As India approves two COVID-19 vaccines, government criticised over lack of data

On Sunday, India approved the restricted emergency usage of two COVID-19 vaccines, one developed indigenously by Bharat Biotech and the other developed by AstraZeneca and Oxford University, but without publishing efficacy data for the homegrown coronavirus vaccine, Covaxin. 

While a government scientist had said that Bharat Biotech’s Covaxin will be ready by February or March this year, the company had earlier said that its vaccine would be launched in the second quarter of 2021 in November. And now, Covaxin has been fast-tracked like no other vaccine in India, a Reuters report said. 

Neither Bharat Biotech nor the Central Drugs Standards Control Organisation (CDSCO) has revealed the efficacy results of the Covaxin. However, the Drugs Controller General of India (DCGI) later on Sunday asked Bharat Biotech to submit the updated safety and efficacy report of the Covaxin. 

Reuters said that a source related to the matter said that the vaccine is more than 60% effective with two doses. 

After Covaxin got approval for emergency use, the opposition leaders and others criticised the government for giving a nod to the vaccine without publishing its efficacy data. Activist Saket Gokhale on Twitter asked, “On what basis was this approval given when Bharat Biotech has NOT shown enough data proving safety and efficacy?”

Gokhale has filed a request under the right to information law asking the central government for the safety and other data of the two vaccines that have been approved on Sunday, reported Reuters.

Congress MP Shashi Tharoor questioned the lack of transparency in vaccine’s approval, as he said the approval was “premature and could be dangerous,” and asked Health Minister Dr Harsh Vardhan for an explanation. 

CPI-M leader Sitaram Yechury also asked the government to publish the data, tweeting, “The announcement about the two vaccine candidates should be accompanied by full disclosure of the minutes of the meetings, information about all the trials and results in order to build confidence in the people. This has been done globally.”

Meanwhile, Samajwadi Party leader and former chief minister of Uttar Pradesh, Akhilesh Yadav, before DCGI’s approval said that he would not take “BJP’s vaccine.”

Congress Rajya Sabha MP Jairam Ramesh also asked Vardhan for clarification, as on Twitter he said, “Bharat Biotech is a first-rate enterprise, but it is puzzling that internationally-accepted protocols relating to phase 3 trials are being modified for Covaxin.”

However, Vardhan hit back at the opposition leaders, saying, “Disgraceful for anyone to politicise such a critical issue.” He added, “Shashi Tharoor, Akhilesh Yadav, and Jairam Ramesh-don’t try to discredit well laid out science-backed protocols followed for approving Covid-19 vaccines.”