Pfizer and BioNTech filed a request with the U.S. Food and Drug Administration in the first week of February for an emergency use permit for their vaccine for children ages 6 months to 5 years. The FDA’s advisory committee on vaccines and related biological products was scheduled to meet on February 15 to review data from vaccine trials and make a recommendation and whether a 2-dose vaccine regimen should be approved.
The data supported the safety of the vaccines, but showed disappointing efficacy, the Washington Post reported Friday.
The agency needs to see data from an ongoing trial of a third dose of vaccine in these younger children to move forward with emergency use permits, said Dr. Peter Marks, director of the FDA’s Center for Biological Evaluation and Research, during a news briefing.
Pfizer and BioNTech said Friday that they expect to have data on three doses available in early April.
Information came in “so fast” during the Omicron wave, “that at this point it makes sense for us to wait until we have data from the evaluation of a third dose before taking action,” Marks said.
“The data we saw made us realize that we had to see data from a third dose as in the ongoing trial in order to decide that we could continue to perform an approval.”
The delay is a sharp change of pace.
Twisted road to authorization
In December, Pfizer said the vaccine appeared to protect the youngest children – infants and toddlers up to 2 – at the same levels seen in teens and young adults, reducing the symptoms in 90% of children who received the shot. However, the 3-microgram dose did not elicit the same immune response in 2- to 5-year-olds.
The dose for infants and young children is about one third of the dose given to children aged 5 to 11 and one tenth of the size of the dose given to persons aged 12 years and older.
At that time, the company decided to expand its trial to include a third dose instead of the two doses that older children and adults receive in a primary vaccine series.
“Given that the investigation is progressing at a rapid pace, companies will wait for three-dose data, as Pfizer and BioNTech continue to believe that it may provide a higher level of protection in this age group,” Pfizer’s press release said. . “This is also supported by recent observations of three-dose booster data in several other age groups that appear to meaningfully increase neutralizing antibody levels and the real-world vaccine protection for omicron compared to the two-dose regimen.”
Pfizer said the study’s independent data monitoring committee supports the continuation of the trial. It believes that the data collected indicate that the vaccine is well tolerated and supports a potential three-dose regimen.
After the FDA postponed the meeting with its vaccine advisers, Marks said it is important for the agency to stay alert to a rapid pandemic.
“What we are dealing with is taking the approach that we should very much take as a public health agency, which is constantly taking in the data that comes to us and adapting it to us,” Marks said. “So what we’re doing now is adapting to this, and yes, some of this was late, but that’s what our job is, it’s adapting to it.”
Dr. Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia and a member of the FDA Vaccine Committee, said he’s glad things went this way.
If the committee had met on Tuesday and voted no, “it would have sent the message to the public that there is something wrong with this vaccine. And then [if] we will come back a few months later and vote yes, people may still be suspicious or less likely to take up the vaccine, “he said.
“My word to parents who have young children is that this is not a ‘no’; it is a ‘not yet’,” he added.
Dr. William Schaffner, professor in the Department of Infectious Diseases at Vanderbilt University Medical Center, said that with cases and hospitalizations going down across the country, there is a little more respite to look at the data and determine the right vaccine plan up front.
“Let’s take a step back and take a deep breath. When we recommend ‘we need to make vaccines for all children aged 6 months to 4 years’, we want to be able to communicate to parents exactly what to expect regarding efficacy and safety, “said Schaffner, a CDC vaccine consultant. “If it takes us a few more days to secure this data, analyze it, think about it and then present it, then let’s take a few more days, because we want to be able to do this in the best possible way. , we can.”
The FDA says it will move as fast as it can
Children have a lower risk of severe outbreaks of Covid-19 infection compared to older or immunocompromised adults. However, about 1% of children receiving Covid-19 will be hospitalized. Infections can also lead to long-term consequences in children, as they do in adults, increasing the risk of diabetes, autoimmune disease and a delayed response to infection called multisystem inflammatory syndrome, which requires hospital treatment.
Dr. Helen Talbot, an associate professor of medicine in the Department of Infectious Diseases at Vanderbilt, called the decision to postpone the meeting “heartbreaking.”
“I think that as a scientist they will have more data faster than they thought and that we will get to see and analyze and really get to dive into the data that is coming,” said Talbot, who is vaccine advisor to the CDC. “But I can imagine parents with kids under 5 being just so frustrated and they’s just so ready to get their kids vaccinated.”
Marks said he understands that parents are eager to get protection for their young children, and the agency is “absolutely committed to moving as fast as we can when we have a submission.”
“We take our responsibility to review these vaccines very seriously because we are parents too, and when we look at the data, I think parents can feel confident that we have set a standard that we feel that if something does not meet this standard., we can not move on. “
As the additional data is collected, it means that “parents will have to trust what they have come to do well, ie they use masking procedures, and they make sure they are vaccinated and take such precautions with their youngest children, “Marks said. “Obviously we will do our part to move as fast as we can once we have the data, but so far we will have to ask parents to help continue to do what they have done.”
CNN’s Carma Hassan contributed to this report.