Covaxin meets WHO standards for protection against COVID-19, says expert panel
Nov 03, 2021
Geneva [Switzerland], November 3 : The World Health Organization (WHO) has issued emergency use listing (EUL) for India's indigenous vaccine Covaxin, adding to a growing portfolio of vaccines validated by WHO for prevention of COVID-19.
The WHO said in a tweet that the Technical Advisory Group, convened by World Health Organisation (WHO), has determined that the Hyderabad-based Bharat Biotech's COVID-19 vaccine meets WHO standards for protection against COVID-19.
"WHO has granted emergency use listing (EUL) to COVAXIN® (developed by Bharat Biotech), adding to a growing portfolio of vaccines validated by WHO for the prevention of #COVID19," WHO said in a tweet.
"The Technical Advisory Group, convened by WHO and made up of regulatory experts from around the world, has determined that the Covaxin vaccine meets WHO standards for protection against #COVID19, that the benefit of the vaccine far outweighs risks and the vaccine can be used," it added.
The global health body said that the Covaxin vaccine was also reviewed by WHO's Strategic Advisory Group of Experts on Immunization (SAGE), and recommended the use of this vaccine in two doses, with a dose interval of four weeks, in all age groups 18 and above.
"Available data on vaccination of pregnant women with the Covaxin 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 said.
Earlier, the WHO panel had sought additional clarifications from the manufacturer of Covaxin, in order to conduct a final EUL risk-benefit assessment for global use of the vaccine.
Bharat Biotech's Covaxin and AstraZeneca and Serum Institute's Covishield are two widely used vaccines in India against COVID-19. WHO has so far approved COVID-19 vaccines of Pfizer-BioNTech, AstraZeneca-SK Bio/Serum Institute of India, Johnson 7 Johnson - Janssen, Moderna, and Sinopharm for emergency use.
Meanwhile, Bharat Biotech on Wednesday said that its COVID-19 vaccine has been granted an extension of shelf life for up to 12 months from the date of manufacture by the Central Drugs Standard Control Organisation CDSCO.
"The CDSCO has approved the extension of shelf life of COVAXIIN up to 12 months, from the date of manufacture. This approval of shelf-life extension is based on the availability of additional stability data, which was submitted to CDSCO. The shelf life extension has been communicated to our stakeholders," the company said in a statement.
Earlier, Covaxin had a shelf life of six months, which was later extended to nine months.
