A high-level emergency meeting, convened by WHO at the request of several governments and representatives of the pharmaceutical industry, was held on 23 October to look at the many complex policy issues that surround eventual access to experimental Ebola vaccines.
Ways to ensure the fair distribution and financing of these vaccines were discussed in an atmosphere characterized by a high sense of urgency. This sense of urgency was conveyed in many ways – from plans for the different phases of clinical trials to be performed concurrently rather than consecutively, to suggested partnerships for expediting clinical trials, to proposals for getting all development partners moving in tandem and at the same accelerated pace.
More than 90 participants, including some of the world’s leading scientists, came, on short notice, from national and university research institutions, also in Africa, government health agencies, ministries of health and foreign affairs, national security councils, and several offices of Prime Ministers and Presidents. Also represented were national and regional drug regulatory authorities, the MSF (Doctors Without Borders) medical charity, funding agencies and foundations, the GAVI alliance for childhood immunization, and development banks, including the African Development Bank, the European Investment Bank, and the World Bank Group.
Main conclusions reached
Impact of vaccines on further evolution of the epidemic
The meeting concluded that vaccines will have a significant impact on the further evolution of the epidemic in any scenario, from best-case to worst-case.
Financing of vaccine development, clinical trials, and vaccination campaigns
The meeting concluded that funding issues should not be allowed to dictate the vaccine agenda. The funds will be found.
The meeting concluded that neither affected countries nor industry should be left alone to bear the burden should lawsuits arise following possible adverse reactions to an Ebola vaccine. To respond to this potential problem, a proposal was made to establish a “club” of donors, in collaboration with the World Bank.
The timing and quantity of vaccine supplies
The meeting concluded that the timing and quantity of vaccine doses should not constrain the design of clinical trials. Industry confirmed that enough vaccine doses would be available.
GlaxoSmithKline’s monthly production capacity for purified bulk vaccine was expected to rise from the current figure of 24,000 doses to 230,000 by April 2015, if they can be filled for release. NewLink’s bulk vaccine manufacturing capacity for the Canadian vaccine was noted to vary, according to the dose selected, from 52,000 doses to 5.2 million doses anticipated for the first quarter of 2015.
Design of protocols for phase 2 and phase 3 clinical trials
The meeting concluded that randomized controlled clinical trials were the gold standard in terms of yielding reliable scientific data for the analysis and interpretation of efficacy. A stepped-wedge design could also yield useful and meaningful data during the special circumstances of the current epidemic.
Priority uses of vaccine when supplies are limited
The meeting concluded that health care workers, including medical staff, laboratory staff, burial teams, and facility cleaners, should have first call on vaccine doses while supplies remain limited. Vaccination of health care workers in the three countries was judged feasible during the first quarter of 2015.
The meeting concluded that the licensure and authorization requirements of regulatory authorities should be streamlined and harmonized, enabling the rapid introduction of vaccines for clinical trials and general distribution, yet with no compromise of scientific standards. In order to deliver the number of doses on the schedules proposed by the manufacturers, regulators must work closely with the manufacturers to find ways to overcome a number of regulatory hurdles.
Urgent measures to improve readiness for clinical trials and vaccines
The meeting concluded that two preparatory measures should be given the most urgent priority: community engagement and social mobilization to prepare populations to understand and accept clinical trials and vaccination campaigns, and the building of basic public health infrastructures, especially given the considerable logistical challenges facing health services in Guinea, Liberia, and Sierra Leone.
Coordination and alignment among multiple partners
The meeting concluded that a mechanism or framework must be urgently established, relying on WHO’s convening and coordination powers, to get all partners working in tandem, according to a single agreed plan and aligned with industry’s “critical paths” analysis.
Determination to finish the job
The meeting concluded that all efforts to develop, test, and approve Ebola vaccines must be followed through to completion at the current accelerated pace, even if dramatic changes in the epidemic’s transmission dynamics meant that vaccines were no longer needed.