The Oxford coronavirus vaccine could still be ready by the end of this year or early next year, the company developing it has claimed, despite trials being paused this week.
Pascal Soriot, the CEO of drug giant AstraZeneca, told an online event he thought vaccine development remained ‘on track’ but they would have to wait for permission from an independent safety panel before resuming research.
Trials were paused on Wednesday after a British woman who received the vaccine reportedly suffered transverse myelitis, or a swelling of the spinal cord.
The company has denied these claims, and said more tests are needed before a final diagnosis can be made.
The Government’s chief scientist, Sir Patrick Vallance, warned yesterday that a coronavirus vaccine may not be ready until after Christmas.
Oxford’s vaccine is one of nine candidates in the world to have reached stage three clinical trials, and has been earmarked as most promising by the World Health Organisation.
Millions of doses have been ordered by nations around the world, should the vaccine prove effective and safe to use.
The CEO of AstraZeneca, Pascal Soriot (pictured), said he still thought the vaccine would be ready by the end of this year
Oxford vaccine volunteer reveals he suffered fever, chills, headache and fatigue
An Oxford AstraZeneca vaccine volunteer has revealed he suffered fever, chills, headache and fatigue 14 hours after having the anti-Covid jab.
A volunteer, who has asked not to be named and received his first shot in May, told MailOnline: ‘I woke up about 2am and I was freezing, but had a temperature above 39C.
‘I felt incredibly weak and couldn’t really get up and move so my partner had to get me a paracetamol.
‘The temperature continued for about a day, and I just felt really weak and lethargic and couldn’t really do anything.’
The volunteer said he felt so unwell and fatigued that all he could do was sleep for most of the second day after the injection.
The volunteer said he was due to have a booster shot on Monday, but the night before he received an email from the project manager cancelling the appointment.
The email read: ‘As an illness in a volunteer that may or may not be related to vaccine has been identified, we are postponing clinics till we have more information.
Oxford coronavirus volunteer Jack Sommers, 35, also received a dose
Jack Sommers, 35, from London, has also taken part in the Oxford coronavirus vaccine trials.
Mr Sommers, a freelance journalist, had his first injection in May and has since volunteered to have another dose
He said: ‘If I was to keel over I would have done it by now. That’s why I’m not scared of having it again.’
This is so careful, it’s run by Oxford University, it’s got the Government involved and it’s got AstraZeneca backing it.
‘They’ve already been through ferrets, mice and monkeys, so they’re about as certain as they can reasonably be that it’s not going to do anyone any harm.
‘My sense is that anyone who volunteered in the first place will not be put off by this, because you’ve got this appreciation of the risks.’
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CEO Soriot said once the volunteer’s illness was diagnosed it would be submitted to an independent safety committee for review, which would decide whether trials can continue.
Answering questions on why research had been paused he said it was ‘very common’ for this to happen during clinical trials.
But he added: ‘The difference with other vaccine trials is, the whole world is not watching them, of course. They stop, they study, and they restart.’
An AstraZeneca spokesman yesterday denied claims that a British woman in the trials had suffered transverse myelitis, stating.
‘We can also confirm that there was a brief trial pause in July while a safety review took place after one volunteer was confirmed to have an undiagnosed case of multiple sclerosis, which the independent panel concluded was unrelated to the vaccine.’
The vaccine, called AZD1222, is being trialled in up to 60,000 patients, which Soriot said was ‘typical’ for trials and large enough for spotting side effects.
‘With this you are going to pick up very rare events.’ he said adding that a planned staggered launch, prioritising at-risk groups, would provide further assurance for the masses that are set to be covered by government plans at a later stage.
Volunteers have been recruited in the UK, US, Brazil and other countries in South America to trial the vaccine.
It uses a weakened version of the common cold adenovirus which has been engineered to carry the protein found on the outside of the coronavirus SARS-CoV-2.
Once participants are exposed to this protein, it is hoped it primes the immune system to mount a successful response if they are later exposed to the real virus.
The director of UK scientific research charity the Wellcome Trust, Jeremy Farrar, said there were often pauses in vaccine trials.
He told BBC radio in an interview that it demonstrated the importance of conducting vaccine trials properly, with independent oversight and the involvement of the regulator.
‘In the end the public must have absolute trust that these vaccines are safe and of course effective, and in the end will hopefully bring the pandemic to a close,’ he added.
The Government’s chief scientist, Sir Patrick Vallance, told a Downing Street press briefing yesterday that a vaccine may still be at least four months away.
‘Vaccines are progressing, some will read out this year in terms of efficacy and safety,’ he said. ‘I think there’s a reasonable chance that therefore we can think about the possibility of vaccination next year some time at larger levels.’
The Health Secretary also warned that the vaccine would not be available this year on Monday, stating: ‘The best-case scenario is that (the vaccine’s roll out) happens this year.
‘I think more likely is the early part of next year – in the first few months of next year is the most likely.’
After it completes clinical trials the vaccine will need to be approved by the regulator, the Medicine and Healthcare products Regulatory Agency, before it is made available to the public.
As many as 100 million doses have already been secured for the UK, Hancock said, while a further 300 million have been ordered by the US.
The roll out will see the vaccine supplied to countries at the same time and in equal amounts to ensure a fair distribution.
AstraZeneca has the capacity to produce close to three billion doses of the vaccine should this be required. Production has already begun, in anticipation of it receiving the go-ahead for use.
He denied claims a volunteer had suffered transverse myelitis, or swelling of the spinal cord
Transverse myelitis cases after a vaccination have been documented before, but concrete links between the condition and vaccinations have not been established, experts said.
The US-based Mayo Clinic concludes that the association so far is not strong enough to warrant limiting any vaccine.
A 2009 review in the journal Lupus of nearly 40 years of English-language publications found 37 cases of transverse myelitis associated with hepatitis B vaccines, measles-mumps-rubella, diphtheria-tetanus-pertussis and others.
The vaccines remained on the market, said Stephen Evans, a professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine.
He added that it was extremely hard to link such autoimmune response to a single factor, saying it is ‘terribly difficult to be sure’.
RBC Capital Markets analyst Bryan Abrahams cautioned the trial participant’s condition must be thoroughly investigated.
‘Even a single case could possibly imply a rate or association higher in the study than what is normally observed sporadically’ he wrote to investors, adding a one in 10,000 risk, if confirmed, would likely be unacceptable.
Race for a coronavirus vaccine: Nine candidates in final stage of clinical trials
As scientists race to develop a coronavirus vaccine to bring the world back to normal, MailOnline has taken a look at the prospective candidates.
Vaccine trials were halted on Wednesday but it may still be ready this year
The Oxford Vaccine
When will it be ready?: The end of 2020/ early 2021. Despite the trials being suspended on Wednesday, its developers and Number 10 remain confident that the vaccine could be ready for use either at the end of this year or early next year. They say a pause is common in trials, and that its development was also stopped in July after a suspected side-effect was detected.
How does it work?: The vaccine works by exposing participants to a weakened common cold adenovirus which has had proteins from the coronavirus SARS-CoV-2 attached to its surface. The idea is that the exposure allows the immune system to build an immune response, meaning they are protected if they are infected by the real virus.
Has the UK secured doses?: Yes, 100 million. The US has secured a further 300 million doses, along with several other countries. These will be rolled out in an equitable manner.
How much does it cost?: AstraZeneca, which is developing the vaccine with Oxford University, has said it will not profit from the it, but may earn extra royalties if the coronavirus becomes an endemic infection like flu. The US has spent $1.2 billion (£930 million) securing doses, meaning they are worth $4 (£3.10) each.
Biontech, Germany
Biontech vaccine may be ready this year
When will it be ready?: At the end of this year, say researchers. The vaccine is being developed by a German company in partnership with American drugmaker Pfizer. It is recruiting 30,000 volunteers to its stage three trials.
How does it work?: This is an RNA vaccine, a type that has never been approved by regulators before. It will involve injecting a fragment of genetic material from coronavirus into participants. This will expose their immune systems to a weakened version of the virus and, hopefully, trigger a response which will protect them from the real virus.
Has the UK secured doses?: Yes, 30 million doses. The US has also ordered 100 million doses.
Price?: The US is paying $2 billion (£1.5 billion) for its doses, or about $20 (£15) a jab.
Moderna, US
Moderna vaccine entered human trials
When will it be ready?: Very end of this year or next year. The vaccine has recruited 20,000 participants for its stage three trials. Providing no potential side effects are observed, it will then go through to a second test on more patients next month. This means it could be available by the end of 2020.
How does it work?: This is an RNA-based vaccine, similar to the one being developed by Biontech.
Has the UK secured doses?: No. Reports suggest the UK’s task force has not managed to secure any doses of this vaccine.
How much does it cost?: The US has ordered 100 million doses at a price of $1.5 billion (£1.1 billion). This means one jab costs $32 (£25).
Sanofi and GlaxoSmithKline, UK and France
Sanofi vaccine won’t be available this year
When will it be ready?: First half of 2021. The vaccine entered phase two clinical trials in September, involving 440 adults. It will reach phase three trials in December this year. There may be setbacks along the way, meaning the vaccine could take longer to develop.
How does it work?: Participants are injected with DNA coding for the antigens of the coronavirus and a chemical which makes it more potent. It is hoped this will trigger an immune response.
Has the UK secured doses?: Yes. Up to 60 million will be supplied should the vaccine be shown to work.
How much does it cost?: Unknown. This information has not been provided.
Sputnik V, Russia
Sputnik V is safe, according to Kremlin, but it has been criticised by scientists
When will it be ready?: ‘Imminently’. The Russian medical research institute and Russian defence ministry have developed this vaccine. But it has faced serious criticism both inside and outside Russia because results from its human trials are yet to be published. It also hasn’t cleared large human trials, with researchers only launching one involving 40,000 volunteers on 26 August. Scientists say the vaccine has been rushed without proper checks, and could pose a risk to those taking it. The Kremlin began appealing for volunteers for the vaccine this week after a first batch was produced, according to the TASS news agency.
How does it work?: The Russian vaccine works by carrying a piece of the coronavirus genetic code into a participant via another virus. It is hoped this will produce an immune response.
Has the UK secured doses?: No. Countries lining up to try the vaccine include Mexico, which has secured 32 million doses, and Kazakhstan, which is set to buy two million.
How much does it cost?: The price of the vaccine is yet to be revealed.
Sinovac, China
It is not clear when the Sinovac vaccine will be available
When will it be ready?: Unknown. The vaccine entered final-stage trials in Brazil in July, and then in Indonesia in August. Results show that while younger and middle-aged people produced antibodies, older people had a weaker immune response. The vaccine was given emergency approval for limited use in July, reports suggest, although it appears to still be subject to testing. It was previously reported as being second only to the Oxford vaccine, but its complete test results are yet to be published. It is one of four vaccine candidates in development in China.
How does it work?: It involves injecting patients with an inactivated form of the virus, prompting their immune systems to develop a response.
Has the UK secured doses?: Unknown. Reports suggest no doses have been secured.
How much does it cost?: China is yet to publish this information.
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