Two candidate Ebola vaccines could be ready for testing in countries west- Africa hard hit in December, a month earlier than previously forecast. And a vaccine manufacturer said it may have million doses available by April, should studies prove it is safe and effective, a much more optimistic scenario described so far.
More and more resources are mobilized for the development of Ebola virus vaccines, the schedule is compressed, said Marie-Paule Kieny, Assistant Director-General of the World Health Organization (WHO) during a press conference about a high level meeting on vaccines that took place yesterday. "Things change from week to week," said Kieny, who also noted that several new donors have offered to assist in the production of vaccines finance and testing. Two new cases of Ebola, one in Mali and the other in New York, have added to the sense of urgency to contain the spread of the deadly virus. But the best-case scenarios discussed may be overly optimistic given the rapid spread of the Ebola virus, especially in Liberia, Sierra Leone and Guinea.
the meeting's objective was "access and financing" of vaccines, many workers in the field initially thought could be developed quickly enough to help this epidemic. But the epidemic continues to grow, there are nearly 10,000 cases officially reported to date, of which about half-dead efforts to accelerate the testing and production of vaccines have gained steam, and that was the last of several meetings related to WHO. ( Science Insider describes some of the key discussion points of the meeting on the basis of documents disclosed to the meeting yesterday ;. The documents were initially distributed to the participants, who included scientists and representatives of businesses, governments and regulators)
in a few weeks, meeting participants have learned enough data are available from small phase tests a vaccine manufactured jointly by the US National Institute of allergy and infectious diseases and GlaxoSmithKline I (GSK), which began in September to launch efficacy studies. A second vaccine, originally developed by the Public Health Agency of Canada and now made by NewLink Genetics of Ames, Iowa, who started the Phase I trials in October could have similar data available in December. Efficacy trials can test both vaccines simultaneously. But the question that looms is the quantity of those products will be available should they be effective, which could be known as soon as April.
Both GSK and NewLink Genetics said at the meeting that they might be able to produce much larger quantities of their vaccines they originally estimated. GSK said it could have 230,000 doses available in April, and could, if it had funding to produce more than 1 million doses per month by December 2015. This would be far from what is needed in the three countries most affected in West Africa, which have a combined population of nearly 22 million. In its most optimistic scenario, NewLink Genetics said it could have 12 million doses of its vaccine ready in April (see table below).
genetic NewLink presentation at the WHO meeting
NewLink genetics offered production estimates based on different doses of its vaccine.
the amount of NewLink vaccine that will be available will depend heavily on how much of the vaccine material is necessary to constitute a "dose" that can teach safely immune system to fight the virus Ebola. The phase I studies in courses should clarify this issue. If the higher dose is needed, 100 million viral particles, the company would have only 125,000 doses ready by April. But if the required dose is only 1 million viral particles, 100 times could be available, NewLink noted in a presentation at the meeting. Kieny stressed Science Insider that "it is not known at this time if [the lower dose] will be enough."
Ira Longini, an epidemiologist at the University of Florida in Gainesville who attended the meeting, said dosage decisions may further delay the NewLink vaccine. Despite the optimistic prediction, he warned that it might not be ready for testing in an efficacy trial which begins in December.
The liability issues are an important part, too, noted participant meet John Arne Röttingen, director of the Norwegian Institute of Public Health Division of Infectious Disease Control in Oslo. Some suggested responsibility should be treated similarly to the vaccine against H1N1, which was made quickly to fight against this pandemic in 09. For the vaccine, drug manufacturers have taken responsibility for product quality, but countries covered responsibility for its use. This model may not be appropriate, others said that the vaccine against H1N1 was a variation on the vaccine formula against flu established; more unknowns-and therefore more risk Surround these Ebola vaccines. Yet Röttingen said: "There seems to be a convergence to create a group that would finance and pay for vaccines and should also take responsibility for the liability issues in cooperation with affected countries"
Several. countries and organizations at the meeting offered to help the development and testing of medium vaccines, Kieny said. MSF is committed to creating a fund if necessary, and some governments and the World Bank have also committed to help finance efforts. GAVI Alliance for vaccines, a public-private partnership that bankroll the majority of vaccines in developing countries could play a big role. Keiny noted that representatives of GAVI "working on a proposal that they would put on their Board of Directors. "The Board of GAVI plans to meet in December
* Ebola files :. Given the current Ebola outbreak unprecedented in terms of the number of people killed and the rapid geographic spread, science and Science Translational Medicine made a collection 'research articles and news on the viral disease available for researchers and the general public.
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