Sell Your Best Shot

Eighteen pharma companies, 14 vaccines, hundreds of nations, billions of people and millions of doses. This is the side story that has emerged out of a pandemic that has killed millions globally, crippled economies, forced the world indoors temporarily and changed the way humans go about their daily lives. The COVID-19 scourge that hit the world around 2019 has by now spawned businesses worth billions of dollars, with the hunt for effective vaccines bringing together governments, companies and the medical fraternity.

UNICEF data shows that the price range for COVID-19 ­vaccine varies between US$ 2.06 to US$ 44. Governments across the world are paying, as well as negotiating, the prices for the same vaccine, some ready to pay a high price too to ­ensure a steady supply for their citizens.

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Vaccine manufacturing across the world started around December 2020 and, according to Airfinity Limited, a London-based real-time life science intelligence service, by March 5 this year, pharma companies had produced 413 million doses. Out of these, the major vaccine producing countries are China (141 million), the US (103 million), Germany/Belgium (70 million) and India (42 million). China is producing thrice and the US is producing twice the number of vaccines that India is currently manufacturing.

In such a scenario, can India emerge as a global leader for Covid vaccines?

“Sixty per cent of (all types of) vaccine production takes place in India. All major global pharma players are collaborating with us whether it is AstraZeneca with Serum Institute or Johnson and Johnson with Biological E Ltd,” says Sudarshan Jain, secretary general of the Indian Pharmaceutical Alliance (IPA) and chairperson for the International Generic and Biosimilar Medicines Association (IGBA) for 2021. In ­addition, India has its own vaccine manufacturers like Bharat Biotech and Panacea Biotech, among others.

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At present, India has two manufacturers whose vaccine are being used. One is the Serum Institute sub-licensed by Astrazeneca and the other one is Bharat Biotech’s Covaxin. Apart from them, Hyderabad-based Gland Pharma has been contracted to supply 252 million doses of Sputnik V, the ­vaccine produced by Russian Direct Investment Fund. Bangalore-based Strides Pharma Science too is in talks for contract manufacturing of Sputnik V.

US pharma companies like Pfizer have refused to manufacture its vaccine in India, while the US government has decided to provide financial assistance to support Indian drug-maker Biological E to produce at least 1 billion doses of Covid vaccine by the end of 2022. Besides, other Indian companies like Zydus Cadila, Panacea Biotec, Indian Immunologicals, Mynvax and Biological E are working on their own vaccines. This is just the beginning of big business for India pharma companies that are emerging as front-runners for sub-­licensing and manufacturing Covid vaccines for 14 serums which have been approves across the world.

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For manufacturing of Covid vaccine, around 200 ­components are required, from APIs (Active Pharmaceutical Ingredients) to vials for packaging and other raw materials. Much of the raw material is manufactured in India, some are imported. These include APIs from China, bags and filters from the US.

In March earlier, Adar Poonawalla, CEO of the Serum Institute of India, disclosed to the World Bank that a US law was blocking the export of certain items, causing difficulties for India pharma manufacturers to ramp up production of Covid vaccine. The move came after the Biden administration announced plans to use the Defence Production Act to boost supplies needed to make Pfizer’s vaccines. Notably, Pfizer is the largest Covid vaccine manufacturer globally, producing 119 million doses, followed by the Chinese company Sinovac, which has produced around 91 million doses.

A senior government official on condition of anonymity says, “The pandemic has taken such an ugly turn that every nation is now becoming selfish. Vaccine is the only immediate ­solution to get a grip on the situation. Lockdowns are no more feasible. It is but natural that developed nations will now flex their muscles. We are already going on war with them for Covid drug patents and we have to look for alternatives, either by ramping up our home production or by looking for new ­importers.” He says India too would resort to gestures like “export bans” if forced or required.

India has so far shipped around 60 million doses to 78 ­countries in Latin America, the Caribbean, Asia and Africa. The government official says, “The countries have appreciated our gesture and are whole-heartedly ready to support us. The Big Daddy tricks and big game won’t work this time because we have stronger backing of friends, including WHO and ­several US philanthropists.”

Despite these hurdles, the pharma industry in India is ­responding positively to the PLI (production-linked incentive) scheme announced by the Modi government, especially for 53 API to make India self-reliant. Many companies like the Serum Institute, Zydus Cadila, Bharat Biotech have ramped up their capability and capacities to manufacture vaccines. Companies are also investing more in R&D for future development of drugs. Partnerships will continue but innovation will become more targeted now, say experts.

They say that by October-November, more licences and ­approvals for Covid vaccines would be given, both in India and globally, and the restricted market scenario will change ­completely. People will have choices which will in turn be a boost for Indian vaccine manufacturers

As the battle for a bigger share of the vaccine market hots up, it is also leading to a patent war. In March, WHO director ­general Dr Tedros Adhanom Ghebreyesus laid a pitch for ­patent waiver for Covid vaccines, saying, “Of the 225 million vaccine doses that have administered so far, the vast majority have been in a handful of rich and vaccine-producing countries, while most low and middle income countries watch and wait. A me-first approach might serve short-term political ­interests, but it is self-defeating and will lead to a protracted recovery, with trade and travel continuing to suffer.” He asked for waving patents temporarily and companies being paid ­royalties for the products they manufacture.

The WHO chief’s statement on royalties came after India along with South Africa slammed developed countries, accusing them of trying to protect the commercial interests of a few companies. Both countries also urged WTO to decide on the issue quickly given the massive impact of the pandemic.

India’s ambassador to WTO Brajendra Navnit told the ­general council meeting, “To slow down the virus’s ability to infect new people and mutate further, we need true vaccine internationalism and TRIPS waiver in an effective and ­pragmatic way to achieve it.” Navneet countered opposition from several countries that argued that the move would not augment manufacturing capacity, while affecting commercial interests of the patent holder.

A senior official from Indian Immunologicals says, “India’s potential for Covid vaccine rides on four major pillars–price, generic formulation, accessibility and cooperation. This will make our journey for vaccines stronger. The patent play by big pharma giants has always been there and it is not new. Most of the research on Covid has been government-funded and that could be used as a stronger argument for patent waiver. Wha­t­ever the scenario, India’s affordable vaccine regime will make it a stronger participant in the world pharma sector.”