India is allowing reserved emergency use of the AstraZeneca (LON:AZN) COVID-19 vaccine and another from the domestic firm Bharat Biotech.
The country is producing both vaccines internally. Serum Institute of India has a contract to manufacture the AstraZeneca vaccine and has stockpiled between 40 and 50 million doses.
Covaxin, the vaccine from Bharat Biotech, was the result of a collaboration with India’s National Institute of Virology.
The Bharat Biotech vaccine’s approval has prompted criticism from the All India Drug Action Network, which stated it was “shocked” at the news. “Disturbingly, it appears that no efficacy data for the vaccine candidate were submitted from the Phase 3 trials that are ongoing and being conducted by Bharat Biotech and ICMR,” the organization said in a statement.
Dr. V.G. Somani, the country’s drug controller, announced the approvals at a news conference yesterday, stating that the country’s regulator, the Central Drugs Standard Control Organization, had a “careful examination” of both vaccines.
Somani also stressed that Covaxin was “safe and provides a robust immune response.”
Dr. Krishna Ella, the founder and chairman of Bharat Biotech, echoed that sentiment, explaining at a press conference that the company had performed clinical trials in more than 12 countries for the vaccine. “We are not just an Indian company — we are truly a global company,” he said.
The company has included approximately 26,000 participants in its Phase 3 clinical trials.
The Bharat Biotech vaccine, like most others, requires two doses.
The Serum Institute has also encountered delays when producing the AstraZeneca vaccine. It had committed to making 400 million doses by the end of 2020, but to date has produced 350 million less than that.
In addition to supplying India, the organization also plans on manufacturing vaccines for developing nations.