TWICE AS NICE
Moderna Covid vaccine is 94.5% effective – but UK won’t get any doses till Spring ‘at the earliest’
A SECOND coronavirus vaccine has been found to be 94 per cent effective - but the UK hasn't ordered any doses.
Trials on more than 30,000 people found that only five given the Moderna jab developed Covid – none with severe symptoms.
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In comparison, 90 people given a dummy vaccine fell ill, according to the US biotechnology company.
However, the UK has no pre-orders of the jab and The Sun yesterday revealed ministers are now scrambling to secure supplies.
Officials said they are in advanced talks to buy millions of the jabs, which uses the same RNA technology as the Pfizer vaccine.
But it will be spring 2021 "at the earliest" before doses are available to Brits - as the US firm is scaling up its European supply chain, a Government spokesman today said.
Together with Pfizer's vaccine, which was found to be 90 per cent effective, the United States could have two jabs authorised for emergency use in December.
The US has struck a £1.16bn ($1.5bn) deal for 100million doses, while the EU has an "unsigned" deal for 160million doses, it's reported.
Meanwhile, Moderna has reportedly made deals with Japan, Canada, Switzerland, Israel and Qatar to supply more vaccines.
It is expected to cost £11.57 ($15.25) per dose, and with two needed per person, it works out slightly cheaper than Pfizer's at £14.79 ($1950) per dose.
Still, British scientists have hailed the announcement as "tremendously exciting" and say it raises the prospect of several effective vaccines.
Moderna's jab was also trialled on those most at risk of severe illness from Covid, including the elderly and ethnic minority groups - offering a boost that the vulnerable will be protected from the deadly bug.
'PIVOTAL MOMENT'
Stéphane Bancel, Chief Executive Officer of Moderna, said: “This is a pivotal moment in the development of our Covid-19 vaccine candidate.
“This positive interim analysis from our Phase 3 study has given us the first clinical validation that our vaccine can prevent Covid-19 disease, including severe disease.”
It comes a week after Pfizer announced its Covid jab had more than 90 per cent efficacy against the disease.
Britain has pre-ordered 40million doses, with the first 10 million ready to be administered by Christmas if the vaccine gets regulatory approval.
But despite showing signs of promise, the Pfizer jab must be stored at about -70C (-94F) - which is much lower than the average freezer can reach.
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In contrast, the Moderna jab can be stored in a fridge for a month - meaning it would be much easier to distribute than the Pfizer frontrunner.
Scientists claim it remains stable at -20C for up to half a year, at refrigerated conditions for up to 30 days and at room temperature for up to 12 hours.
Juan Andres, Chief Technical Operations and Quality Officer at Moderna, said: “The ability to store our vaccine for up to 6 months at -20C including up to 30 days at normal refrigerator conditions after thawing is an important development and would enable simpler distribution."
Moderna also included many high-risk and elderly people in its major clinical trial, which experts claim makes the results more relevant to those most vulnerable to Covid.
The early-stage, interim analysis included 95 participants with confirmed cases of Covid-19, of which 90 had received the placebo and five the active vaccine.
The 95 cases included 15 older adults - aged 65 and over - as well as 20 people who were not white, including 12 from Hispanic or Latino/a backgrounds, four African-Americans, three Asian-Americans and one who was multiracial.
Severe cases of coronavirus were also examined, including 11 in the first interim analysis.
All 11 cases occurred in the placebo group and none in the group which had received the vaccine, known currently as mRNA-1273.
Moderna said its available data does not indicate any significant safety concerns.
However, the 94.5 per cent efficacy from this analysis could drop as further results from the clinical trial are announced.
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'TOOLS TO BEAT COVID'
Dr Stephen Hoge, president of Moderna, said he "grinned ear to ear" when learning about the efficacy of the US firm's coronavirus vaccine.
He told BBC News: "When we got the news from the data and safety monitoring board, I'll admit I broke character and grinned ear to ear for a minute.
"Because I didn't expect, I don't think any of us really hoped that the vaccine would be 94 per cent effective at preventing Covid-19 disease, that was really a stunning realisation.
"But the second thing that was perhaps even more exciting was that it was 100 per cent effective, apparently, at preventing severe Covid-19 disease.
It really means I think we have the tools necessary to finally beat this virus back
Dr Stephen Hoge
"There were 11 cases of severe disease, but all 11 were on placebo, none of the vaccine recipients had had severe Covid-19.
"And those combination of facts mean that the vaccine really is a terrific tool for stopping the pandemic and hopefully stopping the worst of the disease that people are facing.
"When you combine it with the news of last week of Pfizer's vaccine, you've got now two vaccines that are over 90 per cent effective.
"It really means I think we have the tools necessary to finally beat this virus back and I think that's probably the best news of the day for all of us, is that there really are now solutions in our hands and we need to deliver them to the people who can use them."
JAB BOOST
Prof Peter Openshaw, from Imperial College London, said: "This news from Moderna is tremendously exciting and considerably boosts optimism that we will have a choice of good vaccines in the next few months.
He said: "First we heard 90 per cent efficacy from Pfizer and BioNTech, then the Russians said 92 per cent and now Moderna says 94.5 per cent.
“This latest press release is based on a study of 30,000 US adults, including many high-risk or elderly persons.
"This gives us confidence that the results are relevant in the people who are most at risk of Covid-19 and in most need of the vaccines."
Prof Openshaw added that the storage temperatures would also make it "much easier" to deliver than the Pfizer vaccine.
He added: “This is a loud vote of confidence in RNA vaccine technology, which seems to be safe, acceptable and effective in studies of 70,000 people.
"These results set a high bar for the other vaccines in the pipeline.”
The professor of experimental medicine also said it was ";quite good" news in terms of side-effects, with only a tiny percentage reporting symptoms.
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“The first dose caused injection site pain in in about three per cent of people," he said.
"The second dose was associated with transient generalised symptoms in about 10 per cent of people with fatigue, muscle aches and flu like symptoms.
"This seems to indicate that they got the dose about right with acceptable adverse events.
"These effects are what we would expect with a vaccine that is working and inducing a good immune response."
BREAKTHROUGH
With vaccines typically taking years to make it this far, other experts have also welcomed the breakthrough announcement today.
Professor Trudie Lang, who runs the Global Health Network at the University of Oxford, described the news of the efficacy of the Moderna vaccine as "remarkable".
Speaking to BBC News she said she had worked on malaria, TB and Ebola vaccines but "we've not seen anything like this before".
Commenting with reference to the previous announcement over the effective Pfizer vaccine, Prof Lang said: "Having data from two different vaccines, the same technology on two completely different trials, but showing the same outcomes is really exciting."
Asked how the vaccine progress had come about, she said: "The reason why we are in such a good situation with Covid is we've just had this enormous collaboration and global focus."
She explained scientific collaboration and learning from work on an Ebola vaccine had been brought into the work around coronavirus.
Britain's 350million Covid vaccine doses
THE government has ordered 350million doses of Covid-19 vaccine, with some ready to roll out by December 1.
This includes 40million doses of the promising Pfizer shot, which was revealed to be 90 per cent effect last week.
These are the other vaccines which the government has pre-ordered:
Oxford/AstraZeneca: 100million doses
A weakened virus that causes colds in chimpanzees, it has been shown to generate a strong immune response against Covid-19.
It has been genetically changed so that it is impossible for it to grow in humans, making it safe for children, the elderly and people with pre-existing conditions.
Currently in phase-3 trials in the UK, USA, South Africa, Japan, Brazil and Kenya, more than 50,000 test patients have been given the vaccine. Early reviews have shown it to be safe.
A company in Australia has already started making millions of vials in the expectation that trials will be successful.
Novavax: 60million doses
Contains purified piece of the virus that causes Covid-19. When it is administered, the body recognises it as “foreign” and mounts a protective immune response.
It has been shown to generate more antibodies than in patients recovering from severe Covid-19 infections.
Currently in phase-3 clinical trials in the UK and USA.
GSK/Sanofi: 60million doses
Uses the same protein as one of Sanofi’s seasonal flu vaccines coupled with a booster.
In phase-1 clinical trials but early results have been positive.
Valneva: 60million doses
An inactivated whole virus vaccine designed to prompt the body into creating high levels of Covid-19 antibodies.
The government has invested in Valneva’s manufacturing facility in Livingston, Scotland, to create a major UK vaccine factory.
Currently in pre-trial research, with trials due to start in December.
Pfizer/BioNTech: 40million doses
Prevents Covid-19 infection by targeting the virus’s “spike protein”, effectively disabling it before it can cause any damage.
Tested on 40,000 patients, it is currently in phase-3 trials, but the first interim analysis has shown it is 90 per cent effective.
Janssen: 30million doses
Uses a modified common cold virus to act like a Trojan horse that can deploy the Covid-19 virus’s “spike protein” to human cells, causing the body to generate antibodies.
Phase-3 trials among 60,000 patients were recently halted temporarily after an unexplained illness in one volunteer. Trials have since resumed.
= 350million doses in total
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Prof Lang suggested it was unusual to have a "pipeline" of vaccine candidates in development.
"We've got these two messenger RNA vaccines through now and there are other technologies hopefully coming through,@ she said.
"And it would be a fantastic position to be in to have, you know, maybe three or four different vaccines that come through over the next coming weeks and months, and can maybe even do slightly different jobs, but certainly assure supply around the world."
She added that "we need to just wait and see" what data on the Pfizer and Moderna vaccines showed.
She added: "We don't fully know yet what sort of protection these vaccines are going to give, whether they're going to prevent illness and stop transmission or both and it could be that some of the vaccines that come along later, do a slightly different job.
"So until we really have a full understanding of that, which we won't over the next coming months, then the health authorities can make a decision on which vaccine to use most appropriately in different situations."
Prof Stephen Evans, from the London School of Hygiene & Tropical Medicine, said: “This is further encouragement that vaccines will be found to not only have an acceptable efficacy, but an efficacy that is much greater than we had anticipated.
"This is the first study to report on severe cases and, while uncertainty remains, the finding of no severe cases with the vaccine and 11 cases with placebo is very strong evidence that the vaccine prevents severe as well as mild disease.
“A wide range of people with illnesses and from minority groups were included in the trials as well as substantial numbers of older patients.
"We will need much more data and a full report or publication to see if the benefit is consistent across all groups, notably the elderly, but this is definitely encouraging progress."
The FTSE 100 has climbed to its highest point since early June in reaction to the news.
Number 10 said the UK had worked on agreements with vaccine developers who offer "different types of vaccines, can provide early supply to the UK and have advanced manufacturing supply chains in place."
At the end of October, Moderna announced that the UK's Medicines and Healthcare products Regulatory Agency (MHRA), which approves jabs, had started the rolling review process of its vaccine.
Dr Charlie Weller, head of Vaccines at Wellcome, said: "Hopes of ending this pandemic rest on having effective vaccines, treatments and tests.
"It is incredibly promising that the vaccines we urgently need are now on the horizon.
"To have multiple vaccine candidates with interim results that surpass our expectations is phenomenal, and testament to the incredible global research effort this year."
A government spokesperson said: “The news from Moderna appears to be good and represents another significant step towards finding an effective Covid-19 vaccine.
"As part of the ongoing work of the Vaccines Taskforce, the Government is in advanced discussions with Moderna to ensure UK access to their vaccine as part of the wider UK portfolio.
“Moderna are currently scaling up their European supply chain which means these doses would become available in spring 2021 in the UK at the earliest.
“To date, the UK government has secured early access to 350 million vaccines doses through agreements with six separate vaccine developers. This includes 40m doses of Pfizer/BioNTech’s vaccine, which is based on the same platform as Moderna’s vaccine and if approved by the medicines regulator, is expected to begin delivery as early as December 2020.”
JANSSEN TRIALS
Meanwhile, the UK will today become the first country to run final stage trials for a Covid vaccine developed by pharma firm Janssen.
It is the third coronavirus jab to be tested on Brits - after those from Oxford and Novavax - and will involve 6,000 people nationwide.
Ministers have secured access to 30 million doses, should it prove successful, with results expected from mid-2021 onwards.
Interim analysis of phase one and two trials indicated it induces a “robust immune response” and is generally well-tolerated.
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And British drugs giant Glaxo-SmithKline yesterday revealed it has already manufactured “millions of doses” of its Covid jab.
Roger Connor, its president of global vaccines, said the firm had launched mass production and is set to launch final trials.
It is aiming for safety approval in the first half of next year.
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Prof Ugur Sahin, a scientist behind the Pfizer jab, said yesterday: “If everything continues to go well, we will start to deliver the vaccine end of this year, beginning next year.
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“Our goal is to deliver more than 300 million of vaccine doses until April next year, which could allow us to already start to make an impact.”
Side-effects include a slight pain at the injection site and fever for a few days.
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