On Covaxin, India’s own vaccine

Kamala Thiagarajan
Contd from last Saturday
Which other countries have ordered Covaxin?
Bharat Biotech has signed deals with Ocugen, a US based biopharmaceutical company, to produce the vaccine for the US market, and Precisa Medicamentos to supply to Brazil, pending regulatory approval there.
How has Covaxin been received by the medical community?
The emergency approval before phase III trials were completed triggered widespread criticism from the scientific community in India.16
With nearly 14 million coronavirus infections at the time of writing, India has the second highest number of reported cases globally after the US, but the approval came at a time when cases were dropping.
The CDSCO said the vaccine had been approved for “restricted use in an emergency situation” and that it would be deployed in a “clinical trial mode.” This vague terminology, with no official clarification, has left doctors and scientists puzzled, though one doctor The BMJ spoke to said it implied that safety data would be collected.
The All India People’s Science Network, which represents numerous scientific organisations, described the approval of Covaxin as “hasty,” while the All India Drug Action Network, a group of non-government organisations working to increase access to essential medicines, said it was “shocked” and “baffled” by the decision. In the interest of “public welfare and transparency” the group urged regulators to make the data public. To compound this anxiety, one participant in the phase III trials died. The hospital at which the trial took place, the People’s College of Medical Sciences and Research Centre in Bhopal, has been accused of not following proper procedures while screening candidates for the trials.
However, 45 doctors—including two former directors of the All India Institute of Medical Science—labelled the criticisms of Covaxin as “irresponsible.”17 They called the vaccine India’s “gift to humanity.”
Competing interests: I have read and understood the BMJ policy on declaration of interests and have no relevant interests to declare. Provenance and peer review: commissioned; externally peer reviewed. BMJ Publishing Group Ltd