a news release it hopes to eventually make the medication available to children under 6 as well.

Previous studies found Paxlovid to be up to 89% effective in reducing the risk of hospitalization or death, the company said.

Nachman and Dr. Matthew Harris, medical director of Northwell’s vaccine program, both stressed that the primary defense against COVID-19 is getting vaccinated. But Paxlovid could be a useful addition, they said.

"If it has the same efficacy that it does in adults with minimal side effects, it’s just another, I think, good tool in the armament in the fight against COVID," Harris said.

He added that "it’s not a substitute" for the vaccination. "We don’t want people to grow comfortable knowing that there is a decent therapeutic."

The medication, which is taken by mouth, would be prescribed by pediatricians for their patients, with parents picking it up at their local pharmacies, Nachman said.

Stony Brook joined the study because "I felt it was critical for us to understand what’s the right dose for using Paxlovid in children," she said. "It doesn’t make sense to have a medication available for adults that is not available for children."

She said she hopes it gets approved for children sometime this year.

"We don’t want to get to another surge without these tools available to us," she said. "COVID is not going away and we need to have these tools."

Meanwhile, cases of the BA.2 omicron subvariant are increasing in New York State, but medical experts said they are not overly alarmed.

BA.2's prevalence in New York more than quadrupled over the most recent two-week periods for which data is available from the state health department.

Cases among analyzed COVID-19 samples increased from 2.3% to 10.2% of the total from the two weeks ending Feb. 12 to the two weeks ending Feb. 26, state data shows.

The data is based on an analysis of samples collected by the health department’s Wadsworth Center as well as other labs analyzing New York samples.

Harris said he was not especially worried about the variant, in part because overall levels of COVID-19 are down.

"We have seen very, very little COVID in the last several days to maybe even a week or two," he said, referring to Northwell emergency rooms.

"Until the pandemic is over, I’m going to be worried, but I think that BA.2 does not yet seem to be the same threat as the primary omicron variant," he said.

He added: "Ask me again in two weeks and I may have a different answer."

Nachman said: "I am concerned about it as we are with any variant," but so far it has not shown itself to be more contagious or deadly than the original omicron strain.

"Like any other variants, we have to keep an eye on it," she said.

Data from the U.S. Centers for Disease Control and Prevention shows a similar trend with the new variant for the CDC region that includes New York, New Jersey, Puerto Rico and the Virgin Islands.

The data, which covers through the week ending Mar. 5, shows BA.2 making up 17.3% of samples, up from 10.2% for the week ending Feb. 26 and 3.7% for the week ending Feb. 12.

BA.2 is less prevalent nationally, according to the CDC data, which shows it making up 11.6% of samples nationwide for the week ending Mar. 5.

COVID-19 indicators on Long Island and in New York State remained at low levels in the latest test results released Wednesday.

The state reported the lowest seven-day average for positivity since July 20 — 1.46%. Long Island’s average was 1.57% — the same as the previous day.

With Matt Clark

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