Billionaire scientist behind Pfizer and BioNTech’s breakthrough Covid-19 vaccine claims it will ‘bash the virus over the head’ and end the pandemic
- Uğur Şahin, the chief executive of BioNTech, is hugely optimistic about the jab
- But scientists globally have cautioned it won’t be a silver bullet against the virus
- There are still a number of unanswered questions, including if it works in elderly
- BioNTech and Pfizer announced on Monday the jab appears to be ‘90% effective’
- The breakthrough means people could begin getting vaccinated by Christmas
Uğur Şahin, the chief executive of BioNTech, said: ‘If the question is whether we can stop this pandemic with this vaccine, then my answer is: yes’
The leading scientist behind the Pfizer/BioNTech coronavirus vaccine claims it will ‘bash the virus over the head’ and end the pandemic.
Billionaire Uğur Şahin, the chief executive of BioNTech, said: ‘If the question is whether we can stop this pandemic with this vaccine, then my answer is: yes.’
But scientists globally – and the UK Prime Minister Boris Johnson – have cautioned the jab will not be a silver bullet because there are still no guarantees it will work, even though the preliminary news from the trial was a light at the end of the tunnel.
There are still a number of unanswered questions, including whether the jab works in older people – considering most of the trial volunteers were young and healthy.
Full data is expected within the next three weeks, Mr Şahin said. It is expected to be able to prevent Covid-19 illness but whether the jab can stop people carrying the coronavirus and spreading it to others may not be known for a year, he admitted.
BioNTech and Pfizer announced on Monday that their jointly developed vaccine candidate had outperformed expectations in the crucial phase three trials, proving 90 per cent effective in stopping people from falling ill.
The major breakthrough means people could begin getting vaccinated before the year is out, if regulators are satisfied with the safety of the jab.
In an interview with The Guardian, Mr Şahin said he hoped the vaccine would offer at least a year of protection, suggesting an annual booster would be necessary.
No10 has secured a deal for 40million doses of the Pfizer/BioNTech jab, which will protect 20million people at an estimated cost of £600million.
Boris Johnson promised the UK will be at the ‘front of the pack’ for it but tempered expectations, warning the vaccine will not deliver a ‘knockout blow’ to coronavirus.
Husband and wife Uğur Şahin and Özlem Türeci are the couple behind the Covid-19 vaccine that could change the world
A vaccine trial volunteer in Turkey receives a dose of the Pfizer and BioNTech jab at the end of October
Mr Şahin, 55, and his wife Özlem Türeci, 53, are being hailed as the ‘dream team’ behind the world’s hopes for a Covid vaccine.
The pair co-founded Germany company BioNTech in 2008, with the aim of pursuing a much broader range of cancer immunotherapy tools.
The company secured a partnership with Pfizer in March to rapidly develop a Covid-19 vaccine in record time. With the product selected – a two-dose vaccine given over the course of three weeks – a large clinical trial began in July involving more than 40,000 participants.
The global race to find a Covid-19 vaccine took a leap forward on Monday when Pfizer and BioNTech released a press statement claiming their experimental jab is 90 per cent effective.
Boris Johnson has warned that a vaccine will not deliver a ‘knockout blow’ to coronavirus as Tories insisted he must not use the prospect of jabs to keep the country in lockdown longer.
At a bad-tempered PMQs session on Wednesday, Mr Johnson again welcomed the news that Pfizer’s vaccine had been 90 per cent effective in early trials.
But he gave a stern message to the public that they should not be expecting an early end to restrictions, despite claims it could start being rolled out by Christmas.
He said the ‘best way to get this country back on its feet’ was to ‘continue on the path that we are, driving the virus down’.
The premier said science had given the country ‘two big boxing gloves’ via a possible vaccine and mass testing, but added: ‘Neither of them is capable of delivering a knock out blow on its own.
It followed the Downing Street press briefing on Monday evening, in which Mr Johnson said the UK was ‘towards the front of the pack’ to get the critical jabs.
However, he warned that the biggest mistake the country could make now was to ‘slacken our resolve’. ‘Now it is more important than ever to follow the rules,’ he said.
Mr Johnson referred to his previous comments about the ‘distant bugle of the scientific cavalry coming over the brow of the hill’ to salvage the situation. ‘I can tell you that tonight that toot of the bugle is louder, but it’s still some way off, we absolutely cannot rely on this news as a solution,’ he said.
‘The biggest mistake we could make now would be to slacken our resolve at a critical moment.’
He added: ‘I just don’t want to let people run away with the idea that this development is a home run, a slam dunk, a shot to the back of the net, yet. There’s a long way I am afraid before we have got this thing beaten.’
Mr Şahin said ‘we now know that vaccines can beat this virus’, adding that before the results became available, he wasn’t sure whether it would trigger a strong enough reaction from the human immune system.
Now, however, he says the most effective candidate to emerge from the company’s trials attacked the coronavirus ‘in more ways than one’.
Referring to the way the immune system reacts, Mr Şahin said: ‘The vaccine hinders Covid-19 from gaining access to our cells.
‘But even if the virus manages to find a way in, then the T-cells bash it over the head and eliminate it. We have trained the immune system very well to perfect these two defensive moves. We now know that the virus can’t defend itself against these mechanisms.’
T cells are a type of white blood cell produced by the immune system which destroy invading organisms such as viruses.
Scientists have not yet been able to prove that the vaccine can prevent transmission of the coronavirus because the trial was not designed to do so.
It has merely shown so far that the jab prevents people from falling sick, and not that they will not carry it and pass it on to others.
Mr Sahin claimed the high efficacy results have led him to assume the vaccine can halt the spread of the coronavirus, adding: ‘I believe that even protection only from symptomatic infections will have a dramatic effect.’
But establishing for certain whether it can also stop asymptomatic (or ‘silent’) infections could take up to a year.
Further insight into how the vaccine protects people of different ages could come in around three weeks, however.
The final stage trial did not provide data on the most susceptible populations, such as the immunocompromised or older adults.
But the phase one and two trials showed the induction of virus neutralising antibodies in older adults were less than half of that of younger adults, and so may not work as well to protect the most vulnerable.
Mr Şahin said: ‘We only have indirect clues so far [regarding the duration of immunity].
‘Studies of Covid-19 patients have shown that those with a strong immune response still have that response after six months.
‘I could imagine we could be safe for at least a year.’
This would suggest the Covid-19 jabs would need to be ‘topped up’ annually, as well as two doses being necessary for the first vaccination.
Mr Şahin and his wife discovered the outcome of the interim trials on Sunday night in a call from the Pfizer chief executive, Albert Bourla.
Contrary to US president, Donald Trump’s accusations that the results had been held back until after the US election, even Mr Bourla did not know the results of the trial until Sunday night, Mr Şahin said.
After the bombshell phone call, Mr Şahin said: ‘My wife and I sat down, talked to each other and made cups of tea. The relief was a very good feeling.’
Chief medical officer Chris Whitty warned it was essential the country continues to ‘suppress COVID’ despite the vaccine news being a ‘reason for optimism for 2021’
Deputy chief medical officer Jonathan Van-Tam voiced excitement about the Pfizer announcement, saying it boded well for other trial vaccines as they used the same broad approach, targeting the spike proteins of the virus – which it uses to invade cells
HOW PFIZER’S VACCINE COULD COST THE UK £600MILLION
Pfizer’s coronavirus vaccine could cost Britain £588million and wind up being seven times more expensive per dose than the one being developed by Oxford University.
The jab, which the company this week claimed is 90 per cent effective and could be approved by regulators within weeks, is likely to cost at least £15 per dose and must be stored in specially designed ice packs that can cost approximately £5,000 each.
The UK is known to have pre-ordered 40million doses of Pfizer and BioNTech’s jab, 10million of which may be available before the end of 2020.
Costs behind the deal have not been confirmed – instead dubbed commercially confidential – but BioNTech has revealed details of its deal with the US Government.
It has charged the US $19.50 per dose for the first 100million doses, its chief strategic officer Ryan Richardson said this week.
Each person will need two doses of the jab, taken three weeks apart, for it to work properly, meaning use of the vaccine will cost the US $39 per person.
This converts to £29.40 per person in the UK, assuming the same deal has been agreed.
The US may have got a preferential deal, however, because Pfizer is based in New York and it has also bought more than twice as many doses as the UK.
A vaccine being produced by Oxford, however, may cost as little as £2.23 per dose after the university and manufacturer AstraZeneca agreed not to profit from it. The 100m doses of Oxford’s could come in at a significantly lower £223m.
One of the two is likely to become the first coronavirus vaccine to be rolled out in Britain, with the NHS now gearing up to be ready to start delivering a jab from the start of December.
Ministers, who have already spent billions of pounds on protecting the NHS, paying furlough bills and testing people for coronavirus, will no doubt be hoping the cheapest option comes good first.
Dr Andrew Preston, a biologist at the University of Bath, told MailOnline: ‘Presumably if there is some sort of bulk-buy line of thought, then the US buying considerably more than the UK’s 40million doses might mean a cheaper per-shot price, but I really don’t know.
‘One thing is certain. Even though the total cost of the Covid vaccination programme for next year will be eye-watering, it’ll be a tiny fraction of the amount the Government has had to borrow to get through this year.
‘So on that basis, it’s tremendous value for money.’
Born in Turkey, Mr Şahin was raised in Germany, where his parents worked in a Ford factory. Trained as a doctor, Mr Şahin became a professor and researcher focused on immunotherapy.
He worked at teaching hospitals in Cologne and the south western city of Homburg, where he met immunologist Miss Türeci during his early academic career. Medical research and oncology became a shared passion.
Miss Türeci, the daughter of a Turkish physician who had migrated to Germany, once said in an interview that even on the day of their wedding, both made time for lab work.
Mr Şahin came from humble roots to build two billion-dollar companies but still rides to work on his mountain bike.
In January, after reading a scientific paper about the the coronavirus in Wuhan, China, BioNTech assigned 500 of its staff to work on progression of a vaccine.
The jab is known as a messenger RNA (mRNA) vaccine, which is not used for any other vaccine in history. Therefore if it is rolled out, it will be the first mRNA jab ever to be proven in humans.
The mRNA method uses genetic code from the virus to provoke the immune system into making antibodies – proteins that help attack the virus.
Conventional vaccines take genetic information from a virus and cultivate it in a human cell, a process which can take several months longer.
Pfizer and German partner BioNTech are the first drugmakers to show successful data from a large-scale clinical trial of a coronavirus vaccine.
There are around 12 in the world in final stages, including Oxford University’s jab, owned by AstraZeneca, the results of which are expected imminently.
A total of 94 people in the Pfizer/BioNTech trial of more than 43,000 have so far tested positive for Covid-19, and that over 90 per cent of those did not receive the real vaccine.
They were in the placebo group, where people are given a fake vaccine so that what happens to them can be compared with those who get the real thing. Pfizer’s trial has split the participants half and half across the placebo and vaccine groups.
The companies have not revealed the exact number but a 90 per cent efficacy rate suggests that no more than eight people who got the vaccine caught the virus, compared to 86 of those who received a fake jab.
England’s chief medical officer, Professor Chris Whitty, said the findings demonstrated ‘the power of science against Covid’, adding: ‘We must see the final safety and efficacy data, but it is very encouraging.
‘It is essential we continue to suppress Covid, but it is a reason for optimism for 2021.’
Before the vaccine is given to millions of Britons, it must be first be approved by the regulatory body — the MHRA, which has already launched a rolling review of all existing data so it can be fast-tracked through the process.
Health chiefs have repeatedly admitted it is possible the UK could get its hands on a vaccine before Christmas and proving the vaccine is safe remains the only hurdle.
The jab has to be given in two installments so in theory the 10million due in the UK before Christmas mean five million people could receive it.
At a press conference on Monday evening, Boris Johnson said the UK was ‘towards the front of the pack’ to get the critical jabs.
However, he warned that the biggest mistake the country could make now was to ‘slacken our resolve’. ‘Now it is more important than ever to follow the rules,’ he said.
The Prime Minister’s official spokesman said: ‘The results are promising and while we are optimistic of a breakthrough, we must remember there are no guarantees.’
Although the vaccine announcement made by pharmaceutical giant Pfizer and biotech firm BioNTech was a watershed moment after months of coronavirus misery, it does not mean things can go back to normal, for a variety of reasons.
Even if and when the jab gets regulatory approval, it will take some time for enough of it to be produced and distributed.
Dr Charlie Weller, head of the vaccines programme at the Wellcome Trust, said on Monday: ‘We do need to be realistic about what a successful vaccine can offer.
‘Unfortunately, it doesn’t mean that we’ll wake up tomorrow, we’re all given the vaccine and the pandemic ends.
‘But it does give us that light at the end of the tunnel, that hope and that positivity that there is going to be an end to this pandemic.’
Dr Weller said: ‘But even when – I’m being very optimistic here – when the full data comes out, and that vaccine can be rolled out, this is like the best case scenario, we still won’t have enough doses for everyone.
‘And this is why we need a range of vaccines, as well as treatments, and continuing those public health measures of social distancing and wearing masks.
‘It’s not that silver bullet. It is a really positive next step, but it will be the little small steps rather than the giant leap.’
Professor Nilay Shah, head of the department of chemical engineering at Imperial College London, said the findings reported by Pfizer/BioNTech are good news.
But asked if it meant the end of the pandemic, he told PA: ‘Not for some time.’
He added that until the first wave of people – perhaps the 50+ age group, health and social care workers and those with health conditions – are vaccinated, a certain level of restrictions will be in place.
David Nabarro, co-director of Imperial College London’s Institute of Global Health Innovation, said ‘any promising news about a vaccine is great news’, but cautioned that there is still some way to go.
He told the BBC: ‘Everybody who’s hearing and watching this will be saying “wow, does this mean that life can go back to normal in the near future?”
‘We’re not there yet. The vaccine will help, but it’s not going to be a complete game changer.’
But Sir John Bell, regius professor of medicine at Oxford University and a member of the Government’s vaccine taskforce, has been extremely optimistic about the potential of the coronavirus jab.
Asked if people could look forward to a return to normal life by the spring, Sir John told BBC Radio 4’s The World At One: ‘Yes, yes, yes, yes. I am probably the first guy to say that but I will say that with some confidence.’
Dr Michael Head, senior research fellow in global health, University of Southampton, added: ‘This cautiously sounds like an excellent result from the phase three trials, but we should remain a little cautious.’
Deputy chief medical officer Jonathan Van-Tam voiced excitement about the Pfizer announcement, saying it boded well for other trial vaccines as they used the same broad approach.
But he also cautioned that ‘one swallow’ did not make a summer and there could not be an easing of social distancing measures yet.
Pfizer’s next step is expected to be to apply for ’emergency use authorisation’ in the US, for which they will have to go to the Food and Drug Administration (FDA) once they have two months’ worth of safety data — expected to be complete by the end of this month.
The pharma giant did not mention seeking approval in the UK or Europe in announcing the results but it is likely to submit all of the data at the same time.
Pfizer plans to produce 50million doses by the end of the year and 1.3billion in 2021.
A vaccine rollout of such huge scale has never been attempted in the UK and would be a huge logistical challenge.
Matt Hancock said this week the NHS is preparing to roll-out Pfizer’s coronavirus vaccine from the start of next month, with care home staff and residents at the front of the queue.
The Health Secretary said the first Brits will likely get their hands on the jab ‘within weeks’ of it being given the green-light by the UK’s medical watchdog.
A priority list of who should get the vaccine first was drawn up earlier this year by the influential Joint Committee on Vaccination and Immunisation (JCVI) and is now being used as the rollout blueprint.
Professor Van-Tam has suggested millions of people could miss out on the best Covid-19 vaccines because they must be given out as soon as possible.
He said speed is of the essence and the people most vulnerable to Covid-19, such as the elderly and those with cancer, must be given the first quality vaccine that becomes available in a bid to stop the epidemic.
This, scientists admit, will likely mean millions of people get a less-than-perfect vaccine, but getting it early would save more lives than waiting around for a better one.
Everything you need to know about Pfizer’s breakthrough jab
WHAT DO THE NEW TRIAL RESULTS SHOW?
WHY THE PFIZER VACCINE MIGHT NOT BE A SILVER BULLET
Pfizer’s vaccine needs to be stored at ultra-low temperatures, which makes trying to ship and distribute the shots a logistical headache.
The vaccine must be kept at -70C (-94F) which rules out storing it at most hospitals or pharmacies, where jabs are normally kept and administered.
Pfizer’s shot will likely need to be stored in laboratories or specialist hospitals.
To transport it around the country will also require expensive refrigerated lorries.
There are also rumblings from insiders that the UK does not have enough of these lorries or enough medical-grade glass vials and PPE for the mass rollout of a vaccine across the country.
Last month the logistics advisory group 7Bridges – which will be one of the main firms tasked with helping officials mass-vaccinate Brits – said it still hadn’t heard from No10 about a plan for the rollout of the first successful jab candidate.
Philip Ashton, chief executive of 7Bridges, said it was possible that health workers and high risk people could get their hands on a jab by the year’s end.
But it could take up to two years to inoculate the entire nation, he claimed.
The logistics expert does not believe the UK has enough ‘cold chain’ lorries for the transportation of the vaccine doses at present.
The ‘cold chain’ is a system of storing and transporting vaccines at recommended temperatures from the point of manufacture to the point of administration.
POTENTIALLY LOW UPTAKE
There are concerns that a significant amount of people will refuse to take a coronavirus vaccine.
A major University College London study in late September estimated a fifth of Britons will turn down a potential jab.
If crudely extrapolated to the entire country it could mean 13million people refuse to take it.
Researchers found a ‘concerning level of misinformation around vaccines’ which could significantly affect uptake once a Covid-19 vaccine is approved.
In the largest survey of its kind, 22 per cent of 17,500 people asked said they were unlikely to be vaccinated with 10 per cent strongly opposed to it.
Just half (49 per cent) of people asked said they ‘very likely’ to be immunised, while three-quarters (78 per cent) said they considered it ‘likely’.
Scientists think 70 per cent uptake will be enough to achieve ‘herd immunity’ – a form of indirect protection from that occurs when a high percentage of a population has become immune to a disease.
So even if 22 per cent turn it down, community protection might still be possible.
But if public confidence in a vaccine dwindles more then it raises serious concerns.
MINK MUTATED COVID-19
A mutated version of coronavirus caught from mink might render Pfizer’s vaccine less effective than its touted 90 per cent figure.
Scientists believe the virus jumped from farm workers to mink in the summer before being passed back to humans.
As it crossed between species, a mutation occurred on its ‘spike’ protein, which it uses to enter human cells.
This mutation of the protein appears to make the strain more resistant to antibodies, disease-fighting proteins made and stored by the immune system.
Pfizer’s jab trains the body to produce a wave of these antibodies by exposing it to lab-generated genetic material created to imitate what scientists have found inside the coronavirus.
But if the new variant of Covid-19 becomes the prevailing strain then there are fears the vaccine could be less effective.
Ian Jones, a virologist from the University of Reading, told MailOnline the possibility of the mink strain being able to duck the body’s antibody response was a ‘formal possibility’.
He said: ‘In theory, the mink form, which has mutations in the spike protein, could then evade the immune response generated to the vaccines currently in development and form Covid-19-2.
‘There are a lot of reasons why this would not happen easily, but it is a formal possibility which is why the mass cull has taken place.
The UK’s vaccine tsar Kate Bingham said last week Britain has the capacity to produce 10million doses of the Pfizer jab by the end of the year.
But the way the vaccine works is by administering two doses almost a month apart – meaning only 5million Brits will get access.
There are almost a million frontline NHS staff across the UK.
They have been highlighted as top priority for the vaccine by UK health officials because they are the most likely to catch the virus or pass it to already sick people.
It means only a few million vulnerable or elderly Britons will actually get access by Christmas.
The 10million touted doses are also a best-case scenario and it is very likely that issues in the supply chain could hamper the country’s ability to deliver that many doses.
Pfizer and German partner BioNTech said that 94 people in a trial of more than 43,000 have so far tested positive for Covid-19, and that over 90 per cent of those did not receive the real vaccine.
This suggests the vaccine is 90 per cent effective and that no more than eight out of those 94 people actually received the real jab.
Most of the people who tested positive were in the placebo group, where people are given a fake vaccine so that what happens to them can be compared with those who get the real thing.
The companies did not reveal the exact split of how many people had had the vaccine and how many had not.
The results were revealed in a corporate press release, which is not considered transparent enough for independent review, but they will be published in full later this year when the study is more complete.
This phase of the trial will continue until at least 164 participants have tested positive, the researchers said.
While previous studies have been extremely promising – suggesting, for example, that various vaccines boosted the immune system’s response to Covid – this is the first time any jab has been shown to actually ward off the virus.
That the Pfizer jab is 90 per cent effective is far better than scientists dared hope.
WHAT DOES THAT MEAN FOR ME?
The general public will not benefit from the vaccine – if it is approved – for weeks or months to come, but today’s results mean there is a ray of hope that the pandemic could end.
Coronavirus cannot yet be stopped without a vaccine, and one that prevents infections or at least reduces the risk of death could spell the end of social distancing.
In the UK, officials have bought 40million doses of the vaccine and they could be available to the most vulnerable people within months if the study ends well.
WHEN COULD IT BE READY TO GIVE TO THE PUBLIC?
Pfizer and BioNTech have said they will try to apply to the Food and Drug Administration in the US for approval within the next month, provided their final results are as positive as today’s announcement suggests.
This is because Pfizer is an American company, based in New York. BioNTech is a German company so it is likely the same procedure will be followed in the European Union.
It will then be a question of how long it takes regulators to decide, and of how long delivering all the doses takes if it is approved, but it could be just weeks into December.
Before the vaccine is given to millions of Britons, it must be first be approved by the regulatory body — the MHRA, which has already launched a rolling review of all existing data so it can be fast-tracked through the process when the drug giant eventually submits it for approval.
The UK now has the power to approve its own vaccine without waiting for a licence from Europe, because of new laws passed during the pandemic, or an EU approval would also allow Britain to use the jab.
Kate Bingham, chief of the UK’s vaccines taskforce, said last week that it was possible the jab could be ready in Britain before Christmas.
She said there was a ‘possibility of being ready before the end of the year’.
HAS THE UK ALREADY GOT DOSES OF THE VACCINE?
Downing Street today said it has ordered 40million doses of the double-dose vaccine, which would be enough to give to 20million people.
Kate Bingham said last week that 10million doses of the Pfizer vaccine could be available in Britain by the end of year.
It means that, at the absolute most, only 10million Brits will receive the vaccine by Christmas, but the vaccine is given in two shots so this could actually be five million.
A further 30million doses would then be produced and sent to Britain next year – the timescale for this is not yet clear.
HOW DOES THE VACCINE WORK?
The jab is known as a messenger RNA (mRNA) vaccine, which uses genetic code from the virus to provoke the immune system.
Traditional vaccines tend to use damaged or destroyed versions of the real virus to achieve the same effect – if this one works, it will be the first mRNA jab ever to be proven in humans.
The vaccine is made of lab-generated genetic material which is created to imitate what scientists have found inside the coronavirus.
The genetic material (mRNA) is then injected into the body inside a fatty molecule.
The genes are specifically chosen to code for the ‘spike’ protein on the outside of the coronavirus, which are what the virus uses to bind to human cells and infect them.
When the molecules get into the body, they deliver the mRNA into living cells and trick the body into making its own copies of the spike protein.
When these appear in the bloodstream they trigger the immune system in the same way that the real virus would, although the effects are milder because there are no actual viruses driving the infections, so the situation is under the body’s control.
In the process, the immune system learns how to recognise and destroy the spikes so that when it encounters them for real it can kill the virus before it causes Covid-19.
IS IT SAFE?
Pfizer and BioNTech say they have not encountered any safety issues during their trials so far, which have been going on for six months.
This suggests with a good degree of confidence that the vaccine is safe for humans at least in the short term.
Long-term safety can only be proven when huge numbers of people have had the vaccine and had their health tracked for years or even decades afterwards, so scientists cannot yet be 100 per cent sure that no side effects will ever appear.
However, the current phase three trial includes more than 43,000 people from different backgrounds all over the world, all of whom are being closely monitored after having the vaccine.
If people suffer side effects of the vaccine that are more common or more severe than in the placebo group – who received a fake vaccine for comparison – this will be investigated in detail by the researchers.
Pfizer and BioNTech will not be given permission to distribute the jab without showing independent regulators that they have concrete data to prove the jab is as safe as possible.
Regulators will not accept a licensing submission until at least half the people in the trial have been vaccinated for at least two months. That data is expected in a fortnight. Only then will the true safety profile be known.
WHAT ARE SCIENTISTS STILL TESTING FOR?
The trial is still going and will likely not end completely for years to come, because the more data scientists have, the more confident they can be about their results.
In the short term, the researchers must continue to gather safety data and proof that the vaccine is actually working.
The team said they will keep the current phase of the trial open until at least 164 people have been infected with the coronavirus.
They will then compare the infection rate in the vaccine group to that of the placebo group, who got a fake vaccine, to see how much of a difference the jab makes.
They will want to see that significantly fewer people got sick after having the jab, compared to people who had the fake one. Early data suggests this is the case.
WHICH VACCINES HAS THE UK SECURED DEALS FOR?
1. GlaxoSmithKline and Sanofi Pasteur: 60million doses
The Government revealed on July 29 it had signed a deal with pharmaceutical giants GlaxoSmithKline (GSK) and Sanofi Pasteur
If the vaccine proves successful, the UK could begin to vaccinate priority groups, such as frontline health and social care workers and those at increased risk from coronavirus, as early as the first half of next year, the Department for Business, Energy & Industrial Strategy (BEIS) said.
Human clinical studies of the vaccine will begin in September followed by a phase 3 study in December.
The vaccine is based on the existing technology used to produce Sanofi’s seasonal flu vaccine. Genetic material from the surface protein of the SARS-CoV-2 virus is inserted into insect cells – the basis of Sanofi’s influenza product – and then injected to provoke an immune response in a human patient.
2. AstraZeneca (manufacturing University of Oxford’s): 100million
AstraZeneca, which is working in partnership with Oxford University, is already manufacturing the experimental vaccine after a deal was struck on May 17.
Professor Sarah Gilbert, who is leading the Oxford team, is confident the jab could be ready for the most vulnerable people by the end of the year.
Her comments came after the results from the first phase, published in The Lancet on July 20, showed promise.
The team have genetically engineered a virus to look like the coronavirus – to have the same spike proteins on the outside – but be unable to cause any infection inside a person. This virus, weakened by genetic engineering, is a type of virus called an adenovirus, the same as those which cause common colds, that has been taken from chimpanzees.
3. BioNTech/Pfizer: 30million
US drug giant Pfizer – most famous for making Viagra – and German firm BioNTech were revealed to have secured a deal with the UK Government on July 20.
It reported positive results from the ongoing phase 2/3 clinical trial of one called BNT162b1 on July 1. The company is still running phase 2 trials at the moment.
Pfizer’s vaccine is one called an mRNA vaccine, which do not directly inject bits of the virus into the body but send genetic material.
mRNA vaccines programme the body to produce parts of the virus itself by injecting the body with a molecule that tells disease-fighting cells what to build. The immune system then learns how to fight it.
4. Valneva: 60million
The Government has given Valneva — whose vaccine is understood to be in the preclinical stages of development — an undisclosed amount of money to expand its factory in Livingston, Scotland.
While the Government revealed a 60million dose deal on July 20, the company said it had reached agreement in principle with the UK government to provide up to 100million doses.
Valneva’s jab is an inactivated whole virus vaccine, meaning it injects a damaged version of the coronavirus itself into the body.
The virus has been destroyed in a way that makes it unable to cause infection, but the body still recognises it as a dangerous intruder and therefore mounts an immune response which it can remember in case of a real Covid-19 infection.
5. Janssen (Johnson & Johnson): 30million
The Government has agreed to buy 30million doses of a vaccine made by Janssen if it works.
Officials have agreed to help the company in its development of the jab by part-funding a global clinical trial. The first in-human trials of Janssen’s jab began in mid-July and are being done on adults over the age of 18 in the US and Belgium.
The jab is named Ad26.COV2-S, recombinant, and is a type of jab called a viral vector recombinant vaccine.
Proteins that appear on the outside of the coronavirus are reproduced in a lab and then injected into the body to stimulate an immune reaction.
The ‘Ad’ part of the vaccine’s name means it works using an adenovirus – a virus best known for causing the common cold – as a vehicle to transport the coronavirus genetics into the body.
6. Novavax: 60million
Britain has ordered 60million doses of a vaccine being developed by the US-based company Novavax. It will help to fund late-stage clinical trials in the UK and also boost plans to manufacture the vaccine in Britain.
Novavax’s jab, named NVX-CoV2373, showed positive results in early clinical trials.
It produced an immune response in 100 per cent of people who received it, the company said, and was safe and ‘generally well-tolerated’.
Novavax’s candidate is also a recombinant vaccine and transports the spike proteins found on the outside of the coronavirus into the body in order to provoke the immune system.
7. Imperial College London: Unknown quantity
Imperial College London scientists are working on Britain’s second home-grown hope for a jab. The candidate is slightly behind Oxford’s vaccine in terms of its progress through clinical trials, but is still a major player.
The UK Government is understood to have agreed to buy the vaccine if it works but details of a deal have not yet been publicised.
Imperial’s jab is currently in second-phase human trials after early tests showed it appeared to be safe.
Imperial College London will try to deliver genetic material (RNA) from the coronavirus which programs cells inside the patient’s body to recreate the spike proteins. It will transport the RNA inside liquid droplets injected into the bloodstream.
Safety data is still being collected, too.
Before Pfizer and BioNTech can apply to US regulators for permission to use the jab on the public, they must produce two months’ worth of data for at least half of the study’s 38,955 participants who have had both doses of the vaccine.
This data must show that the vaccine can be given safely to large numbers of people without any serious side effects.
Vaccines are not ruled out by any side effects, and regulators will be looking for proof that the benefits of the jab outweigh any potential risks.
WHO WILL GET THE JAB FIRST IN THE UK?
Care home residents and staff will be the first to get a Covid-19 vaccine when one is approved, according to Government advice published in late September.
Everyone over the age of 80 and NHS staff will be second in line, guidance from the Joint Committee on Vaccination and Immunisation says.
Those over 75 will be next in the queue, followed by over-70s, over-65s and high-risk adults under 65 with diseases like cancer.
They will be followed by moderate risk adults under 65 – including diabetics and asthmatics.
Over-60s will be next, with over-55s and over-50s the final priority groups.
The general population will be last to get their hands on a vaccine and they will most likely be prioritised based on age or underlying conditions.
HOW WILL THE VACCINE BE ADMINISTERED IN THE UK?
The UK Government has announced that it is expanding the group of people who will be able to administer vaccines, as well as potentially setting up walk-in or drive-in centres in public locations such as car parks outside GP surgeries.
Physios and paramedics will be trained to deliver Covid-19 jabs to help the NHS carry out its mass vaccination programme through the winter.
Currently, only doctors, pharmacists and some nurses are legally allowed to administer vaccines in the UK.
But new laws passed in October grant more health workers – including midwives and even medical students – to be able to inoculate members of the public.
They are currently being put through ‘robust training’ according to the Government, which it says will ‘save thousands of lives by increasing access to vaccines against killer disease’.
ARE THERE LOGISTICAL PROBLEMS WITH BUYING SO MUCH VACCINE?
Experts have raised concerns that storing the vaccine in Britain might be difficult.
Pfizer and BioNTech’s vaccine may have to be stored at temperatures below -70°C (-90°F) to make sure that it remains stable and can still work when injected.
If they rise to temperatures higher than this at any point between the lab and wherever they are administered from they could become chemically unstable and fail to work properly.
Dr Michael Head, global health expert at the University of Southampton, said: ‘It has been reported that the vaccine requires storage at -70 degrees centigrade, and that is not necessarily routinely available in most health centres even in the UK, let alone globally.’
And Dr Al Edwards, a professor of biomedical technology at the University of Reading, added: ‘The task of producing substantial amounts of a new vaccine and disturbing widely will be a challenge, not least for this particular formulation where ensuring that it can be appropriately frozen until needed and must not be allowed to thaw in transit.’
WHAT DOES THIS MEAN FOR LOCKDOWNS AND SOCIAL DISTANCING?
Social distancing and lockdowns – known as ‘non-pharmaceutical interventions’ – will not come to an end as soon as a vaccine is proven to work.
It would take months to vaccinate enough people for it to actually impact on the spread of coronavirus among the public, especially if people who are more likely to be in care homes or shielding are the first ones to receive the jab.
Experts do not know exactly what proportion of people will need to be vaccinated to develop herd immunity, which is when the virus cannot cause outbreaks any more.
It is thought to be higher than two thirds, which means over 42 million people will need to have a working vaccine.
The UK has not ordered enough of Pfizer’s vaccine to rely on that completely – although more could likely be bought in future – but it has ordered more than 300million doses of other vaccines that could work.
Sir John Bell, regius professor of medicine at the University of Oxford, said on BBC Radio 4 this afternoon: ‘I am really delighted with this result – it shows that you can make a vaccine against this little critter. Ninety percent is an amazing level of efficacy.
‘It rolls the pitch for other vaccines because I can’t see any reason now why we shouldn’t have a handful of good vaccines.’
Asked if people could look forward to a return to normal life by the spring, Sir John replied: ‘Yes, yes, yes, yes. I am probably the first guy to say that but I will say that with some confidence.’
WHAT DO SCIENTISTS SAY ABOUT THE PROGRESS?
Scientists from across the UK have today praised the results of the Pfizer Covid-19 vaccine, saying it could spell an end to the pandemic.
Oxford University’s Professor Peter Horby, who led the team that proved the steroid dexamethasone could save dying coronavirus patients, said: ‘This news made me smile from ear to ear.’
While Dr Paul Hunter, an infectious disease expert at the University of East Anglia, told MailOnline he was ‘really pleased about this result’.
‘You can almost begin to start seeing the light at the end of the tunnel. I just hope it’s not an oncoming train.’
Despite offering a glimmer of hope, other scientists have said the results are still only early indications, so it is important to not get carried away.
Professor Brendan Wren, from the London School of Hygiene & Tropical Medicine, said: ‘A 90 per cent efficacy for a phase three trial is excellent for a new vaccine that could make a huge difference.
‘But more confirmatory safety and efficacy studies are required.
Professor Eleanor Riley, an immunology and infectious disease expert at the University of Edinburgh, added: ‘At face value, this is exceptionally good news.
‘However, the full data set on which the claim is based has not yet been released and so we don’t know exactly what has been found.’
Sir John Bell, medicine professor at the University of Oxford, welcomed the news but said the distribution of the vaccine would be ‘challenging’.
‘They will obviously start in the US – that’s probably appropriate,’ he told BBC Radio 4’s The World at One. ‘BioNTech is a German company so there will be, I am sure, doses made available for Europe.
‘The UK has done a pre-approval agreement to purchase up 30 million doses of this vaccine, so we are very well prepared to get access to this vaccine when it becomes available.
‘The manufacturing challenges are not small, so people need be ready to wait a bit to get it.’
HOW DOES THE OXFORD UNIVERSITY JAB DIFFER?
Oxford’s is an adenovirus vector vaccine, which contains a weakened version of a chimpanzee cold virus that has been genetically changed to trigger the production of immune cells – antibodies and T-cells.
COULD MORE THAN ONE VACCINE BE USED BY THE UK?
Definitely. The Government has orders in place for 300 million doses from six different companies. If more than one is approved, the joint virus committee will decide which people will get which vaccines, depending on the trial data for different age groups. It is unlikely that two vaccines will be used in combination for the same person, at least in the near future – more research will be needed to see if that boosts protection or not.
DOES THIS MEAN AN END TO THE CURSED CORONAVIRUS?
No – and the Government was keen last night to stress adherence to social distancing rules. But if the vaccine is as effective as the results suggest it may mean an end to this phase of the pandemic. Some scientists last night suggested it might even mean a return to normality by spring.
HOW MANY PEOPLE NEED TO BE VACCINATED BEFORE WE TRULY KILL OFF COVID?
To see off the virus we need to achieve ‘herd immunity’, which will mean the virus can no longer spread from person to person and simply dies out. In normal circumstances every person with Covid affects three others – giving the infamous R-rate of 3. For the virus to die out the R rate needs to be reduced to 1. In order to achieve that, 60 per cent of the population would need to be vaccinated. Experts believe that if one or two more vaccines come through – and if they have anything like the same potential – that will be achievable in a year.
HOW MUCH WILL IT COST?
The vaccine will be provided by the NHS for free. It is unclear how much the Government’s deal with Pfizer is worth, but the firm is reported to have struck deals with other nations for around £15 a dose.
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