European countries will have to cover compensation costs if Oxford University's coronavirus vaccine causes any side effects, as part of the EU's deal to secure the experimental jab at a discounted price, it was claimed today.
The European Union is said to have struck a deal with AstraZeneca - which owns the rights to the experimental shot - that diminishes the UK drug giant's liability if people fall ill after being inoculated.
EU countries will pay the reduced price of £2.20 per dose of the Covid-19 vaccine once rigorous scientific trials wrap up and the jab is deemed to be safe by health regulators, likely in early 2021.
Britain has already secured 100million doses of the jab for an undisclosed fee, but AstraZeneca will be expected to shoulder the costs of any negative side effects among Britons.
The EU's deal was struck in August, before late-stage trials of the vaccine were ground to a halt earlier this month when a British volunteer was hospitalised with serious spinal swelling thought to have been triggered by the jab.
But investigators ruled there was no evidence the patient's condition was directly caused by the vaccine and trials have restarted in the UK, Brazil, Indian and South Africa.
Unexpected side effects after a drug has been green-lit by medical regulators are rare because the process for approval is so rigorous. But the speed at which the vaccine is being pursued - vaccines normally take 10 to 15 years to develop - may increase the likelihood of unforeseen problems.
People in the UK are entitled to a one-off tax-free payment of £120,000 if they become 'severely disabled as a result of a vaccination against certain diseases', according to the Government.
But patients need to prove in the courts that their condition was a direct result of a vaccine - which can often be difficult.
AstraZeneca's candidate vaccine, known as AZD1222, is in phase 3 trials - the final stage before safety and efficacy data can be submitted to regulators. Pictured: A Brazilian volunteer receiving the Oxford vaccine, July 24
Trials for AstraZeneca's shot are underway in the US, UK, Australia, Brazil (pictured) and other nations. Phase 3 testing will now be paused while safety data is reviewed
The bloc paid around £300million for 400million doses of Oxford's vaccine in August - but the liability clauses of the deal have not previously been reported.
An EU official - who asked not to be named - told Reuters that AstraZeneca would only pay legal costs up to a certain threshold under the terms of the deal.
They declined to elaborate on the price cap or explain how the costs would be shared with individual European governments.
WHICH COUNTRIES HAVE ORDERED OXFORD'S VACCINE ALREADY?
The UK is the host of research and development efforts of the vaccine, which has been developed by researchers in Oxford and will be manufactured by AstraZeneca, a company based in Cambridge.
The British Government has ordered 100million doses of the jab and has already started manufacturing them so they're ready to go if and when clinical trials are successful. The price paid has not been disclosed.
The US Government has ordered 100million doses of the vaccine and contributed $1.2billion (£910m) to the research and development of the jab.
European Union (EU)
The European Commission has agreed a deal for 300million doses of the vaccine if its clinical trials work, with the option to buy a further 100million. The deal has been made on behalf of countries in the EU. The amount of money spent is unknown.
Australia has confirmed it ordered enough doses of the vaccine to give one to its entire population of 25million people. It is not clear how many doses the nation has ordered. The UK - with a population of 66m but an order of 100m - ordered more than it needs.
One company in China has agreed a deal with AstraZeneca to make at least 100million doses of the vaccine.
Shenzhen Kangtai Biological Products, based in the city of Shenzhen, will increase capacity to 200m per year by the end of 2021.
A Russian company, R-Pharm, also has a deal to produce and distribute the vaccine, but it is unclear how many it will make or what it will pay to AstraZeneca.
Brazilian officials have set aside $360million (£274m) for at least 100million doses of the vaccine. Brazil is currently in one of the worst Covid-19 crises in the world with more than 3.6million official cases so far and 114,000 deaths.
The financial shield, it was reported, would cover both legal costs and potential compensation, which is rarer but potentially a much bigger outlay in the event of something going wrong.
A European Commission spokesman said advance purchase deals 'provide for member states to indemnify the manufacturer for certain liabilities incurred under specific and strict conditions', but 'liability still remains with the companies'.
This means it would be the firm's responsibility to defend its shot in the courts.
Drugmakers have called on EU regulators to set up a Europe-wide compensation scheme, while patients' organisations are calling for an EU-wide fund financed by pharmaceutical firms that would compensate for unexpected side-effects.
The EU legal regime is among the least favourable to drugmakers on compensation claims.
But plaintiffs have rarely managed to win as the law requires them to prove the link between an illness and a vaccine that may have caused it - which is often difficult.
The United States has granted immunity from liability for Covid-19 vaccines that received regulatory approval.
Meanwhile, Russia has said it would shoulder some of the legal liability should anything go wrong with its vaccine, which became the first in the world to be approved last month.
Meanwhile, scientists in the US are calling for answers as to why America's arm of Oxford's Covid-19 vaccine trial is still on hold — two weeks after it was first paused.
AstraZeneca stopped global trials on September 8 because a British volunteer was hospitalised. She has now been discharged.
Uncertainty remains about what happened to the unnamed 37-year-old because of medical confidentiality.
But leaked documents claimed she developed 'transverse myelitis' — a neurological condition which left her struggling to walk.
Doctors restarted trials in the UK on September 12 after an independent safety review committee and the UK regulator, the Medicines and Healthcare Products Regulatory Agency, investigated and deemed it safe to do so.
But US regulators have yet to give it the green light to restart, despite trials of the leading vaccine also continuing in Brazil, India and South Africa.
Scientists are racing to find an effective jab, which could put an end to the pandemic, stop the need for more draconian lockdowns, and save millions of lives.
Experts have blasted drug giant AstraZeneca — based in Cambridge — for not being transparent about the side effect. The firm insists there is no proof to say the adverse reaction was caused by the vaccine itself.
Professor Terry Nolan from the University of Melbourne, said it was entirely plausible the volunteer had suffered transverse myelitis (TM) as a direct result of the vaccine.
The exact cause of TM is unknown, but it has been reported to occur after infections and vaccinations.
Medical news site Stat first reported the pause in the study and said the possible side-effect occurred in a testing volunteer in Britain, who was expected to recover.
The vaccine, developed by Oxford University, is being tested in thousands of people in Britain and the US, and in smaller study groups in Brazil and South America.
An AstraZeneca spokeswoman said the pause is part of a standard review process which occurs in trial if there is a 'potentially unexplained illness' reported in any trial subject, and that the subject's illness could also be coincidental.
'As part of the ongoing randomised, controlled global trials of the Oxford coronavirus vaccine, our standard review process was triggered and we voluntarily paused vaccination to allow review of safety data by an independent committee,' the spokeswoman said in a statement.
'This is a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials.
'In large trials illnesses will happen by chance but must be independently reviewed to check this carefully.
'We are working to expedite the review of the single event to minimise any potential impact on the trial timeline. We are committed to the safety of our participants and the highest standards of conduct in our trials.'
No details about the patient suffering the potential side-effect, or the nature of the reaction, were given.
Temporary holds of large medical studies are not uncommon, and looking into any unexpected reactions is a mandatory part of safety testing. It was not immediately clear how long AstraZeneca's pause would last.
WHICH VACCINES HAVE THE UK SECURED DEALS FOR?
1. GlaxoSmithKline and Sanofi Pasteur: 60million doses
The Government revealed on July 29 it had signed a deal with pharmaceutical giants GlaxoSmithKline (GSK) and Sanofi Pasteur
If the vaccine proves successful, the UK could begin to vaccinate priority groups, such as frontline health and social care workers and those at increased risk from coronavirus, as early as the first half of next year, the Department for Business, Energy & Industrial Strategy (BEIS) said.
Human clinical studies of the vaccine will begin in September followed by a phase 3 study in December.
The vaccine is based on the existing technology used to produce Sanofi's seasonal flu vaccine. Genetic material from the surface protein of the SARS-CoV-2 virus is inserted into insect cells - the basis of Sanofi's influenza product - and then injected to provoke an immune response in a human patient.
2. AstraZeneca (manufacturing University of Oxford's): 100million
AstraZeneca, which is working in partnership with Oxford University, is already manufacturing the experimental vaccine after a deal was struck on May 17.
Professor Sarah Gilbert, who is leading the Oxford team, is confident the jab could be ready for the most vulnerable people by the end of the year.
The team have genetically engineered a virus to look like the coronavirus - to have the same spike proteins on the outside - but be unable to cause any infection inside a person. This virus, weakened by genetic engineering, is a type of virus called an adenovirus, the same as those which cause common colds, that has been taken from chimpanzees.
3. BioNTech/Pfizer: 30million
US drug giant Pfizer - most famous for making Viagra - and German firm BioNTech were revealed to have secured a deal with the UK Government on July 20.
It reported positive results from the ongoing phase 2/3 clinical trial of one called BNT162b1 on July 1. The company is still running phase 2 trials at the moment.
Pfizer's vaccine is one called an mRNA vaccine, which do not directly inject bits of the virus into the body but send genetic material.
mRNA vaccines programme the body to produce parts of the virus itself by injecting the body with a molecule that tells disease-fighting cells what to build. The immune system then learns how to fight it.
4. Valneva: 60million
The Government has given Valneva — whose vaccine is understood to be in the preclinical stages of development — an undisclosed amount of money to expand its factory in Livingston, Scotland.
While the Government revealed a 60million dose deal on July 20, the company said it had reached agreement in principle with the UK government to provide up to 100million doses.
Valneva's jab is an inactivated whole virus vaccine, meaning it injects a damaged version of the coronavirus itself into the body.
The virus has been destroyed in a way that makes it unable to cause infection, but the body still recognises it as a dangerous intruder and therefore mounts an immune response which it can remember in case of a real Covid-19 infection.
5. Janssen (Johnson & Johnson): 30million
The Government has agreed to buy 30million doses of a vaccine made by Janssen if it works.
Officials have agreed to help the company in its development of the jab by part-funding a global clinical trial. The first in-human trials of Janssen's jab began in mid-July and are being done on adults over the age of 18 in the US and Belgium.
The jab is named Ad26.COV2-S, recombinant, and is a type of jab called a viral vector recombinant vaccine.
Proteins that appear on the outside of the coronavirus are reproduced in a lab and then injected into the body to stimulate an immune reaction.
The 'Ad' part of the vaccine's name means it works using an adenovirus - a virus best known for causing the common cold - as a vehicle to transport the coronavirus genetics into the body.
6. Novavax: 60million
Britain has ordered 60million doses of a vaccine being developed by the US-based company Novavax. It will help to fund late-stage clinical trials in the UK and also boost plans to manufacture the vaccine in Britain.
Novavax's jab, named NVX-CoV2373, showed positive results in early clinical trials.
It produced an immune response in 100 per cent of people who received it, the company said, and was safe and 'generally well-tolerated'.
Novavax's candidate is also a recombinant vaccine and transports the spike proteins found on the outside of the coronavirus into the body in order to provoke the immune system.
7. Imperial College London: Unknown quantity
Imperial College London scientists are working on Britain's second home-grown hope for a jab. The candidate is slightly behind Oxford's vaccine in terms of its progress through clinical trials, but is still a major player.
The UK Government is understood to have agreed to buy the vaccine if it works but details of a deal have not yet been publicised.
Imperial's jab is currently in second-phase human trials after early tests showed it appeared to be safe.
Imperial College London will try to deliver genetic material (RNA) from the coronavirus which programs cells inside the patient's body to recreate the spike proteins. It will transport the RNA inside liquid droplets injected into the bloodstream.