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Results of Oxford University’s Covid-19 vaccine trial will be published by the end of December

Results of Oxford University’s final-stage Covid-19 vaccine trial will be published by the end of December, it was revealed today. 

Drugs giant AstraZeneca, which owns the rights to the vaccine, confirmed today it expects data on the effectiveness of the jab within weeks. 

The figures will then be examined by the healthcare regulator MHRA before it is given the green light for use in the wider community.

The NHS is geared up to administer a Covid-19 vaccine as soon as December, if one is proven, the chief executive said this week.

And Kate Bingham, the chairwoman of the UK’s vaccines taskforce, said yesterday inoculations had the ‘possibility of being ready before the end of the year’.

However, the Government is expecting to receive only four million doses of the AstraZeneca jab this year, Ms Bingham said. 

Britain had agreed in May to take 100million doses of the vaccine, with an initial estimate of 30million ready by September 30.

Drugs giant AstraZeneca, which owns the rights to the Covid-19 vaccine developed by Oxford University, confirmed today it expects to release the results of stage two and stage three trials within weeks

The NHS may start rolling out a vaccine to people aged over 85 and front-line staff in early December, according to reports (stock)

The NHS may start rolling out a vaccine to people aged over 85 and front-line staff in early December, according to reports (stock)

AstraZeneca reported at its quarter 3 results webcast that it ‘anticipated’ the results of the phase two and three trials in quarter 4 – by the end of the year.

Chief executive of AstraZeneca Pascal Soriot said: ‘We made encouraging headway in the quarter, despite the ongoing disruption from the Covid-19 pandemic.’

Chief executive of AstraZeneca Pascal Soriot said the results will be published in the fourth quarter

Chief executive of AstraZeneca Pascal Soriot said the results will be published in the fourth quarter  

His comments likely refer to trials being slowed down in the summer due to a lack of coronavirus cases in the Northern hemisphere.  

And he dismissed concerns that pauses in trials due to investigations of volunteers falling ill had delayed progression. 

On two occasions, trial participants had developed symptoms that were feared to have been caused by the jab. And one man died of Covid-19 last month, but was reported to have been given the placebo jab.  

In each event, independent reviews judged it safe to continue experiments after they were stopped for several days.

It comes as AstraZeneca retained guidance for its financial year, and said profit is set to double.  

AstraZeneca presented revenue of 6.6 billion US dollars (£5.1 billion), a 3 per cent rise, despite a nearly four-fifths fall in its collaboration revenue.

The collaboration revenue drop was largely due to a strong third quarter last year for its cancer drug Lynparza, meaning Astra was measured against a high yardstick.

Mr Soriot also hailed the company’s work with diabetes medicine dapagliflozin, sold under the Farxiga brand.

FIRST COVID-19 JABS COULD BE READY FOR CHRISTMAS – BUT ‘WON’T ALLOW LIFE TO RETURN TO NORMAL’ 

Oxford’s coronavirus jab could still be available by Christmas – but taskforce chief says only four million doses will be available for key workers at first. 

Both Pfizer and Oxford University have entered into their final stages of testing with data suggesting the jab could be deployed ‘within weeks’.

Kate Bingham, chairwoman of the government’s vaccine task force, said the inoculations had the ‘possibility of being ready before the end of the year’. 

But she warned that only four million doses of the Oxford vaccine would be manufactured by Christmas – with ten million doses of the Pfizer vaccine potentially being available by January.

The estimate, which falls short of the Government’s suggestion in May that 30million doses could be supplied by September, would mean that mass deployment among NHS workers and the elderly would not yet be achievable. 

Ms Bingham, the UK’s vaccine tsar, has arranged to buy six different vaccines, amounting to more than 350million doses, but there is no guarantee that any will work. 

They will all also have to be submitted for approval by the Medicines and Healthcare products Regulatory Agency (MHRA) but it is not yet known how long this will take.

Professor Andrew Pollard, from Oxford university, agreed that there was ‘a small chance’ its vaccine would be ready before Christmas. 

He said: ‘The first step is to reach the point where we can do an analysis and find out whether or not the vaccine works.

‘I’m optimistic that we could reach that point before the end of this year.’   

Both Professor Pollard and Ms Bingham warned the first wave of vaccines would not be good enough to allow society to immediately return to normal, scuppering Boris Johnson’s promise that ‘life will return to normal next summer’.

The pair made the comments at a virtual House of Commons Science and Technology Committee on November 4.

When Ms Bingham was asked by MPs if a vaccine could wipe out Covid-19 next year, she said: ‘Well, to wipe out coronavirus, I think [the likelihood is] very slim.

‘But to get a vaccine that has an effect both reducing illness and reducing mortality? Very high.’  

And he said the firm had advanced its collaboration with the University of Oxford to launch phase three trials for a antibody drug, which would be given to people who have a weak immune system that may struggle to fight the coronavirus. 

A total of 44 of the vaccine candidates in development are at clinical trial stage.

Of these, nine are in the phase three stage of clinical evaluation and are being given to thousands of people to confirm safety and effectiveness.

There are two frontrunners in the Covid-19 vaccine race – one from German biotech firm BioNtech and US pharmaceutical company Pfizer, and another being developed by the University of Oxford and AstraZeneca.

Both vaccines are currently in phase three clinical trials, which is when scientists assess whether people who have been innoculated are prevented from catching the coronavirus in the community. 

Ms Bingham said data from both vaccine trials could be available this year. And if she puts on ‘rose-tinted specs’ she would hope to see positive interim data from both Oxford and Pfizer BioNtech in early December.

Professor Andrew Pollard, head of Oxford’s vaccine trial team, has also said he is optimistic data on safety and efficacy of their vaccine will be available by the end of the year. 

In August, the Government announced the UK has secured access to six Covid-19 vaccine candidates in development, representing 340million doses.

But only about four million vaccine doses of Oxford’s vaccine would actually be available by the end of the year, Ms Bingham said, with ten million doses of the Pfizer vaccine potentially being available by January.

The first wave of vaccines would not be good enough to allow society to immediately return to normal, Ms Bingham said, scuppering Boris Johnson’s promise that ‘life will return to normal next summer’. 

According to the Joint Committee on Vaccination and Immunisation, older adults resident in a care home and care home workers should be the first to be given any approved vaccine.

All those aged 80 and over and health and social care workers are next on the priority list.  

Work has been going on behind the scenes to prepare for any potential Covid vaccine and how it could be rolled out. 

GPs are gearing up to start delivering any potential Covid-19 vaccines, the head of the NHS in England said this week.

Sir Simon Stevens said family doctors will be ready to start by Christmas ‘if the vaccine becomes available’.

And the Nightingale hospitals, set up in the spring in order to provide more beds for coronavirus patients, could be used as mass vaccination centres. 

Sir Simon told BBC Radio 4’s Today programme: ‘There are over 200 vaccines in development and we believe that we should hopefully get one or more of those available from the first part of next year.

‘In anticipation of that we’re also gearing the NHS up to be ready to make a start on administering Covid vaccines before Christmas, if they become available.

‘We reached an agreement with GPs to ensure they will be doing that, and we’ll be writing to GP practices this week to get them geared up to start by Christmas if the vaccine becomes available.’

GP magazine Pulse reported on Tuesday that family doctors are going to be told to be prepared to start vaccinating over-85s and frontline workers from early December. 

The Oxford vaccine, called ChAdOx1 nCoV-19, uses a weakened version of a common cold virus (adenovirus) which causes infections in chimpanzees.

But the virus has been genetically changed so it is impossible for it to grow in humans. 

It’s a type of immunisation known as a recombinant viral vector vaccine. Researchers place genetic material from the coronavirus into another virus that’s been modified. They will then inject the virus into a human, hoping to produce an immune response against SARS-CoV-2.  

If the vaccines can successfully mimic the spikes inside a person’s bloodstream, and stimulate the immune system to create special antibodies to attack it, this could train the body to destroy the real coronavirus if they get infected with it in future. 

Aside from the Oxford vaccine, a coronavirus jab in Britain is being developed by Imperial College London.

The Imperial vaccine is in phase one of clinical testing, where doses are being given to a small group of people to determine whether it is safe and to learn more about the immune response it provokes.

Pharmaceutical companies Sanofi and GlaxoSmithKline have also teamed up with the hope of making a Covid-19 vaccine available by the middle of next year.

The Sanofi/GSK candidate is in the phase two stage, where the vaccine is being given to hundreds of people so scientists can learn more about its safety and correct dosage. They plan to begin phase three trial by the end of the year.

Vaccines created by GSK and Sanofi, Valneva and Novavax – which Ms Bingham has received in trial – ‘will not be available until late in 2021’.

Other potential vaccines in phase three trials include ones by US drug firm Moderna and Chinese state-owned pharmaceutical company Sinopharm, for which the UK has not secured deals for. 

No10’s stock of potential jabs cover four different types of vaccines – adenoviral vaccines, mRNA vaccines, inactivated whole virus vaccines and protein adjuvant vaccines.

Adenoviral vaccines are weakened versions of adenoviruses, while mRNA candidates are made up of small or inactivated doses of the whole disease-causing organism.

Inactivated whole virus vaccines, on the other hand, contain whole bacteria or viruses which have been killed, while protein adjuvant jabs are those where an adjuvant is added to enhance the immune response. 

WHICH VACCINES HAVE THE UK SECURED DEALS FOR? 

1. GlaxoSmithKline and Sanofi Pasteur: 60million doses 

The Government revealed on July 29 it had signed a deal with pharmaceutical giants GlaxoSmithKline (GSK) and Sanofi Pasteur

If the vaccine proves successful, the UK could begin to vaccinate priority groups, such as frontline health and social care workers and those at increased risk from coronavirus, as early as the first half of next year, the Department for Business, Energy & Industrial Strategy (BEIS) said. 

Human clinical studies of the vaccine will begin in September followed by a phase 3 study in December. 

The vaccine is based on the existing technology used to produce Sanofi’s seasonal flu vaccine. Genetic material from the surface protein of the SARS-CoV-2 virus is inserted into insect cells – the basis of Sanofi’s influenza product – and then injected to provoke an immune response in a human patient.  

2. AstraZeneca (manufacturing University of Oxford’s): 100million

AstraZeneca, which is working in partnership with Oxford University, is already manufacturing the experimental vaccine after a deal was struck on May 17.

Professor Sarah Gilbert, who is leading the Oxford team, is confident the jab could be ready for the most vulnerable people by the end of the year.

Her comments came after the results from the first phase, published in The Lancet on July 20, showed promise.

The team have genetically engineered a virus to look like the coronavirus – to have the same spike proteins on the outside – but be unable to cause any infection inside a person. This virus, weakened by genetic engineering, is a type of virus called an adenovirus, the same as those which cause common colds, that has been taken from chimpanzees. 

3.  BioNTech/Pfizer: 30million 

US drug giant Pfizer – most famous for making Viagra – and German firm BioNTech were revealed to have secured a deal with the UK Government on July 20.

It reported positive results from the ongoing phase 2/3 clinical trial of one called BNT162b1 on July 1.  The company is still running phase 2 trials at the moment.

Pfizer’s vaccine is one called an mRNA vaccine, which do not directly inject bits of the virus into the body but send genetic material.

mRNA vaccines programme the body to produce parts of the virus itself by injecting the body with a molecule that tells disease-fighting cells what to build. The immune system then learns how to fight it.

4. Valneva: 60million 

The Government has given Valneva — whose vaccine is understood to be in the preclinical stages of development — an undisclosed amount of money to expand its factory in Livingston, Scotland. 

While the Government revealed a 60million dose deal on July 20, the company said it had reached agreement in principle with the UK government to provide up to 100million doses. 

Valneva’s jab is an inactivated whole virus vaccine, meaning it injects a damaged version of the coronavirus itself into the body.

The virus has been destroyed in a way that makes it unable to cause infection, but the body still recognises it as a dangerous intruder and therefore mounts an immune response which it can remember in case of a real Covid-19 infection. 

5. Janssen (Johnson & Johnson): 30million

The Government has agreed to buy 30million doses of a vaccine made by Janssen if it works.

Officials have agreed to help the company in its development of the jab by part-funding a global clinical trial. The first in-human trials of Janssen’s jab began in mid-July and are being done on adults over the age of 18 in the US and Belgium.

The jab is named Ad26.COV2-S, recombinant, and is a type of jab called a viral vector recombinant vaccine.

Proteins that appear on the outside of the coronavirus are reproduced in a lab and then injected into the body to stimulate an immune reaction.

The ‘Ad’ part of the vaccine’s name means it works using an adenovirus – a virus best known for causing the common cold – as a vehicle to transport the coronavirus genetics into the body.

6. Novavax: 60million

Britain has ordered 60million doses of a vaccine being developed by the US-based company Novavax. It will help to fund late-stage clinical trials in the UK and also boost plans to manufacture the vaccine in Britain.

Novavax’s jab, named NVX-CoV2373, showed positive results in early clinical trials.

It produced an immune response in 100 per cent of people who received it, the company said, and was safe and ‘generally well-tolerated’. 

Novavax’s candidate is also a recombinant vaccine and transports the spike proteins found on the outside of the coronavirus into the body in order to provoke the immune system. 

7. Imperial College London: Unknown quantity

Imperial College London scientists are working on Britain’s second home-grown hope for a jab. The candidate is slightly behind Oxford’s vaccine in terms of its progress through clinical trials, but is still a major player.

The UK Government is understood to have agreed to buy the vaccine if it works but details of a deal have not yet been publicised. 

Imperial’s jab is currently in second-phase human trials after early tests showed it appeared to be safe. 

Imperial College London will try to deliver genetic material (RNA) from the coronavirus which programs cells inside the patient’s body to recreate the spike proteins. It will transport the RNA inside liquid droplets injected into the bloodstream. 

Read more at DailyMail.co.uk


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