Moderna said it would seek emergency use authorisation for its Covid-19 vaccine for children under the age of six in the US and EU in coming weeks after interim results from its clinical trial showed the jab is safe and produces a positive immune response.
But the results from the late-stage study released on Wednesday by the US drugmaker show the child-sized jab — about a quarter the size of an adult dose — was only modestly effective at preventing infection with the Omicron variant.
The vaccine was 43.7 per cent effective at preventing infection in children aged six months to two years and 37.5 per cent effective in preventing infection in children aged two to under six — a result that Moderna said was consistent with data from clinical trials in adults.
Moderna said the study of 6,700 children under six showed they produced a similar level of neutralising antibodies as young adults, an immune response that protects against infection and severe disease.
Stéphane Bancel, chief executive of Moderna, said the results from the study were good news for parents of young children.
“Given the need for a vaccine against Covid-19 in infants and young children, we are working with the US Food and Drug Administration and regulators globally to submit these data as soon as possible,” he said.
Moderna said its jabs for children under six, which are administered with a four-week interval, were generally well tolerated and no safety concerns were identified. No cases of the rare heart condition called myocarditis were reported in the study, said the company.
If it is approved by regulators, Moderna’s vaccine would become the first Covid shot available to babies, toddlers and pre-school children in Europe and the US. Pfizer delayed an application for emergency authorisation of a vaccine for children under five last month over concerns its jab did not produce a strong enough immune response.
However, some epidemiologists said the relatively low efficacy against Covid infections could raise questions over the vaccine’s usefulness in young children.
“For a vaccine with about 40 per cent efficacy, we should see strong evidence of either direct or population health benefit, which I’m not sure is the case among young children as cases stabilise,” said David Dowdy, an epidemiologist at Johns Hopkins University.
“While expanding access to Covid vaccines should be a high priority, we shouldn’t lower our standards just because this is Covid-19,” he said.
Health experts say vaccinating young children can better protect them from serious illness while helping to reduce transmission of the virus to teachers, parents and the wider community. But there have been fewer Covid-related deaths among Americans under the age of 18 — totalling 1,078 since the start of the pandemic — than the adult population and vaccine hesitancy remains high among parents.
Just one in five parents of young children say they will get their child vaccinated as soon as jabs are authorised, according to a poll by the Kaiser Family Foundation.
Only a handful of countries worldwide, including China and Cuba, have so far begun administering Covid vaccines to children under 6.
Source: Financial Times
