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 has become the second high-profile company to confirm interim results of a clinical trial of its coronavirus vaccine, claiming that the jab is nearly 95 per cent effective
Moderna’s vaccine works in the same way as the one developed by Pfizer and BioNTech, by using genetic material called RNA from the coronavirus to trick the body into making the ‘spike’ proteins that the virus uses to latch onto cells inside the body
CELEBRITIES TO HELP PROMOTE COVID-19 VACCINE
Celebrities and social media influencers will be enlisted to help promote the
Health bosses and ministers are in talks with ‘responsible’ high-profile stars to post positive messages about the jab.
No celebrities have been confirmed but officials suggest Marcus Rashford, the England footballer campaigning to end child hunger, and members of the
There are fears that the torrent of anti-vax content on social media sites could lead to a low take-up of the vaccine, affecting the chances of achieving herd immunity.
A recent survey in the US and UK found that public willingness to take a Covid vaccine fell by 6.4 per cent after reading anti-vax posts.
Under the plans, well-known television doctors will be enlisted, as well as figures with large following on social media, the Guardian reported.
Religious and community leaders are also being consulted in order to allay possible fears over the vaccine among black, Asian and ethnic minorities.
The Government refused to provide details but a source said officials are working closely with Public Health England and NHS England and Improvement ‘to provide authoritative information to the public’.
The Army has already mobilised an ‘information warfare’ unit to fight anti-vax propaganda.
Soldiers from the defence cultural specialist unit, launched in Afghanistan in 2010, are analysing how Britons are being targeted online.
The troops, who belong to the 77th Brigade, are sizing up the level of vaccine-related disinformation from hostile states such as Russia, according to The Sunday Times.
The mass rollout of Covid-19 vaccine will transform the UK into a ‘whole new world’ by the spring, Foreign Secretary Dominic Raab said yesterday.
‘The vaccine will [by then] have been distributed to key workers and the most vulnerable, particularly by age,’ he said.
No10 hastily ordered 5million doses of Moderna’s vaccine in mid-November, when early results of the phase three trial were published. Another 2million doses were secured at the weekend.
But it has been claimed that the UK could end up paying more than twice as much as the US because of the delay in securing the jab.
The deal is expected to cost the UK between £24 ($32) and £28 ($37) per dose, according to reports. The US, which pre-ordered the jab months ago, will pay just $15 (£11.32).
For comparison, the Pfizer jab is expected to cost $19.50 (£14.79) per dose, based on a deal signed with America.
Moderna’s may be cheaper to distribute, however, because it can be kept in a fridge for up to a month and transported in normal freezers at -20°C (-4°F), unlike Pfizer’s which requires specialist freezers to store it at -70°C (-94°F).
Moderna’s vaccine works in the same way as Pfizer’s, by using genetic material called RNA from the coronavirus to trick the body into making the ‘spike’ proteins that the virus uses to latch onto cells inside the body.
But it is different to Oxford University’s vaccine which uses Covid-19 spike proteins – that allow the virus to infect cells – attached to a weakened cold virus to trigger an immune response.
The UK has ordered 100million doses of this shot, which is being reviewed by the MHRA after this was requested by ministers.
The jab may, however, be only 60 per cent effective. In early trials it was administered in a regimen of two full doses, giving the lower efficacy figure.
There were suggestions that it could be 90 per cent effective if given as a half-dose and then a full-dose, but this was dismissed as ‘shaky science’ after it was admitted the extra doses had been given in error.
Moderna’s announcement follows hot on the heels of Pfizer and BioNTech, who said ten days ago they had also submitted their vaccine – which was up to 95 per cent effective in clinical trials – for emergency approval by US regulators.
An emergency US approval for their vaccine could come as soon as December 8 to 10, with shipments in the US alone starting 24 hours after the announcement according to US media.
The MHRA also has this vaccine under rolling review, and could approve it as soon as December 7, reports the Financial Times, which would make the UK the first western country to approve the jab.
It comes after Public Health England (PHE) suggested that the different vaccines could be used interchangeably if giving two doses of the same vaccine was not possible.
Their guidance, published Friday, claims it is ‘reasonable’ for healthcare professionals to offer a different vaccine as the second dose if the same is not available or if the patient does not know what vaccine they initially received.
But they stressed there is ‘no evidence’ on mixing vaccines, meaning every effort should be made to stop this from happening, reports
It was suggested today the NHS could recruit celebrities to encourage people to get vaccinated against the virus, over fears a torrent of anti-vaccine posts on social media could put people off from getting the life-saving doses.
Health bosses and ministers are in talks with ‘responsible’ high-profile stars to post positive messages about the jab, reports the Daily Mail.
No celebrities have been confirmed but officials suggest Marcus Rashford, the England footballer campaigning to end child hunger, and members of the
Moderna said today 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. One person involved in the study who had not received the vaccine died from the virus.
‘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.’
WHAT DO WE KNOW ABOUT THE MODERNA VACCINE?
How was the trial run and what are the results?
More than 30,000 people in the US took part from a wide range of age groups and ethnic backgrounds.
Two doses were given 28 days apart so researchers could evaluate safety and any reaction to the vaccine.
The analysis was based on 196 cases, of which 185 cases of Covid-19 were observed in the placebo group versus 11 cases observed in the active vaccine group.
Moderna also released data relating to severe cases.
All 30 severe cases occurred in the placebo group and none in the group which had received the vaccine, known currently as mRNA-1273.
What happens now?
Moderna has applied to US and European regulators for approval.
The company said on Monday that it would request emergency use authorisation from the US Food and Drug Administration (FDA).
It also said that it would apply for conditional marketing authorisation with the European Medicines Agency (EMA) and progress with the rolling reviews, which have already been initiated with international regulatory agencies.
Will people in the UK get the vaccine?
The UK Government has secured seven million doses of the jab – enough to vaccinate around 3.5 million people.
The vaccine has yet to be approved by the Medicines and Healthcare products Regulatory Agency (MHRA), but doses could begin being delivered next spring if it meets the standards.
How does the vaccine work?
The Moderna jab is a messenger RNA (mRNA) vaccine.
Conventional vaccines are produced using weakened forms of the virus but mRNAs use only the virus’s genetic code.
An mRNA vaccine is injected into the body, where it enters cells and tells them to create antigens.
These antigens are recognised by the immune system and prepare it to fight coronavirus.
No actual virus is needed to create an mRNA vaccine. This means the rate at which the vaccine can be produced is accelerated.
But is the vaccine safe?
Moderna says the vaccine continues to be generally well tolerated, with no serious safety concerns identified to date .
Severe events after the first dose included injection-site pain and after the second dose included fatigue, myalgia (muscle pain), arthralgia (joint pain), headache, other pain and redness at the injection site.
But these were generally short-lived.
Is the Moderna vaccine better than those being developed by Pfizer/BioNTech or Oxford and AstraZeneca?
The UK has placed orders for 100 million doses of the Oxford vaccine – enough to vaccinate most of the population – with rollout expected in the coming weeks if the jab is approved by the MHRA.
Oxford data indicates the vaccine has 62 per cent efficacy when one full dose is given followed by another full dose, but when people were given a half dose followed by a full dose at least a month later, its efficacy rose to 90 per cent.
The combined analysis from both dosing regimes resulted in an average efficacy of 70.4 per cent.
The Government also has orders for 40 million doses of the jab from Pfizer and BioNTech, which has been shown to be 95 per cent effective.
However, it is difficult to say whether one option is better than the other, as each trial has had different protocols and they cannot be directly compared.
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.’
Hilda Bastian, an accomplished Australian scientist turned writer who first pointed out the flaws with the Oxford vaccine results, questioned Moderna’s claim the vaccine was effective acros all age groups.
‘Efficacy was consistent acros age, ethnicity and gender but the press release doesn’t indicate how strong that evidence is,’ she tweeted.
‘As with the other releases, no real data on adverse effects.’
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.
HOW DO THE OXFORD, MODERNA AND PFIZER/BIONTECH VACCINES COMPARE?
Moderna and Pfizer/BioNTech have both released interim results of the final stage clinical trials of their vaccines, with both suggesting they are extremely effective.
Oxford University has published the findings from its second phase, which show the jab provokes an immune response and is safe to use – it is not yet clear how well it protects against coronavirus in the real world.
Here’s how they compare:
PFIZER (US) & BIONTECH (DE)
OXFORD UNIVERSITY (UK)
How it works:
mRNA vaccine – Genetic material from coronavirus is injected to trick immune system into making ‘spike’ proteins and learning how to attack them.
mRNA vaccine – both Moderna’s and Pfizer and BioNTech’s vaccines work in the same way.
Recombinant viral vector vaccine – a harmless cold virus taken from chimpanzees was edited to produce the ‘spike’ proteins and look like the coronavirus.
How well does it work?
94.5% effective (90 positive in placebo group, 5 positive in vaccine group) .
95% effective (160 positive in placebo group, 8 positive in vaccine group).
62% – 90% effective, depending on dosing.
How much does it cost?
Moderna confirmed it will charge countries placing smaller orders, such as the UK’s five million doses, between £24 and £28 per dose. US has secured 100million doses for $1.525billion (£1.16bn), suggesting it will cost $15.25 (£11.57) per dose.
The US will pay $1.95bn (£1.48bn) for the first 100m doses, a cost of $19.50 (£14.80) per dose.
Expected to cost £2.23 per dose. The UK’s full 100m dose supply could amount to just £223million.
Can we get hold of it?
UK has ordered five million doses which will become available from March 2021. Moderna will produce 20m doses this year, expected to stay in the US.
UK has already ordered 40million doses, of which 10million could be available in 2020. First vaccinations expected in December.
UK has already ordered 100million doses and is expected to be first in line to get it once approved.
What side effects does it cause?
Moderna said the vaccine is ‘generally safe and well tolerated’. Most side effects were mild or moderate but included pain, fatigue and headache, which were ‘generally’ short-lived.
Pfizer and BioNTech did not produce a breakdown of side effects but said the Data Monitoring Committee ‘has not reported any serious safety concerns’.
Oxford said there have been no serious safety concerns. Mild side effects have been relatively common in small trials, with many participants reporting that their arm hurt after the jab and they later suffered a headache, exhaustion or muscle pain. More data is being collected.