The World Health Organization convened a high-level emergency meeting with government leaders and pharmaceutical company representatives earlier this week to discuss issues surrounding access to experimental Ebola vaccines.
The World Health Organization (WHO) convened a high-level emergency meeting with government leaders and pharmaceutical company representatives earlier this week to discuss issues surrounding access to experimental Ebola vaccines.
In attendance were executives from pharmaceutical companies developing the vaccines, including GlaxoSmithKline (GSK), Johnson & Johnson, Merck Vaccines, and New Link Genetics. The companies committed to increase production capacity for millions of doses to be available next year, in addition to several hundred thousand doses expected to be ready before the end of the first half of 2015.
Regulatory authorities in Africa and in countries where the vaccines are manufactured also committed to support the accelerated production goal by working under extremely short deadlines.
“As we accelerate in a matter of weeks a process that typically takes years, we are ensuring that safety remains the top priority, with production speed and capacity a close second,“ said Marie-Paule Kieny, assistant director-general of WHO Health Systems and Innovation, in a press release.
The officials at the meeting agreed that vaccines will have a significant impact on the continued evolution of the epidemic under either best-case or worst-case scenarios.
The meeting also reached the conclusion that funding issues should not be allowed to dictate the agenda for vaccine development and distribution issues, as it was stated that the funds will be found.
Phase 1 clinical trial results for most of the advanced vaccines in development are expected to be available by December 2014, with efficacy trials in the affected countries also set to begin by the end of this year. The protocols are being adapted to consider safety and immunogenicity results as they become available.
Trials for vaccines have already begun in the United States, United Kingdom, and Mali, with others set to begin soon in Gabon, Germany, Kenya, and Switzerland in order to determine safety and dosage levels.
Earlier this month, WHO convened an emergency meeting to evaluate the potential of safe and effective treatments. A panel of experts evaluated 2 specific treatments: an experimental drug co-developed by the National Institutes of Health and GSK, and a vaccine from the Government of Canada licensed for further development to NewLink.
Both treatments demonstrated 100% efficacy in testing on nonhuman primates.
Other promising therapies in various stages of development include Johnson & Johnson’s drug that is projected to begin clinical testing in early 2015; Tekmira Pharmaceuticals’ RNA interference treatment, called TKM-Ebola; and ZMapp, which reversed Ebola infection in 100% of subjects during animal testing.
The monthly production capacity for the purified bulk vaccine developed by GSK is expected to increase from the current total of 24,000 doses to 230,000 by April 2015. The manufacturing capacity for the bulk vaccine developed by NewLink varies based on the selected dose, from 52,000 doses to 5.2 million doses expected during the first quarter of 2015.
Earlier this week, the Swiss regulatory authority for therapeutic products approved a trial for an experimental Ebola vaccine, which will be used on approximately 120 individuals. The vaccine, which was developed by the US National Institute of Allergy and Infectious Diseases and GSK, is comprised of a virus that is rendered harmless and used as genetic carrier for an Ebola protein.
After trials begin this week, the first results are expected in December 2014.
“These are dosing and safety trials being held in advance of phase 2 and 3 trials currently scheduled for late 2014-early 2015,” Kieny said. “If shown to be safe and effective, either of the vaccines could be scaled up for production during the first quarter of next year, with millions of doses produced for wide distribution in high-risk countries.”