Gavi pledges $300 million for Ebola vaccines
pharmafile | December 12, 2014 | News story | Manufacturing and Production, Sales and Marketing | GAVI, GSK, GlaxoSmithKline, J&J, JJ, Merck, Vaccine, WHO, newlink
The global vaccines alliance Gavi has committed to buying Ebola vaccines as soon as the World Health Organization recommends one for use.
In a statement Gavi revealed plans that could see up to $300 million used to buy the drugs, which could translate into up to 12 million courses. An additional $90 million could be used to support affected countries in rolling out the treatments and rebuild their ‘devastated’ health systems.
“Gavi will be ready to act as soon as a safe, effective vaccine is recommended for use by the World Health Organization,” adds the alliance, which is funded by governments and the Gates Foundation among others. “Gavi funding could also be used to create stockpiles of first- and second-generation Ebola vaccines which countries can access rapidly in future outbreaks.”
An effective vaccine might be one of the only ways to control the world’s deadliest Ebola outbreak, which has killed over 6,000 people so far, but most of the deaths have been in developing countries which may struggle to afford treatments. Gavi’s money could therefore help provide a commercial incentive to pharma companies in the most affected nations of Liberia, Guinea and Sierra Leone.
No Ebola vaccines have been approved yet, although several firms – including GlaxoSmithKline, Johnson & Johnson and Merck – are fast-tracking trials in a race to keep up with the spread of the virus.
Recently trials of a candidate from Merck – co-developed with NewLink – have been halted after patients complained of joint pains. Four patients in the University of Geneva Hospital (HUG) study reported pains in their hands and feet, which lasted a few days, in the second week of the trials.
“They are all fine and being monitored regularly by the medical team leading the study,” the hospital says in a statement. “The Geneva team has decided to allow time to understand what is happening. This precaution of momentarily suspending the trial is usual and classic in all clinical trials.”
Initial reports from the trial stated that the vaccine had demonstrated no major side effects but a few cases of mild fever.
The hospital added that the study is expected to resume on 5 January after they ensure that the pains are ‘benign and temporary’.
A Merck spokesperson told Pharmafile: “We are aware that a Phase I study being conducted by the University Hospitals of Geneva site has been placed on a temporary hold by the Data Safety Monitoring Board for the VSV Ebola Consortium, as a precautionary measure, following the occurrence of transient complaints of joint pain in small number of study volunteers receiving higher dose levels of the vaccine.
“These events have not been reported at any of the other clinical sites. It is not known at this time whether these events are related to the vaccine or not. We understand the level of vaccine being administered in the trial, which is being conducted at a number of other sites, will proceed using lower doses of the vaccine.
“Results from ongoing and planned Phase I studies will help define the appropriate dose and overall safety and tolerability profile of the experimental rVSV-EBOV vaccine.”
Further trials have recently begun in Gabon, the US, Germany and Canada, with more planned to start in Kenya soon.
George Underwood
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