FDA Plan to Accelerate Pfizer Vaccine for Children Under 5 Fails

Parents of children under age 5 will have to wait until at least April to get their children vaccinated against Covid-19, after the Food and Drug Administration and Pfizer abruptly postponed plans to speed up immunizations this week.

The FDA originally planned to authorize the first two doses of what will eventually become a three-dose vaccine as early as this month. However, Dr. Peter Marks, head of the FDA’s vaccine division, said the update provided by Pfizer and BioNTech does not support a plan to release the first two doses early. Marks acknowledged the decision was sudden but said the FDA was following the science.

“The data we saw made us realize that we need to see data on the third dose in the ongoing trial to determine if we can proceed with authorization,” Marks told reporters in a call Friday, without giving details. to the data.

Acting FDA Commissioner Janet Woodcock said the regulator was keen to act quickly to protect children from omicrons as Covid hospitalizations among the smallest rose to record levels in recent weeks. However, the FDA’s safety and efficacy standards require the agency to wait for more information about the third dose, Woodcock said.

“The goal was to see if two doses would provide enough protection to allow the vaccine to be used in this age group,” Woodcock said in a statement. “Our approach has always been to conduct a regulatory review in response to the urgent public health needs caused by the pandemic while meeting our stringent safety and efficacy standards,” she said.

“Being able to start evaluating initial data was helpful in our review of these vaccines, but at this time we believe additional information should be considered regarding the ongoing evaluation of the third dose,” 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 this will happen after the final data is presented.

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

In recent weeks, the FDA has come under pressure from some parents and doctors to quickly expand the right to protect toddlers to 4 years of age as the omicron variant has swept the country. Children under 5 are the only remaining age group in the US not eligible for vaccination.

Nearly 5,200 children were hospitalized with Covid on January 18, according to seven-day averages from the Department of Health and Human Services, double the number from the previous peak in the fall of 2021. That figure has since dropped to around 3,000 as of Friday, HHS data show.

The American Academy of Pediatrics said in a statement Friday that while the news was disappointing to many parents, it is important to conduct a thorough review process to ensure a safe and effective vaccine.

“A thorough, reliable and transparent process for evaluating vaccine data in this age group is essential to ensure that parents have confidence in offering the vaccine to their children,” the AAP said in a statement.

The problem is that two doses of the Pfizer and BioNTech vaccine did not elicit an adequate immune response in children aged 2 to 4 during clinical trials. Companies estimate a lower dose level of 3 mcg in children under 5 years of age compared to older children and adults who receive 30 mcg shots.

In December, Pfizer and BioNTech amended their clinical trials to study a third dose to determine if it would elicit the immune response needed to protect against Covid. Companies have been saying all along that the data won’t be ready until April.

However, the rapid rise in omicrons over the holidays and throughout 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 approval should not affect parental confidence in the vaccine. He said the change shows the FDA is taking its responsibility seriously and making decisions based on data as it becomes available.

“I hope this will convince people that the process has a standard, that we are following this process,” Marks said. “And we follow the science, making sure everything we authorize has the safety and efficacy that people expect from our regulatory review of medical products.”

Wayne Coff, CEO of the Human Vaccines Project and a professor of epidemiology at Harvard, said there is good reason to expect a third dose to increase the effectiveness of the vaccine in children under 5 years of age. Booster doses have proven effective in preventing severe illness in other age groups, Koff said, and for now, the vaccine should really be considered a three-dose regimen in general for all age groups.

Offit said the Covid shot is likely to become a common childhood vaccine in the future, much like the polio immunization. The US eradicated polio in the 1970s but still vaccinates children because the virus continues to circulate in parts of the world. Public health experts generally agree that an eradication of Covid is unlikely at this point.

“The fact remains that we will need a well-protected population for years and decades. I suspect this will become a routine childhood vaccination,” Offit said.

While it may seem to some parents that expanding vaccine access has taken too long, Koff said the FDA has made the process as expeditious as possible by gradually lowering the eligibility age while meeting safety and efficacy standards.

“First, you have to show that the vaccine is safe and effective in the adult population,” Koff said. “Once you demonstrate that, you can lower the age of teenagers and then eventually younger children and then eventually babies.”

Offit said that children under the age of 18 are less likely to become infected and less severe, which is why the vaccination was primarily aimed at the elderly. While parents wait for a vaccine, he said, they should build a “moat” around their children who are not eligible and make sure everyone who comes into contact with them gets their shots.

While about 75% of U.S. 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 figure is lower for children. Approximately 57% of children aged 12 to 17 are fully vaccinated. According to the CDCand 24% from 5 to 11.

— Nate Rattner of CNBC contributed to this report.

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