The World Health Organization on Wednesday granted Covaxin an emergency use listing, or EUL, which means the ‘made-in-India vaccine will finally be recognized by other countries, and Indians who received the shot need not self-quarantine or face restrictions when traveling abroad.
This is a significant achievement in India’s fight against Covid-19 immunisation. Bharat Biotech in Hyderabad and the Indian Council of Medical Research developed Covaxin, a vaccine that is totally “produced in India.”
Bharat Biotech’s COVID-19 vaccine is India’s first indigenous vaccine, developed in partnership with the Indian Council of Medical Research’s National Institute of Virology (NIV)
“Covaxin was also reviewed by WHO’s Strategic Advisory Group of Experts on Immunization (SAGE), and recommended use of this vaccine (is) in two doses, with an interval of four weeks, in all age groups 18+,” the WHO tweeted.
Last month, the technical advisory panel requested additional clarity from Bharat Biotech for its final risk assessment, which caused the emergency listing to be postponed. Covaxin has been recommended for emergency use listing by the technical advisory group, which convened on Wednesday to make the final decision.
Covaxin has been shown to be effective against symptomatic COVID-19 at 77.8% and 65.2 percent against the novel Delta variant at 65.2 percent. Bharat Biotech announced that the final analysis of Covaxin effectiveness from Phase 3 studies had been completed. Pfizer-BioNTech, AstraZeneca-SK Bio/Serum Institute of India, Johnson 7 Johnson – Janssen, Moderna, and Sinopharm have all had their Covid-19 vaccines authorized by the WHO for emergency use.
According to Bharat Biotech, the Central Drugs Standard Control Organisation (CDSCO) has approved the extension of the shelf life of Covid-19 vaccination Covaxin to up to 12 months from the date of production.
The business stated, “This approval is predicated on the availability of further stability data, which was submitted to CDSCO.”
