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Clamour for sharing vaccine tech and IPR grows louder by states; puts Centre under pressure

The central government, however, believes that the exercise of statutory powers would be 'counter-productive’ at this stage and is actively engaging itself with global organisations at a diplomatic level to find out a solution in the best possible interest of India.

May 11, 2021 / 09:38 PM IST

Delhi Chief Minister Arvind Kejriwal and Andhra Pradesh Chief Minister YS Jagan Mohan Reddy on May 11 wrote letters to Prime Minister Narendra Modi, asking the Centre to nudge the COVID-19 vaccine makers to transfer technology or else exercise patent waiver provisions to allow other manufacturers to produce the vaccines.

Kejriwal in his letter to the Prime Minister urged the government to push the two Indian companies, the Serum Institute of India (SII) and Bharat Biotech to share the formula of their COVID-19 vaccines, Covishield and Covaxin with other manufacturers.

The Delhi Chief Minister said the manufacturers can pay royalty to both the companies.

He further demanded that the government should also consider use of patent waiver flexibilities available under the domestic law.

Kejriwal said it is not possible for both the companies to scale up manufacturing, as per the current demand.

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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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Andhra Pradesh Chief Minister, Jagan Mohan Reddy, was more explicit. He asked the Centre to direct Bharat Biotech to carry out technology transfer of manufacturing the Covaxin and ICMR-NIV to provide the viral strain to whoever was interested and capable of manufacturing the vaccine.

"Please explore the possibility of involving all such production firms and enable them with the technology, IPR (Intellectual Property Rights) etc., to deliver the vaccine as quickly and as affordable as possible," Reddy wrote.

He added: "This shall ensure that IPRs/patents etc., if any, are not a hindrance. Anyone who can manufacture or is interested to manufacture the vaccine, should be encouraged to do so in larger public interest. The entire manufacturing capacity should be mobilised and put to use in this testing time."

The letters from Kejriwal and Reddy, are in line with courts, health activists and NGOs, who are demanding that the government immediately act on facilitating technology transfer or else utilise patent waivers available under Indian law to expand production.

India is going through a deadly second wave of the pandemic, with over 3.7 million COVID-19 active cases and about a quarter of a million deaths.

Both Covishield and Covaxin are protected by patents. Covishield is manufactured and distributed by SII under a license from British-Swedish drug maker, AstraZeneca, while Covaxin is developed indigenously by Bharat Biotech based on the SARS-CoV-2 virus strain provided by ICMR. But the process and the key adjuvant that boosts efficacy are protected by patents.

The central government, however, has been cautious. It said the exercise of statutory powers would be `counter-productive’ at this stage and is actively engaging itself with global organisations at a diplomatic level to find out a solution in the best possible interest of India.

The government further added that the main constraint is in the availability of raw materials and essential inputs. "Therefore, any additional permissions and licences may not result in increased production immediately," it said.

The government said it is presumptuous to assume that the patent holder will not agree to more voluntary licences for such manufacturers who have a new drug manufacturing permission from the Drugs Controller General of India (DCGI).

"However, if such a manufacturer applies for a compulsory licence under section 92, the same may be suitably considered by the Department of Chemicals and Petro-Chemicals,” the government said.

Please read here to know more about the Centre's position on patent waivers.
Viswanath Pilla is a business journalist with 14 years of reporting experience. Based in Mumbai, Pilla covers pharma, healthcare and infrastructure sectors for Moneycontrol.
first published: May 11, 2021 07:59 pm

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