Hopes that the pandemic could come to an end surged, along with stock markets across the world, as the firms became the first to report results from large-scale clinical trial and hailed today ‘a great day for science and humanity’.
The UK has already bought 40million doses of the jab and a quarter of them could be ready to go before the end of the year, and cautious scientists admit the results are ‘excellent’ and ‘really impressive’ – with one even claiming Britain could be back to normal by spring 2021.
Here, MailOnline explains everything you need to know about the vaccine:
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.
Pictured is the first patient to have received the Pfizer vaccine, at the University of Maryland in May this year. Since then, more than 43,000 people have been enrolled in the ground-breaking trial
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.
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.
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.
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.
STOCK MARKETS SURGE ON VACCINE HOPES
Global stock markets surged on hopes of an end to the coronavirus crisis today after the vaccine news broke.
In the US, already on a high after the election delivered a clear result, the Dow and the S&P hit new records after opening up 5.3 per cent and 3.6 per cent.
Pfizer shares, listed in New York, saw a bump of more than 8 per cent.
However, some companies that have fared well during the panic – such as Zoom – saw their values fall.
The FTSE 100 index was up more than 5.5 per cent on the successful trials.
The UK’s FTSE index surged by more than five per cent on the news, taking it to the highest level since August
That put it at the highest level since mid-August, while other markets around the world also recorded sharp gains.
Airline group IAG was up 35 per cent, while Rolls Royce saw a 30 per cent spike.
Cinema and hotel chains also received a massive boost as investors digested the optimistic signs.
In Europe, France’s CAC 40 jumped 5.6 per cent to 5,239, while Germany’s DAX surged 5.1 per cent to 13,112.
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.
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.’
Source: | This article originally belongs to Dailymail.co.uk
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