Sanofi Covid vaccine delayed until end of 2021 – and UK has 60m doses on order
A NEW Covid vaccine that the UK has ordered 60m doses of has flopped at the first hurdle and now won't be available until the end of 2021.
The elderly did not produce a strong immune response to Sanofi's vaccine in early trials.
In theory this would mean they would not be protected from disease.
But scientists believe they will be able to improve the formula and try again.
It's likely to push back the final results of trials until the end of 2021, after initially being expected in the first half of the year.
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.
There are high hopes for the Sanofi vaccine, developed in partnership with the drug giant GSK.
The companies have the largest manufacturing capabilities in the world, and claim to be able to produce one billion doses a year.
The UK secured a deal for 60 million doses in July, enough for half the population if given in two doses, rumoured to cost £500 million.
At this point, ministers had no idea if any Covid vaccine candidate would work, but appeared to place bets on the Sanofi one.
Therefore the delay will come as a huge blow in the fight against the deadly virus.
However, Covid vaccination is now well underway in the UK, after the Pfizer/BioNTech jab started to be given out at NHS hospitals.
"Low response" in elderly
Results of phase 1 and 2 trials announced by Sanofi/GSK on Friday showed "a low immune response in older adults " aged over 50 years old.
The elderly are the most at risk of severe Covid-19 and death, and so it is crucial scientists work to find a jab that can protect them.
Adults aged 18 to 29 years old did show a response to the vaccine, however.
Scientists said it was not a surprise that the vaccine didn't work in the older groups because their immune system is slower, and therefore needs a higher dose to work.
What is the Sanofi/GSK vaccine?
The vaccine produced by GSK and Sanofi is based on the existing DNA-based technology used to produce Sanofi’s seasonal flu vaccine.
It has been combined with GSK's adjuvanted technology, making the Covid vaccine a "protein adjuvant vaccine".
An "adjuvant" is added to some vaccines to enhance the immune response, and has been shown to create a stronger and longer lasting immunity against infections than the vaccine alone.
The use of an adjuvant may reduce the amount of vaccine protein required per dose, which allows more vaccine doses to be produced.
GSK and Sanofi's focuses on recreating the viral spike found on the outside of the SARS-CoV-2 virus.
The 'spike' protein is what the virus uses to bind with cells in the body to invade them and replicate.
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.
Human clinical studies of the vaccine began in September, enrolling around 400 people.
They were to be followed by a phase 3 study in December. But this will be pushed back to early next year now.
But it was still a dissappointment, nonetheless.
Roger Connor, President of GSK Vaccines, said in a statement: “The results of the study are not as we hoped.
"Our aim now is to work closely with our partner Sanofi to develop this vaccine, with an improved antigen formulation, for it to make a meaningful contribution to preventing Covid-19.”
Dr Gillies O’Bryan-Tear, of the Faculty of Pharmaceutical Medicine, said: "Older adults are known to have lower immune responses to such vaccines and this may be overcome by either repeated injections (prime- boost approach) or by increasing the antigen dose within each shot.
"In this case the companies seem to have decided to increase the antigen dose within the shot."
Jean-Daniel Lelievre, head of clinic immunology and infectious diseases at Henri-Mondor hospital in Creteil, France, told Reuters: "We know that more antigen is needed in older patients.
"But when in phase 1 and 2, drugmakers test tolerance and one cannot test strong dosages."
He added: “I would think Sanofi and GSK will be able to improve their vaccine.”
Sanofi said a tweaked formulation had already shown better effects in animal studies.
Delays
The phase 3 study of the vaccine - the largest part which concludes if the virus prevents a person getting sick with Covid-19 - was due to start this month.
However, earlier phases will now need to be re-done, starting from February 2021.
The phase 3 studies will start between March and June of 2021, if the results are positive, which would lead to the data being given to regulators in "the second half of 2021".
Dr O’Bryan-Tea said: “It is disappointing that the GSK/Sanofi Covid vaccine, coming as it does from one of the power houses of vaccine science in the world, has not performed as well as hoped for in the phase 2 study.
“It is a setback in the world's efforts to control the pandemic, but underlies the importance of having multiple options in addressing this pandemic."
What vaccines does the UK have access to?
A number of vaccines are currently being tested - with good results
Recent data from the Oxford/AstraZeneca and Moderna vaccine trials suggests their candidates also have high efficacy, just like the Pfizer jab, which is the first to be used in the UK.
Oxford data indicates the vaccine has 62 per cent efficacy when one full dose is given followed by another full dose.
However, when people were given a half dose followed by a full dose at least a month later, its efficacy rose to 90 per cent.
The combined analysis from both dosing regimes resulted in an average efficacy of 70.4 per cent.
Final results from the trials of Moderna's vaccine suggest it has 94.1 per cent efficacy, and 100 per cent efficacy against severe Covid-19.
Nobody who was vaccinated with the vaccine known as mRNA-1273 developed severe coronavirus.
The UK has secured access to 100 million doses of the AstraZeneca/Oxford University vaccine, which is enough for most of the population.
It also belatedly struck a deals for seven million doses of the jab on offer from Moderna in the US.
All vaccines undergo rigorous testing and have oversight from experienced regulators.
The UK has secured access to:
– 100 million doses of the Oxford vaccine
– 60 million doses of the Novavax vaccine
– Some 30 million doses from Janssen
– 40 million doses of the Pfizer/BioNTech vaccine – the first agreement the firms signed with any government
– 60 million doses of a vaccine being developed by Valneva
– 60 million doses of protein adjuvant vaccine from GlaxoSmithKline (GSK) and Sanofi Pasteur
– Seven million doses of the jab on offer from Moderna in the US
The news follows the start of the Covid-19 vaccine roll out in the UK, using the jab from Pfizer and BioNTech.
It was given regulatory approval from the MHRA last week, and already "tens of thousands" of Britons have been given the jab since December 8, the Health Secretary Matt Hancock said last night.
“As of today, we are vaccinating in 73 hospitals across the UK, tens of thousands of people have had the jab,” he said at a Downing Street news briefing on December 10.
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The UK is the first country in the world to have an approved vaccine for the coronavirus.
And the Oxford/AstraZeneca jab could be the second approved within the coming weeks, with the MHRA currently looking at the data from trials.
The UK government has ordered 340 million doses of Covid-19 vaccines from several manufacturers, 40 million of which are from Pfizer and 100 million from Oxford.
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The UK should have three or four vaccines against Covid-19 by the middle of next year, England’s chief medical officer has said.
Professor Chris Whitty told the Commons Health and Science Committee on December 9 that he expects to have a “portfolio” of several vaccines by the middle of 2021, but advised that the rollout process should still proceed “carefully”.