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The House Select Subcommittee on Coronavirus Crisis on Tuesday asked the U.S. Food and Drug Administration (FDA) for a status update on COVID-19 vaccines for children under 5.

In a letter to FDA Commissioner Dr. Robert Califf requesting a staff briefing, committee members said “millions of young children still remain unprotected because no vaccine has yet been authorized” for this age group.

A top FDA official ​​on Tuesday told The New York Times the agency has not cleared a COVID-19 vaccine for the youngest age group because Pfizer and Moderna have not finished their applications for authorization.

The agency said last week it is considering holding off on reviewing Moderna’s request to authorize its COVID-19 vaccine for children under 5 until it has data from Pfizer and BioNTech on their vaccine for children, pushing the earliest possible authorization of a vaccine from May to June.

Moderna plans to file for Emergency Use Authorization (EUA) of a two-shot regimen by the end of April. Pfizer is expected to file its application in May for a three-shot vaccination using smaller individual doses for children under 5.

The FDA said it would be simpler and less confusing to simultaneously authorize and promote two vaccines to the public, rather than green-lighting one on a faster timetable and the other down the road, Ars Technica reported.

Sources at the FDA told Politico agency officials were worried about authorizing Moderna’s vaccine only to find out just a few weeks later that Pfizer’s offered better protection.

In their letter to the FDA, committee members pointed out that last week, Dr. Anthony Fauci told CNN the FDA is considering holding off on reviewing Moderna’s vaccine in order to authorize it at the same time as Pfizer’s so as not to “confuse” with a staggered rollout.

But lawmakers said they want to see a scientific rationale for that strategy, stating it could lead to a potential delay of several weeks for Moderna’s shot.

According to The New York Times, Dr. Peter Marks, director of the Center for Biologics Evaluation and Research, said the agency will release a schedule this week for its vaccine advisors to review vaccines for the country’s 18 million children under age 5.

Parents “are frustrated, they are confused, and I am, too,” Sen. Patty Murray (D-Wash.), chair of the Senate’s health committee, told Marks during an FDA oversight hearing.

Pfizer and BioNTech delayed seeking EUA earlier this year after a clinical trial showed two doses were less than 50% effective against symptomatic disease. The companies decided to add a third dose to the regimen to see if this would increase effectiveness.

Moderna’s vaccine was only about 40% effective. One of Moderna’s top officials said she expects a booster dose to be necessary and the company is studying the effectiveness of a third dose.

According to the FDA, for a COVID-19 vaccine to receive EUA, it must be at least 50% effective at preventing or decreasing the severity of the disease.

Guidelines for COVID-19 vaccines were released during a briefing on June 30, 2020, with the Senate Committee on Health, Education, Labor and Pensions during which senators sought assurances from former FDA Commissioner Stephen Hahn, Fauci and other top health officials that the expedited speed of development wouldn’t compromise the integrity of the final product.

Risks of COVID-19 for children under 5 minuscule

Children under 5 years old face a low risk of severe disease from COVID-19, Time magazine reported on Monday.

According to the most recent data from the Centers for Disease Control and Prevention (CDC), out of 2,311,870 children under 4 who had COVID-19, 475 deaths were reported, accounting for 0.1% of all COVID-19 deaths.

These numbers, relative to population size, represent a minuscule risk to young children, especially compared to the elderly and those with underlying conditions.

According to Dr. Sean O’Leary, vice-chair of the American Academy of Pediatrics committee on infectious disease, the risks aren’t equal for all children.

Babies under 6 months may have a higher risk for respiratory illnesses, and children with preexisting conditions, such as chronic lung disease, may be more at risk than healthy children.

Pfizer requests EUA of COVID-19 vaccine for children aged 5 to 11

Pfizer and BioNTech on Tuesday announced they applied for EUA of a COVID-19 booster dose for children ages 5 to 11.

In a press release, Pfizer cited data from its Phase 2/3 trial that claimed a third dose produced a “strong immune response” in the younger age group when administered six months after the second dose.

The application was based on data from a small study involving only 140 children 5 through 11 years old who received a booster dose six months after the second dose of Pfizer-BioNTech’s COVID-19 vaccine as part of the primary series.

Pfizer said 30 children who participated in the study revealed a 36-fold increase in virus-fighting antibodies — levels high enough to fight the Omicron variant.

“The clinical trial used to support the notion of a COVID-19 booster for 5- to 11-year-olds is entirely inadequate to make any such recommendation,” Brian Hooker, chief science advisor at Children’s Health Defense, told The Defender.

“This small-scale, limited-time trial contains only 140 patients, which is not sufficiently sized to assess vaccine adverse events at all, especially rarer injuries such as the devastating medical maladies sustained by Maddie de Garay — an adolescent injured in the original Pfizer clinical trial.”

Hooker said he was also concerned there are “no data on the prevention of COVID-19 infection, only neutralizing antibody titers, which are not necessarily predictive of transmission and severity of the disease.”

Dr. Liz Mumper, a pediatrician, also weighed in on Pfizer’s request for EUA of its COVID-19 vaccine in the 5-to-11 age group.

“On the basis of careful risk-versus-benefit analysis, healthy children do not need a COVID-19 vaccine,” Mumper said, because many kids already had COVID-19 and developed robust and durable antibodies.

The booster shot is a 10-microgram dose, the same dosage as the primary vaccination series for the age group.

According to the CDC, as of April, 72% of parents had chosen not to have their 5- to 11-year-olds vaccinated against COVID-19.