Pfizer and BioNTech announced on Monday that three doses of their Covid-19 vaccine generated a strong immune response in children under 5 years of age in a clinical trial.
The companies said the vaccine is safe and well tolerated by children. The drugmakers plan soon to ask international regulators to authorize the vaccine for the age group in which no immunizers are currently approved in most parts of the world.
They expect to complete data submissions to the US Food and Drug Administration (FDA) this week.
According to the companies, three doses of a 3 μg (microgram) formulation of their vaccine generated a similar immune response in children aged six months to less than five years compared to ages 16 to 25 years who received two doses of the 30-year-old formulation. μg of the vaccine in a previous clinical trial.
“The study suggests that a low dose of 3 μg of our vaccine, carefully selected based on tolerability data, provides children with a high level of protection against recent strains of Covid-19,” said BioNTech Chief Executive, Ugur Sahin, in a statement.
An initial analysis of ten symptomatic Covid cases identified as of April 29, while the omicron variant was dominant, suggested vaccine efficacy of 80.3% in the under-five age group, the drugmakers say. This analysis is not conclusive as the study protocol specified that efficacy should be calculated based on at least 21 cases.
Pfizer and BioNTech said final age-group efficacy data will be shared when they become available.
The 1,678 study participants received their third dose at least two months after the second dose. Pfizer said the vaccine was well tolerated, with most adverse side effects being mild or moderate.
The booster dose of the Pfizer vaccine was recommended for those over five years old last Thursday (19) by the CDC (US Centers for Disease Control). According to the agency, the third dose should be applied five months after the primary immunization schedule.
In Brazil, the third dose is only authorized for people over 18 years of age, but Ctai (Technical Chamber of Immunization Advice) approved the recommendation of the booster dose for the age group from 12 to 17 years.
In past situations, the Ministry of Health followed the recommendations given by the chamber.
However, the country has a low rate of vaccination among children – data show that more than half of them may be late for their second dose. Among the youngest, the situation is also slow, since only 30% of Brazilians up to 24 years old received the third dose.
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