uA third dose of Pfizer/BioNTech’s Covid-19 vaccine produced significant protection against the omicron variant of the coronavirus in healthy children ages 5 to 11, the companies said Thursday.
Serological analysis of 30 pediatric participants who received a booster dose in one study showed a 36-fold increase in neutralizing antibodies against the micron, the labs said.
Neutralizing antibodies against the original version of the virus for which the vaccine was designed increased sixfold after the booster injection.
The companies said they plan to apply for emergency use authorization in the United States for a booster dose for this age group in the coming days, with additional requests to global regulatory agencies, including the European Medicines Agency.
The study looked at the safety and immunogenicity of a 10 microgram booster dose in 140 healthy children aged 5 to 11 years. Adults receive a 30 microgram dose of the vaccine.
It is unclear how much demand there is for a third dose of vaccine in this age group. Only 28% of children in this group — about 8 million — are fully vaccinated, according to data from the US Centers for Disease Control and Prevention.
In Brazil, about 21% of this age group is vaccinated with two doses, equivalent to 4.2 million children, according to data from the consortium of press vehicles.
Health experts called the data “promising” but cautioned that the study’s size is too small and that more data is needed to understand the extent to which this booster prevents serious illness and hospitalization in children and how it will fare against future variants. .
“In general, [os dados] are very positive. But they also raise a number of questions. How long will the response be? How well will it withstand future variants?” said Anna Bershteyn of Langone Health NYU.
There was some skepticism about the need for boosters in younger children, due to the reduced risk of serious infection and hospitalization in this age group.
Still, Scott Hadland, chief of adolescent medicine at Mass General Hospital for Children, said many parents are asking for boosters.
“What we keep finding with the pandemic is that when we make vaccines and boosters available, even when they don’t offer perfect protection against infections, they usually protect a lot against serious illness and hospitalizations,” Hadland told Reuters.
Earlier this year, the US Food and Drug Administration (FDA) authorized a third dose of the vaccine for children ages 12 to 15 and for children ages 5 to 11 who are immunocompromised.
The agency said at the time that it will evaluate boosters for children ages 5 to 11 after more children receive two doses.
Translated by Luiz Roberto M. Gonçalves
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