FDA panel hosts June 15 meeting on Pfizer and Moderna vaccines for infants and toddlers

Bridgette Melo, 5, prepares for her inoculation with one of two reduced 10ug doses of the Pfizer BioNtech COVID-19 vaccine during a trial at Duke University in Durham, North Carolina on September 28, 2021 in a still image from the video.

Shawn Rocco | Duke University | via Reuters

The Food and Drug Administration’s expert panel will meet on June 15 to review new data on Pfizer and Moderna’s Covid vaccines for infants and toddlers, setting the stage for the injections to receive approval in the beginning of this summer.

“We know parents are eager for us to determine if these vaccines are safe and effective,” the FDA said in a Twitter post on Monday. “We are working as quickly as possible to carefully review all data.”

The FDA’s independent expert panel will review vaccine safety and efficacy data in an open public meeting and make a recommendation on whether the agency should authorize the injections. The FDA is not obligated to follow the committee’s recommendation, although it usually does.

The FDA announced the June date hours after Pfizer and BioNTech said their three-dose vaccine for children aged six months to 5 years was 80% effective in preventing omicron variant Covid disease based on preliminary data from a clinical trial.

The FDA and Pfizer originally sought to expedite the approval of the first two doses in February during the winter wave of omicron. However, Pfizer decided to delay its application to await data from the third hit after the first two doses had only 30% to 40% efficacy against omicron.

Moderna applied to the FDA to clear its two-dose vaccine for children under age 6 in April. The two-shot vaccine was about 51% effective against omicron infection in children under two years of age and about 37% in children aged 2 to 5 years. However, Moderna’s chief medical officer, Dr Paul Burton, said the antibody levels seen in children should translate into high levels of protection against serious disease.

The FDA said it would complete its review of Pfizer and Moderna’s applications within days of each other, meaning the two vaccines would receive approval around the same time if the agency believes the data supports a decision. such a decision, giving parents two options to choose from.

Moderna’s vaccine for infants and toddlers consists of two 25-microgram injections, while Pfizer uses a triple course of 3 microgram injections. The dosage of both vaccines is much lower than that used by companies for adults.

Children under the age of 5 are the only group in the United States who are not currently eligible for vaccination against Covid. Many parents and doctors have been asking the FDA to allow the injections for months. As the omicron swept through communities during the winter, it also infected large numbers of children. The Centers for Disease Control and Prevention estimates that around 75% of children aged 11 and under had been infected with Covid in February.

Although Covid is normally less severe in children than in adults, hospitalizations of children under age 5 were five times higher during the omicron wave than the previous delta surge, according to the CDC. Public health experts are also concerned that children will develop long Covid and multisystem inflammatory syndrome, or MIS-C for short, a condition associated with a viral infection.

Covid infections are rising again in the United States as even more transmissible omicron subvariants sweep the country. The United States is reporting more than 105,000 Covid cases per day on average on Friday, a 16% increase from the previous week, according to CDC data. Hospitalizations have also increased by 16% over the past week, with more than 3,300 patients admitted with Covid per day on average, the data shows.

CNBC Health and Science

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