WHO issues emergency use listing for eighth COVID-19 vaccine
The World Health Organization (WHO) has issued an emergency use listing (EUL) for COVAXIN® (developed by Bharat Biotech), adding to a growing portfolio of WHO-validated vaccines for COVID-19 prevention caused by SARS-CoV-2.
The WHO's EUL procedure evaluates the quality, safety, and efficacy of COVID-19 vaccines and is required for the supply of COVAX vaccine. It also enables countries to expedite their own regulatory approval for the import and administration of COVID-19 vaccines.
"This emergency use listing increases the availability of vaccines, which are the most effective medical tools we have to end the pandemic," said Dr Mariângela Simo, WHO Assistant Director General for Access to Medicines and Health Products. "However, we must maintain pressure to meet the needs of all populations, with priority given to at-risk groups who are still waiting for their first dose, before we can declare victory."
COVAXIN® was evaluated using the WHO EUL procedure, which included a review of data on quality, safety, efficacy, a risk management plan, and programmatic suitability. The WHO-convened Technical Advisory Group (TAG), comprised of regulatory experts from around the world, determined that the vaccine meets WHO standards for protection against COVID-19, that the benefit far outweighs the risks, and that the vaccine can be used globally.
The vaccine is made from inactivated SARS-CoV-2 antigen and comes in single dose vials as well as multidose vials of 5, 10, and 20 doses.
On October 5, COVAXIN® was also reviewed by WHO's Strategic Advisory Group of Experts on Immunization (SAGE), which develops vaccine-specific policies and recommendations for vaccine use in populations (i.e. recommended age groups, intervals between doses, specific groups such as pregnant and lactating women).
In all age groups 18 and up, the SAGE recommended administering the vaccine in two doses separated by four weeks. COVAXIN® was found to have 78 percent efficacy against COVID-19 of any severity 14 or more days after the second dose, making it ideal for low- and middle-income countries due to its simple storage requirements.
The available data on vaccine vaccination of pregnant women are insufficient to assess vaccine safety or efficacy in pregnancy; studies in pregnant women, including a pregnancy sub-study and a pregnancy registry, are planned.
The emergency use listing (EUL) procedure evaluates novel health products' suitability during public health emergencies. The goal is to make medicines, vaccines, and diagnostics available as soon as possible to address the emergency while adhering to stringent safety, efficacy, and quality criteria. The assessment balances the threat posed by the emergency with the benefit that would accrue from the product's use against any potential risks.
The EUL pathway entails a thorough review of late phase II and phase III clinical trial data, as well as significant additional data on safety, efficacy, quality, and a risk management plan. These data are reviewed by independent experts and WHO teams who take into account the current body of evidence on the vaccine under consideration, as well as plans for monitoring its use and future research.
As part of the EUL process, the vaccine manufacturer must commit to continuing to generate data that will allow full licensure and WHO prequalification of the vaccine. The WHO prequalification process will evaluate additional clinical data generated from vaccine trials and deployment on a rolling basis to ensure the vaccine meets the required quality, safety, and efficacy standards for broader availability.