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The WHO is issuing an emergency list for the eighth vaccine against COVID-19
Today, the World Health Organization (WHO) released the Emergency List (EUL) for COVAXIN® (developed by Bharat Biotech), adding to a growing portfolio of vaccines validated by the WHO to prevent SARS-CoV-2-induced COVID-19.
The WHO EUL procedure assesses the quality, safety and efficacy of the COVID-19 vaccine and is a prerequisite for the supply of the COVAX vaccine. It also allows countries to speed up their own regulatory approvals for the import and use of COVID-19 vaccines.
“This list of emergency uses expands the availability of vaccines, the most effective medical tool we have to end a pandemic,” said Dr. Mariângela Simão, WHO Assistant Director-General for Access to Medicines and Health Products. “But we need to keep up the pressure to meet the needs of all populations, giving priority to at-risk groups who are still waiting for their first dose before we start declaring victory.”
COVAXIN® it was assessed in accordance with the WHO SAD procedure based on a review of data on quality, safety, efficacy, risk management plan and program suitability. The Technical Advisory Group (TAG), convened by the WHO and composed of regulatory experts from around the world, found that the vaccine meets WHO standards for protection against COVID-19, that the benefits of the vaccine far outweigh the risks and that the vaccine can be used globally.
The vaccine is formulated from inactivated SARS-CoV-2 antigen and is presented in single-dose vials and multi-dose vials of 5, 10 and 20 doses.
COVAXIN® also reviewed the WHO Strategic Advisory Group on Immunization Experts (SAGE) on 5 October, which formulates vaccine-specific policies and recommendations for vaccine use in the population (ie, recommended age groups, dose intervals, specific groups such as pregnant women and breastfeeding).
SAGE recommended the administration of the vaccine in two doses, with a dose interval of four weeks, in all age groups of 18 years and older. COVAXIN® it has been found to have 78% efficacy against COVID-19 of any weight, 14 or more days after the second dose, and is extremely suitable for low- and middle-income countries due to simple storage requirements.
Available data on vaccination of pregnant women with the vaccine are insufficient to assess the safety or efficacy of the vaccine in pregnancy; research on pregnant women is planned, including a sub-study on pregnancy and a pregnancy registry.
WHO Emergency List
The Emergency Inventory (SAD) procedure assesses the suitability of new health products during public health emergencies. The goal is to make drugs, vaccines, and diagnostics available as quickly as possible to address an emergency while adhering to strict safety, efficacy, and quality criteria. The assessment weighs the danger posed by an emergency as well as the benefit that would result from using the product against all potential risks.
The SAD pathway includes a rigorous assessment of late phase II and phase III clinical trial data, as well as significant additional data on safety, efficacy, quality, and risk management plan. These data are reviewed by independent WHO experts and teams considering the current evidence of the vaccine under consideration, plans for monitoring its use, and plans for further studies.
As part of the EUL process, the vaccine company must commit to continuing to generate data to enable full licensing and pre-qualification of the WHO vaccine. The WHO prequalification process will evaluate additional clinical data obtained from vaccine testing and administration on an ongoing basis to ensure that the vaccine meets the required standards of quality, safety and efficacy for wider availability.
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SAGE
SAGE is the WHO’s main advisory group on vaccines and immunization. He is responsible for advising the WHO on overall global policies and strategies, ranging from vaccines and immunization technology, research and development, to the provision of immunization and its links to other health interventions. SAGE deals not only with childhood vaccines and immunizations, but also with all diseases that can be prevented by vaccines.
SAGE evaluates evidence of safety, efficacy, efficacy, performance, and programmatic suitability, taking into account the impact on individual health and on public health. The SAGE Interim Recommendations for EUL products provide guidance to national vaccination policy makers. These recommendations are updated as additional evidence becomes available and as there are changes in the epidemiology of the disease and the availability of additional vaccines and other disease control interventions.
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