German biotechnology company BioNTech and U.S. company Pfizer said on Wednesday that their COVID-19 vaccine was 100-percent efficient in children aged between 12 and 15.
The BNT162b2 vaccine was “well tolerated” and elicited robust antibody responses that exceeded even those in an earlier trial of 16 to 25-year-olds, the two companies said in a joint statement.
A pivotal Phase 3 trial enrolled 2,260 participants in the United States, according to BioNTech and Pfizer.
According to the German government, COVID-19 vaccines would only be available for adults initially as not enough efficacy and safety studies have been conducted among children and adolescents.
BioNTech and Pfizer plan to submit their findings to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) “as soon as possible to request expansion of the Emergency Use Authorization (EUA) and EU (European Union) Conditional Marketing Authorization for BNT162b2,” the statement noted.
The two companies vaccinated the first group of healthy children in a global Phase 1/2/3 study last week to evaluate the safety, tolerability and immunogenicity of the COVID-19 vaccine in children aged between six months and 12 years.
Four vaccines have been approved in the EU to date, those produced by Pfizer/BioNTech, Moderna, AstraZeneca and, since March 11, Johnson & Johnson’s single-dose vaccine, which is expected to be available in Germany in limited quantities from mid-April.
After suspending use of the AstraZeneca vaccine in early March, Germany’s federal and state governments agreed on Tuesday that it should only be used for people over 60 years of age due to cases of cerebral vein thrombosis in connection with the immunization.
More than three months after the start of the coronavirus vaccination campaign in Germany, around 4.06 million people had been fully vaccinated by Tuesday, bringing the country’s vaccination rate to 4.9 percent, the Robert Koch Institute (RKI) said.