COVAXIN vaccine gets Emergency Use Listing

The World Health Organization (WHO) has issued an Emergency Use Listing (EUL) for the COVAXIN vaccine developed by Bharat Biotech, adding to a growing portfolio of vaccines for the prevention of COVID-19 caused by SARS-CoV-2.
Earlier this week, Guyana was one of the latest nations to recognise COVAXIN, announced Indian High Commissioner to Guyana, Dr K J Srinivasa. It is now one of eight approved vaccines for travel into the country.
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. 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,” said WHO Assistant-Director General for Access to Medicines and Health Products, Dr Mariângela Simão.
COVAXIN was assessed under the WHO’s EUL procedure based on the review of data on quality, safety, efficacy, a risk management plan, and programmatic suitability. The Technical Advisory Group, convened by WHO and made up of regulatory experts from around the world, has determined that the vaccine meets WHO standards for protection against the novel coronavirus, that the benefit of the vaccine far outweighs risks, and that 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 by WHO’s Strategic Advisory Group of Experts on Immunisation (SAGE), which formulates vaccine-specific policies and recommendations for vaccines’ use in populations.
The SAGE has recommended use of the vaccine in two doses, with a dose interval of four weeks, in all age groups 18 and above. It was found to have 78 per cent 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 from clinical trials on vaccination of pregnant women are insufficient to assess vaccine safety or efficacy in pregnancy; however, initial studies were reassuring. The vaccine has been given to over 120,000 pregnant women in India with no short-term adverse effects noted. Further studies in pregnant women are planned.
“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,” said the WHO. (G12)