WHO issues emergency use listing for Covaxin, India's COVID-19 vaccine

WHO issues emergency use listing for Covaxin, India's COVID-19 vaccine

New Delhi, November 3, 2021

Covaxin, the vaccine developed by Hyderabad-based Bharat Biotech, was today issued an emergency use listing (EUL) by the World Health Organisation (WHO), adding to a growing portfolio of vaccines validated by the world body 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 pre-requisite 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.”

A press release from WHO said 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 October 5 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 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," the release said.

"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," it added.

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.

NNN

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