The tragic consequences of vaccine nationalism and rushed human trials
Shannon Ebrahim, Independent Media’s Foreign Editor
It is the stuff movies are made of – big pharma going into the slums of India to conduct vaccine trials on the most vulnerable and marginalised of society, sometimes with tragic consequences.
We don’t often get to hear about it but this was the experience of slum dwellers in North Bhopal recently, in the rush to market an indigenous Indian vaccine.
Sometime last month, trucks mounted with loudspeakers rolled into the slums of North Bhopal, announcing that anyone who wanted a Covid-19 vaccine could get it at the hospital and receive the equivalent of R156. For many in the area that amount equalled two days’ wages.
This was the third phase of the human trials for the Covid-19 vaccine developed by Bharat Biotech (Covaxin) and the Indian Council of Medical Research. The participants being recruited in North Bhopal are poor. Many of them live in the area that was affected by the 1984 Gas tragedy, and have never received their promised compensation for the toxic effects of the spill.
With lockdown restrictions in place for much of last year, areas in North Bhopal are struggling with high unemployment, and many people were attracted by the payment accompanying the vaccine, and signed forms that they couldn’t read given that many are illiterate.
According to interviews conducted by media outlet Indiaspend, many of the participants were not aware they were agreeing to be part of a vaccine trial, but thought they were being administered the vaccine.
According to several residents interviewed, they were not informed about the possible side effects of the vaccine, and there was little and often no monitoring of the side effects after the vaccines were administered.
The company claims that that there was follow up with the participants, but according to Indiaspend’s investigations, many of those interviewed did not have cellphones and said no one had contacted them to inquire about side effects. They reported that a 74-year-old man experienced continued severe fever and body aches but was unable to report his ill health to anyone. Those who did manage to report their ill health say their complaints were not followed up, recorded or treated.
One of the participants of the third phase trial, Deepak Maravi, died nine days after receiving the vaccine, and several others experienced several illnesses.
Maravi’s wife said no one contacted the family to investigate his death.
Bharat Biotech says his death was not related to the vaccine, but gave no bioethical basis for that.
Ordinarily, when there are severe side effects or death of participants in a vaccine trial, the trial is put on hold for investigations to take place. This was done during the third phase Covid-19 vaccine trials conducted by Johnson and Johnson, AstraZeneca and the Norwegian government, but Bharat Biotech did not pause its trial.
It also failed to publish its clinical protocols and the consent form with provision for audio-visual recording of consent by the illiterate and vulnerable.
What has also been of great concern to groups like India’s National Institute of Immunology has been the speed with which the Bharat Biotech vaccine was granted approval for emergency use just seven weeks into the Phase 3 human trials. The trials began on November 16, and by January 3 the Central Drugs Standard Control Organisation (CDSCO) had granted permission for restricted use of Covaxin in emergency situations, and said the vaccine was in “clinical trial mode”. But under Indian law there are no provisions made for “clinical trial mode”.
The approval lacked efficacy data which is usually arrived at once Phase 3 trials have been concluded. The vaccine trial involves two shots that are supposed to be administered 27 days apart. After the two shots, participants are supposed to be tracked and tested until enough have contracted Covid-19 to allow the vaccine’s efficacy to be analysed. By December 22, Covaxin admitted it had recruited only 13 000 participants – half of its target for the Phase 3 trial. How the vaccine was approved for use just 12 days later has left many dumbfounded.
What seems to have been the catalyst for the rushed approval of the vaccine was the fact that, on January 1, an “expert committee” had recommended that the CDSCO approve the AstraZeneca-Oxford vaccine known as “Covishield” which is being manufactured by the Serum Institute of India.
The following day, a BJP leader tweeted that he was shocked to learn that a UK vaccine was being approved while a homegrown vaccine “lay in the ditch”. The result was that, on January 3, both vaccines were approved for use, and Prime Minister Narendra Modi boasted that the indigenous vaccine was “a testament to the Indian scientific community’s self-reliance.”
Allegations have abounded that the CDSCO was under political pressure to approved the locally developed vaccine quickly.
India’s National Institute of Immunology and the Coalition for Epidemic Preparedness objected to the defiance of the CDSCO guidelines, which requires a minimum efficacy of 50% in Phase 3 trials. Vineeta Bal, an immunologist at the National Institute of Immunology described the approval of a vaccine without phase 3 data as “unconscionable” and said it would hurt public trust and risk frontline lives.
Bharat Biotech has shrugged off safety concerns arguing that unlike the messenger RNA vaccines produced by Pfizer and BioNTech and Moderna, Bharat Biotech’s approach - an inactivated whole virus has a long history of safe use. According to Gagandeep Kang, a microbiologist at Christian Medical College, Vellore, despite the tried-and-true technology, there are questions about Covaxin’s safety. Its adjuvant – an ingredient that bolsters the immune response – is a combination of aluminum hydroxide and an imidazoquinolinone that has never been used in approved vaccines.
“I don’t think anyone can guarantee it won’t cause any adverse effects when tens of thousands of people get the vaccine,” Kang has said.
An epidemiologist at Christian Medical College Jacob John, has been widely quoted as asking: “Are these uncertainties worth rushing a vaccine that is not fully characterised?”
Bharat Biotech plans to manufacture 700 million doses of its vaccine by the end of the year, and the Indian government has bought 25% of its total vials from the company. Health workers will be the first to receive the vaccine.
But not only will Indians be the recipients of the vaccine, so too will those in other developing countries which India almost immediately began marketing its vaccine to.
Two weeks ago, just a week after India approved the Bharat Biotech vaccine, India’s High Commissioner to Nigeria Abhay Thakur was telling Nigerian officials that India would be “very happy” to supply its Covid-19 vaccine to Nigeria after it is rolled out.
He said the vaccine could be supplied to Nigeria on concessional terms. Nigeria will not be the only African country that Bharat Biotech will offer its vaccine to on concessional terms, which has raised concerns among some in the scientific and medical community.
The lesson from the Bharat Biotech story with regard to the Covid-19 vaccine is that when politicians and pharmaceutical companies collude to rush approval for a vaccine just because it is locally produced, it exposes the inherent dangers to public health as a result of vaccine nationalism. The greatest tragedy is that so often it is the poor and marginalised who will suffer the most.