A key advisory committee to the US Food and Drug Administration (FDA) voted overwhelmingly to recommend the use of Pfizer-BioNTech’s coronavirus vaccine for children aged 5 to 11, underscoring that the benefits of inoculation outweigh the risks.
Authorization for the 5 to 11 age group would be an important regulatory step toward reaching about 28 million children for inoculation, most of them back in school for in-person learning.
The vaccine could be available to the younger age group as soon as next week. The FDA is not obligated to follow the advice of its outside experts but usually does.
While no one on the panel voted against the move, several said they were concerned by the idea that this might lead to vaccine mandates for children. Many scientists on the panel said they were bothered about the possible side effects for younger children since that group is not at significant risk of suffering severe COVID-19.
Even though children rarely become seriously ill or die from COVID-19, some develop complications, and COVID-19 cases in unvaccinated children have risen due to the contagious Delta variant.
The age group is “far from being spared from the harm of COVID-19,” with the virus now one of the top 10 causes of deaths in American children, FDA official Mr. Peter Marks told the panel. He said there had been close to 100 deaths in that age group so far, and 1.9 million infections.
FDA staff, in documents posted before the meeting, said the possible benefits of the vaccine in that age group clearly outweigh the potential harms, including the rare risk of heart inflammation.
Only a few other countries, including China, Cuba and the UAE, have cleared COVID-19 vaccines for children in this age group and younger. Since May, the World Health Organization (WHO) has been urging rich countries to reconsider plans to vaccinate children and instead donate COVID-19 shots to the COVAX scheme for poorer countries.
The advisers are expected to pay close attention to the rate of the rare cases of heart inflammation called myocarditis that has been linked to both the Pfizer/BioNTech and Moderna vaccine, particularly in young men.
Pfizer and BioNTech are seeking clearance for a lower, 10-microgram dose version of the vaccine in children, versus 30 micrograms for everyone over the age of 12. The shot has been authorized for those aged between 12-15, since May and cleared for everyone over 16 since December.
The companies have said their vaccine showed 90.7 percent efficacy against the coronavirus in a clinical trial of children aged 5 to 11.
After the FDA, a panel to the US Centers for Disease Control and Prevention will make a recommendation on the administration of the vaccine. The director of the agency will make the final call.
“No matter what size of the safety database, there will always be uncertainties regarding benefits and risks, including, for example, the risk of vaccine-associated myocarditis,” said Mr. Doran Fink, the FDA’s deputy director for vaccine development.
Pediatric vaccinations are an important public health tool to prevent infectious diseases, even ones that do not cause high rates of mortality or hospitalization for children.