India Covaxin: Some Bhopal slum residents thought they were being vaccinated against Covid-19 but were part of clinical trials – CNN

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By Esha Mitra and Julia Hollingsworth, CNN

Updated 7:17 PM ET, Thu February 25, 2021

Bhopal, India (CNN)The white van arrived in slum areas of Bhopal, a city in central India, blasting a message over the speaker system that seemed too good to refuse: “Come and take the coronavirus vaccine and get 750 rupees ($10).”

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Once at the hospital, a large white building with columns and reflective blue windows, 12 participants told CNN they were asked to sign forms, although two people only signed the forms when they received their second shot. Another one gave audio-visual consent and another was asked for a thumb print instead of a signature. However, of those 14 participants, eight said that they were unable to read — the state of Madhya Pradesh, where Bhopal is located, has one of the lowest literacy rates in India at around 70%, according to the country’s most recent Census in 2011. Only participants over 60 said they were offered audio-visual consent forms. The four who could read said they weren’t given the opportunity or time to go through the 10-page form written in Hindi. The form, which CNN has obtained, includes jargon such as “immuno response,” “placebo” and “immunogenicity” — terms that would be confusing to anyone without medical training.
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At least eight Bhopal slum residents told CNN they were not asked about underlying health conditions, even though “uncontrolled” comorbidities is listed as a reason for excluding participants in the trial’s own protocol. Rajesh Panti, 45, a survivor of the Bhopal gas tragedy, said when he received the first dose, he was not asked whether he was taking any medicine. Chillaar said he takes medication for diabetes every morning, but was not asked at the hospital whether he had any underlying health issues. Sarita Jathav, 26, said she is pregnant, but was only told that pregnant women couldn’t take the vaccine when she went to take her second dose, which she did not receive.

Radha Bai (top), Jetender Veria (left) and Man Singh Parihar (right) pictured in Shankar Nagar, a slum in Bhopal, India, on February 7, 2021. All say they did not realize they were participants in Phase 3 Covaxin trials. (Credit: Ajay Bedi/CNN)

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Activist Rachna Dhingra talks to a resident of Oriya Basti slum in Bhopal on January 8, 2021.Activist Rachna Dhingra talks to a resident of Oriya Basti slum in Bhopal on January 8, 2021.
Nasreen is a field worker with Bhopal Group for Information and Action (BGIA) that works with communities affected by the Bhopal gas leak. Nasreen is a field worker with Bhopal Group for Information and Action (BGIA) that works with communities affected by the Bhopal gas leak.

Vaijayanti Marawi and two of her sons in Bhopal, India, on February 7, 2021. Marawi’s husband Deepak Marawi died in December after participating in the Phase 3 clinical trials.

Vaccine trial volunteers wait for a dose of Covaxin at the People's Hospital in Bhopal on December 7, 2020. Vaccine trial volunteers wait for a dose of Covaxin at the People's Hospital in Bhopal on December 7, 2020.
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  • Bharat Biotech receives Drugs Controller General of India approval to conduct Phase 3 clinical trials with 26,000 participants for Covaxin.

  • Covaxin’s Phase 3 clinical trials begins.

  • Bharat Biotech announces it has recruited 13,000 participants — around half its target.

  • Central government’s subject expert committee, which recommends vaccines for emergency approval, says that Bharat Biotech should try to expedite recruitment for Phase 3 Covaxin trials as “efficacy is yet to be demonstrated.”

  • The subject expert committee recommends India’s drug regulator approve Covaxin for restricted emergency use, citing “updated data … in the wake of the incidence of new mutated corona virus infection.”

  • India’s drug regulator gives restricted emergency use authorization to Covaxin and Covishield, the name given to the Oxford-AstraZeneca developed vaccine in India.

  • Bharat Biotech announces that it has finished recruitment and all 26,000 participants have received their first dose.

  • Four Bhopal-based NGOs write to India’s prime minister and health minister, warning them of alleged ethical violations in the Bhopal Phase 3 Covaxin trials.

  • India begins the first phase of its vaccination drive — rolling out Covaxin and Covishield to 10 million healthcare workers.

“You are dealing with people who are highly vulnerable, who are not even fully educated, do you expect them to come and say, ‘These are my rights’?” Amar Jesani

A priest performs prayer rituals on a carton containing the first consignment of Bharat Biotech's Covaxin vaccine.A priest performs prayer rituals on a carton containing the first consignment of Bharat Biotech's Covaxin vaccine.

    Esha Mitra reported from New Delhi and Bhopal, India. Julia Hollingsworth reported and wrote from Hong Kong.
    Additional reporting: Anup Dutta
    Photos and video: Ajay Bedi
    Graphics: Natalie Leung
    Editors: Hilary Whiteman and Jenni Marsh

    Source Article from https://www.cnn.com/2021/02/25/asia/india-vaccine-trials-covid-ethics-intl-dst-hnk/index.html

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