Coronavirus vaccine made by US pharma giant Moderna could be fast-tracked through approval process in UK to get jab to most vulnerable as soon as it's proven to be safe

 The UK's drugs watchdog has started the rolling review process of a coronavirus vaccine being developed by US pharmaceutical giant Moderna, the firm announced.

This means health officials will review data as it becomes available from ongoing studies before a formal application for approval is submitted.

It normally takes years for vaccines to be green-lit by the Medicines and Healthcare products Regulatory Agency (MHRA) as it pores over data to make sure jabs will be safe and effective to dish out to millions of Brits. 

But, by reviewing the findings in real-time, the regulator can fast-track it through the process.

Moderna's vaccine candidate - called mRNA-1273 - is one of the global frontrunners, along with a jab being developed by Oxford University. 

The UK Government has announced frontline health and care workers, and those at an increased risk of serious disease, including elderly care homes residents, will be first in line to get access to a vaccine.

On Monday, Health Secretary Matt Hancock refused to rule out getting the vaccine to these groups before Christmas. Though he admitted the likely timeframe was early next year.      

The UK's drugs watchdog has started the rolling review process of a coronavirus vaccine being developed by US pharmaceutical giant Moderna

The UK's drugs watchdog has started the rolling review process of a coronavirus vaccine being developed by US pharmaceutical giant Moderna

Stephane Bancel, chief executive officer of Moderna, said: 'We appreciate the collaboration we have had to date with regulatory authorities around the world, and the process established by the MHRA to address this ongoing public health emergency.

'This is a great example of what's being done to support efforts to deliver a safe and effective vaccine to UK citizens as safely and efficiently as possible.'

Interim analysis of phase one of the trial showed the vaccine, mRNA-1273, was generally well-tolerated across all age groups and induced rapid and strong immune responses against SARS-CoV-2, the virus which causes Covid-19.

The vaccine is in phase three trials with 30,000 participants to assess whether it works in real-world scenarios. 

In these studies, people are given a dose then researchers wait for them to get infected naturally and check if the vaccine was successful in preventing illness.

Dr Christian Schneider, interim chief scientific officer at MHRA, said: 'We are ready to prioritise and carry out a rolling review of data for candidate Covid-19 vaccines.

'We invite any company to submit licence applications for Covid-19 vaccines they anticipate requiring approval in the early part of 2021 to us as soon as they have relevant information.'

Stephen Evans, professor of pharmacoepidemiology at London School of Hygiene and Tropical Medicine, said: 'Most major regulators have said that they will start to assess early data from the first phases of development of a vaccine.

'Though assessment of the early data has begun, it does not guarantee that this or any other vaccine will be available in 2020, but if the phase three results are good, then this unusual if not unprecedented approach will allow the vaccine to be available more quickly.

'It is entirely possible that other companies have been doing the same thing, either through the UK or other countries' regulatory system, but they have possibly not felt it necessary to announce it publicly.'

It comes after UK Health Secretary Matt Hancock said on Monday that his 'central expectation' is that the majority of the roll-out of a vaccine could be under way in the first half of 2021. 

But he refused to rule out any possibility that people could start receiving a vaccine this side of Christmas.

Mr Hancock told BBC Radio 4's Today Programme that the vaccine programme was 'progressing well'.

Asked how soon NHS staff could be injected with a vaccine, he said: 'Well, we're not there yet.

'The vaccine programme is progressing well. We're in very close contact with the leading candidates.

'On my central expectation, I would expect the bulk of the roll-out to be in the first half of next year.'

Asked if there could be some this year, he said: 'Well, I don't rule that out, but that is not my central expectation.'

Clinical trials for Covid-19 vaccines are ongoing. Some have speculated that two vaccine candidates will report data to regulators this year.

When asked about reports that hospitals are preparing to vaccinate staff, Mr Hancock added: 'We want to be ready in case everything goes perfectly.'

'But it's not my central expectation that we'll be doing that this year. The true answer to your question is, we don't know.

'We don't know when the first vaccine will be available but my central expectation is in the first half of next year.

'Nevertheless, we're doing the preparatory work now for how that will be rolled out - the Joint Committee on Vaccinations and Immunisations has set out the order of priority; and we're doing the logistical work - led by the NHS working with the armed services who are playing an important role in the logistics of it to ensure that we have that rollout programme ready.

'But, you know, preparing for a rollout and actually having the stuff to roll out are two different things.

'It's obviously something that we want to happen as soon as safely can be done. And as fast as safely can be done, but we are not there yet.'

Oxford University's coronavirus vaccine candidate - which is being mass-manufactured by UK pharmaceutical firm AstraZeneca - is also anticipated to be ready for the end of the year or early 2021.

Trial results show the vaccine prompts the release of antibodies and T-cells, which fight Covid-19, in over-55s.

It, like Moderna's jab, is in phase three trials on tens of thousands of people around the world. Its creators expect the preliminary results from these studies within the coming weeks.

Powered by Blogger.