Bharat Biotech's Covaxin vaccine on Wednesday received approval for its emergency use from the World Health Organization (WHO).
An independent advisory panel of the WHO, Technical Advisory Group (TAG) gave the approval to Covaxin.
The TAG has determined that Covaxin was capable of meeting the standard marks set up by the WHO and could give protection against Covid-19, and that the benefits of the vaccine far outweigh the risks and that the vaccine can be used across the world.
The vaccine was also reviewed by WHO's Strategic Advisory Group of Experts on Immunization (SAGE), and recommended use of this vaccine in two doses, with a dosing interval of four weeks, in all age groups 18 and above.
Earlier in the day, the Central Drugs Standard Control Organisation approved an extension of the shelf life of the Covaxin up to 12 months, from the date of manufacture.The data on vaccinating Covaxin into pregnant women are insufficient to assess the safety and its efficacy. Studies in pregnant women are planned, including a pregnancy sub-study and a pregnancy registry, the WHO added.
Covaxin can now be shown as an accepted vaccine on vaccine passports for the purpose of travelling abroad.
According to details by the WHO, the Covaxin has 78% efficacy against Covid-19 of any severity, 14 or more days after the second dose. Its easy storage requirements make it easy and suitable for low and middle-income countries.
Earlier in the day, the Central Drugs Standard Control Organisation approved an extension of the shelf life of the Covaxin up to 12 months, from the date of manufacture. This approval is based on the availability of additional stability data, which was submitted to CDSCO.
Covaxin and AstraZeneca's Covishield are the two widely used vaccines in India.