Lack of data, biased trials, the Indian vaccine worries the medical community

One of the two vaccines against Covid-19 which will be inoculated from Saturday in India, Covaxin, developed by a local company and approved in emergency arouses reluctance in the medical community which is concerned about the lack of data on its clinical trials.

India's colossal vaccination campaign, which begins on Saturday, relies on Covaxin and Covishield developed by AstraZeneca and the University of Oxford both produced by the Serum Institute of India. Some 300 million people will be inoculated with one of the two vaccines by July.

Covaxin, developed by Bharat Biotech and the Indian Council for Medical Research, obtained emergency approval in early January, along with Covishield.

100% sure then assured the Comptroller General of Drugs of India, VG Somani, adding that the regulator would never give his approval if there was the slightest concern in matters of safety.

AstraZeneca filed this week its application for authorization for Covishield with the European Medicines Agency (EMA) which should render its decision at the end of January, if the data communicated is sufficiently "robust and complete".

But the approval of Covaxin which Bharat intends to export in particular to Brazil was granted in India even before the conclusion of its phase 3 trials.

The government has since indicated that the vaccine had been approved in clinical trial mode, meaning that the vaccination campaign would act as phase 3. Far from reassuring All India Drug Action Network (AIDAN), the independent monitoring organization of the pharmaceutical sector, said she was shocked and disconcerted.

West Bengal based doctor and immunization expert Prabir Chatterjee said this irritates a lot of top doctors and scientists.

I guess Bharat Biotech's vaccine, after being evaluated, might be the best, cheapest and most convenient for developing countries," he told AFP. "But (...) I don't believe in starting the vaccination process and using it before it has been proven."l

Few volunteers

The Indian laboratory, an international player in the sector, has already delivered more than three billion vaccines worldwide against diseases such as Japanese encephalitis and hepatitis B.

But its trials of Covaxin have struggled to gather enough participants, having recruited only half of the 26,000 volunteers required at the end of December.

According to its detractors, Bharat Biotech settled with the protocols, in particular in Bhopal (center), where its local partner recruited 1,700 people from underprivileged areas, paid 750 rupees (8 dollars) each.

One of the officials Rajesh Kapur asserted that all appropriate procedures and ethical practices were followed and that individuals were properly informed about the trials before giving informed consent.

However, ten participants interviewed by AFP said they had not been informed of the precise objective of these injections or of the inherent risks.

Among them, Mannsingh Parihar, 70, remembers receiving an injection, along with four other people, on December 21, before being paid for "treatment against Covid."

They haven't said a word (on testing). They made the injection, gave the money and asked me to leave, he told AFP.

In addition, no consent form has been provided to them as this procedure has become mandatory for pharmaceutical trials following a series of scandals in this booming industry.

Similar accounts have been reported by the Indian press and human rights activists. Asked by AFP in an email, Bharat Biotech did not respond immediately.

No informed consent has been obtained, no adverse effects have been recorded, no surveillance and no follow-up have been carried out, Rachna Dhingra, social activist, told AFP.

A certain quality must be given to clinical trials. They require appropriate procedures and adequate data collection, emphasizes Anant Bhan, researcher in bioethics and health policy. If this is not the case, it is obvious that the quality of the data and their reliability will be questioned.