Pfizer seeks emergency OK for Covid shots for kids 6 months to age 5

A student receives help with her mask from transitional kindergarten teacher Annette Cuccarese during the first day of teaching at Tustin Ranch Elementary School in Tustin, CA on Wednesday, August 11, 2021.

Paul Bersebach | MediaNews Group | Getty Images

Pfizer and BioNTech on Tuesday began submitting data to the Food and Drug Administration to provide emergency clearance to children under the age of 5 to receive their vaccine.

The companies said the FDA requested that they begin submitting data for approval of the first two doses of what will eventually be a three-dose vaccine for children aged six months to 4 years. Pfizer and BioNTech said data on the third dose will be finalized and submitted to the FDA in the coming months.

Pfizer and BioNTech began submitting their application for emergency clearance in response to the “urgent public health needs” of younger children, as the omicron variant has resulted in an increase in hospitalizations in this age group.

“As hospitalizations of children under the age of 5 due to COVID-19 increase sharply, our common goal with the FDA is to prepare for future variants and enable parents to help protect their children from this virus,” Pfizers said. CEO Albert Bourla in a statement.

Bourla said children under 5 will ultimately need a third dose to have the best protection against omicron and future Covid variants. By getting the first two doses FDA approved, parents can begin getting their children vaccinated while waiting for the third dose, Bourla said. Pfizer and BioNTech expect to complete their application for emergency approval of the first two doses in the coming days.

Toddlers and children under the age of 5 are the last age group left who are not eligible for vaccination. The FDA is expected to track the approval process for 6-month-olds to 4-year-olds, as it has for other age groups. Once approved, pediatricians will be able to administer shots within a few days.

Parents are eagerly awaiting the vaccine for younger children as the omicron variant sweeps across the country, causing an unprecedented wave of infections over the past month.

Although children have a much lower risk of developing serious Covid disease compared to adults, their hospitalizations with the virus have increased during the recent rise in infections, which has raised concerns about the long-term consequences for children’s health.

“Unfortunately, we are seeing the number of admissions increase for children from zero to 4, children who are not yet eligible for Covid-19 vaccination,” said Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention, told reporters in January.

The White House Chief Medical Officer Dr. Anthony Fauci said last month that he hoped the FDA would approve the vaccine for children sometime in February. Fauci said at the time that younger children would probably need a three-dose vaccine.

Pfizer changed its clinical trial in December to study a third shot after two doses of its 3 microgram vaccine did not produce an adequate immune response in children aged 2 to 4 years. Adults receive two doses of 30 micrograms in their primary series of shots.

Pfizer’s vaccine researcher, Dr. Alejandra Gurtman, said last month that the drug maker planned to have data for children under 5 ready in late March or early April. But a group of 250 doctors sent a letter last month asking the FDA to cut bureaucracy and approve a 3 microgram dose for children. Doctors said it was unethical not to allow parents to vaccinate younger children as the pandemic is raging across the country.

“As children re-enter day care centers, kindergartens and other unavoidable group environments, we all know that the number of young children infected with omicron will increase exponentially, creating the greatest health risk that children have faced collectively throughout the pandemic.” wrote the doctors in their letter.

At least 1,000 children have died from Covid since the pandemic began in 2020, according to CDC data, and hospitals have reportedly seen more than 94,000 admissions of children with Covid. The virus has infected more than 11.4 million children, representing 18.6% of all cases since the pandemic began, according to the American Academy of Pediatrics.

More than 6,000 children have developed multisystem inflammatory syndrome known as MIS-C, according to the CDC. MIS-C is a rare but serious condition associated with Covid, which is characterized by inflammation in several organ systems. At least 55 children have died of MIS-C according to CDC data.

Dr. Grace Lee, a professor of pediatrics at Stanford University, said the pandemic has burdened an entire generation of children, with the long-term effect yet to be seen.

“I also really think we have not yet addressed the long-term effects of Covid infection in children,” Lee told the CDC’s independent committee of vaccine advisers, which she chairs, earlier this month just before the agency approved Pfizer boosters for 12 – for 15-year-old children.

“I think we have not even scratched the surface of what we are going to see,” Lee said.

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