AIIMS director Randeep Guleria said on Sunday that India will use only Oxford-AstraZeneca vaccines in the first phase of COVID-19
Bharat Biotech’s vaccination and Covaxin are just a backup in case the more infectious UK variant of the virus gets out of control. Both vaccines have received approval for emergency use from the Comptroller General of Medicines of India (DCGI), but the go-ahead to Covaxin has raised concerns as Hyderabad-based Bharat Biotech has yet to complete trials in phase III humans.
Speaking to News18, Guleria said that anyone who develops side effects after receiving Covaxin will be eligible for compensation. “India will start acquiring Covaxin if the UK virus variant situation flares up or after testing is completed, whichever comes first. Anyone who receives Covaxin will receive compensation for side effects, just like in clinical trials, “he said.
Guleria’s statement came as leaders in Congress and the left questioned the go-ahead to Bharat Biotech when its Phase III trials have not yet been completed. Congressional leader Shashi Tharoor said the approval was “premature,” while party colleague Anand Sharma asked the government to explain why mandatory protocols and fact-checking were waived. CPM leader Sitaram Yechury said information about trials and results should be made public to build trust among people.
“The announcement on the two candidate vaccines must be accompanied by the full disclosure of the minutes of the meetings, information on all the trials and results to build trust in the people. This has been done globally. Our government should too, ”Yechury said on Twitter. “Any attempt to short-circuit the regulatory process for political gain will damage the good reputation built by the Indian pharmaceutical industry over the years.”
Guleria said the policy on approval is unfortunate. “Scientists don’t know politics. They have done their job tirelessly, ”he said. He added that the chances of the vaccine working against the mutated virus variant are “very high.”
“We are concerned considering what happened in the United States and Europe. We don’t want to land in such a situation. We must have faith in our scientists, they worked very hard, ”he said, referring to cases of allergic reactions among recipients in the West.
The phase III human clinical trials of Covaxin began in mid-November, and are intended to be conducted in 26,000 volunteers and is the first and only phase III efficacy study in the country for a COVID-19 vaccine, and the largest phase III efficacy trial ever conducted for any vaccine in India, a news release from the vaccine manufacturer said Saturday night.
Covaxin has been evaluated in approximately 1,000 subjects in Phase I and Phase II clinical trials, with promising results for safety and immunogenicity, with acceptance in international peer-reviewed scientific journals. It is being developed by Bharat Biotech in collaboration with the Indian Council for Medical Research (ICMR) – National Institute of Virology (NIV).
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