Parents of children under the age of 5 will have to wait at least until April to get their children vaccinated against Covid-19, after the Food and Drug Administration and Pfizer this week abruptly delayed this week. vaccination schedule on an expedited basis.
The FDA originally planned to authorize the first two doses of the three-dose vaccine as soon as this month. However, Dr. Peter Marks, head of the FDA’s vaccine division, said the updated data due to Pfizer and BioNTech did not support the plan to give the first two doses early. Marks acknowledged that the decision was abrupt, but said the FDA followed the science.
“The data that we saw made us realize that we needed to see data from the third dose in the ongoing trial to make a decision that we could proceed with authorization,” Marks told reporters. employee on Friday’s call, without providing specifics on the data.
Acting FDA Commissioner Janet Woodcock said the drug regulator sought to act quickly to protect children against omicrons as the number of Covid hospital admissions among the youngest children rose to a record level in weeks. recently. However, FDA safety and effectiveness standards require the agency to wait for more information on the third dose, Woodcock said.
“The goal is to understand whether two doses provide sufficient protection to move toward authorizing the vaccine in this age group,” Woodcock said in a statement. “Our approach has always been to conduct a regulatory review in response to an urgent public health need caused by the pandemic, while adhering to our rigorous standards for integrity,” she said. Safe and effective.
Woodcock said: “It is possible that starting an assessment of the initial data would be helpful in our assessment of these vaccines, but at this point we believe that additional information is relevant to the assessment of these vaccines. third dose assessment is ongoing”.
Dr. Paul Offit, a member of the FDA’s vaccine advisory committee, said the fast-track plan is based on the assumption that the third dose is safe and effective, but there is no guarantee that this will be the case. when the final data is submitted.
“Imagine us approving it after two doses and then finding out that the third dose is unsafe and then having to withdraw it,” said Offit, a pediatrician and director of the Center for Vaccine Education at the Hospital. Children’s Hospital of Philadelphia said. “I’m glad we’ll wait until we have all the data to make that decision.”
The FDA has come under pressure in recent weeks from some parents and doctors to quickly expand eligibility to protect toddlers up to age 4 as the omicron variant sweeps across the country. Children under 5 are the only age group left in the US not eligible for vaccination.
Nearly 5,200 children were hospitalized with Covid on January 18, according to seven-day average of data from the Department of Health and Human Services, more than double the previous peak in the fall of 2021. That has since dropped to about 3,000 as of Friday, HHS data showed.
The American Academy of Pediatrics, in a statement Friday, said while the news was disappointing to many parents, it was important to have a rigorous review process to ensure vaccines are safe. and efficient.
“A careful, robust and transparent process for evaluating the evidence about vaccines in this age group is essential for parents to trust when providing vaccines to their children,” the AAP said. .
The problem is that two doses of Pfizer and BioNTech vaccines did not produce an adequate immune response in children 2 to 4 years of age during clinical trials. The companies are evaluating a lower dose, 3 micrograms, in children under 5 years of age, compared with older children and adults receiving the 30 microgram injections.
Pfizer and BioNTech revised their clinical trial in December to study a third dose to determine whether that dose induces the immune response needed to protect against Covid. The companies have said all along that the data will not be available until April.
However, the rapid increase in omicrons over the holidays and through January created what Pfizer calls an “urgent public health need” to get children in this age group vaccinated. Marks said the abrupt decision to delay the FDA’s approval will not affect parents’ confidence in the vaccine. He said the change shows the FDA takes its responsibility seriously and makes data-driven decisions as it emerges.
“I hope this reassures people that the process has standards, that process is the process we follow,” says Marks. “And we follow science in making sure that anything we authorize has the safety and effectiveness people expect from our regulatory review of medical products. .”
Wayne Koff, executive director of the Human Vaccine Project and professor of epidemiology at Harvard, says there’s good reason to expect the third dose to improve the vaccine’s effectiveness in children under 5. age. Koff said booster doses have been shown to be effective in preventing severe illness in other age groups, and the vaccine should really be considered a three-dose regimen in general for age groups at this point. this.
Offit said the Covid shot could become a routine vaccine for young children in the future, much like the polio vaccine. The United States eliminated polio in the 1970s, but it still immunizes children because the virus continues to circulate in some parts of the world. Public health experts largely agree that eradicating Covid is unlikely at this point.
“The reality is still, we’re going to need a highly protected population for years and decades. I doubt this will become a routine approach to childhood vaccination,” Offit said.
While some parents may feel it’s taking too long to expand access to vaccines, Koff said the FDA has sped up the process as much as possible by gradually reducing the age of eligibility for the vaccine. while still complying with safety and effectiveness standards.
“Initially, you have to show that the vaccine is safe and effective for adults,” Koff said. “Once you’ve shown that, then you can go down to the ages of teenagers and eventually younger kids and eventually babies.”
Offit says children under 18 are infected less often and less severely, which is why vaccination is focused on older people first. As parents wait for a vaccine, they should build a “moat” around their ineligible children by making sure everyone who comes into contact with them is vaccinated, he said.
While about 75% of adults in the United States received two full doses of Pfizer or Moderna vaccine or a single dose of Johnson & Johnson vaccine on Thursday, the number is lower in children. About 57% of 12 to 17 year olds are fully immunized, According to CDCand 24% out of 5-11.
– CNBC’s Nate Rattner contributed to this report.
