The World Health Organization has defended its decision to delay the approval of India’s homemade coronavirus vaccine Covaxin, saying it cannot cut corners in its process.
The international health body said it was looking for “an additional information” from Bharat Biotech, the Hyderabad-based company that made the vaccine.
The vaccine, which was India’s first indigenously manufactured Covid jab, is one of three currently being used in the country’s Covid-19 vaccination campaign. India’s drugs control body in January approved restricted emergency use of Covaxin. This is 11 per cent of the 98 crore doses administered so far in the country.
“We know that many people are waiting for the WHO recommendation to include Covaxin. #COVID-19 Emergency use list, but we can’t cut corners – before recommending a product for emergency use, we must thoroughly evaluate it to ensure it is safe and effective,” the WHO tweeted on Monday. Said in a series of
“Bharat Biotech – manufacturer of Covaxin – is submitting data to WHO on a rolling basis and these data have been reviewed by WHO experts. WHO is expecting an additional information from the company today.”
Bharat Biotech first submitted the initial set of documents and this “rolling data” for WHO approval in July. The health body has said that whenever this information comes, it will analyze it.
“The timeline of WHO’s emergency use listing process depends on how quickly the vaccine maker is able to reach the WHO to evaluate the vaccine’s quality, safety, efficacy and its suitability for low- and middle-income countries. Able to provide the required data. WHO wrote.
“When the information provided addresses all questions raised, WHO and the Technical Advisory Group will complete the assessment and come to a final recommendation on whether to provide the vaccine with an emergency use list,” it added.
The technical advisory group of the WHO is scheduled to meet on 26 October to consider the listing of Covaxin. However, the health body has not specified what documents it has sought from the pharma company.
The delay in the approval of Covaxin has been a cause of concern for Indians who have been vaccinated with the jab. Without WHO approval, Covaxin is unlikely to be accepted as a valid vaccine worldwide. Bharat Biotech will also not be able to export its vaccine without WHO approval.
Acceptance of Covaxin within India itself was controversial, as it came before Bharat Biotech published the results of its own phase three trials. The approval by Indian Prime Minister Narendra Modi and his cabinet colleagues was celebrated as a success story of large-scale indigenous production.
Credit: www.independent.co.uk /