On April 4, the Maharashtra government issued a notification that said transport workers, delivery service providers, roadside vendors, factory workers and construction workers must get vaccinated “at the earliest as per government guidelines”. Until they are vaccinated, they must get an RT-PCR test done every two weeks, presumably at their own expense. Unvaccinated people in these groups who are not carrying a negative RT-PCR certificate will be fined Rs 1,000, and private establishments employing these staff can be fined Rs 10,000 or even shut down, with effect from April 10.

There has been little protest against these measures. This is partly an indication of the public’s anxiety about the latest rise in cases, but the call for mandatory vaccination started as soon as Covid-19 vaccines became available. Coercion is hardwired into the pandemic response.

This attitude was illustrated in journalist Barkha Dutt’s recent panel discussion on the AstraZeneca vaccine controversy. An opportunity for a considered and balanced discussion on a complex topic – and there has been some – turned into a call for mandatory vaccination, terming vaccine refusal “criminal”.

Reasoning behind the European pause

The topic of the show was important. Regulatory authorities in a number of European countries had paused their use of the AstraZeneca vaccine when they found a small number of vaccine recipients developed a rare blood clotting disorder after taking the vaccine.

In the show aired on March 16, Dutt described the European regulators’ decision as “nutty”, evidently unaware of how regulators must respond to serious post-vaccine incidents, especially for a new vaccine that is being administered at a brisk pace to millions of people.

By March 31, the European Medicines Agency had stated: “A causal link with the vaccine is not proven, but is possible and further analysis is continuing.” On April 7, it completed its investigation and concluded that the combination of blood clots with low platelets should be listed as a very rare side-effect; product information should be updated with warnings; and vacinees should be made aware of signs and symptoms of this disorder, in order to seek urgent help if needed. It also emphasised that the benefits of the vaccine far outweigh the risks. Some countries have restarted use of the vaccine, but restricted its use to people above 55-60 years of age.

Tackling vaccine hesitancy

Fears have been expressed that the controversy, and the pause, may have contributed to Covid-19 vaccine hesitancy, a major concern in India where the cases are rising and vaccines could protect the vulnerable from severe disease and death from the novel coronavirus.

The Oxford vaccine may be associated with a serious illness for a small number of people. Still, it is generally accepted that the risk from Covid-19 is far greater than any risks from the vaccine. The important question is: what should be done to minimise vaccine risks, and to ensure that people who fall ill following the vaccine are treated promptly?

For one, the Indian government could ensure prompt, thorough and transparent investigation of adverse events following immunisation or AEFI. Adverse event surveillance is particularly important for new vaccines because it is during the vaccine rollout to millions that the government picks up rare adverse events that would not have been spotted in even large clinical trials for efficacy and safety. The findings of AEFI investigations could guide refinements in the programme, such as modifications on who should receive the vaccine, or the information given to vaccine recipients, or the post-vaccine follow-up.

Unfortunately, there is an impression that discussing adverse events following immunisation will reduce people’s confidence in the vaccine. Few of the experts who could put pressure on the government have chosen to speak up and loudly. On Dutt’s show, the eminent virologist Shahid Jameel’s otherwise measured comments were weakened by his confidence in AEFI investigations in India. He had been assured by the “top people who are managing the AEFI” that the condition investigated in Europe is not seen in any of the hospitalisations or deaths in India. However, public confidence cannot be based on such private conversations; we need to know the details.

The problem is the government has been opaque about its investigation of serious AEFIs in the Covid-19 vaccine programme. Malini Aisola of the All India Drug Action Network and her colleague Siddharth Das have tracked government records and media reports, and counted at least 135 deaths and hundreds of serious adverse events that occurred following the Covid-19 vaccine since the programme started on January 16.

The government’s website carries the findings of causality assessments of only 10 deaths and three hospitalisations. Six of the cases have been declared to have a “consistent causal association with the vaccination”, but “none have been found to be due to the Covid-19 vaccine”. These brief reports do not give the justification for their conclusions, and public health specialists have pointed out major gaps in the investigation of AEFIs. Requests for prompt investigation of AEFIs and comprehensive findings to be put in the public domain have been met with silence.

A medical staff fills a syringe with the Covishield vaccine before inoculating a beneficiary as part of the countrywide Covid-19 vaccination drive at the Rajawadi hospital in Mumbai. Photo: AFP

Making the vaccine mandatory

Rather than build public confidence in the vaccine by investigating serious illnesses and deaths following immunisation, it is easier for the government – supported by media personalities like Dutt – to demand of the public that they simply trust the government and take the shot. Anyone who is eligible to take the vaccine but does not, is irresponsible, immoral and criminal. For those who don’t like the term “mandatory”, an alternative is to make proof of vaccination a requirement for work, travel, and entry to public spaces – as the Maharashtra government’s notification reads. The Indian Medical Association has actually recommended linking vaccine certificates to the public distribution system.

The fact is that the call for mandatory Covid-19 vaccination is unscientific, unethical and will backfire.

This demand seems to be based on the idea that vaccination will protect others and not getting vaccinated puts others at risk of infection. However, the Covid-19 vaccines currently being administered have been tested for their ability to prevent disease, not infection. It is hypothesised that a vaccinated person is likely to shed less of the virus, thereby reducing transmission. Among the “scientific unknowns” about the currently available Covid-19 vaccines mentioned by the World Health Organisation in its interim position paper on vaccine passports for international travel are: their efficacy in preventing disease and limiting transmission, including for variants, and the duration of protection.

While it is possible that the vaccine will lead to “population immunity” if given to a sufficient proportion of the population, this is at present only a theoretical possibility, and we will know for sure only as countries vaccinate large numbers of their populations.

In India, the vaccination drive has so far covered only a fraction of the 30 crore people prioritised for the vaccine – healthcare workers, frontline workers, those over 60 and those between 45 and 60 with comorbidities – who are vulnerable to infection because of their occupation, or vulnerable to severe disease because of their age or medical conditions. Clearly, the vaccine is not getting to everyone who needs it, and fast enough. While the queues move briskly in urban vaccination centres, they are mostly of the middle class and well off. In both urban and rural parts of the country, the poor face enormous challenges getting access to healthcare, including for the vaccine. The priority right now is ensuring that the vaccine is available to everyone. Questions of population immunity can discussed much later.

The primary objective of the Covid-19 vaccine is to protect individuals against severe disease or death, and individuals have the right to decide whether or not they wish to take the vaccine, for their own protection.

Calls for mandatory vaccination or immunity certificates are not based on science, public health policy or ethics. Mandatory vaccination will exacerbate the inequities of differential access to vaccines, punish those who do not wish to take the vaccine, and deny people the basic right to work. Fake vaccine certificates will join fake RT-PCR negative tests in the list of Covid-19 scams.

Vaccine hesitancy is a combination of many factors, including opacity in regulatory approval (true for both vaccines currently available in the programme) as well as in the investigation of adverse events following immunisation, and poor communication on the vaccine itself. Coercion will only increase hesitancy, not decrease it.

Sandhya Srinivasan is consulting editor of the Indian Journal of Medical Ethics.