FROM the very beginning when the Covid-19 pandemic struck India in early 2020, many questions have arisen about decision-making by the union government on Covid control measures, especially about the extent to which measures instituted have been based on science or other evidence. The importance of these issues is underlined by the fact that serious questions have been raised by science- or health-oriented civil society organisations and also from leading scientists, including members of duly constituted decision-making committees, for instance on imposing lockdowns. Planning and preparedness as regards equipment like test kits, PPE, oxygen etc., were also widely criticised for being divorced from available data. Dubious modelling exercises, supported by high-ranking government officials and science administrators, with implausible predictions, added to the widespread notion of the government being more concerned about message or image management than science or evidence.

The role of decision-making institutions or bodies has also come under scrutiny. Various government bodies dealing with public health, such as the National Centre for Disease Control (NCDC) already exist but have apparently had little role to play in Covid control. A multiplicity of supposedly high-powered committees and task forces but lack of clarity on where decisions were being made and by whom have added to a sense of arbitrariness and doubts about whether science or political management are driving decisions, especially given a lack of transparency. Data gathering has often been inadequate, for example, related to testing or genetic sequencing, or simply not released in the public domain, prompting calls by eminent scientists for data to be made public, unfortunately falling on deaf ears.

These problems continue to plague the union government’s response to the Covid-19 pandemic in India.

EXPANDED VACCINATION AND BOOSTERS     

Policies on vaccination against Covid-19 are a case in point. To be fair, one may concede that there are many unknowns regarding this novel virus and its variants, and about the vaccines and other medicines developed in a very short time to deal with them. Therefore expecting scientific certitude in decision-making would be to expect the near-impossible. Response measures therefore often have to be based on a combination of science, evidence-based reasoning and managerial judgment calls. Nevertheless, decision-making rationale can and should be made transparent and placed before specialist audiences and the wider public so as to build confidence in, and adherence to decisions taken.  

There is little evidence to support population-wide booster doses of vaccines, as often reiterated by WHO on a variety of grounds. While booster shots may offer some additional protection to individuals against severe disease, hospitalisations or deaths, the epidemiological impact booster vaccinations have at the societal level is in doubt. Do booster shots affect the course of the spread of the virus or the future evolution of variants? Evidence around the world would suggest otherwise. Countries like the US, UK or other nations in Europe with early and high rates of booster doses continue to have extremely high rates of infection with both Delta and Omicron variants, although with lower proportions of hospitalisations and deaths compared to the previous wave. The UK and France are respectively witnessing around 1.5 lakh and 3.5 lakh cases daily, other European countries around one lakh, and the US around 8.5 lakh cases. Israel, an early mover on boosters and now beginning fourth booster shots, is witnessing a sharp spike in the new year to around 50,000 cases daily.

And of course, as WHO never tires of pointing out, there is gross inequity in vaccine distribution with 85 per cent of Africans having not received even a single dose. Besides the ethics involved, this means leaving a huge unprotected pool for the virus to spread and evolve, while giving boosters elsewhere, a policy with little rationale.

In India, again as WHO has maintained too, it makes sense to give booster doses to doctors and health workers, since they are the most exposed category, and high infection among them would undermine the health system. The elderly with co-morbidities has some justification too, but then, why not all the elderly? Indeed why not the entire population, like “western” countries many of which now consider only three vaccine doses to be “fully vaccinated?” The unstated answer, if decision-makers were, to be frank, would probably be that there may not be sufficient vaccines to cover the rest.

If vaccine insufficiency is a major factor in decision-making, it raises three questions, namely (a) is the expanded vaccination programme including 15-17-year-olds justified, (b) would it not make sense to first and speedily complete the 2 doses for all the 18 plus population, and importantly (c) why is there a vaccine shortage in the much-touted “vaccine capital of the world,” India, where the government claims it has invested heavily in increasing vaccine production?

COMPLETING VACCINATION

India attained an artificial peak of 20 million vaccinations daily in end-September 2021 on the prime minister’s birthday, yet required a vaccination rate of around 11 million shots daily to complete vaccination by end of 2021 which, obviously, it has not reached. Daily vaccination rates have been fluctuating between four million and 8.5 million since then, nowhere near the requisite numbers. Vaccine production by the two major manufacturers, Serum Institute for Covishield and Bharat Biotech for Covaxin, the latter being only around 10 per cent of the total, seem to have peaked with Serum Institute even saying in early December that they were planning to cut volumes by 50 per cent if further government orders were not received.

Vaccine production data is another opaque area from the government whose claims of sufficient vaccine supply is often contradicted by both State governments and manufacturers. Despite repeated demands to ramp up production through technology transfer to many other vaccine plants in both public and private sectors, this has not happened. This could have enabled meeting domestic demand quickly and then resuming large-scale supply to the Covax initiative for distribution to low-income countries.

While this is clear, some studies have looked at weekly data of stocks with states and suggested that demand, or more correctly vaccine utilization rates, maybe another big problem too.

Currently, around 87.6 per cent of the eligible population of 18 plus has received at least one shot, while 62.5 per cent is fully vaccinated. This means a backlog of around 500 million people or 1000 million doses. If indeed vaccination demand has slowed down, a major effort to step up outreach and other measures is required, with the union government providing strong financial and organizational support to the States. Surely it should be the top priority to first complete this vaccination drive with two doses, which itself would be a mammoth task.

VACCINE, MEDICINE CHOICES AND CONDITIONS         

Having Covaxin as the only vaccine to be used for the 15-17 year age groups is imposing further supply constraints to an already strained situation for Covaxin. Since Zydus Cadilla’sZycov-D has also been granted emergency use authorisation by the drug controller, why has it not been approved for the vaccination drive for the 15-17 year cohort?

The 39-week or nine months gap between the second dose and the booster is another unexplained decision, a much larger gap than the three months in the UK and six months in the US. At current vaccination rates, the third shot may be administered to numerous elderly people only many months later, when its utility may be questionable. Perhaps this decision too is due to vaccine demand-supply mismatch.  

No details have been provided for the decision to extend the shelf-life of Covaxin vials from six months to 12 months, except a bland statement that all requisite conditions have been met. This has expectedly led to considerable doubt, resentment and questioning from a suspicious public, doctors and hospitals, only adding to the cloud of distrust around the regulatory process, especially involving Covaxin, given the history of its “special status” approval without peer-reviewed data.  

The respective roles played or recommendations by the Covid-specific groups such as NTAGI (National Technical Advisory Group on Immunisation) and NEGVAC (National Expert Group on Vaccination for Covid) or the National Covid-19 Task Force are also not clear, nor are the evidence considered or rationale invoked. Big questions remain as to who has taken these decisions and on what basis?    

Finally, a major controversy has broken out regards medicines for the treatment of Covid-19 patients, especially the drug molnupiravir, now owned by US drug major, Merck. After US FDA approval by a narrow majority in December due to concerns about mutagenicity or potential for cell mutations possibly including cancers, the drug has been granted approval by the Central Drugs Standard Controller Organisation (CDSCO) for manufacture and marketing in India. However, the ICMR (Indian Council of Medical Research) and the health ministry have been openly conducting a vigorous campaign against the drug’s use and have not included it in the treatment protocol for Covid-19. Unfortunately, when the drug hits the market, this ICMR stance is unlikely to seriously influence its use by doctors and patients. This problem of contrary stance by different government entities, and a lack of consistency as regards recommendations, has happened earlier too in Covid treatment, for example with hydroxychloroquine, plasma therapy, favipiravir and so on.

Much cleaning up is required in many places.