The World Health Organization (WHO) said on Wednesday that it has approved the homegrown Bharat Biotech Covid-19 vaccine for emergency use listing (EUL), giving the way for it to be accepted as a valid vaccine in many poor countries. India has so far administered 12.14 crore doses of Covaxin nationwide. The WHO’s decision came more than four months after it began evaluating emergency use listing (EUL) assessment for global use of the vaccine. “This emergency use listing expands the availability of vaccines, the most effective medical tools needed to end the epidemic,” said Dr Mariangela Simao, WHO’s assistant director-general.
The decision was delayed for further clarification from Bharat Biotech before conducting a final assessment of the vaccine’s global use. The WHO Strategic Advisory Group of Experts on Immunization also recommended that there should be a time gap of four weeks between the two doses of Covaxin, in the age group of 18 and above.
In addition, people vaccinated with the Covaxin vaccine with WHO EUL approval may travel to countries where they accept WHO-approved vaccines. Before the approval of Covaxin, permission was given only to those who had received the AstraZeneca and Covishield vaccine. Only a few countries, such as Australia and Mauritius, have recognized Covaxin for international travel.
Australia approves India-made Covaxin for travel
Covaxin received an emergency use authorization from the Drug Controller General of India in January. Approval was done in a “clinical trial mode,” where Bharat Biotech must obtain informed consent before administering the vaccine to subjects in a government vaccination drive.
According to sources, 10 million doses have been exported so far, and more countries may ask manufacturers to export Covaxin. Furthermore, an expert group convened by the WHO said there was not enough data on the safety and efficacy of the vaccine in pregnant women. Research is being planned to address those questions.
