Dive Brief:
- Pfizer and BioNTech are asking the Food and Drug Administration for emergency authorization of their COVID-19 vaccine in children under 5 years old, announcing Tuesday they've begun the process of submitting an application at the regulator's request while they continue testing a third dose in that age group.
- U.S. regulators are pushing the companies to move ahead even after they reported disappointing data in December for their original two-dose regimen. At that time, a routine study review suggested the regimen worked only in the youngest children, aged 6 months to 24 months. The drugmakers then decided to study a third dose in the full age group.
- In a statement Tuesday, Pfizer and BioNTech said they have begun the "rolling submission" process in the hopes that younger children can start getting their vaccinations sooner. The FDA has scheduled an advisory committee hearing on Feb. 15 to review the companies' application, which is for the first two doses of a planned three-dose series.
Dive Insight:
Pfizer, BioNTech and the FDA are engaged in something of a high-wire act, trying to move as quickly as possible to protect the youngest children from COVID-19 while working to assure the public that the vaccine remains safe and effective in that age group without all the data in hand.
The companies already have full approval for their vaccine for people 16 years and older and have won emergency clearances for children, first in May for kids 12 through 15 and then in late October for those as young as 5. Hundreds of millions of people have now received the shots, including nearly 9 million children under 12, and data has consistently showed they provide a high level of protection against severe disease and death.
Even so, some parents are still hesitant to vaccinate their children. Only about a third of kids in the 5- to 11-year-old age group have received shots, according to a Kaiser Family Foundation poll published Tuesday. And just 31% of parents of children under the age of 5 say they would vaccinate their children right after inoculations become available.
The surge brought on by the omicron variant has helped alter opinions to some extent; in July, only 20% of parents of a child under 5 said they would immediately pursue vaccination. And the FDA has emphasized urgency as hospitalizations of younger children rise, leading to the highly unusual situation of considering an authorization before the companies have obtained all the supporting results needed.
Pfizer and BioNTech say they will have data on a third dose, given at least eight weeks after the second, "in coming months." The companies emphasized the totality of the data, showing that the vaccine is safe and effective in all age groups over the age of 5. Additionally, they found no safety concerns in the younger children, according to their December statement.
Moderna, which has a similar vaccine, is also testing its shots in the youngest children and plans to have data available in March.
Meanwhile, the Maryland biotech Novavax this week said it's seeking emergency clearance for its COVID-19 vaccine in adults.