The two companies said that 3 doses of their vaccine achieved a strong immune response in children under the age of five, and were safe and well tolerated in a clinical trial.
And they indicated that they intend to ask global regulatory bodies soon to vaccinate this age group, and this group of children does not have a vaccine currently approved in most parts of the world.
Pfizer and Biontech said they expect to complete their submission of data to the US Food and Drug Administration this week.
The clinical trial included 1678 children aged 6 months to 5 years receiving lower doses of the vaccine than those given to older children and adults.
The two companies reported that giving three doses of 3 micrograms of their vaccine achieved a similar immune response in that age group, as in people aged 16 to 2 years, who received two doses of 30 micrograms of the vaccine in a previous clinical trial.
“The study indicates that a low dose of our vaccine of 3 micrograms, carefully selected based on tolerability data, provides young children with a high level of protection against modern strains of Covid 19,” Reuters quoted Ugur Sahin, CEO of Biontech, in a statement. “.
Competitor Moderna published experimental data last March showing that its vaccine was safe and achieved a similar immune response in young children as adults.