Moderna seeks regulatory approval for Covid vaccine as UK orders 2 million more doses

Moderna has announced it is requesting market approval from European and American regulators for its coronavirus vaccine, as the UK said it has secured an additional 2 million doses of the promising candidate.

The Boston-based biotech said on Monday it will present data from its large-scale phase 3 trial, which involved more than 30,000 volunteers, to the US Food and Drug Administration to secure emergency use authorisation (EUA) for its vaccine.

If approval is granted, doses could be made available to the American public towards the end of December.

Moderna said it is also applying for market authorisation from the European Medicine Agency (EMA), with up to 160 million shots of the two-dose vaccine set to be shared between EU member states throughout next year.

The UK government, meanwhile, has increased its share of doses to 7 million – enough to inoculate 3.5 million Britons.

The jab, expected to be rolled out next spring, must first be approved by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), which is currently carrying out a rolling review of the candidate.

The business secretary, Alok Sharma, said: “It is essential that we continue to bolster our portfolio of vaccine candidates to ensure we’re in the best possible position to protect the public once we see that breakthrough.

“The UK was one of the first countries in Europe to sign a deal with Moderna, and I’m delighted we have been able to secure a further 2 million doses of their promising candidate for the British public.”

The new deal comes as Moderna released new analysis of its vaccine on Monday, after first revealing on 16 November that it was almost 95 per cent effective.

A total of 196 infections have now been recorded among trial participants, enabling the biotech to provide a clearer verdict on the effectiveness and safety of its candidate.

Of those volunteers who tested positive for Covid-19, only 11 had been given the vaccine. The remaining 185 cases were observed in the placebo group, giving the Moderna jab an efficacious rate of 94.1 per cent.

Modern said efficacy was consistent across age, gender and race demographics, and has been shown to be 100 per cent effective in preventing severe Covid-19.

The vaccine, named mRNA-1273, continues to be well tolerated and no serious safety concerns have been identified to date, the company added.

Dr Alexander Edwards, an associate professor in biomedical technology at the University of Reading, described the latest announcement as “great news indeed”.

“The more trial data that we have, the greater confidence we have that vaccines can be used to blunt the human cost of Covid-19,” he said.

“As the numbers of cases reported [among trial volunteers] grows, confidence grows that this amazing protection will be maintained in a product that can be rolled out to protect the public.”

Dr Michael Head, a senior research fellow in global health at the University of Southampton, said: “There continues to be a very high level of observed effectiveness, with this effectiveness consistent across older populations and ethnic minorities.”

Moderna intends to manufacture between 500 million and 1 billion doses globally throughout 2021.

The biotech company has said it expects to provide the US government, which helped to fund research into the vaccine, with 20 million doses by the end of the year.

It is understood that Moderna does not currently have an advanced European supply chain in place, but is currently planning to “scale up” its capacity to deliver supplies to the continent throughout the early months of next year.

Downing Street has said the UK’s doses will be made available in spring 2021.

“Every week we are getting more positive news about the range of vaccines in development, and thanks to the work of our taskforce the UK has pre-ordered more hundreds of millions of doses from those companies most advanced in their work,” said health secretary Matt Hancock.

“This includes buying a further 2 million doses of Moderna’s vaccine, on top of the 5 million we’ve already secured.

“With a wide range of vaccine candidates in our portfolio, we stand ready to deploy a vaccine should they receive approval from our medicines regulator, starting with those who will benefit most.”

No 10 has now agreed deals for seven different vaccine candidates, and has access to 357 million doses — the majority of which will be provided by AstraZeneca.

The government initially overlooked the Moderna jab before announcing earlier this month that a deal for five million doses had been reached with the American company.

Moderna said its candidate, named mRNA-1273, can be stored at fridge temperature for 30 days, or -20C for up to six months.

This will make the vaccine more accessible for the global market, unlike the Pfizer vaccine, which needs to be stored and transported at -70C, and can only survive in fridge conditions for five days.

The MHRA will carefully review Moderna’s safety, quality and effectiveness data, once it has all been submitted, to determine how it protects people from Covid-19 and the level of protection it provides.

The Moderna jab uses messenger RNA (mRNA) technology, which relies on synthetically-produced genetic coding to generate an immune response in humans, and is produced at a scale more rapidly than conventional vaccines.

A number of other vaccines that use the same platform are also in development, including the British jab being developed by Imperial College London, sparking hope that these candidates will be equally effective.