Since the start of the pandemic, there has been an urgent need to accelerate the research and development of COVID-19 candidate vaccines. Under the umbrella of the Global Research Roadmap, the WHO Working Group for Vaccine Prioritization was constituted under the leadership of the R&D Blueprint team. This working group provides guidance to vaccine developers from a public health perspective and prioritizes vaccine development options vaccine platform approaches and/or candidates to be considered for further development and potentially considered for late-stage evaluation in the context of the global COVID-19 pandemic.
In the past three months, since its creation following the Global Research and Innovation forum hosted by WHO on 11-12 February, important progress has been achieved including:
- Continuously landscaping and mapping candidate vaccines and their progress across the world. Currently, over 120 candidate vaccines have been mapped, raising the question of how to prioritize the ones that will go from early to later development (from phase I to phase 2b/3 clinical trials).
- Developing specific criteria that vaccine scientists, product developers, manufacturers, regulators and funding agencies can use for prioritization.
- Outlining the desired characteristics for safe and effective vaccines, published in the WHO Target Product Profiles (TPP) for COVID-19 vaccines. The TPP outlines the preferred and minimally acceptable profiles for a human COVID-19 vaccine for long-term protection of persons at high ongoing risk of COVID-19, such as healthcare workers, and for reactive use in outbreak settings with rapid onset of immunity to guide vaccine development.
- Developing a core protocol for a globally coordinated randomized controlled clinical trial for vaccines. Recognizing the critical importance to world health of the rapid availability and deployment of effective vaccines against COVID-19, on 9 April WHO published the core protocol for an international, multi-site, individually randomized controlled clinical trial that will enable the concurrent evaluation of benefits and risks of each promising candidate vaccine within 3–6 months of it being made available for the trial.
- Launching a call for expressions of interest from vaccine trial sites around the world using the core protocol, which will include several candidate COVID-19 vaccines that meet WHO prioritization criteria. This will prepare for the launch of a Solidarity Trial for Vaccines that will build on the platform launched for the Therapeutics Solidarity Trial (see Situation Report 119) and lessons learned. Currently, over 150 sites in more than 40 countries have expressed an interest in joining a Vaccine Solidarity Trial.
- Launching a call for interest in engaging on animal studies for vaccine evaluations with 17 laboratories in 8 countries with animal laboratory facilities.
- Establishing an Expert Group focusing on COVID-19 viruses, reagents and immune assays. The goal of the group is to advance the development of COVID-19 medical countermeasures (vaccines and immunotherapeutic). This is being achieved by providing a platform to discuss availability of viruses and key reagents, to share data on immune assays and the potential for cross reactivity of SARS-CoV-2 with other coronaviruses.
- Establishing an Expert Group focusing on COVID-19 disease modelling and animal models that would replicate human COVID-19 with the goal of accelerating testing of vaccines and therapeutics. WHO provides a pre-clinical model forum to share information and prevent unnecessary repetition of effort.
- Coordinating the Human Challenge Studies Working Group, tasked with consider the feasibility, utility, realistic timelines and approximate costs for establishing a closely monitored experimental challenge model of infection with SARS-CoV-2 (fully virulent or attenuated) in healthy adult volunteers. The Expert Group will also discuss the procedures to be codified and logistical obstacles to be overcome to perform such challenge studies and to propose practical solutions to overcome identified hurdles.
Further information on WHO’s work relating to vaccine research can be found on this webpage.
Source: WHO Situation report.