the highly unusual “rolling authorization.”
Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, suggested that regulators could be short-circuiting the normal process without a clear rationale.
“It doesn’t make sense we would approve a two-dose vaccine on the assumption the third dose would make up for deficiencies of the two doses,” he told The New York Times.
The deficiencies were significant: One person familiar with the data, who spoke on condition of anonymity, told the Times that children aged 2 to 4 who were given two shots were infected at a rate 57 percent lower than the children who were not, and those between the ages of 6 months to 2 years old who got shots were infected at a rate 50 percent lower than those who were not. There were fewer than 100 cases of symptomatic infection — a small fraction of the participants overall — and the margins of error were wide, the person noted.
FDA panel member Dr. H. Cody Meissner, chief of the pediatric infectious diseases division at Tufts Children’s Hospital in Boston, said he was willing to weigh the “rolling authorization” strategy but he worried that rare side effects might be missed in the small-scale trials conducted so far.
The panel’s decision “will partly depend on what are the rates of hospitalization and severe disease in this age group, and what our sense is in terms of potential harm” should the two-dose regimen be authorized, Meissner added.
But Acting FDA Commissioner Dr. Janet Woodcock and Dr. Peter Marks, who oversees the agency’s vaccines office, said Tuesday that it was important to act quickly given the surge in Omicron cases and the likelihood that other variants will follow.
“The need for a safe and effective vaccine for our youngest children is significant, particularly given the rapid spread of the Omicron variant, the notable rise in the number of hospitalizations in young children with severe disease and the possibility that future variants could cause severe disease in those who are unvaccinated,” Marks said in an agency statement.
As the Omicron variant has spread, there has been a steep increase in pediatric cases of the virus, according to the American Academy of Pediatrics (AAP), which gathers state-level data. Even though most young children tend to do well combating the virus, some can get very ill.
AAP President Dr. Moira Szilagyi said in a statement on Tuesday that she was encouraged that “we may be one step closer” to shots for the youngest children.
Last month, “we reported the highest number of COVID-19 cases among children since the pandemic’s onset. More than 3.5 million new cases in children were reported in January 2022 alone,” she told the Times.
If the two-dose regimen is authorized, not every parent is going to race to their pediatrician’s office for shots, according to a new survey from the Kaiser Family Foundation: Only 3 in 10 parents of children under 5 said they plan to get their children vaccinated as soon as shots become available.