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Friday, September 25, 2020

The vaccine volunteers

In efforts to find an end to the Covid-19 pandemic, global hopes rest on an Oxford University vaccine candidate — and the few who have signed up for its advanced trials. The Indian Express meets six among those on whom rests the fate of ‘Covishield’ in India, to find the roads that led them here.

Written by Anuradha Mascarenhas | Pune | Updated: August 30, 2020 7:53:40 am
The vaccine volunteersA total of 1,600 18 years of age or over are to be enrolled in the study for the Oxford-AstraZeneca vaccine or Covishield in India.

It was after exactly five months and four days that the 64 year-old former top official of a pharmaceutical firm in Pune was stepping out of his bungalow. On August 27, he dressed slowly, washed his hands before wearing gloves, put on an N95 mask and safety goggles, and then waited for his wife, 59, daughter, 40, to get dressed similarly and join him in the car. All three of them then headed for the Bharati Vidyapeeth Medical College and Hospital in Pune — to be part of trials for one of the most promising vaccine candidates against the coronavirus as yet.

“Oh my God, it had been so long,” says the 64-year-old. “I had only been listening to tragic news — another healthcare worker I knew passed away due to Covid. In the car, we switched off the AC, sanitised the seats, disinfected the steering wheel and sat diagonally.”

But while the virus might have kept him home all these days, he says he didn’t hesitate on coming to know volunteers were needed for Phase 2/3 clinical trials of Oxford-AstraZeneca vaccine — or Covishield, as it is to be called in India. “There was absolutely no doubt in my mind that I would volunteer.”

Explained

A shot in the dark

The 64-year-old has been closely monitoring the progress of the vaccine developed by Oxford University — including the advanced human trials that are already on in Brazil, South Africa and the United Kingdom. In India, the Phase 2/3 trials started on August 25.

As part of the pharmaceutical industry, he had seen such trials up close, he says, with his team being part of several research studies.

The vaccine volunteers A medical staff delivers the Covishield to one of the volunteers at Bharati Hospital in Pune; (above) the hospital has been part of 50 trials. (Express Photo by Arul Horizon)

“I read the Lancet study (on the Oxford vaccine) and spoke to experts like doctors and policymakers. I found that all of them were optimistic about the vaccine… Also, after reading so much about the results of the safety trials abroad, I felt this vaccine has potential, and decided, why not take it?”

His wife and daughter were not hard to convince either. “Well somebody has to volunteer and take a chance. If this is going to allow me to travel, so be it,” says the 40-year-old who has been staying with her parents since the lockdown.

The RT-PCR and blood result tests had come the day before, certifying that they didn’t have antibodies and hence fit to volunteer. Their driver who has been with them for a while also offered to volunteer, but was rejected as he already had antibodies. On August 27, the family left home at 10.30 am. After they had received the shot, their vitals were monitored for half an hour and, with everything normal, were allowed to go home. The daughter, husband and wife
were back home by 1 pm. “It was comfortable. The team was very professional,” says the 59-year-old.

About 20 km from Pune, at the KEM Hospital and Research Centre at Vadu, which is also a site for the clinical trials, the screening of volunteers is underway. Dr Ashish Bawdekar, the principal investigator at the site, says that the hospital would be enrolling 30 volunteers initially.

The vaccine volunteers Volunteers have been advised to contact the vaccine trial team on the emergency numbers if they face any issues. (Express Photo by Arul Horizon)

In efforts to find an end to the Covid-19 pandemic, global hopes rest on an Oxford University vaccine candidate — and the few who have signed up for its advanced trials. The Indian Express meets six among those on whom rests the fate of ‘Covishield’ in India, to find the roads that led them here

The 64-year-old says it was a well-considered decision, and after they had approached Bharati Hospital, it sent them a consent form via e-mail. The form was nearly eight pages long, and included details on Covid-19, the vaccine, its possible side effects, the blood samples and other interventions needed, what the blood samples would be tested for, and the reimbursement amount to be paid for hospital visits. They were also told they would get two doses in all, on Day 1 and 29, and would be monitored over the next six months.

They were given detailed guidelines on what to watch out for — most importantly fever — and to immediately contact the doctors on the emergency numbers of the vaccine trial team if any issues. What was most important, the volunteers were told, is that they continue with their daily routine.

And that’s what they have done, says the daughter. “I barely felt the needle prick (of the vaccine), came home and ate a simple meal of dal, rice and methi,” she says.

“I need to go out and meet people,” the 64-year-old adds. “It has just been too long.”

***

The 32-year-old, who also has links to the drugs industry as a biostatistician, now holds the distinction of being the first in India to receive the Covishield shot. An employee at a private firm in Pune, the research student says he has been reading up on vaccine development, and joined when he heard that trials were being held in the city. “I decided to volunteer as there is increasing hope that we can find a solution soon to end this nightmare,” he says. “The pandemic has taken a huge toll on our lives. So many people have lost jobs and as youngsters we can volunteer for such trials. This is the least I could do.”

His felicity with data made his decision easier, according to the 32-year-old. “I studied the results of the Phase 2 study in the UK and, as a statistician, understood that there were few side effects.”

Oxford University researchers had reported that the vaccine had triggered a dual immune response in Phase 1 and 2 human trials and had an “accepted safety profile”.

He says he approached Bharati Hospital on own, saying he was interested in volunteering for the trial. “They gave me information about the study being undertaken and told me to sign a consent form… The team took my blood pressure and checked other vitals and since the RT-PCR and antibody test results were negative for Covid, I got the
first dose.”

On August 26, he followed his normal routine and, after breakfast, headed for Bharati Hospital. His parents were waiting eagerly for him when he returned, the 32-year-old says — very proud of the fact that he was the first to get the Covishield dose in India.

A day later, the 32-year-old was back at work.

Also read | Here is how to enrol in a Covid-19 vaccine trial

***

Of the first volunteers, the case of the 48-year-old gynaecologist is special. It is the second time he is part of a clinical trial, the first being when he and his daughter, then 11, signed up for H1N1 vaccine trials at Bharati Hospital in 2009.

That year, India saw 981 deaths due to H1N1 as per the National Centre for Disease Control. In the decade since, over 1.58 lakh people have got swine flu in the country and more than 10,000 have died of it.

Around five years later, the daughter enrolled again for a trial, for a vaccine against cervical cancer, also at Bharati Hospital. The father says both times, their experience was reassuring, with experts regularly following up with them.

This time, the two again cleared tests for Covishield trials, while the 48-year-old’s wife, also a gynaecologist, was rejected as she was found to have developed antibodies for Covid. He got his shot on August 26 (the second to receive the vaccine after the 32-year-old) and his daughter the next day.

While the 48-year-old finished his morning appointments at a private hospital where he works as a consultant before going to the hospital, the daughter, now 21 and in the final year of an engineering degree, went after her online classes for the day were over.

The family has been one on this issue always, the 21-year-old says. “I was in Class 4 or 5 when my parents decided to enrol me as a volunteer in the H1N1 vaccine trials. The second time I volunteered for a vaccine against cervical cancer. I did not have any major side effects. For this trial too we decided unanimously to enrol as volunteers.”

According to the 48-year-old, the decision wasn’t difficult. His scientific bent of mind means he is exasperated at all the talk of immuno-boosters and other non-tested solutions for the coronavirus, he says. “Healthcare workers including doctors have got infected. I have seen some die due to this disease. A vaccine is the solution,” he asserts.

His wife, disappointed at not being able to volunteer, teases that he and their daughter just wanted to be in the limelight.

Needle and the haystack

* A total of 1,600 18 years of age or over are to be enrolled in the study for the Oxford-AstraZeneca vaccine or Covishield in India.

* They will be split into ‘safety cohort’ and ‘immunogenicity (to check for immunity) cohort’.

* Of the 1,600 participants, 1,200 will be split 3:1 to receive either Covishield or a placebo across all sites. They would comprise the safety cohort, and get two doses while no blood samples would be collected to check for antibodies. They would be monitored for six months.

* The remaining 400, part of the immunogenicity cohort, would receive either Covishield or Oxford/AZ-ChAdOx1 nCoV-19, also in a ratio of 3:1 (the same vaccine, but the first produced by Serum and the second by AstraZeneca). After the second dose, blood samples will be taken up to six months to check for antibodies. These trials will be done at only four or five sites.

* The volunteers at Pune so far are part of the safety cohort.

Race against time

* Three vaccine candidates, including two indigenous, are in development in the country.

* Phase 1 trials of the indigenous Covaxin, by Bharat Biotech in collaboration with ICMR, and ZyCoV-D, by Zydus Cadila Ltd, are complete.

* Zydus has started Phase 2 trials. Bharat Biotech will begin in September.

* Oxford-AstraZeneca vaccine is in the most advanced stage. In India, its Phase2/3 trials commenced on August 25.

* 172 countries are in talks to set up COVAX, to reach vaccines to all equitably. It has 9 candidates under consideration, including Moderna, US (Phase 3).

* Russia has cleared ‘Sputnik V’ for civilian use amid doubts; while China cleared CoronaVac developed by its Sinovac Biotech for emergency use in July.

At trial site, a queue to sign up

The clinical trial unit is located on the ground floor of Pune’s Bharati Vidyapeeth Medical College and Hospital, in its non-Covid section and near the ENT and paediatrics OPD. Notices pasted on a door in English and Marathi are the only sign that trials which a country is eagerly waiting for are on here.

The 831-bed Bharati Hospital (350 of these are now kept aside for Covid cases) has been a clinical site for more than 50 vaccine trials so far. Its trial team of 15-odd includes medical social workers, doctors and nurses, who between them handle everything from tests to answering calls, sending emails and counselling volunteers.

But while Bharati itself is not new to such attention, the anticipation has taken it by surprise. Dr Sanjay Lalwani, the hospital’s Medical Director, says people from all walks of life have been making enquiries and sending emails seeking to be volunteers. A medical social worker at the hospital, Sameer Pawar, adds, “A 75-year-old man from Guruwar Peth nearby was among those waiting at the hospital at 9.30 am to get the dose.” Enquiries are also coming from parents of patients in the hospital’s paediatric ward.

This is unlike 2009, when trials were held for H1N1 at the hospital, when it was mainly healthcare workers and doctors who signed up as volunteers.

Dr Mandeep Chadha, former virologist with the National Institute of Virology, Pune, that has been at the forefront of the coronavirus efforts in India from the start, says the novelty and contagiousness of SARS-CoV-2 lend extra urgency to the efforts to find a vaccine. “There was a fair amount of panic during the H1N1 pandemic in 2009 as well, but antiviral drugs, in particular oseltamivir (Tamiflu), were soon available then.”

It was last month that The Lancet published that an Oxford University vaccine candidate against the coronavirus, backed by AstraZeneca Plc, had shown positive results. The Oxford-AstraZeneca vaccine is essentially a weakened version of a common cold virus known as adenovirus. The scientists extracted genes from the spike protein that grows on the surface of SARS-CoV-2 that causes Covid-19, planted them in adenovirus extracted from chimpanzees and modified the virus so that it cannot grow in humans.

On August 2, the Drug Controller General of India permitted the Pune-based Serum Institute of India, the world’s largest manufacturer of vaccines, to conduct the Phase 2/3 human clinical trials of the vaccine in India. Officially, the study is described as ‘Observer-Blind, Randomized, Controlled Study to Determine the Safety and Immunogenicity of Covishield (COVID-19 Vaccine) in Healthy Indian Adults’.

In a big gamble given that the trials are still on, the Serum Institute announced a tie-up with AstraZeneca to produce a billion doses of the vaccine for low-income countries. It is ramping up its facilities and production capacities to meet this target.

In all, there are 17 sites listed with the Clinical Trials Registry, India. A total of 14 or less may eventually participate in the Covishield trials. Initially, 100 volunteers are to be enrolled — with Pune’s two sites, including KEM Hospital and Research Centre, the first off the block. A total of 1,600 eligible people 18 years or older are to be selected as participants in the study.

Seven days after each of the 100 participants have received the dose, the data is to be presented to a Data Safety Monitoring Board, including physicians and statisticians. If there are no major concerns during a temporary halt, the trial would recommence.

As per the study design, 0.5 ml of Covishield is to be administered on Days 1 and 29, intramuscularly.

Once all the testing phases of the clinical trial are completed, data is tabulated, results are obtained and submitted to the Drug Controller General of India for approval. Trial participants are informed about the results and those who have been given a placebo will get the vaccine dose from the company. The regulatory body also inspects the vaccine/factory production and other relevant details.

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