Chinese Covid-19 vaccine contender made by state-owned pharmaceutical may be on the market by December – and cost £100
- Drug giant Sinopharm claims the vaccine will be on the market by Christmas
- It said it will take a further three months for phase three clinical trials to end
- The first two stages showed volunteers had a robust antibody response
- But it is yet to be proven this prevents a person catching the coronavirus
A Chinese Covid-19 vaccine contender may be on the market by December and cost just £100 for two doses.
State-owned pharmaceutical company Sinopharm claims the jab could be ready by Christmas, once final stage trials are over.
Officials feared the vaccine may not be ready until at least next year because a lack of new infections in China made it difficult to test it.
But alternative trial sites abroad have since been set up, with the third and final part of the tests planning to recruit 15,000 volunteers in the United Arab Emirates.
Manufacturers will be able to make 220million doses of the jab a year, a Sinopharm chief said.
But initial trials have shown people may need two or even three shots each for it to be effective.
The population of China alone is 1.4billion, suggesting British and American officials may struggle to get access to the vaccine if it is proven to work.
The experimental jab has shown to trigger antibodies in volunteers from the first and second stages of experiments. It has also been found to be safe.
But although the findings were promising, they do not yet prove the jab can prevent a person catching the virus in the first place.
A Chinese Covid-19 vaccine contender made by Sinopharm (pictured) may be on the market by December and cost £100
The company has the ability to make doses for 110million people. But the population of China alone is 1.4billion, therefore it is unclear if it would be available to any other countries in the near future. Pictured: A staff member of the China National Pharmaceutical Group testing samples of the virus on April 11
China has been competing with US, British and German companies to be the first with a proven Covid-19 vaccine to help end the pandemic.
At least eight vaccine candidates made in China are currently being tested. All are in different stages of clinical trials.
The candidate from China’s government-run company Sinopharm is ‘inactivated’ – it is made by growing the whole virus in a lab and then killing it.
Inactivated vaccines are well known and have been used against diseases such as influenza, measles and rabies.
But they usually don’t provide immunity that’s as strong as live vaccines, so several doses over time may be necessary.
The vaccine was developed alongside experts at the Wuhan Institute of Biological Products and the Beijing Institute of Biological Products.
HAS THE SINOPHARM VACCINE BEEN PROVEN TO WORK?
Sinopharm’s experimental jab has been shown to trigger antibodies in volunteers.
Although the findings are promising, they do not prove the jab can prevent a person catching the virus.
Results of the most recent trial were published on August 13 in the Journal of the American Medical Association (JAMA) and led by Shengli Xia, of the Henan Center for Disease Control and Prevention.
Ninety-six healthy adults from China aged between 18 and 59 years old were assigned to one of the three dose groups (2.5, 5, and 10 μg/dose), or a control group for a placebo jab.
They were given three shots in total, on days 0, 28, and 56.
After seven days, adverse reactions occurred occurred in 20.8 per cent, 16.7 per cent, and 25 per cent of patients in the low-dose, medium-dose, and high-dose groups, respectively.
In the second trial, 224 healthy adults were randomly divided into two groups in which they received a jab on either day zero and 14, or day zero and 21. Some received a medium dose of the real vaccine candidate, while the others were given a placebo.
No more than one fifth of participants in the phase two trial had side effects.
Overall, 15 per cent of participants reported side effects within seven days of the injection, which is ‘lower compared with results of other candidate vaccines’, the researchers said.
The most common side effect was injection site pain. No serious adverse reactions were noted by the researchers.
When looking at the immune response to the vaccine, the trial found ‘the inactivated vaccine may effectively induce antibody production’ based on antibody levels increasing.
The results in both phases indicated that a longer interval (21 to 28 days) between the first and second injections produced higher antibody responses compared with a shorter interval schedule (14-day group).
Antibodies started to increase after a second injection and further increased after the third injection in the phase 1 trial, suggesting the need for a booster injection, the paper said.
No new Covid-19 cases were reported and no participant developed any symptoms of SARS-CoV-2 infection during the trial.
But its not clear if people were protected by the jab or if they had just not been exposed to the coronavirus. And the researchers did not look at home long antibodies lasted in the long-term.
Chairman of Sinopharm Group Liu Jingzhen made the promising claims that the company’s jab will be available on the market in December, after the third stage of clinical trials is over.
‘After the third stage of international clinical trials ends, we can register the inactivated vaccine,’ he said according to the Guangming Ribao newspaper.
‘According to our estimations, by the end of the year, it may appear on the market.
‘I have personally received two shots of the vaccine, there were no side effects.
‘After the inactivated vaccine enters the market, its price will not be too high, it will be around several hundred yuan. Two shots will cost about 1,000 yuan (about $144/£100).’
It is likely that two shots of the vaccine will eventually be recommended because one only gives ’97 per cent protection’, he said.
Mr Jingzhen added: ‘If you do two shots, the probability of protection may reach 100 per cent.’
‘The interval between the first and the second shot usually lasts 28 days. In some exceptional cases, two injections can be done at once in the left and right arm. Four micrograms of the vaccine are injected each time.’
Mr Jingzhen said the Beijing Institute of Biological Products can produce up to 120million inactivated vaccines a year, and the Wuhan Institute of Biological Products can produce an additional 100million.
Considering two doses could be needed, it suggests just a fraction of China’s population alone would be able to be vaccinated.
Mr Jingzehen did not comment on whether the potentially life-saving jab will be available to other countries.
He said it would not be necessary to vaccinate the entire population of China. However, working people living in densely populated areas of the country must receive the vaccine, he added.
‘This highlights the long-standing world shortage of capacity for vaccine production,’ said Keith Neal, an emeritus professor of the epidemiology of infectious diseases, University of Nottingham.
‘Even at $140 this is not affordable for many people across the world who need it. It is much higher than the price estimated for other vaccines.’
Professor Neal also said: ‘Without seeing published reviewed papers, it is difficult to comment on the vaccine.’
The first two stages of clinical trials claimed Sinopharm’s candidate was safe and triggered antibody-based immune responses.
The shot did not cause any serious side effects, according to a paper published on August 13 in the Journal of the American Medical Association (JAMA).
The results were based on data from 320 healthy adults.
Scientists reported that it remained unknown if that was sufficient to prevent Covid-19 infection, researchers developing the vaccine said in the paper.
The company previously said in an online post that 30 employees, including top executives, helped ‘pre-test’ its vaccine in March, before it was approved for its initial human study.
Dr Gao Fu (pictured in this file photo on January 26), the head of the Chinese Center for Disease Control and Prevention says he has been injected with an experimental coronavirus vaccine from China
Scientists vehemently debate such self-experimentation, because what happens to one or a few people outside a well-designed study is not usable evidence of safety or effectiveness.
It is speculated that Dr Gao Fu, the head of the Chinese Center for Disease Control and Prevention, has been injected with the experimental vaccine from Sinopharm.
He said in July: ‘I’m going to reveal something undercover: I am injected with one of the vaccines. I hope it will work.’
He did not reveal which candidate he had received of the several speeding ahead in China.
The candidate moved into a late-stage trial in June – one of a handful of candidates being tested on several thousand people to see if they are effective enough to win regulatory approval.
Sinopharm is testing the potential vaccine in the UAE on 15,000 people, initially in Abu Dhabi because China is recording fewer than 100 cases a day.
The United Arab Emirates was chosen because around 200 different nationalities reside there so it can be trialled in a range of people, officials said. It is recording around 300 cases a day.
The trial will test two vaccines against a placebo. Volunteers – all aged between 18 and 60 – will be given two doses three weeks apart and will be followed for a year.
The state-owned company will also supply the candidate to Pakistan as part of a trial agreement, the Wall Street Journal reported.
More than 150 candidate vaccines are being developed and tested around the world, including six that are in phase three trials.
Russia became the first country to grant regulatory approval to a vaccine after less than two months of human testing.
A shot developed by Chinese firm CanSino Bilogics has been cleared for use in the military.
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.
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