Moderna's Covid shot bolsters immune response in kids under 6

[NEW YORK] Moderna said its Covid-19 vaccine produced a strong immune response in children under 6 years old in initial results from a large final-stage trial that showed modest effectiveness in reducing Omicron infections.

Based on the positive results and the need for Covid shots for young children, Moderna will submit the data to regulators in the US and overseas as soon as possible, according to a statement. The company also said it would also apply for US clearance of its vaccine in 6- to 11-year-olds, after consultation with regulators.

The Biden administration has been frustrated in attempts to expedite Covid vaccines for young children as part of an effort to protect kids and their families. A two-dose formulation from partners Pfizer and BioNTech SE was slowed last month after it showed insufficient signs of effectiveness. In Moderna's study, almost 7,000 children ages 6 months through 5 years received 2 25-microgram doses of the vaccine - a quarter of the adult dose. Lab tests found the shots produced high levels of protective antibodies that were equivalent to those raised in previous trials of young adults, hitting the primary goal of the study.

Moderna also said the vaccine was modestly effective in preventing Covid cases in the study, which mostly took place during recent periods while Omicron was dominant. The shot was 43.7 per cent effective in kids 6 months to under 2 years old and 37.5 per cent effective in kids ages 2 through 5 years. The level of efficacy was consistent with the effect of 2 doses in adults as measured by studies during Omicron's dominance, Moderna said.

No new side effects or safety issues were identified in the study, the company said, and no cases of heart inflammation, a rare side effect linked to messenger RNA vaccines like Moderna's in older kids, were seen. Fever occurred in about 17 per cent of the youngest age group and 15 per cent of the slightly older ones.

The results "are good news for parents of children under 6 years of age," chief executive officer Stephane Bancel said in the statement.

Moderna said it is also preparing to evaluate the efficacy of a booster shot in kids of all ages. BLOOMBERG