The FDA Panel recommends agency Clear Pfizer and Moderna vaccines for young children

An external advisor to the Food and Drug Administration voted unanimously on Wednesday, recommending that authorities approve Moderna and the Pfizer-BioNTech corona virus vaccine for very young children. this week.

Pfizer’s three-dose vaccine is intended for children aged 6 months to 4 years, and Moderna’s two-dose vaccine is intended for children aged 6 months to 5 years. The state has already ordered millions of doses. White House officials say the drug could begin in earnest on Tuesday, depending on regulatory action.

The FDA states that clinical trial data from companies show that each vaccine meets age group safety and efficacy criteria.

More than two years have passed since the pandemic occurred, but the United States has not licensed vaccines for children under the age of five. This is an unmet need and has disappointed many parents. The FDA is expected to respond promptly to the recommendations, followed by the Centers for Disease Control and Prevention later this week.

A panel of advisors voted 21-0, recommending approval for both Moderna and Pfizer vaccines. “I know that Covid and infant mortality may not be that high,” said Dr. Jayportnoy, a pediatric professor at Children’s Mercy Hospital in Kansas City, Missouri. Make the child sick “or hospitalized.

“There are many parents who are eager to get this vaccine, and I think we have a duty to give them a choice,” he added.

Both vaccines reviewed by the Commission on Wednesday appear to be significantly less effective against symptomatic treatment than adult vaccines when they are introduced. The FDA believes that Omicron is far more proficient in evading vaccine protection against infection than the original version of the virus.

Given the decline in protection and the rapid evolution of the virus observed among adult recipients, regulators Children vaccinated against Pfizer and Moderna will probably need a booster. This means that the Pfizer vaccine developed by the German company BioNTech could be vaccinated four times, and the Moderna vaccine could be vaccinated three times.

Both the Pfizer-BioNTech and Moderna vaccines induced levels of neutralizing or virus blocking antibodies comparable to teens and young adults aged 16-25 years. The Pfizer vaccine has been approved for children aged 5 to 15 years since last year, helping regulators prevent hospitalization and death.

After two doses, Pfizer’s vaccine was only about 28% effective in preventing symptomatic infections in children aged 6 months to 4 years. Pfizer suggested that the vaccine was 80% effective after the third dose, but this finding was based on only 10 of a subset of the 1,678 study participants. The study protocol specified that the vaccine efficacy assessment should be based on at least twice that number of cases. Very few cases based on the discovery of efficacy were subject to astonishment between committee members and regulatory agencies on Wednesday.

Dr. Doran Fink, senior regulator of federal vaccines, called Pfizer’s efficacy data preliminary. “We think it’s inaccurate and potentially unstable,” he said. “To be precise, vaccine efficacy after the third dose requires more data.”

Moderna found that the vaccine was 51% effective in preventing symptomatic infections in children aged 6 months to 2 years and 37% in children aged 2 to 5 years. These results appear to be consistent with those reported in the FDA’s Omicron-era adult study. Said. Nevertheless, immunization continues to provide strong protection against serious illnesses that lead to hospitalization and death.

Regulators and company officials spent part of the day discussing the side effects caused by the vaccine. Majority The children were mildly tolerant to clinical trials, including nervousness and crying, drowsiness, malaise, and loss of appetite. A small number of study participants tolerated the fever, which was consistent with the efficacy of other pediatric vaccines.

In the younger age group, fever is more debilitating and may require more urgent medical attention. This is a dynamic that puts a lot of pressure on the manufacturer to properly adjust the dosing. Pfizer chose a dose of only one-tenth of the adult dose in three doses. The first two are given at 3-week intervals, and the third is given at least 8 weeks after the second. Moderna used a quarter of the adult dose and was given twice at 4-week intervals.

Some difficult questions remain. Importantly, neither vaccine has been tested against submutants circulating in the United States. Clinical trials were conducted primarily when Omicron variants became widespread. Two subvariants, BA.4 and BA.5, can become dominant within a month.

Dr. Peter Markes, the FDA’s top vaccine regulator, said at a meeting that there was a great need to protect these children from Covid. He added that hundreds of children died in Covid. This is the rate he said was “very badly comparable” to the deaths of children during the massive influenza surge of 2009 and 2010.

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