Regulatory clearance of the Pfizer Inc. PFE -1.22% and BioNTech SE BNTX -9.95% vaccine for young children may not come until November, according to a person familiar with the matter, after the companies said they won’t ask for the green light for a few weeks.
The companies said Tuesday they provided U.S. health regulators with data from a recent study of their vaccine in children 5 to 11 years old. They said they would file an application asking the Food and Drug Administration to authorize use in the coming weeks, though they had previously targeted submitting the application as early as the end of September.
That timeline for potential availability of the shots prompted parents, public health experts and vaccine experts to anticipate shots as early as October.
Pfizer may not finish its application until mid-October, however, which means the FDA may not make its decision until sometime between Halloween and Thanksgiving, according to the person familiar with the matter.
Pfizer submitted the data Tuesday and is on track to file a formal submission soon, a spokeswoman said.
No vaccines are authorized yet for children 5 to 11 years of age. Many parents have been eagerly waiting to vaccinate their children, especially since many have returned to schools.
The Biden administration and public-health experts have also looked forward to authorization for the younger age group, saying it could help damp the spread of the contagious Delta variant in addition to helping protect the children in school.
The FDA said this month that it was “working around the clock” to help make Covid-19 shots available for children under 12 years old but said that testing and regulatory process needed to play out.
The agency has been reviewing data on the vaccine’s use in child study subjects that Pfizer had submitted earlier, the person said.
In their latest announcement, Pfizer and BioNTech said it provided the FDA data from a positive recent late-stage study in young children for initial review.
The companies said last week that researchers found a two-dose course of the vaccine to be safe and generate a robust immune response in children 5 to 11 years old in a pivotal study. Antibody levels in the children who received the shot were similar to those measured in younger adults in a separate study, the companies said.
The Pfizer-BioNTech vaccine is cleared for use in the U.S. in children as young as 12 years. Vaccination involves taking two doses three weeks apart. Should the FDA green light the vaccine for young children, it would be given on the same schedule but the youngsters would receive a lower dosage than adolescents and adults.
Young children are at a low risk of severe disease and hospitalizations but are going to the hospital in greater numbers than earlier in the pandemic as the Delta variant spreads.
Write to Jared S. Hopkins at [email protected] and Stephanie Armour at [email protected]
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Appeared in the September 29, 2021, print edition as ‘Shots for Children Likely Not Approved Before November.’
