Counter vaccine hesitancy by building trust

Dinesh C Sharma

Science Commentator

The first few days of the Covid-19 vaccination campaign were marked by slower uptake. This was surprising because those covered in the first phase are doctors, nurses and healthcare workers. They are supposed to be well aware of the importance of a vaccine, having been in the forefront of the fight against Covid-19 for the past one year. The slow start was blamed on various factors — glitches in vaccination management software, lack of timely information to those in the list, and also certain level of hesitancy among healthcare workers to take the jab. The software and other logistics issues were addressed and fine tuned as the drive progressed. The numbers subsequently picked up and over two million people have been vaccinated throughout the country so far. Vaccine hesitancy, however, needs a proper and well calibrated response as several million people outside the health sector are next in queue in the coming months.

The World Health Organisation (WHO) defines vaccine hesitancy as ‘delay in acceptance or refusal of vaccination’ despite the availability of a vaccine. It is an umbrella term that covers hesitation and refusal of vaccine due to any reason. Well aware of this, the Ministry of Health and Family Welfare incorporated it in its vaccine communication strategy released prior to the vaccination drive. Vaccine hesitancy, the document mentioned, could arise because of ‘apprehensions around vaccine safety, efficacy’ as well as myths and conceptions. Periodic surveys done by community social media platform, Local Circles, have warned of high level of vaccine hesitancy in India. The last one conducted after one week of the vaccine launch found that 60 per cent people were unsure of taking any of the two Covid-19 vaccines rolled out on January 16. Most of them said they were worried about the side-effects or not sure about the efficacy of the vaccines. An earlier survey done in 19 countries, including India, published in the journal Nature Medicine, reported varying degrees of hesitancy from all countries.

People’s perceptions about a vaccine’s safety, efficacy and side-effects or adverse events decide their attitude to a new vaccine. In order to prevent hesitancy, regulators, governments and vaccine companies have to be transparent about these three key attributes of a vaccine. Perceptions are also shaped by claims and statements played out in the process of vaccine development, clinical trials, regulatory approval and rollout. In the case of Covid-19 vaccines, the government played a dual role — an official agency (ICMR) is a co-developer or partner in both Covishield and Covaxin, and the government is also the vaccinator. So, it is the government’s responsibility to gain people’s trust in both the vaccines. In this very task, the government faltered, causing hesitancy to grow.

The government’s messaging on the two vaccines has been confusing and misleading at times. Instead of focusing on evidence and data, it has focused on celebrations and bravado. Within hours of phase I human clinical trials of Covaxin starting on July 18 , Health Minister Harsh Vardhan tweeted in Hindi saying ‘no side-effects seen in initial trials on humans’, among other claims. It was absurd to talk about side-effects when the first day’s data from trial sites spread across the country was yet to be collated. Even if such data was available, it has to be shared with the regulator and not the minister.

On the same day, Haryana Health Minister Anil Vij announced that three persons enrolled for phase I trial in Rohtak had tolerated the vaccine well and there were ‘no side-effects’. Such statements not only made a mockery of clinical trial process, but sowed seeds of confusion and doubts among the people. A few weeks later, Vij made a public spectacle of participating in phase III of Covaxin trial and then tested positive for Covid-19. The resulting controversy further dented the clinical trial process and bred hesitancy even though Vij’s Covid status had no link with his participation in the trial. In the first place, it was unethical for the ICMR and Bharat Biotech to let a trial participant who was a public figure to announce his participation. There was also the case of Serum Institute of India sending legal notice for Rs 100 crore in damages to a trial participant when he alleged serious side-effects.

The confusion multiplied when the drug regulator gave ‘emergency use authorisation’ to the two vaccines in two distinct ways, without offering any explanation. Covaxin of Bharat Biotech was approved in ‘clinical trial mode’ pending data from ongoing phase III or efficacy trial. Top government functionaries had no convincing argument to defend the decision. For instance, Director of the All India Institute of Medical Sciences, New Delhi — which is also a clinical trial site for Covaxin — declared the vaccine will be a sort of ‘back-up’. The Bharat Biotech Managing Director shot back saying there was no such thing as back- up vaccine. The Health Ministry treated the two vaccines at par in its roll out plans. Independent experts who questioned vaccine approval without efficacy data were dubbed anti-nationals and peddlers of fake news. Politicians like Akhilesh Yadav did their bit by calling it a ‘BJP vaccine’. All such voices provided a perfect cocktail for hesitancy to brew.

The only way to build trust in vaccines and convert hesitancy into acceptance is to be transparent and accountable. The drug regulator should instill public confidence in its approval and regulatory processes. The government, which has a direct stake in both the vaccines, should be transparent about clinical trial and adverse events data. It should accept accountability if something goes wrong during the clinical trials, as it reportedly happened in Bhopal, and for adverse events of a serious nature. Every statement a government functionary makes about the vaccines should be backed by evidence. Instead, the government seems to be in a mood to target critical voices through force and penal action by asking the states to invoke provisions of the Disaster Management Act. Let’s remember, trust can’t be earned through authority, and vaccine hesitancy can’t be countered without trust.

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