Moderna Inc’s Kovid-19 Vaccine The company said in a statement Monday that a strong neutralizing antibody response occurred after two doses in children aged 6 to 12 years.
It said that the data showed that two 50 microgram doses of the vaccine, half the strength of the dose used in the vaccine given to adults, 28 days apart were generally well tolerated.
Most of the side effects were of mild or moderate severity, the company said. The most common solicited adverse events were fatigue, headache, fever and injection site pain.
“We are encouraged by the immunogenicity and safety profile of mRNA-1273 in children aged 6 to 12 years and are pleased that the study met its primary immunogenicity endpoints,” said Moderna Chief Executive Officer Stephen Bansel. “
“We look forward to filing with regulators globally and are committed to doing our part to help end the Covid-19 pandemic with a vaccine for adults and children of all ages,” Bansel said.
The company said it plans to submit the data to the US Food and Drug Administration (FDA), European Medicines Agency (EMA) and other global regulators in the near term.
Shares of Moderna gained 0.8% on Monday in premarket trading in New York. The stock has been under pressure of late, with a fall of nearly 24% over the past month.
An FDA panel from Pfizer Inc and BioNTech SE is expected to review data on the Covid-19 vaccine for 5- to 11-year-olds a day before the data is released from Moderna.
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