US okays Moderna's 'next generation' Covid-19 vaccine

Moderna, a vaccine manufacturer, said late last week that the FDA has authorised its next-generation COVID-19 vaccine.

The new vaccine, mNexspike (mRNA-1283), is a step toward next-generation coronavirus vaccines. It’s made in a way that allows for a lower dose, a fifth of the dose of its current COVID-19 vaccine, Spikevax (mRNA-1273) by refining its immune target.

Moderna’s approval was based on a phase 3 randomised controlled trial involving 11,400 participants ages 12 and older. The trial found that a 10-microgram (μg) dose of mNexspike demonstrated a 9.3% higher relative vaccine efficacy (rVE) compared to a 50-μg dose of Spikevax, with a 13.5% higher rVE in adults ages 65 and older. The two vaccinations have identical safety profiles, according to the manufacturer.

The approval “adds an important new tool to help protect people at high risk of severe disease from COVID-19,” Stephane Bancel, Moderna’s CEO, said in a statement Saturday.

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The Food and Drug Administration approved the new vaccine for use in all adults 65 and older, and for people age 12 to 64 who have a least one health condition that puts them at increased risk from the coronavirus.

That’s the same limit that the FDA set in licensing another COVID-19 vaccine option from competitor Novavax.

Those restrictions are a departure from how the US has handled COVID-19 vaccines until now, reflecting scepticism about vaccines from Health Secretary Robert F. Kennedy Jr. and other Trump officials.

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Moderna’s existing vaccine doesn’t face those limits and has long been used for anyone ages 6 months and older. The company said it expected to offer both options this fall.

The news came just days after the Trump administration cancelled funding for Moderna to develop a vaccine against potential pandemic flu viruses, including the H5N1 bird flu, despite promising early study results.