The COVID-19 vaccine from BioNTech and Pfizer provides 73.2 percent protection for young children aged six months to four years, according to a study published by the vaccine makers on Tuesday.
Three doses of three micrograms each provide infants with a "high level of protection at a time when the Omicron BA.2 strain is highly prevalent," said Ugur Sahin, CEO and co-founder of BioNTech.
German vaccine developer BioNTech and its U.S. partner Pfizer are also developing a bivalent vaccine for this age group which is adapted to the current Omicron BA.4/BA.5 subvariants, Sahin added.
On Monday, the companies filed an application with the U.S. Food and Drug Administration (FDA) for emergency approval for their adapted vaccine for children aged 12 and over.
"Having rapidly scaled up production, we are in a position to immediately begin distribution of the bivalent Omicron BA.4/BA.5 boosters, if authorized, to help protect individuals and families as we prepare for potential fall and winter surges," Pfizer CEO Albert Bourla said.
Meanwhile, the companies' filing with the European Medicines Agency (EMA) is expected to be completed in the next few days. "Given the ongoing evolution of SARS-CoV-2 and its variants, it's of great importance that vaccines can be rapidly adapted to the major circulating Omicron lineages," Sahin emphasized.
Germany's Standing Commission on Vaccination (STIKO) currently only recommends vaccination against COVID-19 for children aged over five. In the age group up to 11, STIKO said healthy children should receive one dose, while those at an increased health risk or with high-risk-contact should receive two.
Of the 5.3 million children aged between five and 11 in Germany, 22.6 percent have had at least one dose of a vaccine against COVID-19. Meanwhile, of the 69.4 million adults in the country aged 18 or over, 85.3 percent are vaccinated against COVID-19, according to official figures.