Pharmaceutical company Pfizer submitted data results to the Food and Drug Administration on Monday. The FDA will review that the datasets are accurate in the coming weeks as well as the possibility for vaccine authorization in younger children. If it grants Pfizer vaccine authorization, children as young as 5 years old could get vaccinated this year.
Pfizer recently announced the success in safety and effectiveness of the study in a press release on September 20. The study studied nearly 2,300 Americans aged 6 months to 11 years old. Those aged 6 months to 4 years old received a tenth of the normal recommended dosage for those 12 years old and older. Those aged 5 years old to 11 years old received a third of the normal recommended dosage.
Professor of Pediatrics David Kimberlin specializes in pediatric infectious diseases at Children’s of Alabama in Birmingham. Kimberlin said he expects the company is only in the beginning stages of receiving possible FDA authorization. If the FDA reviews and accepts Pfizer’s data, it must then be authorized. The Center for Disease Control and Prevention and the American Academy of Pediatrics may also look at the authorization for possible recommendation.
This comes as the AAP reports five consecutive weeks of more than 200,000 pediatric-aged Americans getting the coronavirus. Nearly 6 million American children have tested positive for the coronavirus since the start of the pandemic as of September 23.
Kimberlin said younger children should receive the vaccination because the virus affects them both directly and indirectly. He says children, though less likely to, continue to seek treatment at Children’s of Alabama.
“Less likely doesn’t mean never. It means that there are children who need to be hospitalized, need to be in the intensive care unit, need to be on ventilators and may need to be on heart-lung bypass machines, the most significant severe support a person might need,” Kimberlin said.
The hospital has also seen two to three times more hospital admissions among children over the past two months than seen during the last coronavirus peak in January.
Kimberlin said children can also spread the vaccine among older Americans, which can greatly reduce the country’s chances in achieving herd immunity.
“If you say, ‘Children don’t need the vaccine,’ [then] you have considerably hand-cuffed yourself in terms of being able to get to high enough levels of immunity that any of us can get through this and get back to normal lives,” he said.
Kimberlin has sat with parents who witness their children struggling to breathe, rushing to intensive care units and being put on a ventilator and heart-lung bypass machines at Children’s of Alabama. He said parents have an opportunity to grant their children life and he begs every parent to consider that opportunity.
“The knowledge that that was preventable and that it was within their power to have prevented it,” Kimberlin said. “That devastating weight on the shoulders of a parent, which will not go away, they will carry that for the rest of their lives is something. That is heartbreaking to watch.”
He said the best way to avoid situations like these is to allow their children to get vaccinated. He said he wishes to never meet any new families and children at Children’s of Alabama.
“I hope that I never meet those parents and that I never met their children, and the best way to never meet me is to get the vaccine,” he said.
Kimberlin is hopeful the FDA will approve possible coronavirus vaccines to children ages 5 to 11 years old as early as late October. Children ages 12 to 15 years old were first authorized to receive the Pfizer vaccine in May.
