When can younger children be vaccinated against Covid-19? ‘not yet’

Dr. Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia and a member of the FDA Vaccine Commission, said he was really pleased that things went well in this way.

“My word for parents with young children is that this is not” no “, not” yet “,” he added.

What do I need to do before rolling out a shot?

Before Pfizer’s coronavirus vaccine can be given to children under the age of 5, the FDA must allow emergency use in that age group.

When the FDA Vaccine Commission meeting resumes, it will review data from Pfizer / BioNTech’s EUA-required clinical trials and recommend to the FDA whether to support vaccination approval. The FDA then decides whether to grant emergency approval.

If the FDA approves a vaccine for infants, the CDC’s Vaccine Advisor (Immunization Implementation Advisory Board) will meet to discuss the EUA, review vaccine data, and advise authorities to recommend the use of the vaccine. I will vote for that.

“The FDA uses data submitted by the manufacturer. ACIP can use any other type of data to consider deliberations,” said Vice-Chairman of the American Academy of Pediatrics Infectious Diseases Commission. Dr. Sean O’Leary told CNN.

Next, CDC Director Dr. Rochelle Walensky reviews the ACIP vote, recommends vaccines for children under the age of 5, and approves vaccines for that age group.

How soon can a young child be vaccinated?

Pfizer and BioNTech expect to receive data on three doses in early April, and the FDA said it would act swiftly to review the data and consider an emergency use authorization.

Dr. Peter Markes, director of the FDA’s Center for Biopharmaceutical Evaluation and Research, said on Friday that he understands that parents are eager to get protection for their young children. Submission. “

In December, Pfizer announced that it had decided to add a third dose to its primary vaccine therapy for infants aged 6 months to 5 years. This decision was the first study in children aged 2-5 years, and the original double-dose regimen of a child-sized vaccine did not provide the expected immunity for children aged 2-5 years. Was shown and then done. Up to 2 years old.

The two companies state that data on the third dose given at least 8 weeks after the second dose is expected within the next few months and will be submitted to the FDA.

There are approximately 18 million children between the ages of 6 months and 4 years in the United States who may be eligible for Covid-19 vaccination.

The White House’s coronavirus response coordinator, Jeff Seienz, said at a press conference earlier this month that the United States is ready to deploy the vaccine to children under the age of five after the FDA and CDC have issued operational recommendations. He said it was done.

“Once the FDA has decided, we can start packing and shipping the vaccine,” he said.

“We work closely with pediatricians, family doctors, children’s hospitals and pharmacies to make vaccines available in thousands of locations across the country.”

According to O’Leary, pediatrician clinics are expected to be one of the major places where children under the age of 5 can be vaccinated against Covid-19.

He added that the public health department and pharmacies could be elsewhere.

“Many pharmacies may be unfamiliar with vaccination of children under the age of five, so you need to be a little careful under the age of five. This depends on the different pharmacies,” he said. I am. “We know that many of the current vaccinations are done in pharmacies, but pediatricians and family doctors are very accustomed to vaccination of young children in primary care offices. It’s happening more and more. “

O’Leary added that many pediatrician clinics that currently administer the Covid-19 vaccine to children aged 5 to 11 are likely also vaccination sites for younger children. I did.

The vaccine is given as an injection Muscle administered twice at intervals of about 3 weeks.

Why was the EUA request delayed first?

Pfizer’s decision to extend the vaccine trial in young children and test the triple-dose regimen delayed the initial application to the FDA for vaccine approval for children under the age of five.

There were no safety concerns.

“Previously, there was data that pediatric vaccines for 6 months to 4 years were not as defensive against infection as adult vaccines, which pushed them out and gave them a third dose. That’s why I asked, “former FDA Commissioner Dr. Scott Gottlieb told CBS’s Face the Nation this month.

“But now, the goal of the vaccine is to gain baseline immunity in children, to prevent really bad consequences, and twice if the vaccine is not actually used as a tool to prevent infection in the first place. Do so with the administration of. ” “I think that may be the reason why federal health authorities are rethinking this.”

How are vaccines for younger children different from other children?

For children under the age of 5, Pfizer and BioNTech had already reduced their vaccine doses. For age groups 12 and older, the dose is a 30 microgram vaccine. Pfizer and BioNTech reduced to 10 micrograms for children ages 5-11 and even lower (3 micrograms per dose) for children under 5 years.

“Under the age of five, when we examined different doses in previous trials, they landed at 3 micrograms, which was one-tenth of what they use in adults,” O’Lee Lee says. rice field.

Early tests have shown that this 3 microgram dose provides a strong immune response to children and minimizes the risk of side effects.

What do we know about parents’ willingness to vaccinate their children?

“For the youngest children we have, we still have to take those safeguards when it comes to distance, and ideally people come home. If so, they are vaccinated to minimize the risk, “says Parody, and it is also important to wear a mask.