US biotech Moderna said its Covid-19 vaccine had shown 94.5 per cent efficacy in clinical trials, in the second positive set of results for a potential coronavirus shot in the past eight days.

Last week, US giant Pfizer and Germany’s BioNTech also said their vaccine, which uses the same messenger RNA technology, was found to be more than 90 per cent effective.

The Moderna finding, hot on the heels of that breakthrough, will further boost optimism that the world can turn the corner in the management of the pandemic.

Stéphane Bancel, Moderna’s chief executive, said the moment was “pivotal”.

“This positive interim analysis from our phase-3 study has given us the first clinical validation that our vaccine can prevent Covid-19 disease, including severe disease,” he said.

Out of 30,000 participants in the clinical trials, 95 had been identified with confirmed cases of Covid-19, the company said. Among those infected, only five people had received the two-dose vaccine, known as mRNA-1273, while 90 had received a placebo.

Moderna said it intended to submit the vaccine for approval by the US Food and Drug Administration “in the coming weeks”, raising the prospect of at least two emergency-approved vaccines before the end of the year.

The 95 Covid-19 cases in the trial included older adults and 20 participants identifying as being from diverse communities, Moderna said. The interim analysis, the company noted, “suggests a broadly consistent safety and efficacy profile across all evaluated subgroups”.

Moderna also said it expected its vaccine to remain stable when refrigerated at between 2C and 8C for 30 days, significantly longer than the BioNTech-Pfizer shot, which can survive in a normal fridge for only up to five days and must otherwise be stored at minus 75C.

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Trudie Lang, from Oxford university’s Nuffield Department of Medicine, said it was “very good news indeed to see another vaccine coming through with similar efficacy results as were reported last week from Pfizer”. 

Prof Lang added that the early results suggested different age groups and diverse communities were represented in the protected group. “This is really encouraging and it further demonstrates that a vaccine for Covid is a real probability and that having more than one supplier should help assure better and more equitable global availability.”

Peter Openshaw, professor of experimental medicine at Imperial College London, noted that the trial included “many high-risk or elderly” people. “This gives us confidence that the results are relevant in the people who are most at risk of Covid-19 and in most need of the vaccines,” he added.

The European Medicines Agency said separately on Monday that it had begun a rolling, or accelerated, review of the vaccine. The UK’s sister agency, the Medicines and Healthcare products Regulatory Agency, is also conducting a rolling review of the shot. The US, Canada and Japan have all pre-booked orders, while the EU is negotiating a supply deal.

 

Via Financial Times