The American biotechnology company Moderna announced today that it will ask for the approval of its vaccine for Covid-19 for children aged 6 months to 6 years, after the tests showed that it is safe and causes a strong immune response.
Two doses of 25 micrograms in children of this age produced levels antibodies corresponding to those achieved with the two doses of 100 micrograms in young people aged 18-25 years.
Based on these data, Moderna announced that it will apply for approval of the vaccine to the US Food and Drug Administration (FDA) and the European Coreper, as well as to other regulatory authorities, in the coming weeks.
“The results are good news for parents of children under the age of six,” said Stephen Bancell, the company’s president and chief executive officer. “We now have clinical data on the performance of our vaccine from six-month-old children to older adults,” he added.
Moderna, however, noted a relatively low efficacy of the vaccine in tests performed during the pandemic wave due to the Omicron variant of the new coronavirus. In children from 6 months to 2 years the efficiency reached 43.7% and in the elderly at 37.5%. It is thus considering the possibility of proposing a third dose, in order to increase the effectiveness.
The trial involved 11,700 children in the United States and Canada, of whom 4,200 were two to six years old.
Last month, the FDA postponed the approval of the Pfizer-BioNTech vaccine for children under 5 years of age, estimating that additional data are needed regarding the third dose. The companies said they expect the data to be ready by April.
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