The World Health Organization (WHO) on Wednesday, Nov. 3, granted emergency use listing (EUL) to India’s homegrown COVID-19 vaccine, Covaxin.
Covaxin, developed by Bharat Biotech, is the eight COVID-19 vaccine validated by WHO.
WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) recommended that Covaxin should be used in two doses, with a dose interval of four weeks, in all age groups 18 and above.
The said vaccine 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.
WHO Assistant-Director General for Access to Medicines and Health Products Dr. Mariângela Simão 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.
“This emergency use listing expands the availability of vaccines, the most effective medical tools we have to end the pandemic. 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,” Simão said.
Meanwhile, 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. AAC