WHO nod likely by Sept: Bharat Biotech

Bharat Biotech on Tuesday announced that it applied to the World Health Organisation (WHO) for emergency use listing of its coronavirus disease (Covid-19) vaccine, Covaxin, and expected approvals anytime between July and September, amid rising concerns that the lack of such recognition could come in the way of international travel by those who received this vaccine.

“Application for emergency use listing (EUL) has been submitted to WHO-Geneva, regulatory approvals are expected JulSept 2021,” the Hyderabadbased company said in a statement about its inactivated whole virion Covid-19 vaccine.

As the world opens up after the pandemic, it is likely that countries will put in place restrictions on incoming travellers. In some cases, this may mean mandating vaccination by a vaccine recognised either by that country or WHO.

According to Bharat Biotech, regulatory approvals for Covaxin are currently in process in at least 60 countries. So far, it has obtained emergency use authorisations in 13 countries.

In the second interim analysis of the phase 3 clinical trial results that the company released last month, Covaxin has been found to have an efficacy of about 78%.

The company’s vaccine has also been found to be effective against mutant strains of the virus.

The company is yet to publish the final results of its trial.