Billionaire scientist behind Pfizer and BioNTech's breakthrough Covid-19 vaccine claims it will 'bash the virus over the head' and end the pandemic
One of the leading scientists behind Pfizer and BioNTech's coronavirus vaccine claims it will 'bash the virus over the head' and end the pandemic.
Billionaire Uğur Şahin, the chief executive of German firm 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 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 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, have been 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 statement claiming their experimental jab is 90 per cent effective.
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 the two doses initially needed.
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 claimed to have not known 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
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.
Everything you need to know about Pfizer's breakthrough jab
WHAT DO THE NEW TRIAL RESULTS SHOW?
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.
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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