Moderna Covid vaccine highly effective and safe to use in children, new study finds

US biotech plans to submit data from latest trial to global regulators as it seeks authorisation for jab

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Moderna has said that its Covid-19 vaccine is highly effective and safe to use in children, paving the way for its authorisation among adolescents from next month.

A new trial conducted by the US biotech found that the vaccine was 100 per cent effective in preventing Covid-19 in people aged 12 to 18. No significant safety concerns were identified.

Moderna now plans to submit its findings to global regulators in early June, including the US Food and Drug Administration, as it seeks authorisation for its jab. The Pfizer vaccine has already been approved for use in children in the US.

“It is particularly exciting to see that the Moderna Covid-19 vaccine can prevent Sars-CoV-2 infection,” said CEO Stéphane Bancel. “We remain committed to doing our part to help end the Covid-19 pandemic.”

Some 3,732 adolescent participants were recruited for the trial and given either two doses of the Moderna vaccine or a placebo.

No cases of symptomatic Covid-19 were recorded among the vaccinated group 14 days after receiving a second dose, the company said, compared with four infections in the placebo.

Because the incidence rate of Covid-19 is lower in adolescents, a secondary case definition – as set by the US Centres for Disease Control and Prevention – was also used to include cases presenting with milder symptoms.

Using the CDC definition, which requires only one Covid-19 symptom and a saliva sample positive for Sars-CoV-2, the vaccine was judged to be 93 per cent efficacious.

Common reported side effects included headache, fatigue, chills and pain at the site of injection.

Moderna said it also plans to submit data from its TeenCOVE study to a peer-reviewed publication.

Last week, US research showed that the Moderna and Pfizer vaccines remain highly effective against two coronavirus variants first identified in India.

The lab-based study was carried out by the NYU Grossman School of Medicine and NYU Langone Centre and is considered preliminary because it has not yet been published in a journal.

“What we found is that the vaccine’s antibodies are a little bit weaker against the variants, but not enough that we think it would have much of an effect on the protective ability of the vaccines,” senior author Nathaniel Landau told AFP.

Meanwhile, adolescents in the US have already begun receiving Covid vaccinations. The Pfizer jab has been available under an emergency use authorisation for Americans as young as 16 since December.

And earlier this month, the vaccine was authorised for use in children aged 12 to 15. Last week, around 600,000 adolescents from this age group were vaccinated with the jab.

In March, the Pfizer vaccine was found to be safe to use and highly effective in children. Researchers reported “robust” antibody responses in vaccinated children aged 12 to 15. The jab was 100 per cent effective in preventing symptomatic Covid-19, Pfizer added.

In total, more than 4 million people under 17 had been vaccinated in the US as of 18 May.