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The first batch of GSK’s Ebola experimental vaccine is on its way to Liberia.
The shipment will be the first potentially preventative medicine to reach one of the hardest hit countries.
However, experts say that, with Ebola cases falling, it may be difficult to establish whether the jab offers any protection against the virus.
The vaccine has been produced by British company GlaxoSmithKline (GSK) and the US National Institutes of Health.
GSK said a plane carrying some 300 initial doses of the vaccine was expected to arrive in Monrovia on January 23.
The company hopes the first volunteer will be immunized in the next few weeks.
GSK CEO Andrew Witty said the pace of development was almost unparalleled and was comparable to only the development of a pandemic flu vaccine or new medicines for HIV.
Photo AP
Scientists aim to involve 30,000 volunteers in the trial in total, including frontline health workers.
If all regulations are met, 10,000 volunteers will be given the GSK vaccine.
A matching number will get a placebo, dummy vaccine. And there are plans for a further 10,000 people to get a separate experimental jab.
The results will be compared to see if either vaccine offers any meaningful protection against the virus.
A version of the vaccine has already been tested on 200 healthy volunteers across the UK, US, Switzerland and Mali.
GSK says it has been found to have an acceptable safety profile so far.
However, it is only in affected countries that experts can determine whether it provides adequate protection against the virus.
Dr. Moncef Slaoui, of GSK said: “Shipping the vaccine today is a major achievement and shows that we remain on track with the accelerated development of our candidate Ebola vaccine.
“The initial phase one data we have seen are encouraging and give us confidence to progress to the next phases of clinical testing.”
GSK stresses the vaccine is still in development and the World Health Organization, and other regulators, would have to be satisfied the vaccine is both safe and effective before any mass immunization campaigns could be considered.
Field trials of other promising vaccines – for example one involving the company Merck – are planned in Guinea, Liberia and Sierra Leone in the months to come.
There are reports that a trial of an experimental drug called Zmapp might start in the next few weeks.
However, experts say with the number of Ebola cases falling opportunities to test vaccines and drugs could be limited.
Clinical trials for an effective Ebola treatment are to start in West Africa in December.
The medical charity Medicins Sans Frontieres (MSF), which has been helping lead the fight against the virus, says three of its treatment centers will host three separate research projects.
Meanwhile, Liberia’s President Ellen Johnson Sirleaf has lifted the state of emergency imposed in the country.
Ellen Johnson Sirleaf warned “this is not because the fight against Ebola is over”.
It marks the progress being made in the country, where the weekly number of new infections is falling.
In a radio address she told the nation that night curfews would be reduced, weekly markets could take place and preparations were being made for the re-opening of schools.
One trial involves using the blood of recovered Ebola patients to treat sick people in the Guinean capital Conakry.
Clinical trials for an effective Ebola treatment are to start in West Africa in December (photo Getty Images)
Two antiviral drugs will be trialed in Guinea and an unconfirmed location.
“This is an unprecedented international partnership which represents hope for patients to finally get a real treatment,” said MSF spokeswoman Dr. Annick Antierens.
The Ebola outbreak is thought to have infected more than 14,000 people, almost all of them in West Africa. The death toll has risen to 5,160.
The first trials are due to start next month. Initial results could be available in February 2015.
The World Health Organization (WHO) announced in September that experimental treatments and vaccines for Ebola should be fast-tracked.
Two experimental vaccines, produced by GlaxoSmithKline (GSK) and the Public Health Agency of Canada, have already been fast-tracked into safety trials.
The GSK vaccine is being tested in Mali, the UK and the US. Research on the Canadian vaccine is also under way in the US.
Around 400 people participate in the first trials and they will be extended to other centers if the early results are promising.
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GlaxoSmithKline (GSK) has received a record $490 million fine after a Chinese court found it guilty of bribery.
The record penalty follows allegations the pharmaceutical giant paid out bribes to doctors and hospitals in order to have their products promoted.
The court gave GSK’s former head of Chinese operations, Mark Reilly, a suspended three-year prison sentence and he is set to be deported.
Other GSK executives have also been given suspended jail sentences.
The guilty verdict was delivered after a one-day trial at a court in Changsha, according to the Xinhua news agency.
GSK has received a record $490 million fine after a Chinese court found it guilty of bribery
Chinese authorities first announced they were investigating GSK in July last year, in what has become the biggest corruption scandal to hit a foreign firm in years. The company was accused of having made an estimated $150 million in illegal profits
GSK said it had “published a statement of apology to the Chinese government and its people”.
“Reaching a conclusion in the investigation of our Chinese business is important, but this has been a deeply disappointing matter for GSK,” said GSK CEO Andrew Witty in a statement.
“We have and will continue to learn from this. GSK has been in China for close to a hundred years and we remain fully committed to the country and its people,” he said.
“We will also continue to invest directly in the country to support the government’s health care reform agenda and long-term plans for economic growth.”
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Scientists say that vaccinated monkeys have developed “long-term” immunity to the Ebola virus, raising a prospect of successful human trials.
The experiments by the US National Institutes of Health (NIH) showed immunity could last at least 10 months.
Human trials of the Ebola vaccine started this week in the US and will extend to the UK and Africa.
The World Health Organization (WHO) says more than 2,000 people have now died in the outbreak in West Africa.
Several experimental treatments are now being considered to help contain the spread of Ebola.
Human trials of the Ebola vaccine started in the US and will extend to the UK and Africa
This includes a vaccine being developed by the US National Institute of Allergy and Infectious Diseases and pharmaceutical company GlaxoSmithKline (GSK).
It uses a genetically modified chimp virus containing components of two species of Ebola – Zaire, which is currently circulating in West Africa, and the common Sudan species.
The viral vaccine does not replicate inside the body, but it is hoped the immune system will react to the Ebola component of the vaccine and develop immunity.
Animal research, on which the decision to begin human trials was based, has now been published in the journal Nature Medicine.
It shows four crab-eating macaques all survived what would have been a fatal dose of Ebola virus five weeks later.
However, only half survived an infection 10 months after immunization.
For now this is the best evidence available on how successful such a vaccine would be in people.
The first patient, a 39-year-old woman, was given the vaccine last week as human trials got under way.
There will also be separate trials of the vaccine against just the Zaire Ebola species.
These will take place in the US, the University of Oxford in the UK as well as in Mali and Gambia.
The WHO said safety data would be ready by November 2014 and, if the vaccine proved safe, it would be used in West Africa immediately.
Healthcare workers and other frontline staff would be prioritized for vaccination.
The number of doses currently available is between 400 – if a lot of vaccine is needed for immunity – and 4,000 if smaller amounts are sufficient.
As with all experimental therapies, the WHO has warned hopes of a vaccine must not detract from the proven methods of infection control which have defeated all previous outbreaks.
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Clinical trials of a preventative vaccine for the Ebola virus made by pharmaceutical company GlaxoSmithKline may begin next month and made available by 2015, the WHO said on Saturday.
“We are targeting September for the start of clinical trials, first in the United States and certainly in African countries, since that’s where we have the cases,” Jean-Marie Okwo Bele, the WHO’s head of vaccines and immunization, told French radio.
Jean-Marie Okwo Bele said he was optimistic about making the vaccine commercially available.
Clinical trials of a preventative vaccine for the Ebola virus made by GSK may begin next month and made available by 2015
“We think that if we start in September, we could already have results by the end of the year.
“And since this is an emergency, we can put emergency procedures in place … so that we can have a vaccine available by 2015.”
There is currently no available cure or vaccine for Ebola, a virus that causes severe fever and, in the worst cases, unstoppable bleeding.
It has claimed close to 1,000 lives in the latest epidemic to spread across West Africa this year. Fatality rates can approach 90 percent, although the latest outbreak has killed around 55 to 60 percent of those infected.
Several vaccines are being tested, and a treatment made by San Diego-based Mapp Biopharmaceutical, ZMapp, has shown promising results on monkeys and may have been effective in treating two Americans recently infected in Africa.
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The world’s first malaria vaccine could be approved for use in 2015, experts say.
Reporting in PLOS Medicine, researchers found that for every 1,000 children who received the vaccine, an average of 800 cases of illness could be prevented.
In continuing trials it went on to provide protection some 18 months after the injections were given.
GlaxoSmithKline have now applied for regulatory approval – making this the first vaccine to reach this step.
Malaria affects millions of people worldwide and results in 800,000 deaths each year – the majority in children under five who live in sub-Saharan Africa.
The world’s first malaria vaccine could be approved for use in 2015
In the most advanced trial to date, involving several African countries, 1,500 infants and children were given the RTS,S vaccine.
Revisiting them 18 months after the last injection, researchers found that in young children the vaccine almost halved the number of cases of malaria.
For infants, who were aged six to 12 weeks at first vaccination, the drug reduced episodes of malaria by a quarter.
Though the effectiveness of the vaccine was seen to wane over time, the report suggests it may have the largest impact in areas with high rates of disease.
For example, in some Kenyan cities, 2,000 cases of clinical malaria were prevented for every 1,000 children who received the drug (people in this area are at risk of repeated infections).
GSK has now asked the European Medicine’s Authority to approve it for global use.
The drug-makers say together with other preventative measures such as bed nets and insecticides, this could represent a huge step forward in malaria control.
Scientists are investigating whether a booster could further improve the chances of success.
GSK is developing RTS,S with the non-profit Path Malaria Vaccine Initiative, supported by funding from the Bill & Melinda Gates Foundation.
GlaxoSmithKline (GSK) has agreed to a $105 million settlement with 44 US states and the District of Columbia over allegations it mispromoted three drugs.
The drugs are asthma medication Advair and anti-depressants Paxil and Wellbutrin.
GSK has agreed to a $105 million settlement with 44 US states and the District of Columbia over allegations it mispromoted three drugs (photo Alamy)
The pharmaceutical giant did not admit any wrongdoing, and said the charges came from past issues.
As part of the settlement, GSK must extend its Patient First Program until 2019, which prohibits financial incentives to its sales people, and it is prohibited from paying doctors to speak about GSK’s products or attend conferences.
“This settlement requires GSK to pay a significant penalty and imposes strong new rules designed to prevent future misrepresentations of GSK products,” said California attorney general Kamala Harris in a statement.
GSK insists that many of these practices are already in place.
Pharmaceutical giants Novartis and GlaxoSmithKline have agreed to exchange assets and combine their consumer healthcare units.
Novartis will acquire GSK’s oncology drugs business for $16 billion and sell its vaccines division, excluding the flu unit, to GSK for $7.1 billion.
In a separate deal, Novartis has agreed to sell its animal health division to Lilly for nearly $5.4 billion.
Novartis said the moves would help the company focus on its key businesses.
Novartis will acquire GSK’s oncology drugs business for $16 billion and sell its vaccines division, excluding the flu unit, to GSK for $7.1 billion
“The transactions mark a transformational moment for Novartis,” Novartis CEO Joseph Jimenez said in a statement.
“They also improve our financial strength, and are expected to add to our growth rates and margins immediately.”
The deals are a part of Novartis’s review of its business as it continues to face sluggish growth.
Novartis and GSK said that combining their over-the-counter (OTC) units would help boost the fortunes of both the companies.
The combined unit will have annual revenues of more than $10 billion.
“Opportunities to build greater scale and combine high quality assets in vaccines and consumer healthcare are scarce,” GSK CEO Andrew Witty said in a statement.
“With this transaction, we will substantially strengthen two of our core businesses and create significant new options to increase value for shareholders.”
Glaxo shareholders will get a $6.5 billion capital return from the deal proceeds, the company said.
Pharmaceutical company Eli Lilly has said it is “deeply concerned” by claims that it bribed Chinese doctors to prescribe its drugs.
Chinese paper 21st Century Business Herald cited a former staff, identified by a pseudonym, as saying Eli Lilly paid out 30 million yuan ($4.9 million).
The claims come at a time when China is investigating some drugs firms over similar bribery allegations.
Eli Lilly said it had launched an internal probe last year after a former manager made similar allegations against it.
“At the time of the allegations, we did an exhaustive investigation to search for any evidence of kickbacks,” the company said in a statement.
“Although we have not been able to verify these allegations, we take them seriously and we are continuing our investigation.”
The drugmaker said it interviewed employees, monitored emails and audited expense reports as part of its internal probe.
Eli Lilly has said it is “deeply concerned” by claims that it bribed Chinese doctors to prescribe its drugs
However, it said it had not employed any sales managers by the name of Wang Wei, who was mentioned in the 21st Century Business Herald report.
Eli Lilly is the latest foreign drugmaker to be engulfed by such claims in China.
Earlier this week, a British risk consultant, Peter Humphrey, was formally arrested by Chinese authorities amid a continuing probe into pharmaceutical companies.
One of the companies being probed, GlaxoSmithKline (GSK), is reportedly a former client of Peter Humphrey’s firm, ChinaWhys.
Chinese authorities have accused GSK of directing up to $500 million through travel agencies to facilitate bribes to doctors and officials.
GSK has said that some senior executives in its China office appeared to have broken the law and several GSK employees have also been detained over the last few weeks.
In July, Chinese police had visited the Shanghai office of AstraZeneca and took an employee in for questioning.
According to new reports, bribes are routinely paid by major foreign pharmaceutical companies operating in China.
Five sales representatives for foreign companies told the BBC their firms paid bribes in order to increase sales of their products.
None of them wanted to be identified, fearing they would lose their jobs.
The revelations come as Beijing widens its investigation into drugs-price fixing amid a bribery scandal engulfing drugs giant GlaxoSmithKline.
One of the salesmen said his company paid about $1,000 to get its product back on the shelves at one hospital.
“I don’t deny [giving money to doctors] happens in foreign companies,” the sales representative said.
“It is rare though and only very few people get it,” he added.
GSK was accused of directing up to $500 million through travel agencies to facilitate bribes to Chinese doctors and officials
But he described an incident where a product had been cleared from a hospital’s shelves, which proved to be “an embarrassment” for him and his company.
“If we follow the normal procedure to recover it, it is very complicated. It will cost a lot of money and energy. We looked for a quick way.”
The sales representative admitted that strictly speaking, the money paid out to ensure the product returned to shelves was probably a bribe and that his manager signed it off. He said it would have cost a lot more to achieve the same result through official routes.
“It may cost us more if we have not paid the bribe. It will be a lot of money and energy,” he said.
Such revelations follow last month’s allegations by the Chinese police that the British pharmaceutical giant GlaxoSmithKline had engaged in “mafia-style behavior”. GSK was accused of directing up to $500 million through travel agencies to facilitate bribes to doctors and officials.
A detained Chinese executive from the firm told state television that bribes paid by his company had inflated prices of its products by a third.
GSK has said that it is co-operating with the Chinese investigation.
China’s health care spending is expected to more than double by the end of this decade.
By investigating possible drugs price fixing the authorities are hoping to tackle the rising costs.
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British pharmaceutical giant GlaxoSmithKline (GSK) made “illegal” transfers, say Chinese police as they released details of an investigation into bribery allegations.
Four senior Chinese executives from GSK have been held, said Gao Feng, head of the economic crimes investigation unit.
Gao Feng said GSK had transferred as much as 3 billion yuan ($489 million) to travel agencies and consultancies since 2007.
Chinese police said GSK had transferred as much as $489 million to travel agencies and consultancies since 2007
GSK has said it has not found any evidence of corruption.
However, the company said in a statement last week that it was co-operating with authorities.
On July 11, the Ministry of Public Security said GSK executives had confessed to bribery and tax violations. Authorities said they suspect GSK of offering bribes to officials and doctors to try to boost sales in China.
On Monday, Gao Feng did not go into how much of the money was spent allegedly bribing officials and doctors.
He did, however, say that the probe had found that GSK was mainly responsible for the bribes which included cases of s**ual bribery.
“We have sufficient reason to suspect that these transfers were conducted illegally,” Gao Feng said.
“You could say the travel agencies and GSK were criminal partners.”
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Chinese authorities have announced that some senior executives of the local division of GlaxoSmithKline (GSK) are facing a criminal investigation.
They are being investigated for bribery and tax-related violations, said the Chinese Ministry of Public Security.
They are suspected of offering bribes to officials and doctors in an attempt to boost sales in the country.
GSK said in response to the allegations that it had found no evidence of bribery or corruption in China.
“We are willing to co-operate with the authorities in this inquiry,” the company said in a statement, adding that it had only just received official word of the “specific nature” of the investigation.
“We take all allegations of bribery and corruption seriously,” the statement said.
GSK senior executives are being investigated in China for bribery and tax-related violations
“We continuously monitor our businesses to ensure they meet our strict compliance procedures – we have done this in China and found no evidence of bribery or corruption of doctors or government officials. However, if evidence of such activity is provided, we will act swiftly on it.”
The Chinese Ministry of Public Security said in a statement that police had questioned some of the suspects.
It accused the firm of bribing government officials and doctors, as well as overstating tax receipts.
“The case involves many people, the duration of time is long, the amount of money involved is huge and the criminal activities are malicious,” the ministry said.
Senior executives at GSK are already being investigated by Changsha public security officials for “economic crimes”, the city’s police force said last month. However, it is not clear if the Changsha investigation is related to any of the latest allegations.
Pharmaceutical giant GlaxoSmithKline (GSK) has been accused of market “abuse” by the consumer watchdog, the Office of Fair Trading (OFT).
The OFT alleges that the company paid rivals to delay the release their own versions of GSK’s antidepressant drug Seroxat (paroxetine).
Alpharma, Generics UK and Norton Healthcare all received money not to enter the market with their copies of Seroxat.
Seroxat is a drug used to treat depression.
Consumer watchdog Office of Fair Trading alleges that GSK paid rivals to delay the release their own versions of Seroxat drug
The generic drug makers were attempting to supply the UK market with their versions of paroxetine, which GlaxoSmithKline brands as Seroxat, the OFT said.
GSK accused them of infringing its patent, so to resolve this dispute the pharmaceutical company effectively paid the three companies off, according to the OFT.
If proven, the allegations would be an infringement on the part of all the parties of competition law and on the part of GSK an abuse of its dominant place in the market.
“The introduction of generic medicines can lead to strong competition on price, which can drive savings for the NHS, to the benefit of patients and, ultimately, taxpayers,” said Ann Pope, senior director of services, infrastructure and public markets at the OFT.
“It is therefore particularly important that the OFT fully investigates concerns that independent generic entry may have been delayed in this case.”
The companies will now be asked to respond to its allegations, before the OFT makes a decision on whether or not competition law has been infringed.
