The World Health Organization (WHO) issued an emergency use listing (EUL) for COVAXIN® (developed by Bharat Biotech), adding to a growing portfolio of vaccines validated by WHO for the prevention of COVID-19 caused by SARS-CoV-2.
WHO’s EUL procedure assesses the quality, safety, and efficacy of COVID-19 vaccines and is a prerequisite for COVAX vaccine supply. It also allows countries to expedite their own regulatory approval to import and administer COVID-19 vaccines.
“This emergency use listing expands the availability of vaccines, the most effective medical tools we have to end the pandemic,” said Dr. Mariângela Simão, WHO Assistant-Director General for Access to Medicines and Health Products. “But we must keep up the pressure to meet the needs of all populations, giving priority to the at-risk groups who are still waiting for their first dose, before we can start declaring victory.”
COVAXIN® was assessed under the WHO EUL procedure based on the review of data on quality, safety, efficacy, a risk management plan, and programmatic suitability. The Technical Advisory Group (TAG), convened by WHO and made up 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 far outweighs risks and the vaccine can be used globally.
The vaccine is formulated from an inactivated SARS-CoV-2 antigen and is presented in single-dose vials and multidose vials of 5, 10, and 20 doses.
COVAXIN® was also reviewed on 5 October by WHO’s Strategic Advisory Group of Experts on Immunization (SAGE), which formulates vaccine-specific policies and recommendations for vaccines’ use 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 and above. COVAXIN® was found to have 78% efficacy against COVID-19 of any severity, 14 or more days after the second dose, and is extremely suitable for low- and middle-income countries due to easy storage requirements.
Available data on vaccination of pregnant women with the vaccine are insufficient to assess vaccine safety or efficacy in pregnancy; studies in pregnant women are planned, including a pregnancy sub-study and a pregnancy registry.
WHO emergency use listing
The emergency use listing (EUL) procedure assesses the suitability of novel health products during public health emergencies. The objective is to make medicines, vaccines and diagnostics available as rapidly as possible to address the emergency while adhering to stringent criteria of safety, efficacy, and quality. The assessment weighs the threat posed by the emergency as well as the benefit that would accrue from the use of the product against any potential risks.
The EUL pathway involves a rigorous assessment of late phase II and phase III clinical trial data, as well as substantial additional data on safety, efficacy, quality, and a risk management plan. These data are reviewed by independent experts and WHO teams who consider the current body of evidence on the vaccine under consideration, the plans for monitoring its use, and plans for further studies.
As part of the EUL process, the company producing the vaccine must commit to continue to generate data to enable full licensure and WHO prequalification of the vaccine. The WHO prequalification process will assess additional clinical data generated from vaccine trials and deployment on a rolling basis to ensure the vaccine meets the necessary standards of quality, safety, and efficacy for broader availability.