Covid-19: ‘possible’ Oxford vaccine data will be put before regulators this year

Trials of the Oxford coronavirus vaccine may have gathered enough data to show whether it works and is safe by the end of the year – but it will then need to go through the regulatory process, scientists say.

Sarah Boseley www.theguardian.com

Prof Andrew Pollard, the director of the Oxford Vaccine Group, said it is “just possible” that there may be enough clinical trial data on Oxford University’s Covid-19 vaccine to put before the regulators this year.

Prof Chris Whitty, England’s chief medical officer, has said a vaccine may not be ready until next winter. Pollard suggested they were hoping to go faster.

“I think that Chris Whitty is quite rightly being cautious, that it could take as long as that to first of all demonstrate a vaccine works and is safe and then to go through the processes of regulators looking at that very carefully to make sure everything’s been done correctly,” Pollard told BBC Radio 4’s Today programme.

“But it is also just possible that, if the cases accrue rapidly in the clinical trials, that we could have that data to put before regulators this year, and then there would be a process that they go through in order to make a full assessment of the data.”

That could still mean the vaccine would not be approved this year. The timing is also dependent on trials in countries with high infection rates, so that a clear difference can be seen between those who get the vaccine and those who do not.

“Even with 1,000 people, eventually you’ll have enough information to know whether or not a vaccine works, but that could take years. So, having 20,000 people in our trials already means that that period of time will be shorter, but unfortunately I can’t quite predict the future about how many cases are going to occur.”

Pollard said he hoped that 50,000 people would be involved in the clinical trial for the Oxford University Covid-19 vaccine candidate.

But he stressed that the size of the trial “isn’t really the issue”. What is critical is the number of cases of infection.

“There are a number of trials that we’re running from Oxford here in the UK, in Brazil, and also in South Africa, and the combined size of those three trials together is around about 20,000 people, and AstraZeneca are moving forwards in their trials in the US, hoping to start enrolling 30,000 people.

“So within the trials of the vaccine that was developed here at Oxford University, we’d expect to have perhaps 50,000 or more people in the trials in total.”

He said they would want to have evidence that the vaccine actually works before going to any regulator, including in the US where Donald Trump has said he could seek emergency approval for a vaccine such as the Oxford one in October.

“Emergency use authorisations are well established by regulators both in the United States and in Europe; in fact, you may be aware just this week, the FDA [the US Food and Drug Administration] has granted emergency use authorisation for plasma therapy,” he said.

“So the process of going through emergency use authorisation in an emergency is well established but it still involves having carefully conducted data, just as we are collecting information about the vaccines in clinical trials that are conducted rigorously and evidence that it actually works.

“And so, for our suite of trials that we’re running from Oxford, we would expect to first of all have safety data and then evidence that the vaccine actually works.

“And before anything were to progress from there and of course it’d be AstraZeneca who would then take that forward to regulators.”

AstraZeneca, the pharmaceutical company that is Oxford’s partner in the vaccine development, is separately trialling a new drug that it hopes will prevent and treat Covid-19, with the first volunteers already receiving doses.

The company said the drug, known as AZD7442, is a combination of two monoclonal antibodies.

AstraZeneca said the trial, which will include up to 48 healthy volunteers in the UK aged 18 to 55, will be focused on safety, and the body’s reaction to the drug and how it processes it.

Sir Mene Pangalos, the executive vice-president of biopharmaceuticals research and development at AstraZeneca, said: “This trial is an important milestone in the development of our monoclonal antibody combination to prevent or treat Covid-19.

“This combination of antibodies, coupled to our proprietary half-life extension technology, has the potential to improve both the effectiveness and durability of use, in addition to reducing the likelihood of viral resistance.”

 

He was a tonic for the Tories. Now Johnson is turning toxic

.”..The party that now governs Britain is a weird chimera – a limp Tory body, fired by the imported spirit of Ukip (latterly, the Brexit party), with Johnson’s head hosting Dominic Cummings’ brain. Its doctrine is also a hybrid. Tories who think about such things explain Downing Street’s plan in terms of leftward tilts on economics and rightward slants on nation, culture and identity. …”

Rafael Behr www.theguardian.com 

Tens of millions of people have already had a meal subsidised by the government. More will take advantage of Rishi Sunak’s “eat out to help out” policy before it ends next Monday. None of those diners is in doubt over the identity of their benefactor. The scheme has been marketed with the chancellor’s signature. His party gets a meagre portion of leftover credit.

Propping up restaurants with public debt is not typical Conservative economics, but the pandemic demanded ideological flex and Toryism is an elastic concept. That is the key to its historic success in winning and holding power. Sunak’s mastery of that adaptive method will serve his ambition well, and his ambition has an appetite.

The chancellor understands that leaders need personal brands and how failure to craft one for yourself risks having one imposed by your enemies. “Dishy Rishi” will be happy to join “Boris” in the club of politicians on first-name terms with the electorate. That connection buys a lot of support among Tory MPs, mindful of how shallow affection for their party can be, and how deep resentment of it can run.

Fifteen years have elapsed since David Cameron first identified a need to “decontaminate” the Tories. He succeeded to the extent that Britain has had a Conservative prime minister for the past decade. But winning has involved a cycle of brand laundry that has bleached the party’s identity to a faint pattern, barely distinct behind the character of its leader. Boris Johnson then dyed it the deepest shade of Brexit.

A few Tories balked. Most embraced the change with sincere zeal or went along with it as the best strategy to close down the threat from Nigel Farage. MPs who once muttered in private that Johnson was unfit to be prime minister queued to serve in his cabinet.

In electoral terms, the gamble paid out handsomely. Johnson won big and, with the aid of a vote-repellant Labour leader, captured places that once recoiled from the Tory touch.

The party that now governs Britain is a weird chimera – a limp Tory body, fired by the imported spirit of Ukip (latterly, the Brexit party), with Johnson’s head hosting Dominic Cummings’ brain. Its doctrine is also a hybrid. Tories who think about such things explain Downing Street’s plan in terms of leftward tilts on economics and rightward slants on nation, culture and identity. The aim is to lock in the allegiance of voters poached from Labour by spending on some things (the NHS and infrastructure), while clamping down on other things (crime and immigration).

That trajectory is not very different from the one Theresa May had in mind but failed to pursue for want of time and parliamentary bandwidth. Johnson has the Commons majority. His problem is money. While Sunak is happy to borrow in spades for a pandemic response, the chancellor and other previously frugal Tories are reaching the limit of their tolerance for a fiscal free-for-all.

Without a blank cheque for marginal constituencies, Downing Street will rely on the constant mining of culture-war grievances to persuade people that Johnson is on their side, while a cosmopolitan, London-centric, “woke” Labour party is not. That would be more effective if Keir Starmer responded symmetrically, launching himself into culture wars from a radical left trench, which he shows no sign of doing.

Meanwhile, Conservatives who are attached to the idea of being in a party with its own history and values, as distinct from a band of pro-Johnson political mercenaries, have another problem: Cummings. The prime minister has maverick tendencies but a recognisably Tory style and instincts. His chief adviser does not. Cummings is unsentimental about venerable institutions. He despises the rituals and hierarchies that make a party. His cold-blooded utilitarianism is essentially un-conservative: old structures are presumed obsolete; their preservation viewed as indulgence that slows progress.

Tory MPs liked that attitude in Brexit rhetoric, but sensible ones get nervous when it turns to kicking indiscriminately at pillars of state and society. War on Brussels is a given. Opening a second front against Whitehall and the BBC gets riskier. Picking fights with the military, letting it be known that Cummings can “sort out” the chief of defence staff, starts to look megalomaniac. Loosening planning controls threatens civil war in the Tory shires. Where are the limits? It was one thing for the Conservative party to dabble in recreational revolution, to lift sagging electoral spirits, but MPs are now worried about addiction and overdose.

There is a warning in the condition of the US Republican party, which this week adopted a policy platform of explicit, blind allegiance to Donald Trump. Nothing else.

Differences of culture and constitution diminish the comparison with American politics, yet there is a likeness in the way the Tories fell in thrall to a cult of incoherent nationalistic vandalism, called it renewal, and allowed their party to be hollowed out for use as a vessel to be filled with one man’s vanity. Last year Conservative MPs thought Johnson was their saviour. In time they may see him as a parasite.

They aren’t at that stage yet, not while the party is just about ahead in opinion polls. If that changes, the unravelling could be fast and messy. The one Tory ethic that persists through every ideological mutation is the will to power. Johnson delivered it, thus earning the right to mould what it means to be Conservative in his own image. But it is a thing without substance, a brittle shell around a void. It only looks solid in the hands of a winner.

  • Rafael Behr is a Guardian columnist

 

Will the UK’s housebuilding algorithm join the government’s growing AI graveyard?

There a number of dangers in using algorithms. Owl highlights a couple.

They need to be explained and not just transparent. Neil O’Brien MP published a formula to calculate an “adjustment factor” based on affordability. But what was the underlying logic? What was it supposed to be doing? Where did it come from? As a general rule if those who commissioned and created an algorithm cannot explain, in simple language ,what it is doing, then they themselves don’t understand how it works sufficiently for it to be used.

There has been a number of papers published in recent years suggesting that algorithms used in public service should undergo a rigorous testing process. Obviously the recent algorithms we are hearing about haven’t been thoroughly tested. – Owl 

Thomas Macaulay thenextweb.com 

It’s been a seriously rough few weeks for algorithms in the UK.

The problems started on August 7, when the British government scrapped an algorithm used in visa applications, following allegations that it was creating “speedy boarding for white people.”

Weeks later, England joined Scotland, Wales, and Northern Ireland in ditching a model used to calculate school exam results after evidence emerged that it had penalized poorer students.

The algorithms must have thought their month couldn’t get any worse. But in the last two days, they’ve been hit with another double dose of bad news.

Yesterday, the Guardian revealed that around 20 councils — local government authorities in the UK — have stopped using an algorithm to detect fraudulent welfare claims.

Researchers from the Data Justice Lab (CDJL) found that one algorithm was dumped after falsely flagging low-risk claims as high-risk, while another was dropped because it simply didn’t make a difference to the council’s work.

The CDJL also discovered that Sunderland council had scrapped a separate algorithm designed to make efficiency savings, while Hackney had ditched one that identified children at risk of abuse.

“Algorithmic and predictive decision systems are leading to a wide range of harms globally, and… a number of government bodies across different countries are pausing or canceling their use of these kinds of systems,” Dr Joanna Redden from the Data Justice Lab told the Guardian.

She might not have long to wait to add another to the list.

Meet the planning algorithm

The British government recently introduced a new formula for calculating where new housing is built. But planning consultancy Litchfields today claimed the algorithm would lead to more homes being constructed in the countryside and suburbs — typically Tory-voting areas — and fewer in towns and city centers.

The plans have achieved the rare feat of attracting critics from across the political spectrum.

Conservative MP Neil O’Brien warned Tory-voters wouldn’t want more housing where they live; Labour’s Kate Hollern accused the government of “leveling-down areas;” and the Green Party’s Natalie Benett said the plans would “step up regional inequality even further, and hack into the greenbelt for the benefit of mass housebuilders.” 

Whether the housebuilding algorithm joins the ones used for exam results and welfare claims on the shelf. But it will certainly be under increased scrutiny over the months to come.

 

Algorithm angst: Conservatives detect the hand of Cummings in the planning white paper – West Country Bylines

More on Neil O’Brian MP

Finally, something is getting up the noses of supporters of the Conservatives.

Anthea Simmons westcountrybylines.co.uk 

It seems it’s not the request to slap ‘do not resuscitate‘ orders (DNRs) on all care-home residents at the height of the first wave of the pandemic. Nor is it the ongoing scandal of billions spaffed on non-existent PPE ordered without scrutiny from companies with party connections. It’s not even the non-exam grade fiasco, or the ‘world-beating’ (at failing) ‘test, track and trace’ system, or the explosion in the national debt or the news that we are amongst the worst hit of the major economies or that we are near the top of the tables for Covid-19 deaths relative to population size.

They also don’t seem much exercised by Russian interference in our elections, or Johnson’s endless holidays or the absolute catalogue of ineptitude, blame-shifting and U-turns. None of that appears to be more than an irritation. As for the leaked government contingency plans in the event of a covid-19 second wave coupled with a no-deal Brexit? Nah. Project Fear, innit! (Leaked in the Sun! The Sun!)

But planning…Well, that’s a different story. Take a look at this:

In each region you can see how housing numbers go down in large cities (often below what has been delivered recently!) and up in shire and suburban areas

It also proposes continuing a south-east centric growth model

 

Originally tweeted by Neil O’Brien MP (@NeilDotObrien) on 24/08/2020.

Interesting, huh? But it’s the comments’ section where our curiosity was piqued.

“Having read the papers on new planning proposals put out by Mr Jenrick, I have come to the conclusion that he knows nothing about the function of planning, nothing about rural areas and nothing about Conservative voters. His proposals are a disaster for the Conservative vote and will be a disaster for the countryside. According to this man, it is possible to both build on land and to increase green spaces! A miracle worker, no less. Even if your role is housing minister, surely you should understand that land has more uses than housing. Surely he should know that land is not an elastic commodity. What a disaster.”

Another responds;

“Please don’t labour under the illusion that this has anything to do with Mr Jenrick – he’s just a figurehead. These authoritarian planning proposals, which are utterly top-down and at the expense of local self-determination, are known to come from Dominic Cummings. Local democracy is simply an annoyance for someone as ruthless, tone deaf and philistine as Mr Cummings.”

They can see clearly what’s going wrong.

“This is the price paid for Brexit and the consequent rise of Dominic Cummings. The implemention of his planning dreams, which owe nothing to traditional Conservative values. The Conservative stronghold of the South East is to get a large dose of concrete. Hordes of independent councillors will spring up and quite probably a few independent MPs but the new Blue Wall won’t worry

[…] will greatly weaken the Conservative Party without Labour firing a shot. A rather selfless own goal.”

There are many more comments along these lines, citing Cummings’ thirst for revolution and disruption, good or bad, as the driver behind policy. One goes so far as to describe the planning proposals as ‘Johnson’s poll tax’. Hmm.

We will be writing more on the implications for Cornwall, Devon, Dorset and Somerset but, in the meantime, it’s worth reflecting on what gets the danders up.

 

Boris Johnson dismisses claim he will quit in six months due to Covid fatigue as ‘absolute nonsense’

Is Lord Voldemort practising the Dark Arts in Westminster, briefing against the PM? Is Sir Humphry a fully fetlocked stalking horse for disgruntled members of the party? Has anyone issued a statement saying they have “full confidence” in Boris Johnson? – Owl

By Catherine Neilan, Politics Live Editor 25 August 2020 www.telegraph.co.uk 

The Prime Minister has rubbished suggestions he could step down in the next six months, labelling them as “absolute nonsense”. 

Sir Humphry Wakefield, Dominic Cummings’ father-in-law, had reportedly claimed that Boris Johnson was still struggling to recover from Covid-19 and would stand down in six months, it was reported on Monday. 

Sir Humphry, father of Dominic Cummings’s wife Mary Wakefield, went on to compare the Prime Minister having the virus to being gone in the fetlock, a term used to describe an injured animal. 

“If you put a horse back to work when it’s injured it will never recover,” the Times reported him as telling one of their readers. 

Mr Johnson was hospitalised for two weeks after catching coronavirus back in March, spending three days in intensive care.

He later told journalists that the team had “contingency plans in place… for what to do if things went badly wrong”. 

However, he recovered without having to be intubated and was discharged before spending another fortnight recuperating at Chequers. 

Just days after he returned to work, the Prime Minister became a father again, with he and partner Carrie Symonds welcoming baby Wilfred to the world. 

For several weeks after his return, Mr Johnson appeared gruff and short of breath. He has lately embarked on a fitness regime of jogging and healthy eating as he champions a ‘Better Health’ anti-obesity campaign. 

In July, he said he had already lost more than a stone since he became ill. 

During a visit to a factory in Devon on Monday, the Prime Minister told local reporters: “I’m feeling, if anything, far better than I was because I’ve lost some weight”. 

The report about him stepping down was “absolute nonsense”, he added.

One senior Government source told the Telegraph: “He is buzzing with energy the whole time. This whole thing is absurd.”

Another added: “It is just absolutely bizarre. I have never heard anything further from the truth. It’s utter nonsense.”

The second source said there were “no signs of long Covid-19”, the condition that has plagued some sufferers of the disease many months after infection. 

Mr Johnson has been urged to step up support for these “forgotten victims” of the pandemic. 

Liberal Democrat MP and chair of the coronavirus all-party Parliamentary group Layla Moran has written to the Prime Minister asking him to formally recognise this condition, and set up a working group to address their needs. 

She said: “Those living with the long-term impact of Covid-19 have become the forgotten victims of this pandemic. Many are suffering daily from debilitating symptoms but feel they’re not being listened to or taken seriously.  

“It’s vital the government listens to these concerns and steps up support including for those who weren’t hospitalised or tested. We also need further efforts to boost research into treatments that could provide much-needed relief to patients.  

“We’ve heard harrowing evidence from those who have lost loved ones to this terrible disease and have been given the cold shoulder by Number 10.

“The Prime Minister must commit to meeting with bereaved families and agree to their calls for a judge-led public inquiry.”