Moderna's Covid vaccine to be fast-tracked through approval in UK

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

  • Means health officials will review data as it becomes available in real time
  • Normally takes years for vaccines to be green-lit for approval by the MHRA
  • Moderna’s jab candidate – called mRNA-1273 – one of the global frontrunners

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

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.

A coronavirus vaccine could trigger an immune response that lasts for much longer than the natural protection derived from fighting off the infection, a leading scientist has claimed amid fears immunity may only last a matter of months.

Professor Wendy Barclay, a virologist at Imperial College London, told MailOnline this was possible because the virus can switch off the immune system and stop the body from hunting out the pathogen — unlike vaccines which ‘won’t do that’. 

Her Imperial colleague Professor Paul Elliot also said immunity is likely to ‘fluctuate’ between people. He added: ‘For some viruses there’s lifelong immunity (but) for the coronaviruses that doesn’t seem to be the case.’ 

The Oxford vaccine — a front-runner in the race to find a jab to protect against the virus — uses proteins from the coronavirus that have been attached to a weakened common cold virus to trigger an immune response. 

It may be rolled out before the end of this year, depending on the outcome of Phase III clinical trials — the final stage of tests before a vaccine is approved by regulators.

It comes after a major Government-led study last night found levels of antibodies in the population have dropped 26 per cent in three months.

The REACT-2 project — which sends out tens of thousands of DIY blood tests to work out how much of the population has been infected — found 4.4 per cent of people in England in September had Covid-19 antibodies, proteins in the blood trained to fight off the disease. By comparison, the first round of the study in June found 6 per cent tested positive for the key agents against infection. 

The Imperial experts warned dropping levels of antibodies in the blood could be a warning sign of lower immunity, leaving survivors at risk of getting re-infected within just six months.

But experts have pointed out that the immune system also has T-cells in its arsenal. Studies on how long the disease-fighting cells persist after infection have not been published because the virus has only been known to science for less than a year.

And other scientists said it was possible that the body could still rapidly produce antibodies in the future, even if someone no longer tests positive for them. They said this may not protect them entirely but may lead to them enduring a milder illness.

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.

Race for a coronavirus vaccine: Nine candidates in final stage of clinical trials

As scientists race to develop a coronavirus vaccine to bring the world back to normal, MailOnline has taken a look at the prospective candidates.

Vaccine trials were halted on Wednesday but it may still be ready this year

The Oxford Vaccine

When will it be ready?: The end of 2020/ early 2021. Despite the trials being suspended on Wednesday, its developers and Number 10 remain confident that the vaccine could be ready for use either at the end of this year or early next year. They say a pause is common in trials, and that its development was also stopped in July after a suspected side-effect was detected.

How does it work?: The vaccine works by exposing participants to a weakened common cold adenovirus which has had proteins from the coronavirus SARS-CoV-2 attached to its surface. The idea is that the exposure allows the immune system to build an immune response, meaning they are protected if they are infected by the real virus. 

Has the UK secured doses?: Yes, 100 million. The US has secured a further 300 million doses, along with several other countries. These will be rolled out in an equitable manner.

How much does it cost?: AstraZeneca, which is developing the vaccine with Oxford University, has said it will not profit from the it, but may earn extra royalties if the coronavirus becomes an endemic infection like flu. The US has spent $1.2 billion (£930 million) securing doses, meaning they are worth $4 (£3.10) each.

Biontech, Germany

Biontech vaccine may be ready this year

When will it be ready?: At the end of this year, say researchers. The vaccine is being developed by a German company in partnership with American drugmaker Pfizer. It is recruiting 30,000 volunteers to its stage three trials.

How does it work?: This is an RNA vaccine, a type that has never been approved by regulators before. It will involve injecting a fragment of genetic material from coronavirus into participants. This will expose their immune systems to a weakened version of the virus and, hopefully, trigger a response which will protect them from the real virus.

Has the UK secured doses?: Yes, 30 million doses. The US has also ordered 100 million doses. 

Price?: The US is paying $2 billion (£1.5 billion) for its doses, or about $20 (£15) a jab.

Moderna, US

Moderna vaccine entered human trials

When will it be ready?: Very end of this year or next year. The vaccine has recruited 20,000 participants for its stage three trials. Providing no potential side effects are observed, it will then go through to a second test on more patients next month. This means it could be available by the end of 2020.

How does it work?: This is an RNA-based vaccine, similar to the one being developed by Biontech. 

Has the UK secured doses?: No. Reports suggest the UK’s task force has not managed to secure any doses of this vaccine.

How much does it cost?: The US has ordered 100 million doses at a price of $1.5 billion (£1.1 billion). This means one jab costs $32 (£25).

Sanofi and GlaxoSmithKline, UK and France

Sanofi vaccine won’t be available this year

When will it be ready?: First half of 2021. The vaccine entered phase two clinical trials in September, involving 440 adults. It will reach phase three trials in December this year. There may be setbacks along the way, meaning the vaccine could take longer to develop. 

How does it work?: Participants are injected with DNA coding for the antigens of the coronavirus and a chemical which makes it more potent. It is hoped this will trigger an immune response.

Has the UK secured doses?: Yes. Up to 60 million will be supplied should the vaccine be shown to work.

How much does it cost?: Unknown. This information has not been provided.

Sputnik V, Russia

Sputnik V is safe, according to Kremlin, but it has been criticised by scientists

When will it be ready?: ‘Imminently’. The Russian medical research institute and Russian defence ministry have developed this vaccine. But it has faced serious criticism both inside and outside Russia because results from its human trials are yet to be published. It also hasn’t cleared large human trials, with researchers only launching one involving 40,000 volunteers on 26 August. Scientists say the vaccine has been rushed without proper checks, and could pose a risk to those taking it. The Kremlin began appealing for volunteers for the vaccine this week after a first batch was produced, according to the TASS news agency.

How does it work?: The Russian vaccine works by carrying a piece of the coronavirus genetic code into a participant via another virus. It is hoped this will produce an immune response.

Has the UK secured doses?: No. Countries lining up to try the vaccine include Mexico, which has secured 32 million doses, and Kazakhstan, which is set to buy two million.

How much does it cost?: The price of the vaccine is yet to be revealed.

Sinovac, China

It is not clear when the Sinovac vaccine will be available

When will it be ready?: Unknown. The vaccine entered final-stage trials in Brazil in July, and then in Indonesia in August. Results show that while younger and middle-aged people produced antibodies, older people had a weaker immune response. The vaccine was given emergency approval for limited use in July, reports suggest, although it appears to still be subject to testing. It was previously reported as being second only to the Oxford vaccine, but its complete test results are yet to be published. It is one of four vaccine candidates in development in China.

How does it work?: It involves injecting patients with an inactivated form of the virus, prompting their immune systems to develop a response. 

Has the UK secured doses?: Unknown. Reports suggest no doses have been secured.

How much does it cost?: China is yet to publish this information.

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