Pfizer and German pharmaceutical company BioNTech on Friday announced they were postponing an application with the U.S. Food and Drug Administration that sought an emergency use authorization for its vaccine in children under 5 years of age.
What are the details?
In a press release, the two companies said they were extending their rolling application with the FDA until more data on the efficacy of a third dose of the vaccine is returned and peer-reviewed.
The current application before the drug agency sought authorization on only two doses for children between the ages of 6 months and under 5 years.
"Given that the study is advancing at a rapid pace, the companies will wait for the three-dose data as Pfizer and BioNTech continue to believe it may provide a higher level of protection in this age group," the press release stated.
It added that the companies were seeking more data "because rates of infection and illness remain high in children of this age" due to the Omicron variant's recent surge.
"The extension allows the FDA time to receive updated data on the two and three-dose regimen, conduct a thorough evaluation of it and facilitate a robust, public discussion," the companies explained.
What else?
NBC News noted the move is "a setback for parents eager to vaccinate their young children" since it means vaccines for the young age group will not be available for at least several more weeks.
That news, however, is likely a relief for parents who oppose vaccinating their young children. Without FDA emergency approval or children under 5, vaccine requirements for that age group are unenforceable.
Though the delay, in this case, does not mean the companies are experiencing negative reactions to the vaccine in testing. Rather, they have reportedly found that two small doses of the vaccine may not offer enough protection.
Dr. Peter Marks, who heads the FDA division responsible for vaccine safety, said Friday's announcement should reassure parents that authorities are doing their due diligence to make sure the vaccine is both safe and effective.
"Rather than having any issue of causing anyone to question the process, I hope this reassures people that the process has a standard, that the process is one that we follow, and we follow the science in making sure that anything that we authorize has the safety and efficacy that people have come to expect from our regulatory review of medical products," Marks told reporters during a press call Friday, according to CNBC.
Pfizer previously said in December that two doses didn’t generate a strong enough immune response in children ages 2 to 4. For that age group, each dose is three micrograms. But for children ages 5 to 11, the dosage is 10 micrograms.
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