Why is India buying an untested vaccine when a cheaper option with better safety data is available?

The vials have reached the states and India is all set to embark upon its Covid-19 vaccination drive that will first target the country’s 30 million frontline workers. Strikingly, a quarter of those vials are from Bharat Biotech, the Indian manufacturer behind the Covaxin vaccine, which lacks large-scale safety and efficacy data since its phase three clinical trials are incomplete.

Many health policy experts say the government’s decision to procure such a large consignment from Bharat Biotech at this stage is baffling, particularly since Covaxin is priced higher than the other vaccine at India’s disposal: Oxford-AstraZeneca’s Covishield. Manufactured by the Pune-based Serum Institute, the vaccine’s India-specific trial data are yet to be fully examined, but it has shown favourable results in large scale trials in Brazil and the United Kingdom.

The Indian government has purchased 11 million doses of Covishield for the price of Rs 200 per dose. In contrast, it has paid Rs 295 per dose for 3.85 million doses of Covaxin. Bharat Biotech has offered to supply 1.65 million doses for free as a “special gesture” to the government. Despite the free doses, the cost per dose of Covaxin comes to Rs 206, higher than Covishield.

Indranil Mukhopadhyay, a health economist who teaches at the OP Jindal Global University, said: “There is hardly any justification from either the public health or strategic procurement perspective for the government’s strategy to order Covaxin, when a better and cheaper option is available.”

A ‘backup’ vaccine

In early January, when drug regulator greenlighted Covaxin in the absence of large-scale safety and efficacy data, India’s top vaccine scientists pushed back against the move. Officials in charge of India’s Covid-19 response then played down concerns by saying that the vaccine had only been approved as “backup”.

“When there is a need to vaccinate a large number of people, that cannot be done using only the [Serum Institute] vaccine, Bharat Biotech would be allowed to give the vaccine,” Randeep Guleria, member of the national task force on Covid-19 management, told The Indian Express.

Guleria, who heads the All India Institute of Medical Sciences in Delhi, added for good measure: “The bottom line is that, if we don’t have any surge in cases, then we would use the [Serum Institute] vaccine… Otherwise, we wait for four-six weeks till the final data is out.”

The Indian Council of Medical Research chief Balram Bhargava further clarified that Covaxin had only been cleared to be used in the “clinical trial mode” – consent of the recipients would be sought and they would be monitored for side-effects like they are in a trial.

All of that suggested that the vaccine’s use was going to be rather restricted till Bharat Biotech generated large-scale safety and efficacy data by finishing its phase three clinical trials.

Changed stance

But these assurances have come unravelling one after another in the last couple of days. First, VK Paul, who heads the National Expert Group on Vaccine Administration, said in a television interview that both the vaccines would be treated at par and would be administered simultaneously.

Then, the purchase volumes confirmed as much: the government has procured 11 million doses of Covishield and 5.5 million doses of Covaxin.

Finally, the Union health secretary Rajesh Bhushan put all doubts to rest in a press briefing on January 12. Health workers would not have a choice between Covaxin and Covishield, he clarified. “No country offers beneficiaries such choices,” he claimed.

The numbers

The first lot to get vaccinated, under the government’s plan, would be 30 million healthcare and frontline workers. Since generating immunity against Covid-19 requires two doses of the vaccine, a total of 60 million doses would be required to vaccinate them.

Serum Institute has claimed it has a stockpile of over 50 million doses and will soon have the capacity to produce as many as 100 million doses by March. According to the current plan, around 300,000 people are likely to be vaccinated daily – thus Serum seems well-equipped to meet India’s current demand.

“It is not clear why the government is purchasing such a large quantity of Covaxin when phase three data is still pending,” said T Sundararaman, former director of the National Health Systems Resource Centre, an advisory body of the Union Ministry of Health and Family Welfare. “There was no urgent need as such since there are enough doses of Covishield for the health workers.”

The results of Bharat Biotech’s phase three trials are likely to be out in March. Sundararaman said the government could have easily waited for two months before rushing in to purchase Covaxin.

The cost factor

The cheaper cost of Covishield makes the government’s decision to purchase Covaxin even more confusing.

Some experts say government procurements are not always driven by cost considerations. “I am not expert on clinical matters so I am not qualified to comment which is the better vaccine, but perhaps buying Covaxin is a move to push Atmanirbhar Bharat (self-reliant India),” said Sunil Rajpal of the Indian Institute of Health Management Research.

Others say it may not may have been a matter of choice for the government at all. “I suppose Serum may have offered only that much as they want to export and also sell in the open market at five times the price,” said K Sujatha Rao, former Union health secretary. The company has said it would sell the vaccine at Rs 1,000 per dose to private players.

Mukhopadhyay, the health economist, however, pointed to commercial gains that Bharat Biotech stood to make. “An agreement with a big country like India bears multiple benefits for Bharat Biotech,” he said. “It provides some significant assured return from direct procurement [by the Indian government] and is also an endorsement which would boost its bargaining power with other country governments.”

Top officials at the National Expert Group on Vaccine Administration for Covid-19 did not respond to an email questionnaire seeking more clarity on the factors that shaped the first batch of vaccine procurement.

Centre-state friction

Sundararaman was scathing in his criticism of the government’s decision to purchase Bharat Biotech’s vaccine without adequate data. “Your original sin is sanctioning [the use of Covaxin], then you replicate it by purchasing it,” he said.

Whatever be the reason behind its decision, Rajpal said it was important that the government be transparent about the “guiding principles” which will decide who gets what vaccine.

Health ministry officials have told reporters that the Central government will decide how the two vaccines are distributed among the states. This could cause friction among states and the Centre.

Already, Congress-ruled Chhattisgarh has said that it would not administer Covaxin till trials were fully over. The state’s health minister TS Singh Deo claimed the Centre has agreed to supply it with only Covishield, but no confirmation was forthcoming from the health ministry.