Pfizer and BioNTech said on Monday that preliminary findings of a clinical trial in children under the age of 5 showed that three doses of their coronavirus vaccine produced an immune response strong enough to meet the to be licensed in accordance with the regulations.
In a press release, the companies released results from a small trial of 1,678 children aged 6 months to 4 years, which said the three-dose regimen was 80% effective at preventing infections. symptom. No supporting data was disclosed, and the companies did not say how many children were in the subset. A Pfizer spokesman said the full results from the test will be released next month.
Both Pfizer and Moderna hope to soon win the right to vaccinate the nation’s youngest children. About 18 million children under the age of 5 are the only Americans not yet eligible to be vaccinated against the coronavirus, and parental expectations about when to get vaccinated have consistently been dashed.
Pfizer and partner BioNTech said the number of children in the trial who became ill with Covid was too small to make definitive claims about effectiveness. Only 10 children in the trial became ill with Covid after those in the immunized group received their third dose. The clinical trial protocol stipulates that analyzing the effectiveness of the vaccine requires at least 21 Covid cases. The companies said that final efficacy data, a secondary endpoint for clinical trials, will be shared “when available”.
The Biden administration had hoped to make the vaccine available to children under the age of 5 as early as February. The Food and Drug Administration initially pressed Pfizer to submit data on how effective the two doses were for young children, but withdrew it after Pfizer said the two doses were not effective enough in preventing infections. have symptoms from the highly contagious Omicron variant.
But Pfizer says the new results show that three doses, with the third given at least two months after the second, stimulate the immune system to provide strong protection against the virus with no safety concerns. . The immune response of the small group of trial participants, measured one month after the third dose, compared with the response of those aged 16 to 25 who received two doses, the researchers said.
Dr Albert Bourla, chief executive officer of Pfizer, said: “We are delighted that our formula is for the youngest children, which we have carefully selected to have one tenth of the human dose. large, well-tolerated and induces a strong immune response”. statement. Dr. Ugur Sahin, chief executive officer of BioNTech, said the companies will complete an FDA emergency authorization application for a children’s vaccine this week.
The new findings have heated up a competition between Moderna and Pfizer over which company will make the best vaccine for the youngest Americans. Moderna is recommending a two-dose regimen for children under 6 years of age, using a quarter of the strength of the adult dose. The company said it anticipates that a third dose will be needed as a booster shot, but it has yet to submit any data on that to the government.
The question of which vaccine works at least will be asked indirectly before a committee of outside FDA advisers, at a meeting scheduled for June 15. With both Pfizer and Moderna Both recommend different dosing regimens for the youngest children and present different clinical trial results. , the committee will consider whether each vaccine meets the requirements for emergency use authorization.
In late April, Moderna requested urgent authorization of its children’s vaccine after interim results showed that clinical trial participants had similar immune responses to young adults. when injected with a dose equal to 1/4.
Like Pfizer, the company says its results meet clinical trial criteria for success. Moderna says its vaccine appears to be 51% effective for symptomatic infections in children younger than 2 years old and 37% effective for those 2 to 5 years old.
If Pfizer’s results are published by follow-up data, its performance will be better than Moderna’s. Both companies say their vaccines produce the same side effects as other childhood vaccines that have been used for decades.
On June 14, FDA outside experts will discuss the Moderna vaccine for children and adolescents from 6 to 17 years.
Adeel Hassan contribution report.