AstraZeneca COVID-19 vaccine shows promise in elderly, trial results by Christmas

By Kate Kelland and Alistair Smout

LONDON (Reuters) – AstraZeneca and Oxford University’s potential COVID-19 vaccine produced a strong immune response in older adults, data published on Thursday showed, with researchers expecting to release late-stage trial results by Christmas.

The data, reported in part last month but published in full in The Lancet medical journal on Thursday, suggest that those aged over 70, who are at higher risk of serious illness and death from COVID-19, could build robust immunity.

“The robust antibody and T-cell responses seen in older people in our study are encouraging,” said Maheshi Ramasamy, a consultant and co-lead investigator at the Oxford Vaccine Group.

“We hope that this means our vaccine will help to protect some of the most vulnerable people in society, but further research will be needed before we can be sure.”

Late-stage, or Phase III, trials are ongoing to confirm the findings, researchers said, and to test whether the vaccine protects against infection with SARS-CoV-2 in a broad range of people, including people with underlying health conditions.

Results of those trials should definitely be known by Christmas, the Oxford Vaccine Group’s director, Andrew Pollard, said, adding it was too early to know whether and how well the vaccine works in preventing COVID-19 disease.

“We’re still waiting to get to the point where we can do the analysis to just work out how well the vaccine can protect people, and we’re getting ever closer to that,” he told journalists.

“We are optimistic that we’ll be able to do that before Christmas, and obviously we’ll share that with you as soon as we can at that point.”

The Oxford-AstraZeneca COVID-19 vaccine candidate, called AZD1222 or ChAdOx1 nCoV-19, had been among the front-runners in global efforts to develop shots to protect against infection with the novel coronavirus, or SARS-CoV-2.

But rival drugmakers Pfizer Inc, BioNTech and Moderna Inc have in the past 10 days edged ahead, releasing data from late-stage COVID-19 vaccine trials that shows more than 90% efficacy.

“We’re not in a rush. We and it’s not a competition with the other developers,” Oxford’s Pollard said, adding that AstraZeneca would release headline efficacy data before it was published in an academic journal.

Oxford University has set a target of 53 infections to start the interim analysis of its late-stage trial results, though “lots of cases” in its trial arms in Britain, South Africa and Brazil mean the exact number of infections reported could differ.

Unlike the Pfizer-BioNTech and Moderna shots, both of which use new technology known as messenger RNA (mRNA), AstraZeneca’s is a viral vector vaccine made from a weakened version of a common cold virus found in chimpanzees.

The Phase II trial reported in The Lancet involved a total of 560 healthy volunteers, with 160 aged 18-55, 160 aged 56-69, and 240 aged 70 or over.

Volunteers got two doses of the vaccine or a placebo, and no serious side effects related to the AZD1222 vaccine were reported, the researchers said.

AstraZeneca has signed several supply and manufacturing deals with companies and governments around the world.

(Reporting by Kate Kelland; Additional reporting by Alistair Smout; Editing by Matthew Lewis, Alexander Smith and Nick Macfie)

Britain prepares for COVID-19 vaccine as Oxford forecasts result this year

By Alistair Smout and Guy Faulconbridge

LONDON (Reuters) – Late-stage trial results of a potential COVID-19 vaccine being developed by the University of Oxford and AstraZeneca could be presented this year as the British government prepares for a possible vaccination rollout in late December or early 2021.

A vaccine is seen as a game-changer in the battle against the coronavirus, which has killed more than 1.2 million people worldwide, shuttered swathes of the global economy and turned normal life upside down for billions of people.

There are more than 200 candidates under development and the vaccine being developed by Oxford and licensed to British drugmaker AstraZeneca is seen as a front-runner.

“I’m optimistic that we could reach that point before the end of this year,” Oxford Vaccine Trial Chief Investigator Andrew Pollard said of the chances of presenting trial results.

Pollard told British lawmakers that establishing whether or not the vaccine worked would likely come this year, after which the data would have to be carefully reviewed by regulators and then a political decision made on who should receive it.

“Our bit – we are getting closer to but we are not there yet,” Pollard, director of the Oxford Vaccine Group, said.

Asked if he expected the vaccine would start to be deployed before Christmas, he said: “There is a small chance of that being possible but I just don’t know.”

The National Health Service (NHS) in England is preparing to start distributing possible COVID-19 vaccines before Christmas in case one is ready by the end of the year.

The Oxford/AstraZeneca vaccine is expected to be one of the first from big pharma to be submitted for regulatory approval, along with Pfizer and BioNTech’s candidate.

“If I put on my rose-tinted specs, I would hope that we will see positive interim data from both Oxford and from Pfizer/BioNTech in early December and if we get that then I think we have got the possibility of deploying by the year end,” Kate Bingham, the chair of the UK Vaccine Taskforce, told lawmakers.

Prime Minister Boris Johnson said there was the prospect of a vaccine in the first quarter of 2021. AstraZeneca is presenting its third quarter financial results on Thursday.

‘GAME CHANGER’

Work on the Oxford viral vector vaccine, called AZD1222 or ChAdOx1 nCoV-19, began in January. It is made from a weakened version of a common cold virus that causes infections in chimpanzees.

The chimpanzee cold virus has been genetically changed to include the genetic sequence of the so-called spike protein which the coronavirus uses to gain entry to human cells. The hope is that the human body will then attack the novel coronavirus if it sees it again.

If Oxford’s vaccine works, it could eventually allow the world to return to some measure of normality.

Asked what success looked like, Pollard said: “Good is having vaccines that have significant efficacy – so whether, I mean, that is 50, 60, 70, 80 percent, whatever the figure is – is an enormous achievement.

“It’s a complete game changer and a success if we meet those efficacy end points,” he said, adding it would relieve pressure on the health system.

But Pollard and Bingham agreed that the world would not return to normal immediately. Asked about the chances of a vaccine that would wipe out the coronavirus next year, Bingham said the prospects were “very slim.”

“(But the chances) to get a vaccine that has an effect of both reducing illness, and reducing mortality (are) very high,” Bingham said, adding she was more than 50% confident there would be such a vaccine by early summer.

(Reporting by Alistair Smout and Guy Faulconbridge; Editing by Nick Macfie and Alexander Smith)