Washington DC, 31 August 2020 (PAHO)- The Pan American Health Organization held the XI Regulatory Meeting with the National Regulatory Authorities (NRAs) in the Americas, which took place on 6 August 2020. In this session, representatives from the World Health Organization (WHO) presented the SOLIDARITY clinical trial protocol and the WHO Emergency Use Listing (EUL) process for COVID-19 vaccines.
Ana María Restreto, Unit Head for the R&D Blueprint at the WHO Emergency Programme, presented the ongoing trial “A large international, randomized controlled trial of candidate vaccines against COVID-19”, that is a large, international, randomized controlled clinical trial designed to enable an expeditious, agile and concurrent evaluation of the benefits and risks of multiple candidate preventive vaccines against COVID-19 at international sites with sufficient COVID-19 attack rates.
The goal of the trial is to coordinate prompt, efficient, and reliable evaluation of the many preventive candidate SARS-CoV-2 vaccines under development, to assess their safety and efficacy and to identify those that are likely to be appropriate for deployment to influence the course of the pandemic.
Different candidate vaccines may be available or suitable to enter the trial at different times. For each candidate vaccine, the primary efficacy results are expected within 3-6 months of the vaccine entering the trial.
Evaluation of COVID-19 vaccine safety is one of the primary objectives of this trial. All sites will monitor and report serious adverse events at any time after vaccination, safety monitoring will be continuous at all sites.
The Solidarity Vaccines Trial includes long-term follow-up including for enhanced disease and is designed to provide sufficient evidence of safety and vaccine efficacy against COVID-19.
Carmen Amelia Rodríguez Hernández, Head of the Vaccine Prequalification Team, Department of Regulation and Prequalification at WHO, presented on the WHO EUL process for COVID-19 vaccines, that is a risk-based procedure for assessing and listing unlicensed vaccines, therapeutics and in vitro diagnostics with the ultimate aim of expediting the availability of these products to people affected by a public health emergency.
The EUL helps to determine the acceptability of using specific products, based on an essential set of available quality, safety, and efficacy and performance data. The procedure is a key tool for companies wishing to submit their products for use during health emergencies.
To facilitate access of COVID-19 vaccines, WHO is mapping the identification of regulatory requirements for emergency use during a public health emergency, interactions and agreement with regulatory authorities, and involvement of regulators of potential impacted countries in the EUL review to accelerate decision-making process. However, identifying the target countries can be complex due to the changing COVID-19 situation.
WHO encourages regulatory networks to consider joint reviews, fast track approvals of Clinical trials and when appropriate emergency authorizations, and to prepare a roadmap for each vaccine, which will include expected option and collaboration with country regulators to facilitate local authorization for emergency use.
The virtual meeting was the eleventh meeting held by PAHO to discuss updates on the regulatory response, and to address countries' challenges and concerns.
PAHO’s extensive response to the pandemic has centered on supporting countries with technical guidelines, training, supplies, and information.