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Many trial participants still unsure about vaccine or placebo status, SII info only on request

As India rolls out its second phase of immunisation, Covid trial participants are seeking information about their status. But govt has allowed only individual requests.

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New Delhi: Several volunteers who participated in the clinical trials of Covid vaccines — Covishield and Covaxin — are still unsure about whether they were given the placebo or the vaccine. This comes even as the national immunisation plan for Covid vaccination has reached phase 2 — for people above the age of 60 and between 45 and 60 with co-morbidities. 

In the case of Serum Institute of India (SII)’s Covishield, this is because the Subject Expert Committee (SEC) under the Drugs Controller General of India (DCGI) has recommended that trial participants be informed of their status “upon request of the clinical trial participant only”.

According to the minutes of an SEC meeting held on 3 February, the panel recommended that “the participants randomized to the placebo arm may be unblinded 60 days after the second dose upon request of the clinical trial participant only”.

“Such participant may be offered investigational vaccine as per the dose and schedule prescribed in the protocol,” it added.

Unblinding refers to revealing the information on the vaccine or placebo status.

The SEC order came in response to an SII request seeking permission to unblind data, after the vaccine was given approval on 3 January. It was not immediately clear if Covaxin maker Bharat Biotech has made a similar request.

Conventionally, vaccine trial participants are informed of their status and given the vaccine if in the placebo group, after the completion of a trial.

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What Covishield participants say

Covishield trial participants are expecting to hear from either SII or their respective trial sites about their status, based on verbal information given to them.

“At the beginning of the trial, I was informed verbally that we will get the vaccine if we are in the placebo arm. The last time I asked, I was told that I would be informed soon about my status, but I haven’t heard anything,” said Leena Kulkarni, a 55-year-old participant from Pune. 

“I would like to know so I can figure out what to do next,” she said.

Anuradha Trehan, another volunteer from Pune, said the process of unblinding had started at her centre, but she isn’t aware of her status as yet.

“Someone else I know was called and told he got a placebo, so I believe the process has started. I had asked them last month about when the data will be unblinded, but they said they hadn’t received any protocols at the time. I haven’t yet got any information on my status yet,” said the 45-year-old.

Also read: Why Delhi hospitals, with 100s of vacant beds, are still struggling to cater to all patients

What Covaxin participants say

In December 2020, Bharat Biotech had released a document promising priority vaccination for volunteers in the placebo group.

It said, “If you participate in this trial, this vaccine will most likely get licenced within a few months and if you received a placebo, we will contact you and give you the vaccine, thus giving you priority access to the vaccine (even if you are below 60 years).”

However, participants in the second phase of the study — whose data was presented to the DCGI when the vaccine was approved for the immunisation programme — haven’t been informed of their status.

“I took an antibody test myself to see if I was in the placebo group or vaccine group. My test came out positive. But the company has not informed me even though I have asked. My last visit is in March, I’m hoping they will tell me then,” said Prashandh, a 31-year-old volunteer from Chennai. 

ThePrint reached Bharat Biotech’s communication representatives via texts and calls with queries on the process of unblinding the data, but there was no response until the time of publishing this report.

Covishield trial sites ‘will not approach participants’

ThePrint had reported last month that SII had applied for permission to unblind data on the request of several trial participants. 

The trial had recruited 1,600 participants across 14 trial sites across the country, and began in August 2020.

In September 2020, the Central Drugs Standard Control Organisation (CDSCO) had released draft guidelines for the regulation of Covid vaccines, calling for continued follow up.

It said, “Efficacy trials should include contingency plans for continued follow up and analysis of safety and effectiveness outcomes in the event that a safe and effective vaccine becomes available (e.g., as demonstrated in a planned interim analysis or as demonstrated in another clinical trial). In that case, prior deliberation and examination with CDSCO in consultation with the SEC is necessary to address ethical arguments to break the blind and offer vaccine to placebo recipients.”

Now that SEC has granted permission, a source from SII said the process of unblinding could take time as it was up to the Ethics Committees at each trial site to grant final approval for the process.

“The DCGI has given SII permission, and we have forwarded the dossier to be shared with all ethics committees, who may take some time to grant approvals. Once the ethics committee approves, it can be revealed to participants which arm they were in,” said the source.

“But sites will not approach participants, participants have to ask themselves. This is to maintain the integrity of the study,” the source added.

Some trial sites have already revealed to certain participants what their status is.

“Whoever approaches us, we have got permission to tell them and administer the vaccine. Initially, the permission was only for healthcare workers who had volunteered, but now it is for everyone. We have already administered the vaccine on some participants,” said Dr Murlidhar Tambe, a principal investigator of a trial site in Pune. 

Also read: India has shown capacity to make Covid vaccines on global scale, says WHO chief scientist


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