Safety is 'top of the list' when it comes to making a Covid-19 vaccine, the professor leading Oxford University's vaccine group has said.Sarah Gilb
Safety is ‘top of the list’ when it comes to making a Covid-19 vaccine, the professor leading Oxford University’s vaccine group has said.
Sarah Gilbert, professor of vaccinology at Oxford, said no corners were being cut when it came to ensuring that a vaccine was safe.
Usually the process of making and approving a vaccine takes several years. But already 30,000 volunteers have already received Oxford’s experimental candidate just nine months after the coronavirus was first detected.
Global trials of Oxford’s jab – which Briton has secured 100million doses of – were paused last week when a volunteer fell ill and was taken to hospital.
They resumed on Saturday after investigators said it was safe to do so. Scientists added it was ‘expected’ that ‘some participants will become unwell’ in large vaccine trials.
Government sources have said a vaccine may start to be rolled out across the UK population by next spring. But other scientists, including ones in China, believe one could be ready by this Christmas.
But Professor Gilbert revealed there was a need to ‘temper people’s expectations somewhat’ about a timeline for final delivery because ensuring the vaccine is safe can be a lengthy process.
Sarah Gilbert, professor of vaccinology at Oxford University, said safety is ‘top of the list’ when it comes to developing a Covid-19 vaccine
Asked what message she wanted to give the millions of people waiting for a vaccine, Professor Gilbert told the BBC’s The Life Scientific podcast: ‘I suppose what I’d like them to understand is there are a lot of people working very, very hard on this – and always putting safety at the top of the list.
‘Safety is always paramount in the vaccine development that we do and we need to take our time to go through the process of testing the vaccine properly.
‘I know people are impatient to know the results but we can’t get the result without doing these very careful clinical studies.
‘And then we will report on the results, and then hopefully we’ll be able to move forward and start getting people vaccinated.’
WHICH VACCINES HAS THE UK SECURED DEALS FOR?
The UK’s taskforce has secured more than 200million doses of potential vaccines being produced worldwide
- GlaxoSmithKline and Sanofi Pasteur vaccine, based on seasonal flu: 60million doses
- AstraZeneca/Oxford vaccine, genetically engineered virus: 100million
- BioNTech/Pfizer, mRNA vaccine using genetic material from virus: 30million
- Valneva, an inactivated whole virus: 60million
- Janssen (Johnson & Johnson), injects proteins from virus surface: 30million
- Novavax, proteins from virus surface: 60million
- Imperial College London, mRNA vaccine using genetic material from the virus: Amount not confirmed
Professor Gilbert said it was ‘really important’ to run the clinical trials properly.
Oxford’s jab, being manufactured by the drug giant AstraZeneca, was one of the world’s first vaccines to go into trial.
It’s now in Phase 3 trials, after the first two trials showed the jab prompted a strong immune response. It is yet to be proved that this prevents Covid-19 infection.
Professor Gilbert said: ‘Although the clinical trials got started up quickly and then progressed rapidly, we haven’t missed out any of these steps in the approvals of the safety oversight of those trials.
‘Everything is being done, as it should be done, it’s been done faster than usual because we’ve been able to take out some of the gaps that normally occur, but we’re not cutting any steps out.’
Professor Gilbert said years of work had already been done on the type of vaccine involved in the Oxford vaccine trial, which is why it was able to reach clinical trials so rapidly.
‘That’s the whole point of using this type of technology is that so much of the work’s already been done,’ she said.
‘And it’s taken years to get to this point but we’ve done a lot of work on the technology.
‘And now when we want to apply it to make a new vaccine against a different disease, we can go much more quickly.’
AstraZeneca is one of nine leading US and European vaccine developers who pledged on September 8 to uphold the scientific standards their experimental immunisations will be held against as they race to find a Covid-19 jab.
The companies, including Pfizer, GlaxoSmithKline and AstraZeneca, issued what they called a ‘historic pledge’ after a rise in concern that safety and efficacy standards might slip in the rush to find a vaccine.
Johnson & Johnson, Merck, Moderna, Novavax, Sanofi and BioNTech were also signatories.
CHINA VACCINE ‘COULD BE READY BY NOVEMBER’
Coronavirus vaccines being developed in China could be ready for use by the general public as early as November, an official with the Chinese Center for Disease Control and Prevention (CDC) has announced.
Phase 3 clinical trials for the country’s vaccine candidates were proceeding smoothly and Chinese citizens could receive the shots in November or December, Wu Guizhen, CDC chief biosafety expert.
Speaking to state broadcaster CCTV, Wu said ordinary Chinese citizens can expect to receive the shots ‘fairly soon’.
‘It would be about November or December,’ she told the presenter. ‘Ordinary people can be vaccinated with the vaccine, because according to its phase III clinical results, the current progress is proceeding very smoothly.’
Wu, who said she has experienced no abnormal symptoms in recent months after taking an experimental vaccine herself in April, did not specify which vaccines she was referring to.
China has four Covid-19 vaccines in the final stage of clinical trials. At least three of those have already been offered to essential workers under an emergency use programme launched in July.
A unit of state pharmaceutical giant China National Pharmaceutical Group (Sinopharm) and US-listed Sinovac Biotech are developing the three vaccines under the state’s emergency use programme.
A fourth COVID-19 vaccine being developed by CanSino Biologics was approved for use by the Chinese military in June.
Sinopharm said in July that its vaccine could be ready for public use by the end of this year after the conclusion of Phase 3 trials.
The next day, the news broke that trials of Oxford University’s coronavirus vaccine were being put on hold in the UK, US, South Africa and Brazil after a British volunteer was rushed to hospital with a ‘serious adverse reaction’.
The New York Times reported that a volunteer in the UK trial had been diagnosed with transverse myelitis, an inflammatory syndrome that affects the spinal cord and can be caused by viral infections.
This has never been confirmed by AstraZeneca or Oxford due to confidentiality reasons.
The global trials were resumed again on Saturday to much relief, following the recommendations of an independent safety review committee and the UK regulator, the Medicines and Healthcare Products Regulatory Agency.
Health Secretary Matt Hancock said of the news: ‘This pause shows we will always put safety first. We will back our scientists to deliver an effective vaccine as soon as safely possible.’
AstraZeneca’s Covid-199 vaccine trial remains on hold in the United States, however, pending a US investigation, sources told Reuters.
Professor Gilbert said there was still a lot of work to do to set up vaccination clinics and think about transporting a vaccine around the world, which may affect when the jab is available.
‘It’s not going to be as it is in the movies where there’s some kind of breakthrough and then suddenly the entire world is protected, there’s a lot of hard work still to be done,’ she said.
She said everyone involved the development of the vaccine had worked in parallel which meant, for example, that manufacturing had already started on the vaccine.
But she said the team ‘don’t know when we’re going to get the results’ from the clinical trial because it depended on enough people in the study becoming infected with coronavirus.
Asked if the vaccine could be ready in early 2021, she said: ‘We need to get the efficacy results from the clinical trials, and we need then to present that data to a regulatory authority who will authorise emergency use of that vaccine, and that regulatory authority is different in different parts of the world.
‘And then of course we need to have enough vaccine in the freezer manufactured and ready to go to start vaccinating people.
‘So, when will all of that happen? Impossible to say. It’s possible that it happens end of this year, early next year.
‘Nobody can actually put a date on that because so many things have to fall into place.’
Professor Gilbert has commented before that she was confident a vaccine could be ready by the end of 2020.
She said ‘the end of the year target for getting vaccine roll-out is a possibility but there’s absolutely no certainty because we need three things’.
Those three things are the results from phase three trials, the ability for manufacturers to produce large quantities of the virus, and regulators to approve the vaccine.
Russia became the first country in the world to grant regulatory approval to a Covid-19 vaccine on August 11 after less than two months of human testing.
The move stirred uproar in the scientific commumity that it may be putting national prestige before sound science and safety.
Despite President Vladimir Putin claiming the jab, dubbed Sputnik V, had passed ‘all the needed checks’, there was no evidence of this.
However since then, results from two early clinical trials done in Moscow – published in the prestigious British journal The Lancet – indicate the vaccine is safe and effective.
The Russian scientists behind the studies said the jab stimulated an immune response in all inoculated participants and did not cause any serious health issues.
Independent Western scientists said the results were ‘somewhat reassuring’ but warned the trials were too small and narrow to justify injecting millions of Russians – just 76 people were involved in the study.