The World Health Organization has approved a new COVID-19 vaccine locally manufactured in India for emergency use. The organization issued its approval Wednesday for Indian drugmaker Bharat Biotech's vaccine candidate - a move expected to bolster global vaccine supplies, especially for poorer nations who otherwise have no access to affordable vaccines.
The WHO said its technical advisory group has found that the benefits of the Indian company's vaccine, called Covaxin, far outweigh its risks and it had met all of the organization's standards. The WHO said the approval of the vaccine had been delayed because it had to wait for Bharat Biotech to submit additional clarifications before it could finish its final risk-benefit assessment for the vaccine.
Even before the end of the late-stage study, which revealed the injection to be 78% effective against severe Covid-19, Covaxin was granted emergency use authorization in India earlier in the year.
Like other vaccines, Covaxin is given in two doses with a four-week gap in age groups 18 and older. The WHO's Strategic Advisory Group of Experts on Immunization also gave the same recommendations in using the vaccine in other countries.
The emergency use designation would allow Bharat Biotech to supply Covaxin to nations that base their regulatory decisions on WHO recommendations. The WHO's clearance will pave the way for India to supply the COVAX global vaccine sharing program, which is co-led by the WHO and aims to provide low- and middle-income nations with fair access to vaccines.
The organization said the listing procedure is a requirement for COVAX vaccine supply and permits nations to expedite their own regulatory permission to import and distribute COVID-19 injections. India has given or sold around 66 million Covid-19 doses, including Covaxin, before halting international vaccination exports in April.
In early July, the Hyderabad-based business, which created Covaxin in collaboration with an Indian state research organization, began exchanging data with the WHO. The vaccine is the seventh to be approved by the WHO following the approval of two mRNA vaccines from Moderna and Pfizer.
Bharat Biotech has already received backlash over how it had conducted its trials. More than a dozen Phase 3 trial participants in the Indian city of Bhopal earlier this year said that they weren't aware they were part of a clinical experiment and assumed they were getting vaccinated instead. The trial's organizers, Bharat Biotech, ICMR, and People's Hospital in Bhopal, have all denied misconduct.
