India’s Local Covid-19 Injection Wins WHO Emergency Use Approval

The WHO tweeted that its technical advisory group had ruled that the benefits of the injection, known as Covaxin, significantly outweighed the risks and that it met WHO standards for protection against COVID-19.

The decision had been delayed because the advisory group requested further clarification from Bharat Biotech before conducting a final risk-benefit assessment for the global use of the vaccine.

The WHO Strategic Advisory Group of Experts on Immunization also recommended the use of Covaxin in two doses, four weeks apart, in groups 18 years and older. These recommendations are in line with the guidance of the company.

Covaxin received emergency use authorization in India in January, even before the completion of its last-stage trial, which later found the injection to be 78% effective against severe Covid-19.

The WHO decision is expected to help millions of Indians who have received Covaxin to travel outside the country.

Trapped in a village in South India for nine months and unable to return to work in Saudi Arabia, Sugathan PR said he was very happy to hear the news.

“I am very relieved with the development as the WHO approval precludes the need to take a local vaccine in Saudi Arabia,” Sugathan told Reuters, adding that he planned to leave for Dubai on Sunday en route to Saudi Arabia. read more

The emergency use list would allow Bharat Biotech to ship Covaxin to countries that rely on WHO guidance for their regulatory decisions.

Sharing with the world

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

The listing procedure is a prerequisite for the supply of the COVAX vaccine and allows countries to accelerate their own regulatory approval to import and administer COVID-19 injections, the WHO said in its statement.

Before stopping vaccine shipments abroad in April, India had donated or sold more than 66 million doses of Covid-19, including Covaxin.

Bharat Biotech said in a statement that it has set Covaxin manufacturing to reach an annualized capacity of 1 billion doses by the end of 2021, with technology transfer activities in progress with companies in India and elsewhere.

More than a dozen slum residents in an Indian city say they thought they were being vaccinated.  They were part of clinical trials

“It is important that Bharat Biotech improves its production capacity to meet the improved demand from other countries after this approval,” said Prashant Khadayate, GlobalData pharmaceutical analyst.

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

“WHO’s emergency approval will further enhance Covaxin’s credibility and boost our indigenous research capabilities globally. Additionally, we may see better penetration of Covaxin use in other countries,” added analyst Khadayate.

The Hyderabad-based company, which developed Covaxin with an Indian state research body, began sharing data with the WHO in early July.

Bharat Biotech’s vaccine is the seventh to gain WHO endorsement after two mRNA injections from Pfizer / BioNTech and Moderna, adenovirus vector vaccines developed by AstraZeneca and its Covishield version manufactured by the Serum Institute of India and Johnson & Johnson, and China inactivated vaccines from Sinovac Biotech. and Sinopharm.

Bharat Biotech has faced controversy about the vaccine in the past. Earlier this year, more than a dozen Phase 3 trial participants in slum areas of the Indian city of Bhopal told CNN that they did not realize they were part of a clinical trial; instead, they thought they were being vaccinated.

Bharat Biotech, ICMR and the People’s Hospital in Bhopal, which led the trial, have denied wrongdoing.

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