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Putting out clinical trial data in public domain may help allay Covid vaccine hesitancy: Expert

Dr Naveen Thacker, who was administered the Covishield shot at Ahmedabad Civil Hospital in the presence of Chief Minister Vijay Rupani on January 16, also assured the medical community that there is “no reason to run away from Covaxin”.

By: Express News Service | Ahmedabad |
January 28, 2021 3:39:59 am
Covaxin, Covishield, covid vaccine, india covid vaccine data, india covid vaccine trials, Oxford–AstraZeneca, indian express newsTo build confidence and allay vaccination hesitancy among the public, Dr Thacker said, putting out the data in public might help. (Representational)

AS CONCERNS over Covid-19 vaccines continue 10 days since the inoculation drive began across the country and the state, paediatrician Dr Naveen Thacker, among the first to receive the Oxford–AstraZeneca developed Covishield shot in Gujarat, said an “immediate reaction” from scientists soon after the emergency use authorisation of Bharat Biotech-ICMR developed) Covaxin has led to a “division among people”.

Dr Thacker was among the four panellists at a webinar conducted by the Indian Institute of Public Health, Gandhinagar (IIPH-G), Wednesday to dispel common misconceptions, myths, misinformation around the Covid-19 vaccines.

Asked how well does it bode for Covaxin and fears around it in absence of data from clinical trials, Dr Thacker, who is also the executive director at International Pediatric Association (IPA) told The Indian Express, “Yes, I’m also among one of those who are asking for transparency of data. But it is not available in the public domain. For confidence building, ‘risk communication and community engagement’ principles dictate that it (data) has to be honest and it has to be transparent… The scientific community or the medical community is never satisfied without data. But for an administrator, those who are running the country or state, they might have to take a hard decision at a time when people are dying and are affected (by Covid-19).”

To build confidence and allay vaccination hesitancy among the public, Dr Thacker said, putting out the data in public might help. He added Covaxin’s approval for restricted emergency use in clinical trial mode took an “unnecessary political turn”.

“Upon approval, some (scientists) demanded data. Some others started defending the vaccine, which was totally baseless (because there was no data on its efficacy then )… It has taken a political turn, which is unnecessary,” he said. On Wednesday, the doctor said, Covaxin released a preprint concluding that the vaccine is effective on the new UK variant of novel coronavirus mutation.

Dr Thacker, who was administered the Covishield shot at Ahmedabad Civil Hospital in the presence of Chief Minister Vijay Rupani on January 16, also assured the medical community that there is “no reason to run away from Covaxin”.

“Had I been given Covaxin on January 16, I would have taken it. First, because the technology (of vaccines) is 200 years old. It is safe and is nothing new. Second, data for phases 1 and 2 trial is available publicly (conducted on animals), both of which phases dealt with the safety of the vaccine. We have data on the safety of the vaccine, there is no concern about that. China is another country where the vaccine was approved without efficacy data and thereafter the efficacy was measured… We have seen none of the vaccines from other countries with efficacy less than 50-60 per cent. Reasonably everyone knows, no vaccine is less efficacious than 50 per cent.”

IIPH-G director Dr Dileep Mavlankar, also among those to be vaccinated first, addressed some of the common misconceptions around the Covid-19 vaccine. He said misconception around the vaccine existed around the world but “are in minority”.

Responding to some common queries where people have expressed concern over a vaccine being developed within a year when it otherwise takes decades, Dr Mavlankar said following a pandemic seen after 100 years, saw a reduction in a waiting period with RNA coding declared within a month by China, saw faster permissions from various levels, including ethics committee, companies etc, all of which led to rapid development of the vaccines.

He added one should not refrain from taking the vaccine even if one has been infected, since transmission may see an increase once schools, colleges and organisations reopen fully.

Referring to the death of 28 persons in Norway soon after taking the vaccine, Dr Mavlankar said, “It is true, but correlation cannot be causation, the deaths are under investigation. In Norway, every week there are 400-odd deaths, so 28 is negligible. In India too, two deaths have been notified but this too may be incidental so one cannot conclude that they died due to vaccination.”

Of the 4.57 lakh health workers registered, a total of 95,909 have been inoculated across Gujarat so far, which is more than one-fifth of the intended first-priority group, data provided by the state health department stated.

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