Tag: vaccine trial

Vaccine: Bhopal Patients Say ‘Weren’t Given Consent Forms or Told It Was a Trial’

Many participants have alleged they were led to believe they were getting the vaccine itself.

New Delhi: Two reports, by The Caravan magazine and NDTV, have found that several people who had taken part in COVID-19 vaccine trials in Bhopal were not informed that it was trials that they were participating in. Many of them, who have claimed to be illiterate and belong to severely disadvantaged sections of the society, have said that they signed up believing that they were getting vaccinated.

In trials held by the People’s College of Medical Sciences and Research Centre – a private hospital – residents of four areas close to the Union Carbide factory that caused the gas disaster of 1984 were allegedly told that they would get an injection that would prevent COVID-19.

The areas are Gareeb Nagar, Shankar Nagar, Oriya Basti and JP Nagar. Residents were allegedly offered Rs 750 each for receiving the shots. The location is significant considering that more than 100 survivors of the industrial tragedy died after testing positive for COVID-19 until early December, 2020. The Caravan report says that some of the survivors were also part of the trials.

While the NDTV report does not mention which vaccine was used in the trial on the Bhopal residents, Caravan says it was Covaxin, Bharat Biotech’s vaccine candidate that is already embroiled in other controversies.

Also read: Expert Panel Changed Tack on Covaxin in One Day, Minutes Show

Some of those who received shots told NDTV that they were not given the ‘informed consent’ form, which acts as legal proof that a recipient was informed of the situation and was willing to sign up for it, as is mandatory for such trials. Some were not even told of probable side effects and received no follow up calls from the hospital.

Out of the nearly 250 people who took part in the trials, many also said that they did not know if they will be insured in case they needed treatment for complications arising from the vaccine.

While the hospital has denied the allegations and professed ignorance when NDTV pointed to specific instances and names, the claims by trial participants constitute severe violations of norms.

While participation in trials constitute risks, the process is made fruitful by trust between volunteers and medical practitioners. The latter are supposed to inform the former fully of said risks and the former owe it to the latter to report truthfully on the effects. Many of the trial participants in Bhopal could not do the latter either, because they could not read or write but were nonetheless handed a four-page symptom booklet.

In an analysis of trial ethics, one of India’s authorities on India’s COVID-19 vaccine journey, Gagandeep Kang, had written, “We must respect those who participate in clinical trials as volunteers for a greater good. And as clinical researchers, our responsibility is to make sure to do all that we can to minimise risk.”

NDTV has quoted working men and women as having run into unforeseen situations because of having been vaccinated without knowing what would follow. A 37-year-old man, Jitendra Narwaria, was reportedly compelled to shell out money for medicines after participating in the trial.

Narwaria’s children, he said, have no food and the additional expense was an imposition.

Narwaria appears to be the same ‘Jitendra’ the gas tragedy survivor who has been quoted in the Caravan report, but has been identified only by his first name and as a ’36-year-old’. He was reportedly enrolled in the phase three trials of Covaxin – something he realised much after going to the hospital.

Two vaccines have been approved for emergency use by the CDSCO, out of which, Covaxin, has been green-lit in a confusing “clinical trial mode”. Both approvals have come under scrutiny, are being called hasty, and have already put pressure on a process that can only thrive on complete clarity.

The Caravan account says that while Jitendra had informed trial authorities of health complications, he was told that the vaccine would “clean his blood, [and] not cause a fever”. The report says that while it is not known whether he received the vaccine or a placebo, Jitendra developed jaundice in the aftermath of the vaccine and was forced to seek treatment elsewhere when the hospital did not pay for his treatment or tests. Still ill and in debt to feed his children now, Jitendra was never told whether his complications were due to the shots he received.

Caravan has reported that a total of seven people have said that they had suffered as a result of being administered vaccine (or placebo). Some of them were, however, not asked to pay for subsequent tests and medicines, unlike Jitendra.

According to the New Drugs and Clinical Trial Rules of 2019, Bharat Biotech, as the sponsors of the clinical trial, must ensure that medical expenditure of a trial participant is taken care of should complications arise out of a vaccine administered to them.

Also read: DCGI’s Covaxin Verdict Forces First Vaccine Recipients To Make a Tough Call

The hospital’s dean Dr A.K. Dixit told NDTV that all ICMR guidelines had been maintained and “all participants were required to stay back for 30 minutes to check for immediate adverse effects and a seven-day follow-up was conducted over the telephone.”

This is not the first time that Bhopal gas tragedy victims have suffered due to involvement in an unethical drug trial. In 2011, a Right to Information request revealed that 10 survivors had died in barely monitored drug trials run by companies like Pfizer, AstraZeneca and Sanofi.

Meanwhile, Madhya Pradesh’s medical education minister Vishwas Sarang had a strange take on the matter, telling the news channel that political detractors of the Bharatiya Janata Party were spreading this news. Sarang also promised an investigation into the matter.

Watch | BioNTech Pfizer Vaccine’s Trial Participant Describes Her Experience

It’s important to note that testing is not yet complete.

EU Commission President Ursula von der Leyen has described the BioNTech-Pfizer vaccine as the most promising so far, although it’s important to note that testing is not yet complete. A student from Berlin who’s been taking part in the phase 3 trials told DW what it was like.

This video is brought to you by DW and The Wire. For more such videos, click here.

COVID-19: AstraZeneca Halts Oxford Vaccine Trial After Report of Adverse Effects

AZD1222, also known as the Oxford vaccine, is one of nine COVID-19 vaccines currently undergoing phase 3 clinical trials around the world.

Bengaluru: The British-Swedish pharma company AstraZeneca has temporarily halted phase 3 clinical trials of the AZD1222 COVID-19 vaccine after a trial participant reportedly developed severe adverse reactions, STAT News has reported. Rebecca Robbins, a reporter with the news outlet, tweeted the statement the company had issued early on September 9; in full:

As part of the ongoing randomised, controlled global trials of the Oxford coronavirus vaccine, our standard review process triggered a pause to vaccination to allow review of safety data. This is a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials. In large trials illnesses will happen by chance but must be independently reviewed to check the carefully. We are working to expedite the review of the single event to minimise any potential impact on the trial timeline. We are committed to the safety of our participants and the highest standards of conduct in our trials.

In a follow-up, the company specified that it had “voluntarily” paused the trial – as if to indicate the pause hadn’t been called for by any external regulators.

Reuters also reported a similar statement by a company spokeswoman named Michele Meizell: “Our standard review process was triggered and we voluntarily paused vaccination to allow review of safety data by an independent committee.”

AZD1222, also known as the Oxford vaccine because its developers are affiliated to the University of Oxford, is one of nine potential COVID-19 vaccines currently undergoing phase 3 clinical trials around the world. According to STAT News, clinicaltrials.gov – the American clinical trials registry – indicates its phase 3 trials are underway in 62 sites in the US, although not all have kicked off, and that phase 2/3 trials are on in Brazil, South Africa and the UK.

It remains unclear which site the patient who suffered the severe adverse reaction is enrolled at as a participant or what the reaction was. However, the patient is reportedly expected to recover.

The results of a phase 1/2 clinical trials of the same vaccine conducted in the UK were published in The Lancet on July 20. In that paper, the researchers conducting the trial wrote, “Local and systemic reactions were more common in the [group that received the vaccine] and many were reduced by use of prophylactic paracetamol, including pain, feeling feverish, chills, muscle ache, headache, and malaise. There were no serious adverse events related to” the vaccine. This suggests a severe adverse reaction is likely to be a clinically worse condition.

Watch: India’s Daily Increase in COVID Cases Shows No Sign of Decline Unlike Other Countries

STAT News wrote, “It was not immediately clear what steps were being taken at study sites across the US in response to the hold. Clinical holds in ongoing studies often involve a pause in recruiting new participants and dosing existing ones, unless it’s deemed in the interest of participant safety to continue dosing.”

AZD1222 uses a virus to deliver a gene belonging to the novel coronavirus into the body, to induce an immune response of the sort that the body is likely to remember and reuse in future. The virus itself, called the viral vector in this context, is an adenovirus – a type of DNA virus – whose ability to cause an infection of its own has been inactivated in the lab. During tests, however, researchers do stay alert to complications arising due to the viral vector as well as other causes.

According to Niranjana Rajalakshmi, a veterinary microbiologist, writing in The Wire Science on August 25: “Thus far, no adenovirus-vectored vaccines have been licensed to prevent diseases in humans; there is only one veterinary vaccine that uses an adenovirus vector – for rabies.”

(The Russian ‘Sputnik V’ COVID-19 vaccine also uses an adenovirus-mediated mechanism, but with two vectors instead of one.)

As Priyanka Pulla reported for The Wire Science in July, in phase 1 trials, “the vaccine is given to healthy human adults to evaluate its safety”. In phase 2, the vaccine is evaluated for its ability to evoke an immune response in a carefully chosen cohort of people, and the strength of the response.

If phase 1 and 2 trials yield overwhelmingly positive results, the manufacturer is entitled to apply for an emergency use authorisation with the US Food and Drug Administration in the US, and corresponding bodies in other countries (such as the Drug Controller General of India). Such authorisation may be granted on the condition that phase 3 trials, which combine checks for safety and efficacy in a very large cohort of patients, will be conducted even as the vaccine is cleared for public use.

The hold AstraZeneca has placed on the AZD1222 vaccine trials could compromise its ability to apply for this authorisation. However, the likelihood is, again, unclear.

But emergency use or not, phase 3 trials will be the ultimate arbiter of whether a vaccine is ready for primetime – even as the demand for a vaccine or an effective drug to prevent or control COVID-19 has only been rising. By September 8, the novel coronavirus had until then infected 27,236,916 people around the world and killed 891,031 people, according to the WHO.

Within the next two weeks, India is poised to have the world’s highest cumulative COVID-19 case load. The country has been reporting the highest number of daily new cases among all countries in the world since the first week of August. As on 8 am on September 9, according to the Union health ministry, India had reported 4,280,422 cases and 72,775 deaths in all due to its COVID-19 epidemic (as well as 900+ “non-virus deaths”), and over 75,000 new cases.

Combined with a widely denounced state response characterised by short-sightedness and moral bankruptcy, the idea of a vaccine or drug that can rapidly arrest the epidemic’s progression is growing more and more outsized. In this regard, the Serum Institute, Pune – the world’s largest manufacturer of vaccines by volume – has signed a deal with the University of Oxford to distribute the AZD1222 vaccine in India and has invested more than Rs 3,300 crore to this end.

And Adar Poonawalla, CEO of the Serum Institute, told the New York Times in early August that he was “70 to 80 percent sure” the vaccine would clear phase 3 clinical trials as well.