Will the WHO’s Covaxin approval answer questions about the vaccine’s trials?

Indian Health Minister Harsh Vardhan holds a dose of Bharat Biotech’s COVID-19 vaccine called COVAXIN, during a vaccination campaign at All India Institute of Medical…
Indian Health Minister Harsh Vardhan holds a dose of Bharat Biotech’s COVID-19 vaccine called COVAXIN, during a vaccination campaign at All India Institute of Medical…
Image: Reuters/Adnan Abidi
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The World Health Organization (WHO) has issued an emergency use listing for Covaxin, India’s homegrown covid-19 vaccine. But will the global health body’s decision answer crucial questions about this covid-19 vaccine?

Co-developed by Hyderabad-based company Bharat Biotech, in collaboration with the government’s Indian Council of Medical Research (ICMR), Covaxin was granted emergency authorisation in the country in January. At that time, its phase-3 human trials were still ongoing and none of its efficacy data had been published. The national vaccine committee’s authorisation was, not surprisingly, heavily criticised.

Bharat Biotech contended that the platform used to develop the inactivated virus vaccine was a well-established one, unlike the new technology of mRNA vaccines. The committee, on the other hand, claimed that Covaxin would be effective, even necessary, to combat the alpha variant (first found in the UK in December 2020).

Irregularities in its approval process, and allegations of corruption and ethical violations could be perhaps questions that the WHO’s process for enlisting might answer. But it also may be beyond the organisation’s mandate given that its primary focus is on safety and efficacy.

The wait for efficacy data

During a press conference in January, Bharat Biotech chairman and managing director Krishna Ella said his company will, “within a week”, produce data pertaining to Covaxin’s efficacy against the alpha variant.

That, however, happened only in July after, crucially, millions had already taken the shot. Based on data from the 25,800-people study, the company claimed that the vaccine was about 78% effective against symptomatic covid-19.

Yet, it is still not the most used option in India—of the more than one billion shots administered till now, only about 10% were of Covaxin.

This ethical issue extends to its trial, too.

Ethical issues with the trial

On Jan. 10, a week after Covaxin’s approval, volunteers in Bhopal alleged that neither Bharat Biotech nor the hospital where the trial was conducted had followed the due process while enrolling them.

The allegation—denied by the firm—included side-stepping informed consent, non-acknowledgement of side effects, and not offering medical care during adverse events.

Several volunteers alleged they were herded into vehicles and taken to the hospital site. Some were paid 750 rupees ($10), which, according to activists representing the volunteers, was meant to lure the impoverished into the project. Bharat Biotech, however, said the amount only met the cost incurred by volunteers and was “not an inducement.”

One trial volunteer died in December. While Bharat Biotech confirmed his participation, it refused to reveal if he was given the placebo or the vaccine, saying the study was still blinded. It also said the death was unrelated to the vaccine.

Even as the company fought local battles, Covaxin’s troubles went international.

Covaxingate and the Bolsonaro government

Covaxin was at the heart of a corruption scandal in Brazil, which led to an inquiry into Bharat Biotech’s $324 million contract with the Jair Bolsonaro government.

In June, Brazilian whistleblower Luis Ricardo Miranda alleged he was being pressured by an aide of the country’s health minister to clear a $45 million payment to Madison Biotech. Miranda was the head of medical imports in the ministry. The company was not listed in the original contract, but it later came to light that it was a partner of Bharat Biotech in Singapore.

An inquiry was launched on June 24. Eventually, the Bharat Biotech deal was suspended.

The vaccine maker denied any wrongdoing, despite additional allegations of a $200,000 payout to lobbyists. Company co-founder Suchitra Ella, along with Precisa Medicamentos, its Brazil partner, were part of the India-Brazil Chamber of Commerce (IBCC). It was found that the Brazilian entity had transferred $200,000 to the IBCC in two instalments in February.

Bharat Biotech has since severed its ties with Precisa Medicamentos.