All set for vaccine rollout amid probing questions

Dinesh C Sharma

Science Commentator

THE new year has begun with a sense of optimism on the pandemic front as two Indian vaccines against Covid-19 are on the verge of being rolled out throughout the country. As trucks with boxes containing vials were shipped this week from the vaccine factory in Pune to different cities, they were tracked like a VIP consignment. The arrival of cargo planes with the precious boxes was welcomed by health officials and the boxes were transported to cold stores through ‘green corridors’ created for a traffic-free journey. In Hyderabad, health officials performed puja when the boxes arrived at the government facility under the glare of television cameras. Never before in the history of healthcare in India has a humble medical tool like the vaccine received this kind of treatment. The euphoria around the Covid vaccine is understandable as it comes as a ray of hope during the pandemic that has already lasted a year. The vaccination drive beginning this weekend is also the largest India has ever implemented.

The two vaccines for which the Health Ministry has placed the orders are locally manufactured — one under licence from a foreign company and another fully developed in India. The emergency regulatory approval granted to Covishield of the Serum Institute of India (SII) and Covaxin of Bharat Biotech has not been without controversies. All three phases of clinical trials of the SII vaccine have been completed, while the Phase 3 trial of the Bharat Biotech vaccine is still on and it has been given the go-ahead in the ‘clinical trial’ mode. Bharat Biotech has claimed that its vaccine is not a ‘backup’ but a fully ready one. The government, too, has placed a huge order on a par with that of the SII vaccine. It is unclear if the Bharat Biotech vaccine will be rolled out along with the SII one or the government will wait for results of the ongoing Phase 3 clinical trials. Since the government has placed an order of 5.5 million doses with Bharat Biotech, it needs to clarify if all these doses will be administered in the ‘clinical trial mode’ as per the regulatory approval.

During the upcoming vaccination drive, one crore healthcare workers will be covered, followed by two crore frontline workers. Then will come the turn of an estimated 27 crore citizens above 50 years of age and those with co-morbidities. In all, the plan is to vaccinate 30 crore people in the extended first phase of the drive. At its peak, the polio campaign had covered 17 crore children.

One of the most challenging tasks during mass vaccination drives is to monitor adverse events post vaccination. These adverse events could range from mild fever, rashes at the injection site and headache to allergic reactions. Vaccines will be given to people across age groups, ethnicities and those with underlying conditions. Adverse events are bound to occur as no vaccine is ever perfect, and there are a lot of unknowns about all Covid vaccines. The challenge is to have a mechanism for timely detection, reporting and follow-up of adverse events and a system to address them satisfactorily. This is a major point of concern as the Bharat Biotech vaccine will be administered as if it is in the ‘clinical trial mode’. The World Health Organisation has advised countries to develop surveillance systems for identifying and responding to ‘adverse events following immunisation’ (AEFI) as well as ‘adverse events of special interest’ (AESI).

Both Covid-19 vaccines are being rolled out in an emergency situation. Vaccine manufacturers are asking the government to grant indemnity from claims that may arise due to serious reactions. For serious side effects during a clinical trial, the regulatory authority has well-laid-out procedures and protocols. In the case of a vaccine injury, trial participants are liable to seek compensation under clinical trial rules. But companies often contest such claims, as it happened with a volunteer participating in a clinical trial of the SII vaccine. Bharat Biotech has also denied that the death of a volunteer during the Phase 3 trial of its vaccine in Bhopal was related to the trial dose. Bharat Biotech and Indian Council of Medical Research (the co-developer of the vaccine) must state clearly how they intend handling such events when the vaccine is given to lakhs of people in the ‘clinical trial mode’. This is critical because the government’s past record in dealing with cases of polio occurring due to vaccine-derived polio strain has not been clean.

Addressing all such issues is vital as an inadequate response may lead to vaccine hesitancy among people. The discourse on truncated regulatory approval given to the Bharat Biotech vaccine has already led to anxiety among people, including healthcare workers. There are some pockets where vaccine hesitancy may emerge, going by experience with childhood vaccination in the past. Even a few cases of adverse events, if not addressed quickly and adequately, may become a reason for hesitancy to grow. In addition, too much focus on the vaccine may breed complacency in the general population regarding preventive measures like wearing masks and practising social distancing. The number of new infections is on the decline in India, but the threat of new strains and another surge can never be ruled out. Communication strategies relating to the pandemic need to take care of this issue as well.

At present, the two Indian vaccines are being rolled out in the public sector as far as healthcare and frontline workers are concerned. There is no clarity on who will fund the phase covering 27 crore people — the Centre, states or the people themselves. The clamour for making available vaccines in the private sector for those who can afford to pay will grow in the months to come. This should be done only after enough production becomes available and when all those in the vulnerable groups have been vaccinated.

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