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Food and Drug Administration staff said on Sunday that the coronavirus vaccine developed by Pfizer and its German partner, BioNTech, for children under 5 is effective in producing a virus-blocking response and raised no security issues, a prelude to a crucial review this week by the agency’s independent advisers.
The analysis by FDA scientists was published ahead of a meeting of independent experts from the agency on Wednesday, who will study an application for an emergency use authorization for the Pfizer-BioNTech vaccine in the United States. younger children. It will also review an application from Moderna to use its vaccine in children under 6 years of age. FDA staff said Friday that Moderna’s vaccine for babies and young children was safe and effective.
After the advisors make their recommendations, the FDA will decide whether to follow the panel’s advice, which it often does. If approved by the agency and given by the Centers for Disease Control and Prevention, the vaccines could be available starting next week.
The FDA said the Pfizer-BioNTech vaccine met the main requirement for efficacy: it generated an immune response at least as strong as the protection offered by young adults from the vaccine.
Overall, the agency said, preliminary data indicated that the vaccine was 80.4% effective in preventing symptomatic covid-19. The rate was 75.6% for infants and young children aged six to 23 months, and 82.4% for children aged 2 to 4 years.
But the FDA said it was too early to reach “definitive conclusions” about the vaccine’s effectiveness.
Side effects were minimal and included irritability and drowsiness for children 6 to 23 months of age, and pain at the injection site and fatigue for children 2 to 4 years old, the FDA said.
Infants and children under the age of 5, a group of 19 million, are still the only age group in the United States that is not yet eligible for a coronavirus vaccine.
Some parents eagerly awaited vaccinations for their young children, eager to give them the same protection that older children, teens, and adults have long had. But surveys show that most parents intend to wait before vaccinating their children or are not interested in pediatric vaccines.
The FDA made it clear on Sunday that it believes vaccines for the younger group are critical. Given the uncertainty of the pandemic and likely Continued transmission of the virus in the coming months, “the deployment of the vaccine for use in children aged 6 months to 4 years is likely to have a beneficial effect on the morbidity and mortality associated with COVID-19 in this age group.” , said the agency.
The Pfizer-BioNTech vaccine trial consisted of two groups of children: 6 to 23 months and 2 to 4 years. The first two injections were given three weeks apart, 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 distance between the second and third shots was significantly longer than the eight weeks established by the protocol. For children aged 2 to 4 years, the mean interval between the second and third injection was 10.7 weeks. It was 12.9 weeks for the younger children.
Assuming the Pfizer-BioNTech and Moderna vaccines are approved, parents and pediatricians will have a choice. Some may prefer the Pfizer-BioNTech vaccine because of the preliminary indications that it is more effective. But the three-shot regime takes longer to complete than the modern two-shot series, which could discourage some parents. On the other hand, the Modern vaccine tends to cause more fevers, the data show.
Most children are expected to receive their vaccines at pediatric offices, but states and communities are also planning vaccine clinics, and some pharmacies will administer vaccines. Some places will offer both vaccines, but many pediatric clinics say they will only provide one.
Sallie Permar, a pediatric vaccine expert at Weill Cornell Medicine in New York, said her facility will 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-shot regimen produced the necessary immune response. The vaccine was shown to be 51% effective in preventing disease in children aged 6 months to 2 years and 37% effective in children aged 2 to 5 years.
Vaccines for young children have followed 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 did not meet the immune response target for the 2-4 year old group. Vaccine manufacturers added a third injection to their trial, delaying vaccine availability by months.
But in late January, federal officials made the startling suggestion that there could be a way forward for the two-dose regimen, despite disappointing results. They said that even if the vaccine did not achieve the goal of an immune response, which is measured in the laboratory, the vaccine could still protect children from infections.
But these data were also disappointing, with only 28.3 percent effectiveness, according to the latest figures, which reflect the appearance of the omicron variant of coronavirus. The FDA abandoned the plan to speed up the vaccine and decided to wait for the results of a third dose.