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The lead researcher behind Oxford University’s coronavirus vaccine today revealed she hopes the jab ‘isn’t too far off’ being approved by the regulators and rolled out to millions of Britons.
Professor Sarah Gilbert said that, although she couldn’t pre-judge the decision of the medicines watchdog, she ‘really hoped’ Britons would be receiving the jab soon. No10 hopes it will be given the green light before Christmas.
The UK has ordered more than 100million doses of the Oxford/AstraZeneca vaccine which, if given the green light by regulators, will significantly expand the country’s arsenal to tackle the virus and finally end the pandemic.
But the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) faces a difficult task deciding whether to approve the vaccine, after volunteers in its clinical trials received different doses.
More than 9,000 received two full doses of the jab – a regimen that was 62 per cent effective against the virus – but a further 3,000 received a half dose and a full dose – which results suggest was 90 per cent effective.
The second group, however, is smaller and included no one who is over 50 and more at risk from the virus – making it hard to determine which regimen is best. Other data also suggests the two full-doses provoke a better immune response.
Top scientists say the 62 per cent effective dosing regimen is effective enough to be approved. But other vaccines that have produced results appear to be much more successful, with Pfizer’s blocking around 95 per cent of infections in clinical trials.
More than 140,000 Britons have already received the Pfizer/BioNTech coronavirus vaccine, after it was approved by the MHRA earlier this month. The UK has bought 40million doses – and has already received at least 800,000.
But this supply could be increased by 20 per cent – meaning an extra 130,000 doses – after it emerged there is enough fluid left in the five-dose small glass containers it comes in for a sixth dose.
Pfizer said the extra fluid is there to protect against spills and any vaccine fluid that is lost after it becomes stuck to the syringe.
The Oxford Covid-19 jab (pictured) could be approved by regulators very soon, its developer Professor Sarah Gilbert said today
Professor Gilbert, pictured, also said she suffered sleepless nights during its development
GPs told to use extra dose of Pfizer’s Covid vaccine as NHS updates advice
GPs have been told to use a sixth dose of Pfizer’s Covid-19 vaccine by the NHS, after it emerged yesterday that its vials contain an extra shot of the jab.
Britain’s medical regulator says every vial – the small glass container which holds the liquid vaccine – holds five doses, administered in 0.3ml shots. But it admitted that once the vaccine is diluted before being given out, a vial holds as much as 2.25ml – enough for seven and a half doses.
Doctors and nurses administering the vaccine have now been told to use one of the extra doses ‘at their discretion’, in a weekly webinar with NHS England.
The sixth dose will boost the amount of vaccine available in the UK by 20 per cent, allowing an extra 160,000 people to get the shot with the 800,000 delivered this month alone. It could also mean up to 8million more people could be vaccinated using the Pfizer jab once the UK receives its total order of 40million doses.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) confirmed to MailOnline yesterday that ‘small’ amounts of the jab are going unused, and that the vials contain extra in case of spills and because some gets stuck in the syringe.
It insisted, however, that ‘additional product is not being wasted’ because the extra liquid was never intended to be used and is only there as a backup.
Speaking to BBC Radio 4’s Today programme, Professor Gilbert said the trial results had pleased but also ‘intrigued’ researchers and ‘immediately led to thoughts of wanting to do more work’.
‘So it wasn’t quite the climax that it might have been,’ she said.
‘But we’re very happy with with the way the vaccine is performing, really looking forward to the point where people can start to be vaccinated outside of clinical trials.
‘Obviously I can’t prejudge that moment, the regulator’s have to be given their time to make their decisions but I really hope that that moment isn’t too far off.’
It took regulators eight working days to give Pfizer’s vaccine the go-ahead after the Department of Health officially requested they evaluate it. But the Oxford/AstraZeneca vaccine has yet to be approved, despite being under review for nearly a month.
The jab would likely be ready to go within days when it is eventually approved – it is being manufactured in England and is easy to transport because it can be stored in normal fridges or even at room temperature.
Professor Gilbert also told the programme how she endured sleepless nights while developing the vaccine.
‘Running a research group is a bit like running a small business,’ she said.
‘I have to think about where the money’s going to come from, what staff I’ve got, how long their contracts are. Because they’re only funded for the contracts that I have funding to pay them for.
‘So it is like running a business and I unfortunately don’t spend as much of my time working on the science as I would like to but it’s necessary to keep all the other things going in order to be able to do science that really has impact.’
The mother of grown-up triplets added that she was sometimes known to send emails at 4am during its development, when she woke up late at night and thought through all the possible obstacles to getting the vaccine trials completed.
Describing the team’s work on creating a vaccine, she said the final parts of the jab were designed in a weekend.
She said: ‘We’d already made a lot of decisions about how we were going to design the vaccine but it was just the parts that we had to wait for the actual sequence to get, and then that was put together.
‘But a lot of it is using methods we’d used previously – there’s only small parts of it that are unique to this vaccine.’
It comes after an AstraZeneca boss said it would have run the trials differently had it been in charge.
AstraZeneca’s Dr Mene Pangalos told BBC Panorama, in an episode that will air tonight: ‘There is no doubt I think that we would have run the study a little bit differently if we had been doing it from scratch.
‘But ultimately it is what it is and I think the Oxford group have done a fantastic job and then we’ve done as good a job as we possibly can to translate that into the data-set that we can provide to the regulators and to regions around the world for the approval.’
Dr Pangalos has previously said the different dosing regimes given in the trials were due to ‘serendipity’ – meaning the occurrence of events by chance in a happy and beneficial way.
As many as 200 centres in the UK are ready to start administering vaccines, the health secretary said. Pictured is a man getting the jab yesterday in Manchester
AstraZeneca was not part of the team that invented the vaccine but later joined the project as a manufacturer, meaning it did not help design the first trials.
Professor Gilbert has previously said the chances of their vaccine being approved by the end of 2020 were ‘pretty high’.
But regulators are still yet to give the green light, or say which dosing regimen to use.
The professor has previously suggested the second dosing method may be more effective because the first shot ‘primes the immune system’ before the second improves the response.
It has been suggested this could also better reflect a natural infection, when a small dose of the virus is battled off by the immune system, before a larger dose.
On concerns over the efficacy of the Oxford/AstraZeneca jab, Professor Gilbert previously said: ‘What’s important is vaccinating population, not vaccinating people and thinking about efficacy on an individual level.
‘And if we don’t have enough doses of the Pfizer vaccine to vaccinate everybody, then we’ll be much worse off than being able to vaccinate large numbers of people with other vaccines.’
Source: Daily Mail