Today, the World Health Organization (WHO) has an Emergency Use List (EUL) for COVAXIN. issued® (developed by Bharat Biotech), contributing to a growing portfolio of WHO-validated vaccines for the prevention of COVID-19 caused by SARS-CoV-2.
The WHO’s EUL procedure assesses the quality, safety and efficacy of COVID-19 vaccines and is a prerequisite for the supply of COVAX vaccines. It also allows countries to expedite their own regulatory approval to import and administer COVID-19 vaccines.
“This emergency list increases the availability of vaccines, the most effective medical tools we have to end the pandemic,” said Dr Mariângela Simão, WHO deputy director general for access to medicines and health products. “But we need to keep pushing to meet the needs of all populations, and prioritize those at-risk still waiting on their first dose before we can start proclaiming victory.”
COVAXIN® was assessed according to the WHO EUL procedure based on the assessment of data on quality, safety, efficacy, a risk management plan and programmatic suitability. The Technical Advisory Group (TAG), convened by WHO and composed of regulatory experts from around the world, has determined that the vaccine meets WHO standards for protection against COVID-19, that the benefit of the vaccine is much greater beyond the risks and that the vaccine can be used worldwide.
The vaccine is composed of an inactivated SARS-CoV-2 antigen and is presented in single-dose vials and multiple-dose vials of 5, 10 and 20 doses.
COVAXIN® was also reviewed on Oct. 5 by the WHO’s Strategic Advisory Group of Experts on Immunization (SAGE), which formulates vaccine-specific policies and recommendations for the use of vaccines in populations (i.e., recommended age groups, intervals between doses, specific groups such as pregnant and lactating women ).
The SAGE recommended the use of the vaccine in two doses, with a dose interval of four weeks, in all age groups 18 years and older. COVAXIN® found to have 78% efficacy against COVID-19 of any severity 14 or more days after the second dose, and is ideally suited for low and middle income countries due to its convenient storage requirements.
The available data from clinical studies of vaccination of pregnant women are insufficient to assess the safety or efficacy of the vaccine during pregnancy; however, the initial studies were reassuring. The vaccine has been given to more than 120,000 pregnant women in India with no short-term side effects. Further studies in pregnant women are planned.
WHO Emergency Use List
The Emergency List (EUL) 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 the emergency, while adhering to strict criteria of safety, efficacy and quality. The assessment weighs the threat of the emergency as well as the benefit that would come from using the product against any risks.
The EUL trajectory includes a rigorous review of data from the late Phase II and Phase III clinical studies, as well as substantial additional data on safety, efficacy, quality and a risk management plan. This data is reviewed by independent experts and WHO teams who consider the current body of evidence on the vaccine being considered, its use monitoring plans and plans for further research.
As part of the EUL process, the company producing the vaccine must commit to continuing to generate data to enable full WHO licensing and prequalification of the vaccine. The WHO prequalification process will review additional clinical data generated from vaccine trials and its implementation on a rolling basis to ensure the vaccine meets the necessary standards of quality, safety and efficacy for wider availability.
View all EUL listings
SAGE is the WHO’s main advisory group on vaccines and immunization. It is tasked with advising WHO on general global policies and strategies ranging from vaccines and immunization technology, research and development to the provision of immunization and its links with other health interventions. SAGE is not only concerned with vaccines and immunization for children, but with all diseases that can be prevented by vaccination.
SAGE assesses evidence on safety, efficacy, effectiveness, impact and programmatic suitability, taking into account both individual and public health impact. SAGE Interim Recommendations for EUL products provide guidance for national vaccination policymakers. These recommendations will be updated as additional evidence becomes available and if there are changes in disease epidemiology and the availability of additional vaccines and other disease control interventions.
See interim recommendations from Sage