India’s approval of a domestically developed vaccine for COVID-19 without publicizing its efficacy has raised safety concerns.
In what Prime Minister Narendra Modi said was a “decisive turning point,” Indian authorities on Sunday granted emergency-use approval to a vaccine developed by Oxford-AstraZeneca and homegrown Covaxin.
The green light officially began one of the world’s largest mass immunisation drives, where an estimated 300 million people will receive the jab on priority basis over the course of the year. With more than 10.3 million COVID-19 cases, India is the world’s worst affected country after the United States.
India’s drug regulator said that both manufacturers have submitted data showing they are safe to use. But Covaxin has not released results from its continuing Phase 3 trials, which are crucial tests to determine how the vaccine behaves in a larger and more diverse group of test participants.
“We are extremely alarmed and shocked because it signifies the grant of regulatory approval without any efficacy data,” medical watchdog All India Drug Action Network (AIDAN) said in a statement. “The Phase 3 trials are currently ongoing and it is too early for data to meet the criterion for an interim analysis.”
Covaxin is manufactured by pharmaceutical firm Bharat Biotech in collaboration with the Indian Council of Medical Research, a government research body.
Dr Krishna Ella, chairman of Bharat Biotech, said the company expects to release the vaccine’s efficacy in March. He also claimed that Covaxin was being unfairly targeted for scrutiny.
Reuters has reported that Covaxin’s efficacy “could be more than 60% with two doses” according to an anonymous source with knowledge on the matter. That would meet the generally accepted 50 percent threshold required for regulatory approval.
Experts have previously raised concerns over the potential premature rollout of vaccines developed by China and Russia.
On Dec. 30, China’s Sinopharm said its COVID-19 vaccine was almost 80 percent effective based on the results of its final-stage trials. But the state-run pharmaceutical giant did not release details that scientists said are required to assess a vaccine’s reliability, such as the number of people involved in the trials and their demographic. The Chinese drug regulator approved the vaccine the next day.
Scientists have expressed similar doubts about the homegrown vaccine developed by the Russian state-backed Gameleya Center after it was approved in August ahead of its Phase 3 trials.
Malini Aisola, the co-convenor of the AIDAN, said India’s approval of Covaxin despite a lack of efficacy data is an example of nationalist politics creeping into science.
“You can’t discount the fact that there is a strong interest in bringing out a homegrown vaccine, and it would be a source of national pride,”Aisola told VICE World News. “But that doesn’t change the fact that there is something off about the regulatory process, and the specific legal provisions for granting both these vaccine approvals have not been disclosed by the regulator.”
In July 2020, the Indian Council of Medical Research was criticized for sending a letter to 12 institutions conducting Covaxin trials that urged them to “fast-track” the vaccine by August 15, India’s independence day. Scientists said at the time that the vaccine would take at least six more months to complete.
Aisola added that the Serum Institute, the world’s largest vaccine manufacturer that was tasked with conducting the Indian trials of the Oxford-AstraZeneca vaccine, is also yet to reveal safety and immunogenicity data from its Indian trials.
In December, a trial participant in India filed a lawsuit against the Serum Institute alleging serious side effects. The vaccine manufacturer hit back with a defamation case.