COVID-19 vaccination: The fears and challenges ahead

Dr Pragya Shukla still remembers the sleepless nights. Early days of the pandemic meant COVID-19 tests would take long enough for results to arrive by midnight. Those who tested positive had to be hospitalised, as per government guidelines. "There was much fear, apprehension among the staff. With the vaccination, there’s hope for us,” 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 3.8 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 numbers in some states including Maharashtra, Andhra Pradesh, Karnataka, while others such as Chhattisgarh, Delhi, are struggling to catch up. Reports of the rollout 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.

Shukla, 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, was among her first 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. “Our health systems can do much more, but haven’t been able to do so owing to supply constraints [of vaccine doses]. It is worrying that the order of five crore doses that the central government had planned to purchase has not been delivered by the company [Serum Institute of India] yet. Instead, only 1.65 lakh doses have been delivered yet. I understand that while the Serum Institute of India had made tall commitments about supplying in India, and countries such as Brazil, it hasn’t been able to fulfill its commitments,” the official said.

Some industry sources suggest that in the coming months—as early as March-April—several vaccine companies are likely to launch their shots 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,” says 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 open. Delhi Chief Minister Arvind Kejriwal has said that residents of the state would get free vaccines even if the Union government is unable to do so. 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 PMJAY 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. Besides, no one should be forced to take the shot, even if it's free,” Rao said.

With few players in the fray, the prices would come down only if there's enough competition. "Since manufacturing capacities are low, and there are priority populations, it is only fair that the government is controlling procurement and distribution now. That said, there’s an intense push from private players to push their shots into the open market, and make profits,” 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 runs counter to its licensing agreement with AstraZeneca to supply one billion doses for low-and-middle-income countries, says Aisola. "To begin with, the government could have negotiated for a better price with Serum than the Rs 200 per dose plus taxes. In European markets, the price for the same dose is 1.78 euro (Rs 159 approx). With Bharat Biotech, too, the government that has a higher stake, the prices could have been lower. Now, the Rs 295/dose has become a benchmark for the company to negotiate,” says Aisola. Industry estimates suggest that the cost of making one dose would amount to Rs 50 per dose, she said, and the quoted price of Rs 1,000 amounted to “robbery”.

However, Aisola and others reckon that prices would come down as more players enter the market. “It’s like what happened with COVID-19 testing, where prices eventually came down.”

Globally, the Covax facility, a consortium of 190 countries, was formed so that rich countries could fund vaccine development, negotiate better given the complex price negotiations, and help countries that did not have enough resources for vaccines by offering them the shots for 20 per cent of their population. In case of India, the percentage stands at 10 per cent because of the country’s larger population as compared to the rest. However, rich countries were cutting bilateral deals with vaccine developers and bypassing the Covax facility. This, WHO director general Dr Tedros Adhanom Ghebreyesus, said was driving up vaccine prices—an attempt was being made 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.

Aside from providing enough safe and affordable vaccines, the government’s challenge will also be to monitor adverse events closely—580 cases of adverse events following immunisation have 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, of which one has been said to be “not linked to the vaccine” and caused due to cardiopulmonary disease. The 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. 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 said. In the case of the death of a health department employee in Ballari, Karnataka, 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 diagnosed, others may go undiagnosed. 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,” 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 vent if there’s any occurs and is 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.