FDA plan to fast track Pfizer vaccine for children under 5 fails to deliver, leaving parents waiting until April

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Parents of children under 5 years old will have to wait until at least April to vaccinate their children against covid-19, after the Food and Drug Administration (FDA) and Pfizer abruptly delayed plans to obtain the vaccines this week. authorized fast track.

The FDA had originally planned to license the first two doses of what will ultimately be a three-dose vaccine as soon as this month. However, Dr. Peter Marks, chief of the FDA’s division of vaccines, said the updated data presented by Pfizer Y BioNTech did not support the plan to withdraw the first two doses early. Marks acknowledged the decision was abrupt, but said the FDA was following the science.

“The data we saw made us realize that we needed to see data from a third dose in the ongoing trial to determine that we could proceed with authorization,” Marks told reporters during a call Friday, without providing details. about the data

Acting FDA Commissioner Janet Woodcock said the drug regulator had tried to act quickly to protect children from omicron as Covid hospitalizations among the very young rose to record levels in recent weeks. However, FDA safety and efficacy standards required the agency to wait for more information on the third dose, Woodcock said.

“The goal was to understand whether two doses would provide enough protection to move forward with licensing the vaccine for use in this age group,” Woodcock said in a statement. “Our focus has always been to conduct regulatory review that is responsive to urgent public health needs created by the pandemic, while adhering to our rigorous standards for safety and efficacy,” he said.

“Being able to start evaluating early data has been helpful in our review of these vaccines, but at this time we feel that additional information on the ongoing evaluation of a third dose should be considered,” Woodcock said.

Dr. Paul Offit, a member of the FDA’s vaccine advisory committee, said the fast-track plan was based on the assumption that the third dose was safe and effective, but there is no guarantee that will be the case once it is released. send the final data.

“Imagine passing it after two doses and then finding out the third dose was unsafe and then having to withdraw,” said Offit, a pediatrician and director of the Center for Vaccine Education at Children’s Hospital of Philadelphia. “I’m glad we’re going to wait until we have all the data to make that decision.”

The FDA had come under pressure in recent weeks from some parents and doctors to rapidly expand eligibility to protect young children up to age 4 as the omicron variant swept the country. Children under 5 years of age are the only remaining age group in the US that is not eligible for vaccination.

Nearly 5,200 children were hospitalized with Covid on Jan. 18, according to a seven-day average of data from the Department of Health and Human Services, double the previous peak during the fall of 2021. That number has since fallen to about 3,000 a starting Friday, HHS data shows.

The American Academy of Pediatrics, in a statement Friday, said that while the news was frustrating for many parents, it’s important to have a rigorous review process to ensure a safe and effective vaccine.

“A careful, robust, and transparent process for evaluating the evidence for the vaccine in this age group is essential if parents are to have confidence in offering the vaccine to their children,” the AAP said.

The problem is that two doses of the Pfizer and BioNTech vaccine did not produce an adequate immune response in children aged 2 to 4 years during clinical trials. The companies are testing a lower dose level of 3 micrograms in children younger than 5 years, compared to older children and adults who receive 30 microgram injections.

Pfizer and BioNTech modified their clinical trial in December to study a third dose to see if it would produce the immune response needed to protect against Covid. The companies had said all along that the data would not be ready until April.

However, the rapid increase in omicron during the holidays and into January created what Pfizer called an “urgent public health need” to vaccinate children in this age group. Marks said the FDA’s sudden decision to delay authorization shouldn’t affect parents’ confidence in the vaccine. She said the change shows the FDA takes its responsibility seriously and makes decisions based on data as it emerges.

“I hope this reassures people that the process has a standard, that the process is one that we follow,” Marks said. “And we follow the science to make sure that anything we authorize has the safety and efficacy that people have come to expect from our regulatory review of medical products.”

Wayne Koff, executive director of the Human Vaccines Project and a professor of epidemiology at Harvard, said there is good reason to hope that the third dose will improve the vaccine’s effectiveness in children younger than 5 years. Booster doses have been shown to be effective in preventing serious illness in other age groups, Koff said, and at this point the vaccine really should be considered a three-dose regimen across the board in all age groups.

Offit said the Covid vaccine will likely become a routine childhood vaccine in the future, like the polio immunization. The United States eliminated polio in the 1970s, but still vaccinates children because the virus continues to circulate in some corners of the world. Public health experts largely agree that eradication of Covid is unlikely at this time.

“The fact is that we are going to need a highly protected population for years and decades. I suspect this will become routine childhood vaccination,” Offit said.

Although some parents may feel it has taken too long to expand access to the vaccine, Koff said the FDA has expedited the process as much as possible by progressively lowering the age of eligibility while adhering to standards of safety and efficacy.

“At first you have to show that the vaccine is safe and effective in the adult population,” Koff said. “Once you’ve shown that, then you can go down in terms of the age of teenagers and then eventually younger kids and eventually babies.”

Offit said children under 18 are infected less frequently and less severely, so vaccination has been focused on older populations first. As parents wait for the vaccine, they should build a “moat” around their ineligible children by making sure everyone they come into contact with has received their shots, she said.

While about 75% of American adults are fully vaccinated with two doses of the Pfizer or Moderna shots or one dose of the Johnson & Johnson vaccine as of Thursday, that number is lower for children. About 57% of people ages 12 to 17 are fully vaccinated, According to the Centers for Disease Control and Preventionand 24% of those from 5 to 11.

— CNBC’s Nate Rattner contributed to this report.

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