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)
- Scientists heralded ‘ray of hope’ at the end of a very challenging year
- Error in trials led to some volunteers receiving a half dose and full dose regime
- This was 90 per cent effective, compared to a 62 per cent as two full doses
- Oxford University could make millions after taking six per cent of profits
- And two professors could also become millionaires after inventing the jab
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.
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.
More than 24,000 volunteers were involved in Oxford’s phase three trials in the UK and Brazil, half of which were given the vaccine and the rest were given a fake jab
Leading the team is Sarah Gilbert, a British vaccinologist who is Professor of Vaccinology at Oxford University
The Medicines and Healthcare products Regulatory Agency (MHRA) today approved the Oxford coronavirus vaccine for people in the UK
DOSING ERROR IN OXFORD VACCINE TRIALS LED TO CONFUSION OVER WHETHER HALF DOSE SHOULD BE GIVEN
An error in the Oxford coronavirus vaccine trials led to suggestions patients should receive a half dose followed by a full dose, instead of the two full doses recommended.
In the trials volunteers receiving two full doses were 62 per cent likely to be protected from the virus.
But in those that got a half dose up to 90 per cent were thought to have achieved immunity.
The discrepancy left regulators poring over reams of data to establish which dosing regimen to approve.
But today Britain’s regulator approved the vaccine to be given as too full doses.
Dr June Raine, its chief executive, said today their analysis revealed it was not ‘borne out’ that the half dose gave greater protection against Covid-19.
In the trials fewer people received the half dose – 3,000 compared to 9,000 – and it was given to no one over 55, who are more at risk from the virus.
The mix-up 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 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.
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.
The mix-up has left regulators across the world scratching their heads over whether to approve the vaccine, because it has different trial data to others.
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 Oxford vaccine is a genetically engineered common cold virus that used to infect chimpanzees. It has been modified to make it weak so it does not cause illness
A graph showing vaccine orders made by the EU, US, Canada, UK, Japan and Australia
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
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.
Dr Feitosa had been treating Covid-19 patients since March in the emergency rooms and intensive care units at two hospitals in Rio de Janeiro, Globo said.
He graduated from medical school last year, and was in good health prior to contracting the disease, family and friends told the newspaper.
Oxford University said at the time the trials would continue after the death, adding an internal review had revealed no safety concerns.
Oxford University stands to make millions from the vaccine’s roll out, alongside the scientists behind the jab.
Bosses at Oxford made the deal with AstraZeneca – the UK pharmaceutical giant that will manufacture and distribute the vaccine – to avoid repeating mistakes in the past.
The last time the university saved the world from deadly infections, through its development of penicillin in 1940, it was not savvy enough to make money from it.
Although the first three billion doses will be supplied at cost, the vaccine may then have to be taken annually – like the flu jab – to give a booster shot as immunity diminishes.
Should the vaccine be approved in other countries and be required every year, they could stand to make hundreds of millions of pounds.
It is also the easiest vaccine to roll out at present because it can be stored in a household fridge, whereas Pfizer’s needs to be kept at -70C (-94F).
The deal between Oxford and Cambridge-based AstraZeneca was likely struck back in spring, but was reported in October by the Wall Street Journal.
Louise Richardson, the vice chancellor of Oxford, said the university was keen not to make the same mistakes as it did 80 years ago with penicillin.
In 1940, Oxford scientists Howard Florey and Ernst Chain proved penicillin could clear bacterial infections, leading to the world’s first antibiotic.
Despite revolutionising medicine at the time, the university barely made any money from its discovery.
Oxford professors Ms Gilbert and Mr Hill also stand to get a cut from the jab, after their start-up was behind the invention.
For comparison, influenza vaccines make around £4billion profit for pharmaceutical companies every year, globally.
Several Chinese investors, including a Dutch arm of the controversial Chinese firm Huawei, also own shares in the company listed as Vaccitech’s biggest funder.
It means Huawei — which has been blacklisted by the UK and US amid fears it could use its tech to spy on the West — may also gain handsomely if the Covid-19 jab is proven to work and be safe over the next few months.
The Oxford scientists behind new COVID vaccine: A mother of triplets who is ‘used to working on no sleep’, the biologist who failed to get into medical school and an Everest mountaineer are all on team
They are the lab-coat wearing virus-fighting team who may have landed the killer blow in the battle against Covid-19.
Oxford University has today announced its clinical trial results for its jab, which show it is up to 90 per cent effective at stopping the virus.
The news is a huge boost to the Government, which already has 4million doses ready to be administered as soon as it’s approved and has ordered 100million.
The jab is expected to cost just £2 a time and can be stored cheaply in a normal fridge, unlike other vaccines made by Pfizer and Moderna that showed similarly promising results last week but need to be kept in ultra-cold temperatures using expensive equipment.
But who are the ‘fantastic five’ behind the newest jab – which the Government hope could help restore normality to British life?
Sarah Gilbert
Leading the team is Sarah Gilbert, a British vaccinologist who is Professor of Vaccinology at Oxford University
Sarah Gilbert is a British vaccinologist who is Professor of Vaccinology at Oxford University.
She has more than 25 years experience in the field and has previously led the development and testing of a universal flu vaccine, which underwent clinical trials in 2011.
Professor Gilbert is not just busy at work, she’s got her hands full at home too, being the mother of triplets.
Born in April 1962, she attended Kettering High School, before attending the University of East Anglia, in Norwich, where she studied Biological Science and later University of Hull for her doctoral degree.
She later took roles in Gloucestershire, Nottinghamshire and Leicestershire before joining the lab of Irish vaccinologist Adrian Hill, where she carried out research into malaria. The pair are both involved in Oxford University spin-off biotech firm Vaccitech.
She was made Professor at the Oxford-based Jenner Trust in 2010 and started work on research for a universal flu vaccine, which underwent clinical trials in 2011.
The 58-year-old’s work this year on the Covid-19 vaccine has earned her a spot on The Times’ ‘Science Power List’ in May 2020.
She has had to juggle the intense work with her home life, including being a mother to triplets – all of who are now at university.
Earlier this year, Professor Gilbert told the Independent: ‘I’m trained for it – I’m the mother of triplets.
‘If you get four hours a night with triplets, you’re doing very well. I’ve been through this.’
Adrian Hill
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
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.
Formed in November 2005, the institute is named after Edward Jenner – the inventor of vaccinations.
Born in Dublin, Ireland, in 1958, Professor Hill attended Belvedere College in Dublin for secondary school. He later went on to study medicine at Trinity College in Dublin, before transferring to Magdelan College in Oxford – where he completed the rest of his medical degree.
He later joined charity the Wellcome Trust and in 2014 he led a clinical trial of a vaccine for Ebola following the outbreak in Africa.
According to the New York Times, Professor Hill became interested in vaccines in the early 1980s, when he visited an uncle who was a priest working in a hospital in Zimbabwe.
He said: ‘I came back wondering, ‘What do you see in these hospitals in England and Ireland?’. They don’t have any of these diseases.’
Andrew Pollard
Andrew Pollard is the director of the vaccine group. He is also a Professor of paediatric infection and immunity at the University of Oxford
Andrew Pollard is the director of the Oxford vaccine group. He is also a Professor of paediatric infection and immunity at the University of Oxford, honorary consultant paediatrician at Oxford Children’s Hospital and Vice Master of St Cross College, Oxford.
After obtaining his medical degree at St Bartholomew’s Hospital Medical School at the University of London in 1989, he trained in paediatrics at Birmingham’s Children’s Hospital.
He later specialised in Paediatric Infectious Diseases at St Mary’s Hospital, London, UK and at British Columbia Children’s Hospital, Vancouver, Canada.
He has been a member of the World Health Organisation’s SAGE committee on Immunisation since 2016.
He has published 46 papers in his field and has supervised 37 PhD students.
His publications includes over 500 manuscripts and books on various topics in paediatrics and infectious diseases.
Outside of work, Professor Pollard made the first British ascent of Jaonli (6632m) in 1988 and Chamlang in 1991 (7309m) and was the Deputy Leader of the successful 1994 British Medical Everest Expedition.
Teresa (Tess) Lambe
Teresa Lambe is an associate professor and investigator at the Jenner Institute. She has previous experience working on vaccine research, including into Ebola, the common flu and MERS – another coronavirus
Teresa Lambe is an associate professor and investigator at the Jenner Institute.
She has previous experience working on vaccine research, including into Ebola, the common flu and MERS – another coronavirus.
Dr Lambe grew up in County Kildare, Ireland, and went on to study pharmacology and molecular genetics at University College Dublin, before moving to Oxford University in 2002.
Outside of her work she likes to job and spend time with her husband and children, something which she says she has not had much time to do this year.
She told the Irish Times: ‘I love science and working on vaccines, and I am lucky that this means I get to do something constructive in this pandemic. I want to help, and that keeps me going.’
Professor Katie Ewer
Despite being unable to make the grade for medical school, Katie Ewer did not give up on her dreams. She took up microbiologist instead, and grew fascinated by infectious diseases
Despite being unable to make the grade for medical school, Katie Ewer did not give up on her dreams.
She took up microbiology instead, and grew fascinated by infectious diseases.
After completing her PhD in the subject she joined Oxford University’s Jenner Institute – where she has spent the last 13 years working on a malaria vaccine.
She is now a senior scientist at the Jenner Institute.
When asked by Esquire magazine earlier this year whether the work to develop a vaccine had been stressful, she simply replied: ‘Yes.’
She added: ‘I try not to think about it too much.’
Professor Ewer also added that she has stopped using social media, adding: ‘I had to stop engaging with it because if I think too much about it, I get really stressed.’
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