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(CNN) --
Parents will have to keep waiting to find out when they can get their youngest children vaccinated against Covid-19.
Pfizer and BioNTech submitted an application to the US Food and Drug Administration (FDA) in the first week of February for an emergency use authorization for their vaccine in children 6 months to 5 years.
The FDA's Advisory Committee on Vaccines and Related Biologics has scheduled a meeting for February 15 to review data from trials of vaccines in young children and make a recommendation on their use.
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But the FDA announced Friday that it will postpone the meeting because "new data has recently emerged."
"This will give the agency time to consider the additional data, allowing for a transparent public discussion as part of our regular scientific and regulatory processes for COVID-19 vaccines. We will provide an update on the schedule for the advisory committee meeting once that we receive additional data on a third dose in this age group from the company's ongoing clinical trial and have an opportunity to complete an updated evaluation," Acting FDA Commissioner Dr. Janet Woodcock and the FDA said in a statement. Dr. Peter Marks, director of the FDA's Center for Biological Evaluation and Research.
In December, Pfizer said the vaccine appeared to protect younger children, infants and children up to 2 years old, at the same levels seen in adolescents and young adults, reducing symptoms in 90% of children who got the shot.
However, the 3 microgram dose did not produce the same immune response in children aged 2 to 5 years.
The dose for infants and young children is approximately one third of the dose given to children 5 to 11 years of age and one tenth of the dose given to children over 12 years of age.
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The company decided to expand its trial to include a third dose, instead of the two that older children and adults receive in the vaccination schedule.
While it was still investigating a third dose, in early February the company said it had decided to go ahead and submit authorization for the two-dose vaccine "with pediatric cases of COVID-19 exceeding 10 million and at the FDA's request."
In a press release on Friday, Pfizer said it continues to share data from its pediatric vaccine trial with the FDA.
With the rise of the omicron variant of the coronavirus, high rates of infection and illness among minors have allowed the company to quickly amass the data it needs for the study protocol.
"As the study proceeds at a rapid pace, the companies will await data from all three doses, as Pfizer and BioNTech continue to believe it may provide a higher level of protection in this age group," the statement said.
“This is also supported by recent observations from three-dose booster data in several other age groups that appear to significantly increase neutralizing antibody levels and real-world vaccine protection for the omicron variant compared to the omicron variant. two-dose schedule.
Pfizer and BioNTech expect to have data on the level of protection of the three doses in early April.
The extension will give the FDA the time it needs to review the data from the two- and three-dose vaccination schedules.
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Marks said in a call with reporters Friday that the FDA needed to adapt its strategy to keep up with the rapidly changing landscape of the pandemic.
"The data has come in so quickly that we have to be able to look through it, and looking through it, we realize now, in the data that came in very quickly because of the large number of omicron cases, that in this At this time, it makes sense for us to wait until we have the data from a third dose evaluation before taking action," he said.
"The data we reviewed made us realize that we needed to see data from a third dose as in the ongoing trial to make a determination that we could proceed with an authorization."
Marks said it's important for the agency to remain nimble in the rapidly changing environment of the pandemic.
"We didn't know that omicron was going to be on the scene much before the end of November. So what we're doing is taking the approach that we should be taking as a public health agency, which is to constantly take the data that's coming in and adjust to it. So what we're doing now is adapting to this, and yes some of this data was released late, but that's our job is to adapt to it," he said.
The COVID-19 caseload among children has been "extremely high" during the omicron surge, the American Academy of Pediatrics said Monday.
More than 7 million pediatric cases have been recorded since September, and more than half of them have occurred this year.
There are some 18 million children under the age of 5 in the United States who have been without the protection of any vaccine against covid-19 because the FDA has not authorized it
Children are at lower risk of severe COVID-19 infection compared to older or immunosuppressed adults.
But about 1% of children who get covid-19 will be hospitalized.
Infections can also have long-term consequences in children, just as they do in adults, increasing the risk of diabetes, autoimmune diseases, and a delayed reaction to infection called multisystem inflammatory syndrome, which requires hospital care.
To authorize COVID-19 vaccines for emergency use, the FDA previously established a 50% effectiveness requirement, which means the vaccines have to prevent the disease or lessen its severity by at least 50%. of the people who receive them.
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Since the data has not been made public, it is not clear whether the Pfizer/BioNTech vaccine for younger children meets that standard after two doses.
Pfizer said Friday that the study's independent Data Monitoring Committee supports continuing the trial.
He considers that the data collected indicates that the vaccine is well tolerated and supports a possible three-dose scheme.
Marks said he understands that parents are anxious to get protection for their young children and said the agency is acting urgently, but it has to get this right.
"We take our responsibility to review these vaccines very seriously because we're parents, too, and by reviewing the data, I think parents can feel reassured that we've set a standard where we feel if something doesn't meet that standard, we don't we can move on," Marks said.
"In the case of parents who really feel this, we empathize with them, because I suspect that they are not only worried about the current situation, even if there is a decrease in cases, but they are worried about future variants that may arise, and so we also think So this was not based on the drop in the number of cases, because it's still a shocking number that we're seeing every day."
-- CNN's Carma Hassan and Brenda Goodman contributed to this report.
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