INDIA – The World Health Organization has granted Emergency Use Approval to India’s Bharat Biotech’s Covaxin after several rounds of discussion on the inactivated-virus vaccine.

The Technical Advisory Group (TAG) which recommends the vaccine for Emergency Use Listing (EUL) had initially sought additional clarifications from Bharat Biotech on October 26, after which it granted approval to the vaccine.

The decision had been postponed because the advisory group wanted more clarification from Bharat Biotech before conducting a final risk-benefit analysis for the vaccine’s global use.

TAG granted the authorization after analyzing the risks and benefits involved and coming to a conclusion that the benefits outweigh the vaccine’s risks and satisfies the WHO standards set EUL.

The vaccine, which was found to have 78 percent efficacy after two doses spread over four weeks, is “extremely suitable for low- and middle-income countries due to easy storage requirements,” according to the UN body.

Covaxin is the first WHO-approved vaccine that was entirely developed and manufactured in India.

Based on inactivated coronavirus antigens, it is the WHO’s eighth Covid-19 vaccine, joining those from Pfizer/BioNTech, Moderna, AstraZeneca, Johnson & Johnson, Sinopharm, and Sinovac.

“This emergency use listing expands the availability of vaccines, the most effective medical tools we have to end the pandemic,” said Mariangela Simao, WHO’s assistant director-general for access to medicines and health products.

The WHO’s Strategic Advisory Group of Immunization Experts also advised using Covaxin in two doses at intervals of four weeks in people aged 18 and up. These recommendations are consistent with the company’s recommendations.

The WHO decision is expected to make it easier for millions of Indians who have received Covaxin to travel outside of India.

Sharing with the world

The WHO’s approval may also pave the way for India to commit supplies to the COVAX global vaccine sharing effort, which is co-led by the WHO and aims to provide low- and middle-income countries with equitable access to vaccines.

According to the WHO, the listing procedure is a requirement for COVAX vaccine supply and allows countries to expedite their own regulatory approval to import and administer COVID-19 shots.

India had donated or sold more than 66 million Covid-19 doses, including Covaxin, before halting overseas vaccine shipments in April.

“It is important for Bharat Biotech to improve its production capacity to meet the improved demand for other countries following this approval,” said Prashant Khadayate, a pharma analyst at GlobalData.

“The WHO emergency approval will further improve the credibility of Covaxin and will boost our indigenous research capabilities at a global level. Moreover, we can see improved penetration of Covaxin usage in other countries,” analyst Khadayate added.

Covaxin is the second-most popular vaccine after Covishield in India as part of the COVID-19 vaccination drive, according to GlobalData’s Pharma Intelligence Center.

Covishield, Astrazeneca’s Indian-made version, remains the most popular jab, accounting for the majority of India’s 810 million jabs. The WHO has approved it, but the UK only recognized the vaccine after India expressed outrage at its refusal.

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