W.H.O.’s Refusal to ‘Cut Corners’ for India’s Vaccine Prompts Delay

New Delhi has allegedly delayed committing supplies of Covaxin, India’s first state-made Chinese coronavirus vaccine, to a World Health Organization (W.H.O.) vaccine drive after the W.H.O. on Monday said it refused to “cut corners” in granting the inoculation emergency use approval, Reuters reported Tuesday.

An unnamed source allegedly told Reuters on October 19 it was “frustrating that India had yet to confirm any supply to COVAX, despite a promise last month by the health minister to meet the commitment to COVAX and others during the quarter to December.”

COVAX is a W.H.O.-led initiative aiming to distribute Chinese coronavirus vaccines to poorer nations that would otherwise struggle to obtain them.

News that India has allegedly delayed a planned donation of its state-made coronavirus vaccine to COVAX comes just 24 hours after the program’s main advocate, the W.H.O., claimed it could not “cut corners” to grant Covaxin emergency use approval. The statement seemed to imply that India’s Covaxin lacked sufficient data demonstrating its safety or efficacy.

“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,” the United Nations (U.N.) health body wrote in a statement posted by its official Twitter account on October 18.

“[B]efore recommending a product for emergency use, we must evaluate it thoroughly to make sure it is safe and effective,” the statement read.

“Bharat Biotech — the manufacturer of Covaxin — has been submitting data to WHO on a rolling basis and WHO experts have reviewed these data,” the organization said.

“WHO is expecting one additional piece of information from the company today,” the public health body revealed, without specifying what type of information it anticipated.

The W.H.O. said its time frame for granting a vaccine emergency use approval “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.”

“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,” the U.N. agency concluded.

Bharat Biotech is an Indian multinational biotech company that developed Covaxin together with a scientific research body funded by India’s federal government. The company started sharing data on Covaxin with the W.H.O. in early July, according to Reuters.

Bharat Biotech published phase III trial data for Covaxin on July 3 showing the inoculation to be nearly 78 percent effective against the Chinese coronavirus.

“Along with partner scientists at the Indian Council of Medical Research, the company said the vaccine had an overall efficacy of 77.8 percent against symptomatic COVID [Chinese coronavirus],” the Hindu reported at the time.

“The latest Covaxin study is yet to be peer-reviewed and appears on a pre-print server,” the newspaper noted.

New Delhi’s drug regulator approved Covaxin for emergency use within India in early January, six months before Bharat Biotech completed late-stage clinical trials for the vaccine.