WASHINGTON — Pfizer and BioNTech said on Monday that preliminary findings from a clinical trial of children younger than five showed that three doses of their coronavirus vaccine produced a strong enough immune response to meet the criteria for regulatory authorization.
In a news release, the companies said the three-dose regimen had been 80 percent effective in preventing symptomatic infection in a subset of the 1,678 trial participants, who were 6 months through 4 years old. A spokeswoman for Pfizer said comprehensive results from the trial would be disclosed next month.
About 18 million children under the age of 5 are the only Americans not yet eligible for vaccination against the coronavirus, and both Pfizer and Moderna are hoping to soon win authorization to vaccinate them. But parents’ hopes for a time and date when shots will be offered have been repeatedly dashed.
Pfizer and its partner, BioNTech, said the number of children in the trial who fell ill with Covid-19 was too small to make a definitive statement on efficacy. Only 10 participants became ill with Covid after those in the vaccination group were given the third dose. The clinical trial’s protocol specified that analysis of vaccine efficacy required at least 21 Covid cases. The companies said that final data on efficacy, a secondary endpoint for the clinical trial, would be shared “once available.”
The Biden administration had hoped to offer vaccine doses to those under 5 as early as February. The Food and Drug Administration initially pressed Pfizer to submit data on how well two doses worked for young children, but pulled back after Pfizer said two doses were not sufficiently effective in preventing symptomatic infection from the highly contagious Omicron variant. The company then began focusing on a three-dose regimen.
In late April, Moderna sought emergency authorization of its pediatric vaccine after interim results showed that clinical trial participants had a similar immune response to young adults when given a dose one-fourth as strong. It was expected to finish submitting its data to the F.D.A. this month.
Moderna initially hoped regulators would put its data before the F.D.A.’s expert committee of outside advisers on June 7th. But federal officials have said they would consider a brief delay in reviewing Moderna’s application if it meant they could evaluate Pfizer’s at the same time. The F.D.A. announced Monday that the committee would consider both Pfizer’s application for a three-dose regimen and Moderna’s application for a two-dose regimen on June 15.
The delays have deeply frustrated many parents of young children, who complain that the rest of the nation has moved on from the pandemic while they continue to limit play dates, travel, dining out, trips to grocery stores and more. Of the nearly 500 parents who answered a reader callout from The New York Times on Monday, many complained that the F.D.A. and Centers for Disease Control and Prevention were moving too slowly to get initial shots to the youngest group, while older Americans bolster their protection with booster shots. The respondents are not considered representative of the U.S. population.
“I understand they want all the data, but we know that the vaccine has been extremely effective at preventing severe disease in all age groups and is very safe,” said Dr. Tress Goodwin, who practices emergency pediatric medicine and is a mother to three-year-old twins in Washington, D.C. “It’s crazy to think that my kids won’t be vaccinated until more than a year and a half after I got vaccinated myself.”
“It has been demoralizing when that goal post keeps getting pushed further and further down the line,” she added.
Cheryl Hillis of High Point, N.C., was so concerned about protecting her 3-year-old daughter that she enrolled her in a Pfizer trial in Atlanta and made the long road trip to that city twice. She will hit the road a third time at the end of the week, for the final dose. Ms. Hillis has been home-schooling her three other children — ages 9, 11 and 14 — until her youngest gets vaccinated.
Like some other parents who answered the newspaper’s callout, she does not expect a pediatric vaccine to protect against infection as well as the adult vaccines did when they were first authorized, before an onslaught of variants cut their potency. At this point, she said, many parents are mainly interested in staving off long Covid, hospitalizations and deaths among the youngest demographic.
“We have almost no options to keep our children safe, save isolation,” she said in an interview.
Pfizer said that its new results showed that three doses, with the third given at least two months after the second, stimulated the immune system to strongly protect against the virus, with no safety concerns. Researchers said the immune response of the subset of trial participants, measured one month after the third dose, compared favorably to that of people 16 to 25 who received two doses. No supporting data was disclosed, nor was the number of children in the subset.
“We are pleased that our formulation for the youngest children, which we carefully selected to be one-tenth of the dose strength for adults, was well tolerated and produced a strong immune response,” Dr. Albert Bourla, Pfizer’s chief executive, said in a statement. Dr. Ugur Sahin, chief executive of BioNTech, said the companies would complete their F.D.A. application for emergency authorization of the pediatric vaccine this week.
With Pfizer and Moderna proposing different dosing regimens and delivering different results, the question of which vaccine works better will be central for the F.D.A. But the agency’s regulators and their outside advisers are expected to independently evaluate each vaccine to see if it meets the requirements for emergency authorization. On June 14, the advisory committee will also discuss the Moderna vaccine for children and adolescents from 6 to 17 years.
Moderna is proposing a two-dose regimen for children younger than 6, using a dose one- quarter the strength of its adult dose. The company has said it anticipates that a third dose will be necessary as a booster shot, but it has not yet submitted any data on that to the government.
Moderna said in late April that its interim results showed that clinical trial participants had an immune response similar to that of young adults when given the quarter dose.
Like Pfizer, the firm said its results met the clinical trial’s criteria for success. Moderna said its vaccine appeared to be 51 percent effective against symptomatic infection among children younger than 2, and 37 percent effective among those 2 to 5.
If Pfizer’s results are borne out by subsequent data, its efficacy would be better than Moderna’s. Both companies say their vaccines produce similar side effects to other pediatric vaccines that have been used for decades.
At this point, Aaron C. Hall, the father of a three-year-old and an infant in Murfreesboro, Tenn., said that he would accept any efficacy rate above zero. “It has been very frustrating to essentially remain in semi-quarantine while the rest of the world has moved on,” he wrote.
Adeel Hassan contributed reporting from New York.
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