COVID-19 vaccination: The fears and challenges ahead

Dr Pragya Shukla still remembers the sleepless nights. Early days of the pandemic meant Covid tests would take longer, and at times, results would arrive by midnight. Those who tested positive had to be hospitalized, as per government guidelines. "There was much fear, apprehension among our staff. With the vaccination, there’s hope,” says Shukla, head of department, clinical oncology, Delhi State Cancer Institute, one of the 81 sites that had been listed by the Delhi government as a site for Covid-19 vaccination.  

Shukla is one among over 6.31 lakh healthcare and frontline workers who have taken either Covishield or Covaxin as part of the government’s drive to vaccinate three crore persons in the first phase. The roll-out has seen higher coverage in states including Telangana, Odisha, Rajasthan, Uttar Pradesh; others such as Tamil Nadu, Punjab and Puducherry, are struggling to catch up. Reports of the roll out experiencing teething troubles have been pouring in, even as vaccinators are trying hard to counter vaccine hesitancy among sections of healthcare workers. While resident doctors at Delhi's RML demanded that they be administered Covishield instead of Covaxin, another doctor at a private hospital in Mumbai said he didn't want to be a "guinea pig" for the vaccine.  

At her centre, Shukla, who is also the nodal officer for Covid-19 vaccination at the Delhi State Institute details some of the operational troubles – with the CoWin app crashing, physical records had to be made, calls had to be made to several beneficiaries since the app messaging didn't work, and it had to be ensured that vaccines supplies were safely delivered. Building trust among her staff, though, has been among her priorities. “I took the first shot to convince them that it was safe,” says Shukla.  

On the ground, several such as Shukla and her colleagues are gearing up to deal with the challenges of vaccinating lakhs of people in the coming days. For the policymakers and administrators, the months ahead are no less daunting. One of the major challenges in the coming days would be supply constraints, said a state government official who did not wish to be identified.    

Though there are estimates ranging from a few months to end of 2021 before the vaccines would be available in the open market, some industry sources suggest that as early as March-April, Covid-19 vaccines are likely to be available in the private market. In that context, experts say concerns over rampant profiteering would have to be addressed. "The government should have negotiated prices with the vaccine companies and healthcare workers could have purchased at those prices. For those who can't afford, the doses should be given free. In the coming months, the government should consider price control for vaccines," said Dr Jacob John, professor, CMC Vellore.     

While the Union government has said that the doses would be free for the first three crore vaccines, the issue of who pays for the 27 crores in other priority groups is still unclear. Delhi chief minister Arvind Kejriwal has said that residents of the state would get free vaccines even if the central government is unable to provide them free. But some disagree with the idea of "vaccine populism", arguing that those who can afford should pay, and money from other public health priorities should not be diverted to fund Covid-19 vaccination. “Governments should only pay for those who cannot afford. These beneficiaries can be decided based on the basis of those who have PM-JAY cards, or are part of the government's other welfare schemes. For the rest, the cost has to be borne by the vaccines. Price control has to be in place for private markets, so that profiteering can be curbed,” says Rajeev Sadanandan, former additional chief secretary health and family welfare, Kerala. 

Former health secretary J.V.R. Prasada Rao said that though states could give free vaccination, they ought to have enough budget for that. "I am pleased that state governments are now thinking of putting more money in health programmes. However, large states such as Maharashtra, Uttar Pradesh would especially find it challenging to find funds and manage the huge administrative exercise. Unlike polio, this is not an eradication programme, it's a disease control programme," Rao said.  

With few players in the fray, the prices would come down only if there's enough competition. "Since supplies are still limited, and there are priority populations requiring vaccination, it is not unreasonable for the government to control procurement and distribution now. While Serum Institute has been pushing hard for permission for private sale of its vaccine, perhaps the government is not keen,” says Malini Aisola, co-convenor, All India Drug Action Network.   

Last year, AstraZeneca had announced that it would not be making any profit from the vaccines during the pandemic. SII's chief Adar Poonawalla's statements that Covishield vaccine could be priced at Rs 1,000 per dose in the private market appears to undermine AstraZeneca's pledge to provide the vaccine at affordable prices in poor countries, says Aisola. SII is the only Indian company with a license for Oxford/AZ vaccine. 

"The government could have negotiated lower prices on both vaccines given also the governmental support to the development and trials of the vaccines in India. India is paying a higher price of Rs 200/dose (plus taxes) than the EU which negotiated a price of 1.78 (Rs 159 approx) for the Oxford/AstraZeneca vaccine." 

Besides, Aisola says no plausible explanation has been offered for the Rs 295/dose (plus taxes) procurement price for Bharat Biotech's vaccine. The company is giving the government some amount of free doses but this is limited to the initial orders. The price will also serve as a benchmark for negotiations with other countries,” says Aisola. Industry insiders have estimated that the manufacturing costs would not exceed Rs 50 per dose, she said, and the proposed price of Rs 1,000 [Serum vaccine] amounted to “highway robbery”. 

Globally, the equitable distribution of vaccine is worrying. This is despite the existence of Covax, a consortium of 190 countries, that was formed so that rich countries could fund vaccine development, negotiate better prices, and help countries that did not have enough resources for vaccines, by offering them the shots for 20 per cent of their population.  

India, too, is eligible for doses for 10 per cent of its population from the Covax facility. The percentage is lesser due to India's comparatively large population as compared to the other eligible countries. However, rich countries were making their own bilateral deals with vaccine developers, and bypassing Covax. This, WHO director general Dr Tedros Adhanom Ghebreyesus, said was driving up vaccine prices, and can be read as an attempt to jump to the front of the line. "It wouldn't be right that younger, healthier people receive the vaccine in developed countries while the older, vulnerable in low- and middle-income countries would have to wait for their shots," he said.       

Aside from providing enough safe and affordable vaccines, the government’s challenge will also be to monitor adverse events closely – until Jan 19, 580 cases of adverse events following immunisation had been reported. Of these, seven have required hospitalisation. “These numbers are about two different vaccines, and they should be looked at separately. That said, as far as I can tell, so-called immediate adverse events seem to be quite limited, in both numbers and severity. My guess is that the associated hype and anxiety might also contribute a bit to such immediate adverse effects,” said Dr Satyajit Rath, former immunologist, NII.   

Two deaths have also been reported. One death, that took place in Moradabad, UP, was of a 52-year-old man, who was vaccinated on the first day. The post-mortem report indicated pus in lungs, and an enlarged heart. The cause of death was found to be cardiopulmonary disease, and said to be "not linked to vaccination". Rath said that the development of pus in completely normal lungs within a day after vaccination was very unlikely. “Knowing if an individual is ill or not at the time of planned vaccination is basic information that should be asked for,” he added. In yet another case, where a health department employee in Ballari, Karnataka, who received vaccination on January 16, died on January 18, the district adverse events committee concluded that the 43-year-old died due to heart attack.         

The challenge of ascertaining whether a death is linked to the vaccine or not depends on each case. Experts say that there are situations such as extreme allergic reactions where a trial drug or vaccine leading to death can be robustly inferred, while in others it may be more difficult to establish the link.   

“As we scale up these things [adverse events] are to be expected. There will be a wide variety of reactions, and while some will be identified and followed up on, others may go on unidentified ore reported. What is important is that each of these events are followed up, post vaccination. A majority wouldn’t be linked to the vaccine, but since these are new vaccines, and we are still learning, due process and caution has to be exercised. It's important to maintain trust in these times with transparent and clear communication as to how the vaccine linkage has been ruled out. If, unfortunately, it is found to be linked to vaccination, we will have to then figure out what the implications are for particular groups or the larger roll-out,” says Dr Anant Bhan, Bhopal-based researcher on bioethics.   

Currently, what is bound to complicate matters, says Bhan, is that if a death is linked to Bharat Biotech’s Covaxin, which is being administered in “clinical trial mode”. “This brings into play the classification of a death [in the event if it is found to be linked to the vaccine] as a serious adverse event as is the case in a clinical trial, and role of ethics committees, legal requirements, as well as a call on whether to halt the trial or not has to be taken. In this case, such details are unclear, including, for instance, the role of ICMR [co-sponsor of the trial] in each of these events,” said Bhan.

With countries such as Norway reporting and investigating the deaths of the 23 frail, elderly people following the Pfizer vaccine, there are concerns all over the world over the implications of vaccine administration in specific groups such as the very old, or terminally ill. It is imperative that Indian authorities, too, exercise caution and transparency in investigating and reporting adverse events. Already, with a hasty approval of the Covaxin shot, the trust in authorities is at stake. Any further damage to public confidence could have serious consequences for the vaccination drive.