Moderna will submit their coronavirus vaccine for emergency approval

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Moderna will today submit its Covid vaccine for emergency approval in the US and Europe, after the final analysis of its last-stage trial showed that the jab is 94.1 per cent effective at preventing infection.

Results from the Massachusetts-based company’s stage three trials mark a landmark success for the vaccine, with the firm’s chief executive Stephane Bancel claiming it could ‘change the course of this pandemic’.

Only 11 volunteers who received the jab tested positive for the coronavirus. For comparison, there were 185 cases in the equally-sized placebo group. More than 30,000 participants have taken part in the study since it began several months ago.

Moderna claimed the vaccine’s efficacy against preventing severe Covid-19 was 100 per cent, with none of the 30 patients deemed to be critically-ill getting the jab, which needs to be taken in two shots. The firm also said there were no safety concerns with the jab, and that the vaccine worked in all age groups.

Experts today heralded the results as ‘very good news’. Britain has already bought 7million doses of Moderna’s vaccine, with officials left scrambling to secure the jab when promising preliminary results came out a fortnight ago.

Matt Hancock has already admitted it won’t be available in the UK until at least March because the firm needs to drastically ramp up its supply chain. But the US is expected to get its hands on 20million doses before the New Year.

The Food and Drug Administration (FDA) in the US and European Medicines Agency (EMA) will today be sent the results along with a request for emergency approval, with a meeting with US regulators expected in less than three weeks on December 17.

Regulators in the UK, the Medicines and Healthcare products Regulatory Agency (MHRA), will also be handed the figures. They have been running a ‘rolling review’ and plan to give a verdict in the ‘shortest time possible’ – but it can take days for it to be green-lighted.

Britain’s drug watchdog is already assessing a rival vaccine made by Pfizer and German firm BioNTech. Officials have bought 40million doses of it – and hope a quarter of the supply will be available by Christmas, which is enough to vaccinate around vulnerable Britons.

The Health Secretary has already said the NHS would be ready to begin a mass-vaccination programme from tomorrow, with the Army involved in the mammoth operation that will be carried out in GP surgeries as well as empty Nightingale Hospitals.

But with no Covid vaccine yet approved, it means the first step of getting Britain back to normal life won’t begin for at least several days. Health sources have pointed to both December 7 and December 9 as being the potential day for the colossal scheme will begin.

Moderna also said their phase 3 trials showed that the vaccine was effective across all age groups, with 33 of the 196 infections recorded in people aged over 65. It is not clear whether any of these individuals had received the vaccine.

They also said no concerns were raised over its effect on non-white ethnic groups, after 42 people from diverse backgrounds were included in the study.

‘This positive primary analysis confirms the ability of our vaccine to prevent COVID-19 disease with 94.1 per cent efficacy and importantly, the ability to prevent severe COVID-19 disease,’ said Moderna’s chief executive officer Stephane Bancel.

‘We believe that our vaccine will provide a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalisations and death.’ 

The landmark figures represent just a 0.4 per cent drop in the reported efficacy of the vaccine on November 16, which was based on the first 95 infections in the study where five were in people who had received the jab.

Dr Stephen Evans, an epidemiologist at the University of Southampton, said the two figures were ‘essentially identical’ and showed the jab was ‘very good’ at preventing severe as well as mild Covid-19 infections.

‘These results are essentially identical to those announced on November 16, with a few more details,’ he said. ‘In my comment on November 16 I noted that it was important not to pay too much attention to the exact percentage value of the efficacy. 

‘While the best estimate is 94.1 per cent against all Covid-19 disease, the statistical uncertainty in this is such that the data are compatible with a true efficacy of about 87 per cent. This is of course, still a very good efficacy. 

‘Similarly, the 100 per cent efficacy against more severe disease is compatible with an efficacy of 90 per cent again, this is very good and is some evidence that severe as well as mild disease is prevented.’

He added: ‘There seems to be no evidence that efficacy is worse at older ages, though with only a total of 33 aged 65 and over, the uncertainty in these results on their own is considerable.’   

Dr Alexander Edwards, an immunologist at the University of Reading, said the results were ‘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 grows, confidence grows that this amazing protection will be maintained in a product that can be rolled out to protect the public.

‘The most significant part of this news is that we should remember RNA vaccines are really new, and potentially have really significant advantages over some other older types of vaccines. Moderna have also recently announced improvements to the product stability, allowing normal fridge distribution for up to 30 days, and frozen storage in normal (-20) freezers, which will help with logistics.’

Dr Michael Head, senior researcher in global health at the University of Southampton, said: ‘These revised findings are very much in line with those previously announced by Moderna. 

‘This is essentially good news, in that there continues to be a very high level of observed effectiveness, with this effectiveness was consistent across older populations and ethnic minorities. 

‘There were also no serious adverse events caused by the vaccine. We must of course reserve a little caution as we await the final published results, but for now we can retain the existing optimism that this new generation of vaccines may be deployed in the near future.’

Professor Azra Ghani, chair in infectious disease epidemiology at Imperial College London, said the results demonstrated a ‘high efficacy’ of the vaccine.

‘The results have been tested across a diverse population and are reported as being consistent in different sub-groups although these numbers are not given and we should wait for further information in the scientific article that is being prepared. 

‘Although not yet reported, the trial includes a secondary endpoint of asymptomatic infection – efficacy against this would be very welcome as it would give the first indication of the broader indirect impact that widespread vaccination could have in reducing onward spread.’

Over the weekend the UK announced it had secured a further two million doses of the jab after the Government said it had made business minister Nadhim Zahawi responsible for the national deployment of jabs. 

Vaccines in the UK would normally be authorised by the EMA until the end of the Brexit transition period this year. But the MHRA can still give the green light to jabs in cases of urgent public need.

On November 20 Pfizer said it was submitting a request for emergency authorisation for its vaccine to the FDA.

The American pharmaceutical giant – most famous for making viagra – claims its jab is 95 per cent effective and works in older people who are most vulnerable to the virus.

The US Food and Drug Administration (FDA) have been doing a ‘rolling review’ of the vaccine. It means the approval process could be wrapped up in a matter of days and the high risk people could start getting their hands on it by the end of the year.

But officials still face the mammoth task of transporting and storing the jab, which may need expensive specialist freezers and huge supplies of dry ice to keep it at the required -70°C (-94°F).

Pfizer and BioNTech, the German firm involved in making the jab, have not yet submitted its vaccine for approval from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).

But the companies send they intend to in the coming days. If the vaccine is approved in the US, it suggests a similar roll out could soon take place in Britain.

Oxford University’s vaccine results have been accused of being based on ‘shaky science’ after it emerged their efficacy figure – of 70 per cent effectiveness – was based on an amalgamation of the volunteers who received a half-dose and a full-dose and those who received two full doses.

Hilda Bastian, an accomplished scientist turned writer who blogs for the British Medical Journal (BMJ), claims data from the Oxford trials has been ‘patched together’ and excludes results from the groups most vulnerable to Covid.

In a piece for Wired, the Australian said the critical flaw was that a dosing error led to a huge boost in the success rate – experts accidentally gave some volunteers one-and-a-half doses of the jab rather than two full doses that people are meant to get.

The trials were also never designed to test this hypothesis, which leaves the door open to subconscious biases creeping into the study methods or data, making the study less rigorous.

She wrote: ‘This week’s ‘promising’ results are nothing like the others that we’ve been hearing about in November [the studies the results are based on were less rigorous] — and the claims that have been drawn from them are based on very shaky science.

‘The problems start with the fact that Monday’s announcement did not present results from a single, large-scale, Phase 3 clinical trial, as was the case for earlier bulletins about the BNT-Pfizer and Moderna vaccines…

‘The fact that they may have had to combine data from two trials in order to get a strong enough result raises the first red flag…. As far as we know, some of this analysis could hinge on data from just a few sick people.’ 

AstraZeneca’s executive president for research, Mene Pangalos, dismissed the criticism of the half-dose and full-dose results last week, saying the ‘mistake is actually irrelevant’.

He said: ‘Whichever way you cut the data – even if you only believe the full-dose, full-dose data… We still have efficacy that meets the thresholds for approval with a vaccine that’s over 60 per cent effective.

‘I’m not going to pretend it’s not an interesting result, because it is – but I definitely don’t understand it and I don’t think any of us do.’