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Food and Drug Administration officials said on Sunday that the coronavirus vaccine, produced by Pfizer and its German partner BioNTech, for children under 5 is effective in generating a virus-blocking response and not raising safety concerns, a prelude to a crucial review this week by the agency’s independent advisers.
The analysis by FDA scientists was published before a meeting on Wednesday by the agency’s independent experts, who will consider a request for permission for the emergency use of the Pfizer-BioNTech vaccine in young children. He will also consider Moderna’s request to use the vaccine in children under 6 years of age. FDA staff said on Friday that Moderna’s vaccine for infants and young children is safe and effective.
Once counselors make their recommendations, the FDA will decide whether to follow the panel’s advice, which it often does. If the agency clears the vaccines and the Centers for Disease Control and Prevention refuses, the vaccines may be available from next week.
The FDA says the Pfizer-BioNTech vaccine meets the basic requirement for effectiveness – it generates an immune response at least as strong as the protection given to young adults by the vaccine.
Overall, the agency said, preliminary data show that the vaccine is 80.4 percent effective in preventing symptomatic covid-19. The percentage is 75.6% for babies and young children aged 6 to 23 months and 82.4% for children aged 2 to 4 years.
But the FDA said it was too early to reach “final conclusions” about the effectiveness of the vaccine.
Side effects are minimal and include irritability and drowsiness for children ages 6 to 23 months and injection site pain and fatigue for children ages 2 to 4, the FDA said.
Babies and children under the age of 5 – a group of 19 million – remain the only age group in the United States that does not yet qualify for a coronavirus vaccine.
Some parents are looking forward to vaccines for their young children, eager to provide them with the same protection that older children, teenagers and adults have had for some time. But studies show that most parents intend to wait before vaccinating their children, or are not interested in pediatric vaccines.
The FDA made clear Sunday that it believes vaccines for the youngest group are critical. Given the uncertainty of the pandemic and probably “Continued transmission of the virus in the coming months,” the introduction of the vaccine for use in children aged 6 months to 4 years is likely to have a beneficial effect on COVID-19-related morbidity and mortality in this age group, “the agency said.
The Pfizer-BioNTech vaccine trial consisted of two groups of children, 6 to 23 months of age and 2 to 4 years of age. The first two injections were given at three-week intervals, and the third was given at least eight weeks after the second dose. Each of the three doses is three micrograms, one-tenth of what adults receive.
For many children, the difference between the second and third injections was significantly longer than the eight weeks specified in the protocol. For children aged 2 to 4 years, the average interval between the second and third injection is 10.7 weeks. For younger children it was 12.9 weeks.
Assuming that Pfizer-BioNTech and Moderna vaccines are cleared, parents and pediatricians will have a choice. Some may prefer Pfizer-BioNTech because of preliminary indications that it is more effective. But the three-shot mode takes longer to complete than the two-shot series of Moderna, which may discourage some parents. On the other hand, the Moderna vaccine tends to cause more fevers, the data show.
Most children are expected to receive their vaccines in pediatric clinics, but states and communities are also planning vaccine clinics, and some pharmacies will administer vaccines. Some sites will offer both vaccines, but many pediatricians say they will only provide one.
Sally Permar, a pediatric vaccine expert at Weill Cornell Medicine in New York, said her facility would offer both.
“While there may be some confusion, it gives you more flexibility,” Permar said. “Parents can weigh all the information and decide.”
On Friday, the FDA said Moderna’s two-injection regimen produced the necessary immune response. The vaccine has been shown to be 51% effective in preventing disease in children between 6 months and 2 years of age and 37% effective in children aged 2 to 5 years.
Vaccines for young children follow a winding – and often confusing – path marked by disappointing results, delays and changes in regulatory strategies.
Pfizer and BioNTech initially tested a two-injection vaccine regimen, but announced last December that the approach failed to meet the target of an immune response for the 2 to 4-year-old group. Vaccine developers added a third dose to their experience, delaying the availability of the vaccine for months.
But in late January, federal officials made the surprising suggestion that there might be a way forward for the two-dose regimen, despite disappointing results. They said that even if the vaccine misses the target of the immune response, which is measured in the laboratory, the vaccine can still protect children from infections.
But those data also proved disappointing, with only 28.3 percent effectiveness, according to the latest data reflecting the emergence of the omicron variant of the coronavirus. The FDA abandoned the plan to speed up the vaccine and decided to wait for the results of the third dose.
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