WHO Lists Additional COVID-19 Vaccine for Emergency Use and Issues Interim Policy Recommendation
The Sinopharm COVID-19 vaccine, produced by Beijing Bio-Institute of Biological Products Co Ltd, has been listed for global emergency use. “The addition of this vaccine has the potential to rapidly accelerate COVID-19 vaccine
access for countries seeking to protect health workers and populations at risk,” said Dr. Mariângela Simão, WHO Assistant-Director General for Access to Health Products. “We urge the manufacturer to participate in the COVAX Facility and contribute to the goal of more equitable vaccine distribution.”
WHO’s Emergency Use Listing (EUL) is a prerequisite for the COVAX Facility supply and expedites countries’ individual approval processes. The EUL, assessed by the product evaluation group and a Technical Advisory Group (TAG), evaluates the safety, efficacy, risk management plans, and programmatic suitability of COVID-19 vaccines. The Strategic
Advisory Group of Experts on Immunization (SAGE) has reviewed the vaccine as well, and on-site inspections of the production facility were also conducted by WHO for the Sinopharm vaccine.
The Sinopharm vaccine is an inactivated vaccine suitable for low-resource environments. It is the first vaccine with a vial monitor that responds to heat and indicates whether the vaccine can be safely used. It has been recommended by WHO for adults 18 years old and above, and efficacy was estimated to be 79%. No upper age limit has been recommended, however, few adults over the age of 60 were enrolled in clinical trials, and countries are advised to monitor the safety and effectiveness of the vaccine in this age group.
WHO emergency use listing The EUL evaluates novel health products during public health emergencies with the goal of making them rapidly available, and carries out risk-benefit assessments. Late phase II and phase III clinical trial data is assessed as part of the process, as well as data on safety, efficacy, quality, and a risk management plan. This is then further reviewed by experts and WHO teams. The WHO prequalification process assesses additional data from
vaccine trials to ensure standards of safety, efficacy, and quality are met.
SAGE advises WHO on overall global policies and strategies ranging from vaccines and technology, research, and development, to delivery of immunization and its linkages with other health interventions.
SAGE and EUL are separate, complementary processes; SAGE is policy-oriented, while the EUL assesses the quality, safety, and efficacy of products. In COVID-19 circumstances, the Secretariat of SAGE and the EUL team have been working together to facilitate listings and recommendations to be issued in a synchronized manner.