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Covid vaccine could be rolled out for vulnerable Britons before it is approved by regulators

A Covid-19 vaccine could be rolled out for vulnerable Brits before it gets approved by medical regulators, according to the UK’s vaccine tsar. 

Normally, it takes up to two years before a medication is given the green light by the European Medicines Agency (EMA) and the UK’s drugs watchdog. 

But experts believe a coronavirus jab will be fast-tracked through the process and be granted emergency use authorisation within 70 days.

Kate Bingham, chair of the UK’s vaccine taskforce, said vulnerable Brits could get a vaccine even quicker than that on compassionate grounds. 

Health Secretary Matt Hancock has already announced frontline health and care workers, and those at an increased risk of serious disease, including elderly care homes residents, will be first in line to get access to a vaccine.

Over-50s and those with heart and kidney disease would be next, according to Mr Hancock, who said health bosses were also considering fast-tracking access for people from BAME backgrounds, who are disproportionately affected by Covid-19. 

Hopes of a Covid-19 vaccine by the end of the year were raised again this week after Oxford University revealed there was still a chance it could deliver its experimental jab by Christmas.

There has been growing concern not enough people are catching the virus in the public anymore, which makes it hard to test whether the jab actually protects people from catching it.

Oxford has moved its trials abroad to South Africa and Brazil — where Covid-19 is still rife — to speed up the so-called efficacy trials. 

Kate Bingham, head of the UK vaccines taskforce, A coronavirus vaccine could be rolled out in Britain before it has been approved by medical reglator

Kate Bingham, head of the UK vaccines taskforce, said a coronavirus vaccine could be rolled out in Britain before it has been approved by medical regulators under compassionate grounds

Oxford scientists say it's possible their AZD1222 jab will be available by December, or by early 2020

Oxford scientists say it's possible their AZD1222 jab will be available by December, or by early 2020

Oxford scientists say it’s possible their AZD1222 jab will be available by December, or by early 2020

Mrs Bingham said vaccine manufacturers were in constant communication with the UK Medicines and Healthcare products Regulatory Agency (MHRA) to get any jab rolled out as quick as possible, if trials are successful.  

She told The Telegraph: ‘Oxford will file their submission with the EMA, plus there is a route for compassionate or emergency use in the UK, and MHRA have been working joined at the hip with these different vaccine companies.

‘By engaging regulators early and involving them in key decision-making and key safety aspects everything can be done much more quickly.

WHAT ARE THE LEADING COVID-19 VACCINE CANDIDATES? 

University of Oxford

Oxford University academics began developing the ChAdOx1 nCoV-19 vaccine in January. It is now named AZD1222, after the researchers signed a manufacturing partnership with pharmaceutical giant AstraZeneca.

Human trials started on April 23 and they are now in the final phase, with trials being carried out in the UK, Brazil and South Africa. 

Lead of the project Professor Sarah Gilbert told The Times she is ’80 per cent’ confident of its success.

The science behind Oxford’s vaccine attempt hinges on recreating the ‘spike’ proteins that are found all over the outside of the Covid-19 viruses.

It is made from a weakened version of an adenovirus from chimpanzees that has been genetically changed so it is impossible for it to grow in humans. 

Imperial College London 

Fifteen volunteers have already been given Imperial’s trial jab and testing is expected to ramp up to include as many as 200-300 participants in the coming weeks. A second trial, with 6,000 people, will come later. 

But Professor Robin Shattock, lead researcher, said the vaccine won’t be available until at least 2021 even if everything goes according to plan. 

If the jab works, the team want to make it as cheap as possible so the entire British population could be vaccinated for the ‘really good value’ of just under £200million.

Imperial’s vaccine also attempts to mimic the spikes on the outside of the Covid-19 virus. However, it will work by delivering genetic material (RNA) from the virus, which programs cells inside the patient’s body to recreate the spike proteins.

Pfizer/BioNTech

US drug giant Pfizer — famous for Viagra — and German firm BioNTech have been working on a number of potential Covid-19 vaccines under the ‘BNT162 program’. 

It reported positive preliminary results from the ongoing Phase I/II clinical trial of one called BNT162b1 on July 1. Tests on 24 volunteers showed that it was well tolerated and produced dose dependent immunity.

Dr Kathrin Jansen, Pfizer’s head of vaccine research and development, said the vaccine ‘is able to produce neutralizing antibody responses in humans at or above the levels observed’ in Covid-19 survivors.

Pfizer received fast track designation from the US Food and Drug Administration (FDA) for two of their four potential Covid-19 vaccines this month. 

The vaccine is one which injects RNA – genetic material – which codes the body to produce proteins that look like the spike proteins that would be found on the outside of the real coronavirus.

Valneva

French firm Valneva have yet to begin human trials of their Covid-19 vaccine, called VLA2001. Company bosses hope to scale up testing by the end of this year.

The jab is currently only in pre-clinical studies — meaning it is being tested in the lab and on animals.

If proven successful, the vaccine will be manufactured at its facilities in Livingston, Scotland and in Solna, Sweden. 

Valneva’s jab is based on injecting people with dead versions of the coronavirus.

This is called an inactivated whole virus vaccine and works by injecting the virus itself but versions that have been damaged in a lab so that they cannot infect human cells. They can be damaged using heat, chemicals or radiation.

Even though the viruses are inactivated the body still recognises them as threats and mounts and immune response against them which can develop immunity.

Moderna 

Massachusetts-based Moderna was the first US company to start human trials of its potential Covid-19 vaccine, known as mRNA-1273, on March 16.

The jab has proven to trigger an immune response in all 45 injected volunteers, according to a study published in the prestigious New England Journal of Medicine on July 14.

Moderna’s shot showed early promise in its phase 2 human tests last month. The company reported that it triggered antibody production on par with that seen in recovered coronavirus patients. 

CanSino 

Chinese vaccine Ad5-nCoV, made by CanSino, was the very first shot to enter clinical trials earlier this year and is a leading candidate.

A trial of 108 healthy volunteers in China showed it safely triggered an immune response in participants.

Results published May 22 in The Lancet showed most of the people dosed with the vaccine had immune responses, although their levels of antibodies thought to neutralize the virus were relatively low. Researchers saw a stronger ramp-up of other immune compounds, called T-cells, that might also help fight the infection off.   

Johnson & Johnson 

The drug giant started work on the vaccine in January, two months before Covid-19 was labelled a global pandemic. 

A vaccine trial spearheaded by Johnson and Johnson will start recruiting people in September, with clinical data available by the end of the year.

An ’emergency use’ batch of the vaccine is anticipated to be authorised as early as 2021, which would likely be prioritised for vulnerable people.

CureVac

CureVac, a German company, secured permission last month to begin first phase clinical trials of its attempt at a coronavirus vaccine.

The vaccine, named CVnCoV, works by injected RNA designed to force the production of coronavirus-like proteins in the body and trigger an immune response.

The first trials will involved 168 people between the ages of 18 and 60 in Germany and Belgium.

‘I don’t know how long it will take, but regulators are receiving all the non-data aspects of the trials already so they can look at manufacturing facilities and assays and lots of things that are non-clinical before they open the envelope and get the results.’

Boris Johnson this week dampened hopes of a vaccine in the near-future by admitting he wasn’t certain a jab would be available until 2022. 

But just hours later Oxford scientists said their candidate – called AZD1222 – could be ready by December at the soonest. 

Promising data has shown the Oxford jab is safe and provokes an immune reaction that lasts for at least two months. 

More than 91 per cent of volunteers injected produced an immune response against the coronavirus that lasted a month or more.

Immune responses remained strong for at least 56 days, according to results in The Lancet. 

The jab is already being manufactured by pharmaceutical giant AstraZeneca and the UK Government has ordered 100million doses ahead of time. 

But ministers aren’t putting all of their eggs in one basket and have struck deals for a further 90million doses of two types of experimental jab being developed in France and Germany. 

Britain is shoring up stocks of vaccines in development all over the world in its spread-betting approach in the hope that at least one of them will pay off.

One of those, made by BioNTech, has shown good results in early trials which proved it could produce a safe immune response in a group of 45 people. 

Matt Hancock has told the House of Commons health select committee that he is optimistic a vaccine will be ready this year.

Asked by MPs whether a jab would be ready in time for Christmas, the Health Secretary said: ‘I can’t promise to play Santa. I am an optimist in life, and in the best case scenario the answer is yes. 

‘My job is not to second guess whether we will or not – vaccines are an uncertain science and we need to be cautious, but I will throw everything at it.’

Results from the first phase of clinical trials of Oxford’s vaccine were published on Monday in the British medical journal, The Lancet.

They revealed that the Covid-19 vaccine had been given to 543 people out of a group of 1,077.

The other half were given a meningitis jab so their reactions could be compared and scientists could be sure the effects of the coronavirus jab weren’t random.

Researchers wanted to find out whether the vaccine boosted either of two types of immunity — antibodies, which are disease-fighting substances; and T-cell immunity, with T cells able to produce antibodies and also to attack viruses themselves.

The vaccine produced ‘strong’ responses on both accounts, the study found.

It showed that the T cell response aimed at the spike protein that appears on the outside of the coronavirus was ‘markedly increased’ in people who had had the jab, in tests of 43 of the participants. These responses peaked after 14 days and then declined before the end-point of the trial at 56 days.

Antibody immunity, on the other hand, peaked after four weeks and remained high by day 56, the point at which the last measurement was taken, meaning it may well last for even longer.

After 28 days, up to 100 per cent of a group of 35 people still had a strong enough ‘neutralising’ immune response to destroy the virus, researchers found.

A neutralising response means the immune system is able to destroy the virus and make it unable to infect the body.

The researchers could not test this on more people because they didn’t have enough time, they explained.

Scientists had to wait a month after vaccinating people, with many of them vaccinated in late May. And Sir Mene Pangalos, a vice-president of research and development at AstraZeneca, said the tests used were ‘very laborious’ so the team weren’t able to get more data in time for the paper.

Sir Mene added that the researchers were ‘veering towards a two-high-dose strategy’ because that seemed to be producing the strongest immune response.

Professor Adrian Hill, director of the Jenner Institute at Oxford, said: ‘It’s possible there’ll be a vaccine being used by the end of the year.

‘What that needs is enough cases in the probably about 50,000 people who will be in trials by six weeks’ time, including the very large US trial, and to have an adequate incidence.

‘But of course the vaccine has to work. Even if it worked by early November, it might be a little before that, you might have emergency use authorisation in a month and then you would be deploying in December.

‘So it’s possible but we certainly can’t guarantee it – that depends on incidence of the disease, as I said earlier.’

And vaccine researcher Dr Sandy Douglas added: ‘A really important part of the question of when the vaccine will be available is “Who will it be available to?”

‘I think the vaccine may be available for some people in high risk groups in the UK by the end of the year. But it won’t be made available to everybody immediately.

‘It’s likely to be given to the people who have the most to gain from it earliest, then gradually introduce it for other people.’

A second study, of a vaccine being made by the Chinese company CanSino, has also had promising results published in The Lancet this week.

That jab, which works in the same way – by piggybacking coronavirus genes onto a common cold virus – has also produced both antibody and T cell immunity.

The study involved 508 people, of whom 253 received a high dose of the vaccine, 129 received a low dose and 126 were given a placebo.

In a group who were given a high dose of the vaccine, 95 per cent of people still had immune responses 28 days after receiving the jab.

More than half of them (56 per cent) still showed what is called a ‘neutralising’ antibody response, meaning their immune system could destroy the virus completely. And 96 per cent of them had a ‘binding’ antibody response, meaning their antibodies could latch onto the viruses and prevent them getting into the body but did not destroy them completely.

In the low dose group, 47 per cent of people had a neutralising response after four weeks and 97 per cent had a binding response. 91 per cent still had some form of immune reaction a month after the jab.

The results of both trials came after announcements earlier today that the Government has bought orders for two other potential vaccines from France and Germany.

Agreement has been reached for 30million doses from German firm BioNTech and the US company Pfizer, and 60million doses from France’s Valneva.

BioNTech’s vaccine is another one that has shown good results in early trials.

A first-phase study on 45 adults, nine of whom received a placebo, found that the vaccine was well-tolerated and didn’t produce serious side effects.

It also triggered the immune system in the right way in all of those who it was given to. The immune reaction was dose-dependent, meaning people who received larger doses produced a larger immune response.

The figure is in addition to the 100million doses of vaccine that are being developed by Oxford University in partnership with AstraZeneca, as well as another at Imperial College London which started human trials in June.

The speed at which Covid-19 vaccines are being developed has been described as ‘unprecedented’ and a marvel of modern science.

Normally it takes years or even decades to get one into human trials but international collaboration, huge amounts of funding and the instantaneous publishing of scientific research online has allowed scientists to do it in record time.

The Oxford jab, for example, took just 103 days to get from being designed on a computer to entering human trials.

Long, repeated testing means it takes, on average, 10 years to develop a vaccine, according to the Wellcome Trust,

First trial results of Oxford’s Covid-19 jab reveal it is safe and provokes an immune reaction that lasts for two months 

Oxford University’s experimental jab is safe and provokes an immune reaction that lasts for at least two months, research shows. 

Hugely-anticipated clinical trial results of the vaccine — one of the front-runners in the world’s race for a jab — revealed more than 91 per cent of volunteers injected produced an immune response against the coronavirus that lasted a month or more. 

Immune responses remained strong for at least 56 days, according to results in The Lancet. But it won’t be licensed for human use yet because it has not been proven to work and the results only show it has promise.

The scientists who did the study, however, said it is ‘possible’ that the vaccine could be ready by December if tests keep going according to plan. Another added that people in the most at-risk groups could get the first jabs in the winter.

Crucially, nobody suffered any bad side effects from the vaccine and it is stimulating the immune system as scientists hoped. Some people developed headaches, tiredness and pain in their arm after they were given the jab, but scientists claimed none of the side effects were severe. 

Oxford University’s vaccine — called AZD1222 — is already being manufactured by pharmaceutical giant AstraZeneca and the UK Government has ordered 100million doses ahead of time.

Researchers on the project said ‘the early results hold promise’ but added much more is still needed.’ Infectious disease scientists warned ‘there is still a long way to go’ before any vaccine is rolled out. 

If the vaccine is given to the public it is likely to be in two doses given close together, developers said, because that seems to strengthen the body’s response.

Results from the first phase of clinical trials of Oxford’s vaccine were published in the British medical journal, The Lancet.

They revealed that the Covid-19 vaccine, named AZD1222, had been given to 543 people out of a group of 1,077. 

The other half were given a meningitis jab so their reactions could be compared and scientists could be sure the effects of the coronavirus jab weren’t random.   

Researchers wanted to find out whether the vaccine boosted either of two types of immunity — antibodies, which are disease-fighting substances; and T-cell immunity, with T cells able to produce antibodies and also to attack viruses themselves.

The vaccine produced ‘strong’ responses on both accounts, the study found.

It showed that the T cell response aimed at the spike protein that appears on the outside of the coronavirus was ‘markedly increased’ in people who had had the jab, in tests of 43 of the participants. These responses peaked after 14 days and then declined before the end-point of the trial at 56 days.

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