A health worker inoculates a woman with the dose of the Covaxin vaccine against the Covid-19 coronavirus during a door-to-door vaccination campaign in a residential area of ​​Chennai on October 19, 2021.

Arun Sankar | AFP | Getty Images

The World Health Organization (WHO) said on Wednesday it had approved the Covid-19 vaccine from Indian drug maker Bharat Biotech for emergency use, paving the way for its acceptance as a valid vaccine in many countries poor.

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

The decision was delayed as the advisory group sought further clarification from Bharat Biotech before proceeding with a final risk-benefit assessment for the global use of the vaccine.

The WHO Strategic Advisory Group of Experts on Immunization has also recommended the use of Covaxin in two doses, with an interval of four weeks, in the age groups 18 years and older. These recommendations are in line with the company’s guidelines.

Covaxin received emergency use clearance in India in January even before its advanced stage trial ended, which then found the vaccine to be 78% effective against severe Covid-19.

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

Stuck in a village in southern 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 at this development as the WHO approval rules out the need to take a local vaccine in Saudi Arabia,” Sugathan told Reuters, adding that he was planning to leave for Dubai on Sunday on his way there. ‘Saudi Arabia.

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

Sharing with the world

The WHO approval could also allow India to engage in the global Covax vaccine sharing effort, which is co-led by the WHO and aims to provide equitable access to vaccines for income countries. low and intermediate.

The registration process is a prerequisite for the procurement of Covax vaccines and allows countries to expedite their own regulatory approval to import and administer Covid-19 vaccines, the WHO said in its statement.

Before slowing overseas shipments of vaccines in April, India donated or sold more than 66 million doses of Covid-19, including Covaxin.

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

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

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.

“The emergency WHO approval will further enhance the credibility of Covaxin and strengthen our local research capacity globally. In addition, we can see an improvement in the penetration of the use of Covaxin in other countries. “added analyst Khadayate.

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

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

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