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Pharmaceutical firms GlaxoSmithKline and Sanofi launch human trials of promising coronavirus vaccine

Drug companies GlaxoSmithKline (GSK) and Sanofi are joining the race to discover a Covid-19 vaccine and starting human clinical trials this week.  

The pharmaceutical giants have enrolled more than 400 people for the phase one and two trial, which will assess the safety of the vaccine candidate. 

The UK Government signed a deal with the companies in July for 60million doses — rumoured to cost £500million — in the hopes that it will prove to a success.

Results of the initial testing, across 11 sites in the US, are anticipated in early December, with the third phase beginning before 2020 is over.   

The Department for Business, Energy and Industrial Strategy previously said the jab could be given to high-risk Britons as early as the first half of next year, if it passes trials. 

GSK and Sanofi together have the largest vaccine manufacturing capability in the world, and believe their jab has the ‘potential to overcome the pandemic’ which has already killed 863,000 people.

The vaccine, one of 34 now in clinical trials, is based on the existing DNA-based technology used to produce Sanofi’s seasonal flu vaccine. 

If all the vaccines pre-ordered by the UK are successful and go into production the country will have a massive stockpile of 340million jabs – enough to give every person in the country five each. 

Roger Connor, president of GSK Vaccines said: ‘Moving this vaccine candidate into clinical development is an important moment in the progress towards addressing the global pandemic we are all facing.

‘This builds on the confidence shown by governments already in the potential of this protein-based adjuvanted vaccine candidate, which utilises established technology from both companies, and can be produced at scale by two of the leading vaccine manufacturers globally.

‘We now look forward to the data from the study, and if positive, beginning a phase three trial by the end of the year.’

Thomas Triomphe, executive vice president and global head of Sanofi Pasteur, said: ‘Sanofi and GSK bring proven science and technology to the fight against the global Covid-19 pandemic, with the shared objective of delivering a safe and effective vaccine.

‘The initiation of our clinical study is an important step and brings us closer to a potential vaccine which could help defeat Covid-19.

‘Our dedicated teams and partner continue to work around the clock as we aim to deliver the first results in early December.’

The first phase of the trial, on a small group of volunteers, is to make sure the vaccine is safe. Healthy subjects 18 to 49 years of age will be vaccinated to establish the correct dose for the vaccine.

The second part will assess the efficacy, making sure the vaccine actually produces an immune response in the body. It will involve older participants.

When trials move into the third phase, involving hundreds to thousands more people, scientists assess whether the vaccine actually prevents people from catching the coronavirus.

Oxford University is now going through the third phase of clinical trials. UK drug giant AstraZeneca, which owns the rights to the vaccine, said on September 1 it had enrolled 30,000 American volunteers to take part in its phase three clinical trial.

It now means 50,000 people worldwide are taking part in studies to see whether the jab – known as AZD1222 – can actually prevent people getting infected with Covid-19.

GSK and Sanofi’s vaccine works in a similar way to Oxford’s and both focus on recreating the viral spike found on the outside of the SARS-CoV-2 virus which infects human cells. 

The ‘spike’ protein is what the virus uses to bind with cells in the body to invade them and has become the focus of scientific research.

The vaccines aim to prime the body’s immune system to bind to the protein and disable the virus before it takes hold in the body. 

The difference between the two vaccines is how the spike is created. 

Sanofi’s vaccine is based on its commercial and world-leading DNA Recombination technology which it initially developed for influenza vaccinations.

This jab has been combined with GSK’s adjuvanted technology which enhances the body’s immune response.

An adjuvant can reduce the amount of vaccine protein required per dose, which allows more vaccine doses to be made quicker.

The combination of a protein-based antigen together with an adjuvant is well-established and used in a number of vaccines, including for shingles and hepatitis B.

Oxford’s vaccine however, is based on a genetically tweaked version of the common cold virus that usually infects chimps.

The virus was weakened and its genetic material altered so it produced spikes which are identical to those of SARS-CoV-2.

Researchers hope their version will make the body recognise and develop an immune response to the spike protein – recognisable in images of the virus – that will help stop Covid-19 from entering human cells and therefore prevent infection.  

Roger Connor, president of GSK Vaccines, said: ‘We believe that this adjuvanted vaccine candidate has the potential to play a significant role in overcoming the Covid-19 pandemic, both in the UK and around the world.’ 

The Government’s deal with GSK and Sanofi is among a string of agreements the British Government has made to get its hands on a vaccine.

Companies including Janssen Pharmaceuticals – which is owned by Johnson & Johnson – and Novavax, Pfizer, AstraZeneca and Valneva have all also received orders for their jabs.

Officials are taking a spread-betting approach ordering stacks of numerous types of jab in the hope that at least one of them will work.

Deals for a total 340million doses have so far been announced for the nation, which has a population of around 67million people.

It means the UK is set to get early access to six vaccines, which work in four different ways. Officials are hedging their bets because nobody knows which, if any, will ultimately be successful. It may even be necessary to give people more than one vaccine to get a strong immune response.

And it may be the case that if a vaccine cannot stop coronavirus from spreading, it could reduce the severity of a patient’s symptoms to prevent deaths.

Until clinical trial results appear, it is unclear whether people are likely to be given just the best-performing jab or a combination of different types. 

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