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COVID-19 second wave | Smash bureaucratic barriers, allow voluntary licensing for Covaxin immediately

Granting access to technology and know-how to Indian generic drug makers to produce Covaxin can quickly help fill the gaps in vaccine supplies.

April 19, 2021 / 11:58 AM IST
File image of the Covaxin COVID-19 vaccine

File image of the Covaxin COVID-19 vaccine

Scientists have delivered the product—the vaccines. Not just one, but several of them in a record time, demonstrating science’s pioneering capabilities. The problems are now about getting these administered.

The sudden and gigantic surge in COVID-19 case loads in India underlines the enormity of the task at hand. It is not about the vaccines. It is about the vaccination exercise. Nothing less but a universalised immunisation programme will end the pandemic, or at the very least, enable in breaking the chain and contain the spread.

Currently, two vaccine producers—the Pune-based Serum Institute of India (SII) and Hyderabad-based Bharat Biotech—are producing 64 million doses a month in India. SII is manufacturing 60 million doses of Covishield, while Bharat Biotech is producing 4 million doses of Covaxin a month.

This, effectively, translates into just above two million jabs a day. The current rate of more than four million daily shots is primarily driven by existing supplies that have been stockpiled since January.

The ability to carry out the world’s mass vaccination exercise in record time, will depend on keeping vaccine supplies of hundreds of millions of doses flowing uninterruptedly for months.

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COVID-19 Vaccine

Frequently Asked Questions

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How does a vaccine work?

A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.

How many types of vaccines are there?

There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.

What does it take to develop a vaccine of this kind?

Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.

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India’s first goal should be to vaccinate about 700 million people, which would include all above the 18 years. The task, for vaccine producers and the government, is to secure continuous supplies of 1.4 billion doses over a 12-month period. Given this titanic necessity, the current COVID-19 supply capacities fall significantly short.

Blatant Patents

This begs one major question. Why cannot companies other than Bharat Biotech and SII be given out contracts to manufacture their vaccines in bulk? Such a move will allow ramping up of vaccine production by several millions.

The answer to that lies in intellectual property rights and the way these are granted and implemented across the world. Vaccines, like most other so-called “innovator” drugs, are subject to patent protection under the World Trade Organisation’s (WTO) Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement.

The TRIPs agreement, to which India is a signatory, makes it mandatory for member countries to guarantee 20-year patent protection to companies that produce “new drugs.”

Covishield, developed by the University of Oxford and AstraZeneca, has already patented the vaccine, implying that it will enjoy monopoly over the vaccine technology for two decades.

Indian patent laws, however, allow for voluntary and compulsory licensing of patented drugs to boost supplies and keep drug prices affordable.

Under voluntary licence (VL) that patent holder (University of Oxford-AstraZeneca in the case of Covishield) gives licence to a third party (SII in this case) either with an exclusive or non-exclusive right, the right to manufacture, import and distribute a pharmaceutical product and much more.

The licensee of the patent (SII) acts as an agent of the company and is primarily done through a mutual contractual agreement.

The Indian Patent Act, which got amended in 2005 and is TRIPs-compatible, also provides for compulsory licensing. Effectively, if the government deems fit, local generic drug makers can be allowed to use the technology of patented drugs after the end of three years from the date of a patent grant.

Compulsory licences can be granted on a variety of grounds including to “address public health problems”. There has not been a bigger, and graver, public health emergency than the COVID-19 crisis in 100 years. Therefore, there cannot be better reason to invoke the compulsory licensing clause and allow several India drug makers to locally produce Covishield in bulk.

Why is it not being done? The answer lies in the time, or rather the shortness of it, and the dire nature of the COVID-19 crisis. The application for the compulsory licence requires the minimum waiting period of three years of time. Covishield’s global patent is about a year old. India can invoke the compulsory licensing clause only some time in 2023. This is too long a wait to afford in the current circumstances.

That leaves the only option of substantially enhancing Bharat Biotech’s Covaxin through voluntary licensing. The voluntary licenses are based on a mutual contractual agreement between the patent holder and the third party who is a generic manufacturer. Granting access to technology and knowhow through voluntary licences to Indian generic drug makers to produce Covaxin can quickly help fill the gaps in India’s COVID-19 vaccine supplies.

Covaxin is an indigenous vaccine candidate. Importantly, it is also a government-backed shot, developed by Bharat Biotech with institutional and research support from the Indian Council of Medical Research (Delhi) and the National Institute of Virology (Pune). This status of support of the sovereign can hasten voluntary licensing, can save litigation time and cost and, most importantly, save many lives.

The TRIPS Way

There is also another road to allow for rapidly boosting supplies of patented COVID-19 vaccines. This route runs through the World Trade Organisation (WTO), the global trading cop.

Last year, India and South Africa moved a joint proposal at the WTO asking for a temporary waiver of the intellectual property rights (patents) on COVID-19 vaccines and drugs.

Both the countries have argued that when production of vaccines needs to be scaled up to meet demand, WTO should recommend “a waiver from the implementation, application, and enforcement of” certain provisions of the TRIPS Agreement (waiving IP rights like patents, copyright, and trademarks) for prevention, containment or treatment of COVID-19.

Since then, the proposal has been co-sponsored by other developing countries. In the last five months, the TRIPS Council has discussed this issue both formally and informally.

On May 5 the World Trade Organisation's (WTO) General Council is likely to discuss a proposal on the matter by India and South Africa. On April 16, ten Democratic Senators led by influential Bernie Sanders have urged US President Joe Biden to support India and South Africa's proposal to the WTO to temporarily lift certain intellectual property barriers and allow countries to locally manufacture COVID-19 diagnostics and vaccines, arguing that this is key to end the pandemic and a strong American recovery. The Biden administration has not made a decision on the issue yet.

A favourable move at the WTO still appears a long shot. Until then, granting immediate voluntary licences to a clutch of local pharma companies to produce Covaxin by millions should not be victim to red-tape and bureaucratese.

The nation, indeed the world, is at war. With an enemy that is unseen. It assaults people in millions. It first deals a body blow, saps the enemy—you, I and hundreds and thousands like us—of oxygen.

The only weapon humanity has is the power of science. Vaccines, and other medicines, will have to be administered at a manic pace to win this war against COVID-19. It is a no-brainer on whose side the world should be in this trade-off between protecting the rights and investments of the innovators and lives and health of billions.
Gaurav Choudhury is consulting editor, Moneycontrol.
first published: Apr 19, 2021 11:58 am

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