India’s Covid-19 vaccine programme has gone off-kilter, especially after the government decided to throw it open to those between 18 and 45 years of age. Under the new Liberalised Accelerated National Covid-19 Vaccine Strategy, as the central government policy is called, there has been a huge surge in demand for vaccines since May 1, when people in the 18-45 years bracket became eligible for shots. It was nearly 680-700 million doses for over 340 million people above 45, plus another 600 million doses for Phases I and II. Now it has increased to nearly one billion doses, just for the first dose for all eligible. India requires nearly 2.2 billion doses (of the two-dose vaccines) for its adult population and possibly another billion if it decides to vaccinate young children at some point.

The government boasts it has already inoculated 134.4 million people (as of May 9, but mind you: only the first shot), which is barely 10 per cent of India’s 1.36 billion-plus population; the percentage of fully vaccinated people is just 2.63 per cent (or 35.8 million). In comparison, the US and UK have fully vaccinated 36 and 27 per cent of their population, respectively. India will fall short even of its initial goal of covering 300 million people by August unless it is able to double its current average of 1.7 million doses per day. Going by the current rate, it will require three years to inoculate India’s entire adult population.

Already, the government’s new ‘liberal’ vaccine policy is causing much angst across the country, as states report shortages of vaccines to inoculate the 18-44 age group, for whom vaccinations officially opened on May 1. In addition, there are concerns about vaccine equity, with the more prosperous and connected urban populations cornering the bulk of the supply, leaving the poor exposed. The mayhem has led to experts like epidemiologist Dr Gagandeep Kang asking for “a rollback of the new policy”. The Supreme Court, too, has been hearing petitions seeking a revision of the new policy. The Union government, however, bluntly

told the nation’s highest court on May 10 that the vaccine policy is in the executive domain and there is “little room for judicial interference” and that “any overzealous though well-meaning judicial intervention may lead to unforeseen and unintended consequences”.

But even as the government effectively asked the court to mind its own business, it has done little to inspire confidence that it knows the way and has a workable plan. What options does the government have to re-tailor its strategy, given that vaccines have become the first line of defence in India’s battle against the runaway pandemic?

In its affidavit to the Supreme Court, the central government justified its new policy, claiming that it would lead to an increase in overall production of vaccines as well as speed up delivery to people. Under the new policy, it has liberalised imports of foreign vaccines apart from permitting state governments to purchase vaccines directly from manufacturers to meet the increased demand from the 18-44 age group while the Centre remains committed to providing free vaccines to the 45+ years demographic. The Centre also rationalised that with states announcing that they would give the vaccine free to those between 18 and 44 years, the equity issue had also been addressed.

SEASON OF HARD CHOICES

While the new policy makes several necessary tweaks, both state government officials and experts feel these cannot resolve the problem at hand for various reasons.

Among the biggest issues is the current limited production of Covid-19 vaccines. India’s two licensed manufacturers—the Serum Institute of India (SII) and Bharat Biotech—are in the process of increasing capacities, SII from 60-70 million doses a month to 100 million doses a month, possibly by June. SII, which has to provide 100 million doses of the previous order, has received additional orders from the Indian government of 110 million doses by July. SII was also committed to supplying over 100 million doses to the WHO-led Covax facility in February and March, but could deliver only 18.2 million doses as India banned exports following the second wave. Bharat Biotech is augmenting its capacity to produce 700 million doses a year or around 60 million a month by commissioning its plants in Hyderabad and Bengaluru. Production may double by June. Its main constraint is that a quick scale-up is not easy, as inactivated vaccines are extremely complex and expensive to manufacture, resulting in lower yields when compared to live-virus vaccines like Covishield. The third available vaccine is Russia’s Sputnik V. Dr Reddy’s Laboratories has exclusive marketing and distribution rights for the first 250 million doses for India. It has so far shipped in 150,000 doses.

Alongside, the central government has also been making efforts to augment capacity by other means. For instance, the department of biotechnology (DBT) roped in three state-run vaccine-makers—Haffkine Institute, Indian Immunologicals and Bharat Immunologicals & Biologicals Ltd (BIBCOL)—to make more doses of the indigenously developed Covaxin. The aim is to get 20 million doses from Haffkine and 10 million each from the two others by June. Vaccine experts say this is an ambitious target. “The government should have given adequate funds at least a year ago to augment capacities like these, which could have come into production by now,” says public health expert Muralidharan Nair, partner at consulting firm EY.

The recent measures could help India ramp up monthly production from the current 80-100 million doses to around 170-190 million doses by July or August. Yet, even at the increased rate, it would take until May 2022 to get India’s adult population vaccinated, which is an unacceptable timeline given the ferocity of the second wave and the possibility of another wave later this year. It does not include the 41 per cent or 462 million Indians below 18 years. The government needs to find more vaccines and sources of production to meet the demand, and its own targets. However, the government told the Supreme Court on May 9 that SII would be producing 65 million doses, Bharat Biotech 55 million and Sputnik V about 12 million doses by July. The three PSUs entrusted with making Covaxin—Haffkine (20 million), and Indian Immunologicals and BIBCOL (about 10-15 million each) by August-September—could take production to 140 million doses.

BOOKING NEW DOMESTIC VACCINES

In the immediate future, India can also place orders for Covovax, the new vaccine being developed jointly by the SII and US biotech firm Novovax, to be produced in India and Europe and likely to be launched by September. It aims to provide over a billion doses a year.

Bharat Biotech’s intranasal Covid-19 vaccine BBV154 may prove to be another game-changer. Being developed under a licensing agreement with the Washington University School of Medicine, it has completed Phase I studies and is in the process of submitting interim data to the Drug Controller General of India (DCGI). If approved after the remaining two rounds of trials, production of the vector-based vaccine at scale may be quick and easy, according to the chairman and managing director of Bharat Biotech, Krishna Ella. Central and state governments can also opt for large quantities of Sputnik V or the recently launched ‘Sputnik Light’, a single-dose version of Sputnik V with lower efficacy (79.4 per cent).

Yet another wholly indigenous vaccine, closer to launch is Zydus Cadila’s three-dose plasmid DNA vaccine, ZyCoV-D. It can be administered into the body without a needle. The DNA vaccine platform can resist mutated virus to a good extent and scaling up production is easier. The vaccine has completed advanced Phase-III clinical trials and has placed data before the DCGI for review. Zydus is also carrying out a two-dose trial. The company is expected to get Emergency Use Authorisation (EUA) soon. It has created an in-house manufacturing capacity of 100 million doses per year and has roped in a couple of contract manufacturers to make an additional 150 million doses a year. Experts say the government should urgently support and facilitate Zydus Cadila to rope in new contract manufacturers and scale up production.

Another Indian vaccine that may come out within the next 3-4 months is from the Hyderabad-based Biological E. Its vaccine, under development with Baylor College of Medicine in Houston and the US-based Dynavax Technologies, has got clearance from India’s drug regulator to conduct Phase-III clinical trials. The company hopes to launch the vaccine with an initial 75-80 million doses a month from August if it clears the final regulatory hurdle. It had also entered into a contract-manufacturing deal with Johnson & Johnson’s Janssen Pharmaceuticals unit in August 2020 to make 600 million doses a year of the J&J vaccine Ad26.COV2.S in India. Biological E had also acquired multinational Akorn’s India unit at Paonta Sahib in Himachal Pradesh, which can manufacture about 165 million doses a year. In April, J&J said it was in talks with the Indian government to begin clinical trials of its single-dose vaccine. Sources say local production can happen only by the fourth quarter of this year, but with the new relaxed norms for vaccine import, J&J can sell finished vaccines in India from its overseas manufacturing units, given the crisis in the country. Aurobindo Pharma is another company that can quickly manufacture vaccines in this emergency, say sources. They note that while its in-house Covid-19 vaccine is still being tested in Phase I trials, it is doubling capacity from the current 220 million doses a year to 480 million doses by June 2021.

In addition to these developments, experts say the Indian government should urgently fund the private and the public sector to invest heavily and create vaccine manufacturing capacities. It can, for instance, utilise the Integrated Vaccine Manufacturing Complex that public sector HLL Healthcare subsidiary HLL Biotech had set up in 2017 at Chengalpet near Chennai with an investment of over Rs 900 crore. Planned by the previous UPA government in 2021, it was supposed to contract manufacture National Immunisation Programme Vaccines, both for public and private vaccine-makers. The facility has the capacity to make 550 million doses but hasn’t made a single vaccine till date.

HUNT FOR FOREIGN VACCINES

Even as the government makes efforts to boost the domestic development and production of vaccines, it is in consultation with major international manufacturers like Pfizer, Moderna and J&J to bring in their vaccines, as it revealed in its affidavit to the Supreme Court. However, the chances of Pfizer-BioNTech and Moderna directly selling their vaccines—the most efficient so far, even against the new mutations of the virus—in huge quantities and at lower prices to India seem remote in the near future. Pfizer expects to deliver 1.6 billion doses under signed contracts in 2021. It has already committed a total of 600 million doses to the European Union and another 300 million to the US. As of May 3, it had shipped about 430 million doses to 91 countries. Moreover, Pfizer and BioNTech have several orders for 2022 and 2023 and are struggling to augment capacity to meet the demand.

Similarly, Moderna has increased its 2021 supply forecast to between 800 million and 1 billion doses and is investing to make up to 3 billion doses in 2022. The company has Advance Purchase Agreements (APAs) of $19.2 billion for scheduled delivery in 2021. Moderna has so far delivered 100 million doses and is trying hard to make a billion doses this year, if possible. Though politically sensitive, India can also book China’s WHO-approved Sinopharm vaccine, which was widely used by the UAE, or Curevac’s soon-to-be-launched messenger RNA vaccine, which is like the Pfizer and Moderna vaccines but which can survive at room rather than freezing temperatures, say sources.

Meanwhile, with a growing worldwide movement to get international pharma giants to relax their patent licences and allow other companies with the capability to start manufacturing the vaccines, India has the option of doing so unilaterally. Provisions such as Section 92 of the Indian Patent Act allow the government to exercise its right to break patents and the monopoly of the patent-holder in a national emergency. This ‘compulsory licensing’ provision can be exercised even if the application is pending grant. The main issue with Covid-19 vaccines is that they are not under patent protection but have data protection in the form of a ‘trade secret’ as per the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). (Vaccine formula, manufacturing protocols and clinical trial data are filed and kept as ‘trade secrets’ by respective countries’ drug regulators where the vaccines are sold.)

As part of his election promise, the Joe Biden administration in the first week of May suggested suspending intellectual property rights to boost the supply of Covid shots, which the US pharma lobby is vehemently opposing to guard business interests. India and South Africa had proposed diluting TRIPS on October 2 last year to help low-income countries cheaply access Covid-19 vaccines. Though over 100 countries supported the move, the EU and the US opposed it. ‘This decision (of the Joe Biden government) will sow confusion between public and private partners, further weaken already strained supply chains and foster the proliferation of counterfeit vaccines,’ Stephen J. Ubl, president and CEO of the Pharmaceutical Research and Manufacturers of America (PhRMA), said in a statement on May 5. PhRMA’s opposition is not good news to resolve the current crisis India and other Covid-19 vaccine-starved countries are facing.

“Instead of waiting for the WTO to reach consensus (which may take months), the Indian government should proactively immediately approach and negotiate with individual countries and vaccine manufacturers to evolve a mechanism for partnership, technology knowhow and raw material-sharing, so that multiple Indian companies can make the vaccine as fast as possible in India,” says P.H. Kurien, the former Controller General of Patents, Designs & Trade Marks in India, who invoked the first and only compulsory licence issued so far in India. (In 2012, Kurien allowed Natco Pharma to manufacture German multinational Bayer’s patented cancer drug Nexaver, then a costly drug.)

Kurien says India should negotiate a ‘conditional waiver of TRIPS norms to share data and graded royalty’ with vaccine innovators, like lesser fee as royalty for the first few months to tide over the current crisis, which can be increased in subsequent months or years.

There are plenty more hurdles to cross. “Vaccine manufacturing is a complex process with hundreds of steps for production, testing and release, which requires specific knowledge, expertise, facilities, knowhow, etc. Unless knowledge and expertise are also transferred, large-scale manufacturing of vaccines may not be feasible,” says Sai D. Prasad, president, Developing Countries Vaccine Manufacturers Network (DCVMN), and president, quality operations, Bharat Biotech. “Patent or compulsory licensing is not the issue in the case of vaccines, it is how we transfer the technology, manufacturing knowhow, readying plants capable of making them and a skilled workforce,” adds Gopakumar Nair, a patent expert and promoter of GNA Patent Gurukul. For all of this to happen, the government must act decisively and be quick in releasing the necessary funds.

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