A trial testing an experimental Ebola vaccine has been suspended amid concerns over potential side-effects.
The decision to pause the Swiss clinical trial at the University of Geneva was taken after four volunteers reported suffering joint pain in their hands and feet.
The hospital said the move is a ‘precautionary measure’, after the volunteers had the injection 10 to 15 days earlier.
The Geneva researchers reported on December 2 that the first people vaccinated with the experimental drug had experienced no serious side effects, with a few suffering a mild fever.
But today, the hospital said the four patients had suffered joint pain, which lasted a few days.
Scientists are racing to develop vaccines to combat the deadly virus, which has killed more than 6,300 people – the majority in the West African nations, Sierra Leone, Liberia and Guinea.
Experts believe millions of doses of vaccine may be needed to bring this, the worst Ebola outbreak in history, to an end and contain future epidemics.
The global vaccines alliance, GAVI, has today committed up to $300 million to buy any future vaccines.
GAVI, which is funded by governments and the Bill and Melinda Gates Foundation, said it is ready to begin procurement of a vaccine as soon as the World Health Organisation (WHO) recommends a drug for use.
Officials involved in the Swiss trial of a drug developed by the Canadian government and licensed to two US companies, NewLink and Merck, said all 59 volunteers who received the jab were fine.
‘They are all fine and being monitored regularly by the medical team leading the study,’ the hospital said in a statement.
The trial was started last month and is set to resume on January 5 in 15 volunteers after checks to ensure the joint pain symptoms were ‘benign and temporary’, the hospital said.
The team was in close contact with researchers in the United States, Germany, Canada and Gabon who are carrying out the same trial with the Merck and NewLink vaccine, it said.
‘These centres have not observed symptoms of inflammation in their volunteers to date,’ it added.
WHO vaccine expert Marie-Paule Kieny, said the delay would allow time to see how widespread the problems are.
But it was expected that after the delay the trial will be able to continue as originally planned, she added.
‘It’s not a setback, not at all,’ she said in Geneva.
And the WHO downplayed the setback, pointing out that temporary suspensions are not uncommon in clinical trials.
Researchers hope safe and effective vaccines will get a green light as soon as next year, although there is uncertainty over how well they will work and how many doses will be needed.
Last month WHO director general Dr Margaret Chan said a vaccine to protect millions from Ebola decades after the virus was first detected in the 70s, does not exist because the disease previously only affected poor African nations.
The head of the World Health Organisation’s scathing conclusion came at a point when nearly 5,000 people had lost their lives to the hemorrhagic fever.
Dr Chan criticized drugs companies for turning their backs on ‘markets that cannot pay’.
She said the current outbreak – the most deadly in history – has exposed two WHO arguments ‘that have fallen on deaf ears for decades’.
Addressing the regional committee for Africa in Benin on November 3, Dr Chan said: ‘Ebola emerged nearly four decades ago. Why clinicians are still empty handed, with no vaccines and no cure?
‘Because Ebola has historically been confined to poor African nations.
‘The R&D (research and development) incentive is virtually non-existent.
‘A profit-driven industry does not invest in products for markets that cannot pay.
‘WHO has been trying to make this issue visible for ages. Now people can see it for themselves.’
But the money now earmarked by GAVI will help to bridge the gap and is expected to be enough to procure up to 12 million courses of a vaccine.
WHO vaccine expert Marie-Paule Kieny, said the commitment is ‘fantastic’.
In addition to helping tackle the current epidemic, the money could also be used to create stockpiles of Ebola vaccines, similar to those that exist for yellow fever, meningitis and cholera.
A further $90 million will be made available from GAVI’s funds to help those affected in the hardest hit nations, and introduce the vaccines while helping to rebuild their broken health systems.
GAVI, which was set up in 2000 with private and government donor backing, has a track record of bulk-buying vaccine supplies from manufacturers at a low price for the developing world.
Since 2000, around 440 million children have been immunised against a range of diseases through its programmes.
GAVI said its board had decided to prepare for procuring Ebola vaccines while still awaiting a green light for the first product, ‘in light of the seriousness of the situation and the risks associated with delays in making a vaccine available’.
Two vaccines, one from NewLink and Merck and a rival shot from GlaxoSmithKline, are already undergoing human trials and third one, made by Johnson & Johnson, is about to enter clinical testing.
‘We’ve had individual discussions with all of the manufacturers and continue to work closely with them,’ GAVI’s chief executive, Seth Berkley, said.
GAVI said it would meet the funding needs of the Ebola vaccine programme using a combination of existing and new financing.
It also plans to join forces with other initiatives that have already pledged funding to address the Ebola crisis. – Agency Report.
