WHO defends delay in approving India’s Covaxin jab: ‘We are aware that many are waiting’

‘We cannot cut corners,’ says WHO

Stuti Mishra
Tuesday 19 October 2021 09:16
Comments
<p>Covaxin has been administered to over 112 million people and accounts for 11% of total Covid vaccines given in India</p>

Covaxin has been administered to over 112 million people and accounts for 11% of total Covid vaccines given in India

The World Health Organisation has defended its decision to delay the approval of India’s homemade coronavirus vaccine Covaxin and said that it cannot cut corners in its process.

The international health body said that it was looking for “one additional piece of information” from Bharat Biotech, the Hyderabad-based company which created the vaccine.

The vaccine, which was India’s first indigenously made Covid jab, is one of three currently being used in the country’s Covid-19 inoculation drive. India’s drugs control body had approved the restricted emergency use of Covaxin in January. It accounts for 11 per cent of the 980 million doses administered in the country so far.

“We are aware that many people are waiting for WHO’s recommendation for Covaxin to be included in the #COVID19 Emergency Use Listing, but we cannot cut corners — before recommending a product for emergency use, we must evaluate it thoroughly to make sure it is safe and effective,” the WHO said in a series of tweets on Monday.

“Bharat Biotech — the manufacturer of Covaxin — has been submitting data to WHO on a rolling basis and WHO experts have reviewed these data. WHO is expecting one additional piece of information from the company today,” it added.

Bharat Biotech first submitted documents and the initial set of this “rolling data” for WHO approval in July. The health body has said it will analyse the information as and when it comes in.

“The timeframe for the WHO Emergency Use Listing procedure is dependent on how quickly a company producing the vaccine is able to provide the data required for WHO to evaluate the vaccine’s quality, safety, efficacy and its suitability for low- and middle-income countries,” the 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 whether to grant Emergency Use Listing to the vaccine,” it added.

The WHO’s technical advisory group is scheduled to meet on 26 October to consider the listing for Covaxin. However, the health body has not specified which documents it has sought from the pharma company.

The delay in approval for Covaxin has been a concern for Indians who have been inoculated with the jab. Without the WHO’s approval, Covaxin is unlikely to be accepted as a valid vaccine around the world. Bharat Biotech will also be unable to export its vaccine without the WHO’s nod.

The approval of Covaxin within India was itself controversial, as it came before Bharat Biotech had published the results of its own phase three trials. The approval was nonetheless largely celebrated as a success story of indigenous production by Indian prime minister Narendra Modi and his cabinet colleagues.

Register for free to continue reading

Registration is a free and easy way to support our truly independent journalism

By registering, you will also enjoy limited access to Premium articles, exclusive newsletters, commenting, and virtual events with our leading journalists

Please enter a valid email
Please enter a valid email
Must be at least 6 characters, include an upper and lower case character and a number
Must be at least 6 characters, include an upper and lower case character and a number
Must be at least 6 characters, include an upper and lower case character and a number
Please enter your first name
Special characters aren’t allowed
Please enter a name between 1 and 40 characters
Please enter your last name
Special characters aren’t allowed
Please enter a name between 1 and 40 characters
You must be over 18 years old to register
You must be over 18 years old to register
Opt-out-policy
You can opt-out at any time by signing in to your account to manage your preferences. Each email has a link to unsubscribe.

Already have an account? sign in

By clicking ‘Register’ you confirm that your data has been entered correctly and you have read and agree to our Terms of use, Cookie policy and Privacy notice.

This site is protected by reCAPTCHA and the Google Privacy policy and Terms of service apply.

Join our new commenting forum

Join thought-provoking conversations, follow other Independent readers and see their replies

Comments

Thank you for registering

Please refresh the page or navigate to another page on the site to be automatically logged in