Britain will only have 530,000 doses of the Oxford/AstraZeneca vaccine at its disposal from Monday, the Health Secretary Matt Hancock revealed today after the game-changing jab was approved by the UK medical regulator.
The initial doses fall significantly short of the number touted by the Government in recent months. In May, officials suggested 30million doses of Oxford’s jab would be ready by the end of the year and last month the UK’s vaccine tsar toned the estimate down to 4million, citing manufacturing problems.
But the UK has ordered 100million doses in total and AstraZeneca has promised to deliver 2million a week by mid-January, raising hopes that 24million of the most vulnerable Britons could be immunised by Easter.
In a bid to speed up the roll out, Britain’s regulators are now recommending the jab is given in two doses three months apart, rather than over a four-week period, allowing millions more to be immunised over a shorter time period.
But ministers face the mammoth challenge of trying to rapidly ramp up vaccination capacity to curb the spread of a highly-infectious mutant strain racing across the country. Only about 280,000 Brits are being inoculated against Covid each week and NHS workers — who play a critical role in administering the vaccines — are dealing with record numbers of hospital patients.
Top experts, including members of SAGE, have warned ministers they need to ramp up weekly vaccination rates seven-fold by mid-January to prevent the NHS from being overwhelmed this winter. The new strain of Covid has caused a sharp spike in infections and, while it doesn’t appear more deadly, it spreads more easily than the regular virus which increases the overall volume of people falling ill and needing hospital care.
Today’s approval only applies to two full doses and not the half-dose, full-dose regimen that scientists claimed was up to 50 per cent more effective, with regulators admitting there was not enough data to approve the latter tactic.
But it still significantly increases the likelihood of the Government achieving the target because, unlike the Pfizer jab, Oxford’s can be stored in a normal fridge which makes it easier to transport to care homes and GP surgeries.
Virtually the whole of England is facing brutal lockdown until the spring after Matt Hancock ramped up England’s squeeze and announced three quarters of the country will be in Tier Four from midnight. He warned that vaccines are the only hope of ending the devastation.
Britain will only have 530,000 doses of the Oxford/AstraZeneca vaccine at its disposal from Monday, Health Secretary Matt Hancock admitted today
Top experts, including members of SAGE, have warned ministers they need to ramp up weekly vaccination rates sevenfold to 2million by mid-January to prevent the NHS from being overwhelmed this winter. Currently about 280,000 Brits are being inoculated each week
A volunteer is administered the coronavirus vaccine developed by AstraZeneca and Oxford University, which has been approved for use today
During a round of interviews this morning, AstraZeneca boss Pascal Soriot promised the firm will be able to hit the ambitious target of delivering 2million doses a week by mid-January, while Matt Hancock claimed the NHS could deliver the jab ‘at the pace AstraZeneca can manufacture’ and insisted the bold aim was ‘absolutely deliverable’. But he refused to commit to an actual figure.
There will be doubts about whether scaling up vaccinations so significantly in a matter of weeks is possible. Mr Hancock has also repeatedly failed to hit numerous targets throughout the pandemic, including goals to ramp up test capacity.
But ministers’s hopes of a dramatic scale-up were given a huge boost this morning as the Government’s joint committee on vaccination and immunisation (JCVI) recommended a single dose of either vaccine should be given to as many vulnerable people as possible, rather than sticking to the two-dose strategy.
Regulators have said that both vaccines provide sufficient protection against Covid after the first injection, with the second shot providing long-term immunity. Britons will still receive a second dose of vaccine, but it could be as long as three months later as opposed to the initial plan to give it within four weeks.
It is a direct response to spiking Covid cases and hospitalisations across the UK that are being driven by a new, highly-infectious strain that emerged in the South East England in September. Health bosses now want to give as many people as possible an initial dose, rather than holding back the second doses, so more of the population can enjoy at least some protection.
No10 has pinned its hopes on the Oxford vaccine finally putting an end to the perpetual cycle of locking down and opening up, which has devastated the economy and wider healthcare.
But life is unlikely to go back to normal by Easter even if 24million people are vaccinated because two-thirds of the population will still be vulnerable to the disease. Scientists say herd immunity — when enough of a population becomes immune that the virus fizzles out — will only be achieved when 70 per cent of people are protected. Some experts in the US have warned the figure could be as high as 90 per cent.
HOW DOES THE OXFORD VACCINE WORK?
The vaccine – called ChAdOx1 nCoV-19 – uses a harmless, weakened version of a common virus which causes a cold in chimpanzees.
Researchers have already used this technology to produce vaccines against a number of pathogens including flu and Zika.
The virus is genetically modified so that it is impossible for it to reproduce in humans and cause infection.
Scientists have transferred the genetic instructions for coronavirus’s specific ‘spike protein’ – which it needs to invade cells – to the vaccine.
When the vaccine enters cells inside the body, it uses this genetic code to force the body’s own cells to produce the surface spike protein of the coronavirus.
This induces an immune response because it makes those cells look like the virus, which effectively works as a training aid for the immune system to learn how to fight the virus if the real thing gets into the body.
In clinical trials Oxford’s vaccine was 62 per cent effective at preventing a coronavirus diagnosis if given as two doses, and 90 per cent when one half dose was given followed by a further full dose.
The difference, experts say, may be because a smaller dose the first time allows the body to create a better picture of what the virus will look like before it attempts to launch a full-scale attack, as with a full dose, giving quality first and then quantity later.
Mr Hancock said today’s decision meant Britain can ‘accelerate the vaccine rollout’ and ‘brings forward the day when we can get our lives back to normal’, adding: ‘We will be able to get out of this by the Spring.’
He told Sky News: ‘It is going to be a difficult few weeks ahead. We can see the pressures right now on the NHS and it is absolutely critical that people follow the rules and do everything they can to stop the spread, particularly of the new variant of this virus that transmits so much faster.
‘But we also know that there is a route out of this. The vaccine provides that route out. We have all just got to hold our nerve over the weeks to come.’
Asked if he could provide a timeline for when under-50s without pre-existing conditions may be vaccinated, Mr Hancock told Times Radio: ‘It depends on the speed of manufacture, I wish I could give you a date, your invitation right now, but we can’t because it depends on the speed of the manufacture.
‘This product, it’s not a chemical compound it’s a biological product so it’s challenging to make, so that is the rate-limiting factor in terms of the rollout.
‘Now that we have two vaccines being delivered we can accelerate, how fast we can accelerate will be determined by how fast the manufacturers can produce.
‘But what I can tell you is that I now have a very high degree of confidence that by the spring enough of those who are vulnerable will be protected to allow us to get out of this pandemic situation.
‘We can see the route out and the route out is guided by this vaccine and that’s why this is such good news for everyone.’
The race is now on to ramp up vaccine capacity to 2million per week. ‘Professor Lockdown’ Neil Ferguson, an epidemiologist at Imperial College London and member of SAGE, told the BBC yesterday the 2million doses was ‘what we need to be getting to, very quickly indeed’.
Professor Ferguson – who quit SAGE after he was caught breaking social distancing rules to meet his married lover during Britain’s first lockdown – was giving his support to a study by the London School of Hygiene and Tropical Medicine, which concluded the vaccine target would need to be met and Tier 4 would be needed across England to protect intensive care wards.
The study said there was nothing to indicate the new strain of the virus, which first emerged in Kent in September and has quickly become the dominant strain, was more deadly or causes more serious illness than normal Covid.
But because it appears to be 50 per cent more infectious, it has the potential to cause a more severe wave of cases that lead to many more hospitalisations.
Pfizer warns there is NO proof its Covid jab works when doses are taken 12 weeks apart as UK regulator scraps 21-day rule in desperate attempt to get millions more vaccinated
The UK medical regulator is now recommending Covid jabs are given in two doses three months apart, rather than over the intended four-week period, to allow millions more people to be immunised over a shorter time period.
The strategy will apply to both Pfizer/BioNTech’s vaccine and the newly approved jab by Oxford/AstraZeneca, despite limited data around the effectiveness of the initial doses.
It is a direct response to spiking Covid cases and hospitalisations across the UK that are being driven by a new, highly-infectious strain that emerged in the South East England in September.
Health bosses now want to give as many people as possible an initial dose, rather than holding back the second doses, so more of the population can enjoy at least some protection.
In a thinly-veiled swipe at the UK, Pfizer warned that any ‘alternative’ dosing regimens should be closely monitored by health authorities. The US firm said there was ‘no data’ in its studies to show its vaccine protects against Covid when taken 12 weeks apart.
‘Data from the phase three study demonstrated that, although partial protection from the vaccine appears to begin as early as 12 days after the first dose, two doses of the vaccine are required to provide the maximum protection against the disease, a vaccine efficacy of 95 per cent,’ Pfizer said in a statement.
‘There are no data to demonstrate that protection after the first dose is sustained after 21 days.’
Throughout the testing stage of the Oxford vaccine, volunteers were given a second dose four weeks after receiving the initial shot.
However, AstraZeneca confirmed a small sub-group was injected with a second dose following a three-month wait and enjoyed sufficient protection.
‘It may be necessary to greatly accelerate vaccine roll-out to have an appreciable impact in suppressing the resulting disease burden,’ the study said.
Oxford University/AstraZeneca’s vaccine was approved this morning by the UK medical regulator and will begin to be rolled out from Monday, raising hopes that the 2million a week target can be achieved.
AstraZeneca’s chief executive Pascal Soriot told BBC Radio 4’s Today programme deliveries will be ramped up ‘very rapidly’ in the first and second week of January.
He added: ‘We will start delivering this week – maybe today or tomorrow we will be shipping our first doses. The vaccination will start next week and we will get to one million a week and beyond that very rapidly.
‘We can go to two million. In January we will already possibly be vaccinating several million people and by the end of the first quarter we are going to be in the tens of millions already.’
AstraZeneca said it aimed to supply millions of doses in the first quarter of next year as part of an agreement with the Government to supply up to 100 million doses.
In another major boost, the JCVI this morning gave the Government the green light to give just a single dose of the Covid vaccines to as many vulnerable groups as possible, as opposed to sticking to the intended two-dose strategy.
The JCVI said everyone who receives the Pfizer/BioNTech and Oxford University/AstraZeneca vaccines will still receive their second dose, but this will be within 12 weeks of the first. They were originally intended to be given within a month of each other
Professor Wei Shen Lim, chairman of the JCVI, said that with Covid infection rates currently at a high level, the ‘immediate urgency is for rapid and high levels of vaccine uptake’.
He said that after a first dose people acquire a high level of protection, and the JCVI therefore recommends delivery of the initial dose should be prioritised for both the Pfizer and AstraZeneca vaccines.
He told a Downing Street data briefing: ‘This will allow the greatest number of eligible people to receive vaccine in the shortest time possible and that will protect the greatest number of lives
A spokesperson for the Department of Health and Social Care (DHSC) said: ‘Everyone will still receive their second dose and this will be within 12 weeks of their first. The second dose completes the course and is important for longer term protection.’
This means that the vaccines can be deployed in a way that reaches as many people as possible as quickly as possible – with the emphasis on targeting the vulnerable groups first.
Former PM Mr Blair welcomed that the government seemed to be following his blueprint of using the available stocks to give a single dose to as many people as possible.
‘The trial results make the case for using all available vaccines to vaccinate people with the first dose, without holding back a second dose for each person, overwhelming,’ he said.
‘The first dose gives a high level of immunity – enough to halt hospital admissions – and the second dose is in any event at its most effective 2/3 months after the first, by which time we will have extra supplies of the vaccine to cover second doses.
Pregnant women can take Covid vaccine ‘when potential benefits outweigh the risks’
Pregnant and breastfeeding women can take either of the two approved coronavirus vaccines ‘when the potential benefits outweigh the risks’, the UK’s medicines regulator said.
The Pfizer/BioNTech vaccine can also now be administered to people with a wide range of food and medicines allergies, experts said at a Medicines and Healthcare products Regulatory Agency (MHRA) briefing.
However, people allergic to ingredients in the vaccine should not take it, MHRA chief executive Dr June Raine said.
And the interval between people receiving the first and second doses of the Pfizer/BioNTech vaccine has been increased to ‘at least’ 21 days.
Dr June Raine, MHRA chief executive, set out a series of updates for usage of the Pfizer vaccine, which was approved on December 2, in a briefing on Wednesday.
She said previous advice had not recommended its use by pregnant and breastfeeding women due to ‘an initial lack of evidence on a precautionary basis’.
She said: ‘But now that we have reviewed further data that has become available, the Commission on Human Medicines has advised that the vaccine can be considered for use in pregnancy when the potential benefits outweigh the risks, following an individual discussion with every woman.
‘Women should always be discussing benefits and risks of having the vaccine with their health professional, reaching a decision together based on individual circumstances, and women who are breastfeeding can now also be given the vaccine, subject to that individual discussion.’
MHRA written guidance published on Wednesday about the Oxford/AstraZeneca vaccine, approved hours earlier, said preliminary animal studies do not indicate direct or indirect harmful effects for pregnancy, embryo-foetal development, childbirth or postnatal development.
It recommends the vaccine should only be considered for use in pregnancy when the potential benefits outweigh the potential risks for the mother and foetus.
It said it is not known whether the Oxford vaccine is excreted in human milk.
Advice by the Joint Committee on Vaccination and Immunisation (JCVI) has also been amended, the UK’s four chief medical officers said in a statement.
The JCVI now recommends that either vaccine should be considered in pregnancy where the risk of exposure to Covid-19 is ‘high and cannot be avoided’, or where the woman has underlying conditions heightening her risk of serious complications.
They said: ‘Those who are trying to become pregnant do not need to avoid pregnancy after vaccination, and breastfeeding women may be offered vaccination with either vaccine following consideration of the woman’s clinical need for immunisation against Covid-19. The UK chief medical officers agree with this advice.’
Previous MHRA advice said people with a range of allergies to food and medicines should not be given the Pfizer/BioNTech vaccine.
Dr Raine said growing evidence from a pool of at least 800,000 people in the UK and probably 1.5 million people in the US who have had the vaccine has ‘raised no additional concerns’.
This, she continued, ‘gives us further assurance that the risk of anaphylaxis can be managed through standard clinical guidance and an observation period following vaccination of at least 15 minutes.
‘And so the Commission on Human Medicines has now advised that anyone with allergy to food or other medicine or vaccine can have the Pfizer/BioNTech vaccine.
‘Of course, anyone with a history of allergic reaction to this vaccine, or its ingredients, should not.’
‘In addition, the Government should consider urgently: acceleration of the vaccination programme. Of course, 1m vaccinations a week is remarkable by normal standards.
‘But given the rates of transmission and the costs of lockdown, we need to do much more. Given the advantages of the AstraZeneca vaccine in terms of simplicity to administer – like the flu jab – we should surely be using every available potential resource including all pharmacies, occupational health capacity and those suitable to be trained fast to administer vaccines and increase the rate of vaccination.
‘And we should think about greater flexibility in the plan, with vaccination of groups most likely to transmit the virus and hotspot areas as well as age and vulnerability.’
Some scientists have welcomed the decision, saying it will allow greater ‘flexibility’ in the vaccination programme. But pharmaceutical giant Pfizer said that it only assessed its vaccine on a two-dose regimen whereby people were given the jab three weeks apart.
In a statement it said: ‘Pfizer and BioNTech’s phase three study for the Covid-19 vaccine was designed to evaluate the vaccine’s safety and efficacy following a two-dose schedule, separated by 21 days.
‘The safety and efficacy of the vaccine has not been evaluated on different dosing schedules as the majority of trial participants received the second dose within the window specified in the study design.
‘Data from the phase three study demonstrated that, although partial protection from the vaccine appears to begin as early as 12 days after the first dose, two doses of the vaccine are required to provide the maximum protection against the disease, a vaccine efficacy of 95%.
‘There are no data to demonstrate that protection after the first dose is sustained after 21 days.
‘While decisions on alternative dosing regimens reside with health authorities, Pfizer believes it is critical that health authorities conduct surveillance efforts on any alternative schedules implemented and to ensure each recipient is afforded the maximum possible protection, which means immunisation with two doses of the vaccine.’
Commenting on the decision, Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine, said: ‘The decision to allow both the currently UK authorised vaccines to be given with a greater delay between doses to maximise the numbers getting one dose as rapidly as possible is a sensible one.
‘It cannot have been an easy decision, since the evidence on the efficacy of one dose was more limited, but the crisis in the UK requires more than the usual regulatory approach.’
Professor Robert Read, head of clinical and experimental sciences within medicine at the University of Southampton, added: ‘JCVI has advised that whilst we should be prepared to give people the second dose, it is acceptable to give that within 12 weeks of the first dose. This allows some much-needed flexibility in a programme as big as this.’
Ian Jones, professor of virology at the University of Reading, added: ‘A level of immunity sufficient to prevent severe disease can be generated after only one inoculation of this vaccine so the revised JCVI advice to prioritise giving those at risk their first dose is a sensible idea.
‘It will allow more people in this group to be treated with initial supplies, reduce the threat of hospitalisation from Covid-19, and accelerate the return to normality.’
Lawrence Young, professor of molecular oncology at Warwick Medical School, said: ‘To maximise the number of at-risk groups receiving the vaccine, the first dose will be given to as many people as possible with the second dose being delayed for up to 12 weeks. This will allow the 100 million vaccine doses ordered by the UK Government to be rolled out to as many people as possible starting as soon as next week.’
Mr Hancock will announce the changes to Tiers in the Commons later with insiders questioning whether the vaccine news has been released as a precursor for stricter lockdown restrictions.
Yesterday’s infection tally of 51,135 is the highest toll officially recorded by the Department of Health in a single 24-hour period and it marks a sharp 44 per cent rise on last Tuesday’s figure of 36,804.
Reacting to Oxford’s approval today, a Department of Health and Social Care spokesman said: ‘The Government has today accepted the recommendation from the Medicines and Healthcare products Regulatory Agency (MHRA) to authorise Oxford University/AstraZeneca’s Covid-19 vaccine for use.
‘This follows rigorous clinical trials and a thorough analysis of the data by experts at the MHRA, which has concluded that the vaccine has met its strict standards of safety, quality and effectiveness.’
In a statement, Health Secretary Matt Hancock said: ‘This is a moment to celebrate British innovation – not only are we responsible for discovering the first treatment to reduce mortality for Covid-19, this vaccine will be made available to some of the poorest regions of the world at a low cost, helping protect countless people from this awful disease.
‘It is a tribute to the incredible UK scientists at Oxford University and AstraZeneca whose breakthrough will help to save lives around the world. I want to thank every single person who has been part of this British success story. While it is a time to be hopeful, it is so vital everyone continues to play their part to drive down infections.’
And Professor Andrew Pollard, director of the Oxford Vaccine Group and chief investigator of the Oxford trial, said: ‘The regulator’s assessment that this is a safe and effective vaccine is a landmark moment, and an endorsement of the huge effort from a devoted international team of researchers and our dedicated trial participants.
‘Though this is just the beginning, we will start to get ahead of the pandemic, protect health and economies when the vulnerable are vaccinated everywhere, as many as possible as soon possible.’
Data published in The Lancet medical journal in early December showed the vaccine was 62% effective in preventing Covid-19 among a group of 4,440 people given two standard doses of the vaccine when compared with 4,455 people given a placebo drug.
Of 1,367 people given a half first dose of the vaccine followed by a full second dose, there was 90% protection against Covid-19 when compared with a control group of 1,374 people.
The overall Lancet data, which was peer-reviewed, set out full results from clinical trials of more than 20,000 people.
Among the people given the placebo drug, 10 were admitted to hospital with coronavirus, including two with severe Covid which resulted in one death. But among those receiving the vaccine, there were no hospital admissions or severe cases.
The half dose followed by a full dose regime came about as a result of an accidental dosing error.
However, the MHRA was made aware of what happened and clinical trials for the vaccine were allowed to continue.
In an interview with the Sunday Times, AstraZeneca chief executive Pascal Soriot suggested that further data submitted to the regulator showed the vaccine could match the 95% efficacy achieved by the Pfizer/BioNTech and Moderna vaccines.
‘We think we have figured out the winning formula and how to get efficacy that, after two doses, is up there with everybody else,’ he said.
On Monday, Calum Semple, professor of outbreak medicine at the University of Liverpool and a member of the Scientific Advisory Group for Emergencies (Sage), described the vaccine as a ‘game changer’ but said it would take until summer to vaccinate enough people for herd immunity – when the virus struggles to circulate’.
To get the wider community herd immunity from vaccination rather than through natural infection will take probably 70 per cent to 80 per cent of the population to be vaccinated, and that, I’m afraid, is going to take us right into the summer, I expect,’ he said.
A dosing error, the death of a Brazilian doctor, and the trial being paused: The troubled path to getting Oxford’s Covid jab approved in Britain (and how two professors behind the vaccine stand to make MILLIONS)
Britain today approved the Oxford/AstraZeneca Covid-19 vaccine, paving the way for millions to receive the jab within weeks and offering hope that the UK could be ‘out’ of the coronavirus crisis by the spring.
But it has been a troubled road to getting the vaccine over the line.
Regulators were left with a dilemma after it emerged the jab was 62 per cent effective when given as two full doses, yet could prevent up to 90 per cent of infections when administered as a half dose followed by a full dose.
Leading the team is Sarah Gilbert, a British vaccinologist who is Professor of Vaccinology at Oxford University
Adrian Hill is an Irish vaccinologist and director of the Jenner Institute – which develops vaccines and carries out clinical trials for diseases including Malaria, Tuberculosis and Ebola
The second dosing method, however, was based on a tiny sample size and included no-one over the age of 55 — who are most at risk from the virus.
And the scientific trial of the jab was plunged into crisis mode in September after a volunteer suffered ‘transverse myelitis’ — swelling in the spine. Academics behind the study dismissed the side effect as being linked to the jab but conceded that they had to pause the research to investigate the matter.
They were rocked again in October when Brazilian doctor and trial volunteer Dr João Pedro R. Feitosa, 28, died from Covid-19 after getting a jab, but it quickly emerged he was in the experimental group and did not get the Oxford vaccine.
It comes after it was revealed Oxford University stands to make hundreds of millions of pounds if its coronavirus vaccine proved successful, after it secured a deal giving the institution six per cent of all profits.
And Oxford professors Sarah Gilbert and Adrian Hill — who helped develop the jab — also stand to make millions after their company Vaccitech created the experimental jab alongside experts at the university’s Jenner Institute.
Companies House records show the experts own 10 per cent of the company, which was valued at £65.8million last year before the pandemic hit. It means the pair will be entitled to their share of revenue when the Covid-19 jab makes it to market.
AstraZeneca has promised not to make money on the first three billion doses — but with booster shots and the spectre of further vaccines being needed in the future, they could stand to rake in hundreds of millions.
The Medicines and Healthcare products Regulatory Agency (MHRA) today approved the jab to be given as two doses between four to 12 weeks apart.
The significant gap sparked hopes that millions more people could be vaccinated quicker, allowing the UK to exit the pandemic faster.
Dr João Pedro R. Feitosa (pictured), a 28-year-old from Rio De Janeiro, Brazil, was confirmed to be the volunteer who died in the Brazilian arm of AstraZeneca and the University of Oxford’s coronavirus vaccine trial
They also approved the jab to be given as two full doses. It is thought they took this decision because there was ‘too little’ data available to approve it as a half dose followed by a full dose.
The MHRA’s chief executive Dr June Raine told a press conference today the higher effectiveness of the half dose was not ‘borne out’ in analysis.
The dosing mix-up in the trials, which left regulators with a headache, happened because of a measurement blunder by Oxford University’s researchers.
In May, a quality check on a vaccine delivery from a manufacturer in Italy found the chemicals were more potent than ordered, according to an investigation by Reuters.
The Italian firm, IRBM/Advent, insisted batch K.0011 contained the right concentration of vaccine after checking it using a genetic test known as quantitative PCR, which works out the amount of viral material per millilitre.
But Oxford used a different type of test that estimates the amount of viral matter based on how much ultraviolet (UV) light the material absorbed.
The university believed its method gave a more accurate measurement and so diluted the dose meaning it became a half dose batch.
The error, detailed by documents published in journal The Lancet, happened as a product mixed with the solution before it is administered interfered with the UV test, leading to an overestimate of the batch strength.
The mistake was only picked up in June, after Oxford scientists found those that received doses from batch K.0011 suffered less potent side-effects.
With the blessing of the UK’s drug regulator the MHRA, they pressed ahead with the trial and gave those volunteers – and all other volunteers – full doses for the rest of the study.
An AstraZeneca boss said earlier this month the company would have run the trials differently if it had been in charge.
Dr Mene Pangalos told BBC Panorama: ‘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.’
Trials were also suspended on September 9 when a volunteer was rushed to hospital with inflammation in the spinal cord.
After an assessment they were allowed to resume in the UK on September 12, but the US kept them paused for a further month.
An internal safety report revealed the British patient was diagnosed with transverse myelitis, an inflammation of a section of the spinal cord.
The condition damages the myelin sheath, an insulating barrier of fatty protein that protects the nerves, and interrupts messages sent by spinal cord nerves.
This results in pain, weakness, abnormal sensations, and problems of the bladder and bowel – and can even lead to permanent paralysis.
But according to documents obtained by the Wall Street Journal regulators ruled that the vaccine did not directly cause the neurological issue but that a link between it and the shot should not be ruled out.
The death from Covid-19 of volunteer Dr Feitosa plunged the trials into further turmoil in October, after it was reported by Brazilian media.
But newspaper Globo and news agency Bloomberg later revealed he was in the control group and had not received the Oxford vaccine, citing sources close to the trials.