AstraZeneca to begin supplying 100 million doses of Covid-19 vaccine to UK from September - if trials succeed
AstraZeneca will begin supplying an order of 100 million doses of a Covid-19 vaccine for British people in September - if ongoing trials prove successful.
CEO Pascal Soriot confirmed on Sunday (May 24) that the UK government had ordered the doses of the University of Oxford’s vaccine candidate, which AstraZeneca will produce.
And he said he was “quite confident” the vaccine would work - but stressed there was a “race” on to prove its efficacy through trials with volunteers as coronavirus cases in the community declined.
“We have to run as far as possible before the disease disappears so we can demonstrate that the vaccine is indeed effective,” he said, revealing that trials were also going ahead in Brazil, which is firmly in the grip of Covid-19.
AstraZeneca announced last week that it had concluded the first agreements for at least 400 million doses of the vaccine.
Health secretary Matt Hancock has said the first 30 million doses for the UK could be available by September.
The United States has ordered 300 million doses, as part of President Donald Trump’s Operation Warp Speed initiative to speed up vaccine production.
AstraZeneca has received more than $1bn from the US Biomedical Advanced Research and Development Authority (BARDA) for the development, production and delivery of the vaccine, starting in the autumn. The programme also includes a phase III clinical trial with 30,000 participants and a paediatric trial.
The company says it has so far secured total manufacturing capacity for one billion doses and is aiming to conclude further agreements with several parallel supply chains, expanding capacity further in the coming months “to ensure the delivery of a globally accessible vaccine”.
Appearing on the BBC’s Andrew Marr Show on Sunday, Mr Soriot was asked if British people will be among the first to get the vaccine, should it prove effective.
“We have actually received an order from the British government to supply 100 million doses of vaccine and those will go to the British people,” he said. “And there is no doubt that starting in September, we will start delivering those doses of vaccine to the British government for vaccination.”
But for that to happen, two things must happen.
“The vaccine has to work - that is one question - and the other question is, even if it works, we have to demonstrate it,” said Mr Soriot.
In taking the vaccine to its first clinical trial just 69 days after the SARS-CoV-2 virus was identified as the cause of the Covid-19 outbreak, a record has already been set.
The phase I clinical trial of the recombinant adenovirus vaccine - which was known as ChAdOx1 nCoV-19 but will now be called AZD1222 - began in April, to assess its safety, efficacy and ability to provoke an immune response in more than 1,000 healthy volunteers aged 18 to 55 years across several trial centres in southern England.
Trial data is expected shortly and, if positive, will lead to late-stage trials in a number of countries.
Meanwhile, a phase II clinical trial is getting under way to expand the age range of people assessed, with 10,260 people across the UK being enrolled, including some children aged 5 to 12 and some people aged over 70. The phase III trial will assess how it works in a large number of people over 18.
But Prof Adrian Hill, director of the Jenner Institute at Oxford University, which created the vaccine technology, has acknowledged that there is only a 50 per cent chance of getting any result at all from the trials as the coronavirus disappears quickly from communities. This makes it difficult to prove any difference between vaccinated volunteers and the control arm in the trial.
The trials are prioritising those with a higher chance of being exposed to the SARS-CoV-2 virus, such as frontline healthcare workers.
Failure to prove the vaccine’s effectiveness would, of course, leave open the prospect of further waves of the virus.
“We are racing as quickly as we can to implement this clinical trial,” revealed Mr Soriot, alluding to the huge impending US trial.
“We are also running trials in Brazil and in Brazil, as you know, the disease is very intense at the moment. We are looking at Russia.
“So we still have all the opportunities to show the benefit of this vaccine. But it is very clear it is a race.”
The pressure of time also restricted the chances of other vaccines being developed, he noted.
If the Oxford vaccine does prove successful, one question is whether it will prevent the virus from infecting an individual, or simply prevent it from making someone sick, raising the question of whether they could still transmit it,
A small study in rhesus macaques suggested it could prove to be the latter - the virus was still present in their noses after the vaccine was administered, research found.
“What it showed is the vaccine protected the animals against the disease. None of those animals developed pneumonia, lung disease,” Mr Soriot told The Andrew Marr Show.
“The question around the vaccine is will some patients need a second dose and also will the vaccine eliminate the virus from the body, or simply protect them against being sick. But being protected from being sick would already be a huge plus.”
AstraZeneca has said it “recognises that the vaccine may not work but is committed to progressing the clinical program with speed and scaling up manufacturing at risk”.
Mr Soriot revealed that supply chains are being set up by the company around the world, including in the UK, US, Europe, India and China.
“There will be no competition between countries as it relates to supply,” he said. “I think everybody around the world will be able to get access to this vaccine, which will cost a couple of pounds. We are doing it at cost - at no profit. So I don’t think there will be a question of who gets it first - everybody will be able to get it.
“The supply for the UK will be manufactured in the UK.”
The supply for Europe will primarily be manufactured on the continent.
“We are really working hard to make sure we offer fair and equitable access to everybody around the world,” said Mr Soriot.
AstraZeneca is working with international organisations such as the Coalition for Epidemic Preparedness Innovations (CEPI), Gavi the Vaccine Alliance and the World Health Organisation (WHO) to ensure this fair access.
Note that country-by-country comparisons are complicated by different testing regimes.
Announcing the orders for 400 million doses last week, Mr Soriot said: “This pandemic is a global tragedy and it is a challenge for all of humanity. We need to defeat the virus together or it will continue to inflict huge personal suffering and leave long-lasting economic and social scars in every country around the world.
“We are so proud to be collaborating with Oxford University to turn their ground-breaking work into a medicine that can be produced on a global scale. We would like to thank the US and UK governments for their substantial support to accelerate the development and production of the vaccine. We will do everything in our power to make this vaccine quickly and widely available.”
The vaccine is made from a weakened version of a common cold virus, known as an adenovirus, that causes infections in chimpanzees. It has been genetically changed so that it is impossible for it to replicate in humans.
Professor Andrew Pollard, head of the Oxford Vaccine Group, said: “The clinical studies are progressing very well and we are now initiating studies to evaluate how well the vaccine induces immune responses in older adults, and to test whether it can provide protection in the wider population. We are very grateful to the huge support of the trial volunteers in helping test whether this new vaccine could protect humans against the pandemic coronavirus.”
Mene Pangalos, executive vice president, biopharmaceuticals R&D, at AstraZeneca, said: “The speed at which this new vaccine has advanced into late-stage clinical trials is testament to Oxford’s ground-breaking scientific research. We will do everything in our power to engage with governments, multilateral organisations and partners around the world to increase production and distribution and ensure rapid, fair and equitable distribution of a globally accessible vaccine.”
Meanwhile, AstraZeneca - which is building its new £550m global HQ and R&D centre on Cambridge Biomedical Campus - is also conducting trials on repurposing some of its existing medicines to treat Covid-19. CALAVI and ACCORD trials are under way to assess Calquence (acalabrutinib), while the DARE-19 trial is testing Farxiga (dapagliflozin) in Covid-19 patients.
The firm’s scientists are also working to create new antibody treatments.