Modera says its Covid-19 vaccine safe for kids aged 6-11; to submit data to regulators soon
PremiumModerna said the participants in the trial received two 50 microgram doses -- half the dose initially given to adults -- spaced 28 days apart
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Moderna Inc.’s Covid-19 vaccine generated a robust neutralizing antibody response after two doses in children aged 6 to under 12 years, said the company in a statement on Monday.
It said the data showed two 50 microgram doses of the vaccine, half the strength of the doses used in the vaccine given to adults, given 28 days apart was generally well-tolerated.
Moderna said majority of the side effects in the trial, which had 4,753 participants, were mild or moderate in severity, with fatigue, headache, fever and injection site pain the most common.
“We are encouraged by the immunogenicity and safety profile of mRNA-1273 in children aged 6 to under 12 years and are pleased that the study met its primary immunogenicity endpoints," said Stéphane Bancel, the chief executive officer of Moderna.
“We look forward to filing with regulators globally and remain committed to doing our part to help end the Covid-19 pandemic with a vaccine for adults and children of all ages," added Bancel.
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% in premarket trading in New York on Monday. The stock had been under pressure of late, sliding by about 24% over the past month.
The release of data from Moderna comes a day before an FDA panel is expected to review data on the Covid-19 vaccine for 5- to 11-year-olds from Pfizer Inc. and BioNTech SE.
The Moderna Covid-19 vaccine has been authorized for adults over the age of 18 years, and recently gained clearance for a third dose in some Americans.
Approval in India
Moderna had in June the first messenger RNA jab and the fourth overall to be authorized for emergency use in India as the Drugs Controller General of India granted its local partner Cipla Ltd an import licence.
It was the first foreign vaccine to get approval under the government’s revised norms for accelerated regulatory clearance.
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