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As large countries like the United States and China rush to vaccinate their populations with rapidly approved vaccines, tens of millions of doses prepared for India are in storage despite being cleared for use.
While distribution to other countries began shortly after approval with price agreements signed in advance, New Delhi and Serum Institute of India Ltd. – the world’s largest vaccine manufacturer by volume and AstraZeneca Plc’s local partner – has engaged in months of behind-the-scenes haggling and has yet to sign a formal supply agreement. This has left at least 70 million doses of the vaccine in limbo despite the urgent need in a country facing the world’s second largest epidemic.
On Sunday, the CEO of Serum billionaire Adar Poonawalla said Indian officials had agreed “orally” to buy 100 million doses at a “special price” of 200 rupees ($ 2.74) a shot, below of Prizes of $ 4 to $ 5 given to the British government. The company then wants to sell vaccines to individuals and businesses at a premium of Rs1,000 within two to three months.
The Indian government may be looking to pressure Serum to lower its prices, as evidenced by its controversial move to give the green light to a rival vaccine developed by a local company that is still recruiting volunteers for phase testing final, according to Abhishek Sharma, analyst at Jefferies.
The stalemate has cost precious time in a country where infections have crossed the 10 million mark and reflects the tension between the public interest and the private profits of pharmaceutical companies who want to quickly recoup their investments in the pandemic.
While wealthier developed economies have mostly avoided price disputes in their deployments so far, the question of how much vaccinations should cost amid a pandemic that kills more than 10,000 people every day in the world. world is likely to become more important as distribution expands to developing countries. .
For Prime Minister Narendra Modi, every penny spent on the price of a vaccine in a country home to more than 1.3 billion people will have serious financial consequences for his administration.
“When you buy in bulk there is obviously the advantage of being able to negotiate the price,” said Randeep Guleria, member of Modi’s task force for the management of Covid-19 and director of the Indian Institute of Medical Sciences. , in an interview on Monday. He added that negotiations are underway within the framework of the procurement policy and “obviously they will also be able to decide the market price afterwards.”
Guleria said the purchase contract would be signed “anytime now”. India is ready to deploy Covid-19 vaccines within 10 days of being approved by the drug regulator, Health Secretary Rajesh Bhushan told reporters on Tuesday at a briefing. He did not say whether a price or supply agreement had been signed.
It took five to six days for the first jabs to be deployed by the UK after giving emergency nods to the Pfizer Inc. and Astra-Oxford Vaccines.
‘Bad business’
In October, people with knowledge of the matter told Bloomberg that New Delhi had set aside Rs 500 billion for vaccination efforts, estimating an overall cost of around $ 6-7 per person. A spokesperson for the Indian Ministry of Health could not be reached for comment.
“The government doesn’t give money to the private sector so easily,” said Ramana Laxminarayan, founder of the Center for Disease Dynamics, Economics & Policy, from the Indian capital. “They are just good at playing the game because they have budget pressures – the bureaucrats, if they come back with a bad deal, the minister will fire them immediately and say ‘get me a better price’.
India’s immunization plan says 300 million people will be vaccinated in the first stage of deployment, starting with health workers, followed by police and soldiers, then those with co-morbidities and people with over 50 years. Guleria said this process would take three to four months to complete.
Local officials across the country have been urged to establish priority vaccination lists, but preparatory work appears uneven, according to interviews with doctors and local officials. Some localities also appear to be preparing to administer two different vaccines at the same time.
Although AstraZeneca’s vaccine has been tested in global trials and received an emergency license from UK and Indian regulators in recent days, the Hyderabad-based vaccine developer Bharat Biotech International Ltd. has yet to begin analyzing Phase 3 test data, but also gained limited use approval from the South Asian nation over the weekend.
“Several vaccines are going to be used,” said Amit Thadani, surgeon at Nirmaya Hospital in Mumbai. “They’re going to assign a particular type of vaccine to be used only in one district, so if there is a problem, it’s easy to identify which particular vaccine is causing it.”
Serum, which has an agreement with AstraZeneca to produce at least one billion doses, has already reduced its initial production target by 100 million by December due to slower-than-expected approvals.
Poonawalla began broadcasting publicly debates about potential vaccine prices in September, which some health experts saw as part of a lobbying effort.
In Sunday’s interview, Poonawalla was optimistic that a written deal would be reached soon within days. “We’ve already packed it, we just have to send it on trucks across the states and have it delivered,” he said, referring to the 70 million doses the company is ready to distribute. .
“Early approval”
Meanwhile, India’s decision to grant Bharat Biotech’s restricted approval of Covaxin despite the lack of final data on the effectiveness of the tests has baffled observers. In August, the company’s president, Krishna Ella, told a conference that their vaccine would be cheaper than bottled water – which would imply a cost of less than half of what Serum’s vaccine offers. AstraZeneca.
“The hasty approval of Covaxin, even as an alternate candidate, is driven primarily by commercial considerations from the Indian government,” Sharma, Mumbai-based healthcare analyst at Jefferies, said in a report on Sunday. If Covaxin “is able to demonstrate its effectiveness in the coming months, subsequent vaccines will have to compete on both price and effectiveness.”
The rapid approval of Bharat Biotech may also be due to the fact that India does not want to be beholden to a single vaccine manufacturer.
Echoing a long-standing debate over the role of private pharmaceutical companies, there is already growing concern that Serum’s position as the sole domestic supplier of a potentially life-saving vaccine is too powerful.
Outside of India, AstraZeneca only supplies governments and has not yet signed any private agreements with companies or individuals. However, Serum wants to access the higher margin private market within a few months, where it plans to increase the price of the shot fivefold, according to the pricing plans shared by Poonawalla.
First mover
The proposed price of Rs 1,000 per dose is “absolutely a price increase and takes advantage of its first-comer position,” said Malini Aisola, New Delhi-based co-organizer of the All India Drug Action Network, a watchdog. of health. “Personally, I don’t think they should provide an approval for private use at this time.”
But for the better-off in Indian stratified society, waiting for the Byzantine public health system to dispense doses is not an option.
A large private bank is awaiting guidance from the government on benchmark dates and prices that would allow it to consider procuring the vaccines directly from manufacturers, according to officials at the lender, who asked not to be identified as the deliberations are private.
For now, Serum is still awaiting its first order from the government. Poonawalla said India must first get enough vaccines for its most needy. “If we were to sell it the way we wanted, it makes sense that some of the most vulnerable people might miss it,” he said.
New Delhi also knows that the vaccine maker will not be able to easily transfer these massive volumes elsewhere.
“India buys a lot of vaccines from Serum Institute every year and they know how to play this game,” Laxminarayan said. “India can wait a little longer, but for Serum it won’t be so easy for them – the government has ways to lean on it.
– With the help of Ragini Saxena and Suvashree Ghosh
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