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Indian pharma cos welcome patent waivers on COVID vaccines, says tech transfer needed to scale up

Experts say India has a considerable knowledge base on vaccine platforms such as whole virion vaccines (inactivated or live virus), viral vectors and recombinant proteins. Here the patent waiver may not be of much help.

May 07, 2021 / 10:37 AM IST
Covid-19 vaccine (Representational image)

Covid-19 vaccine (Representational image)

The Indian pharma industry welcomed the decision by the US government to support the temporary waiver of Trade-Related Aspects of Intellectual Property Rights (TRIPS) on Covid-19 vaccines. The industry said, along with patent waivers, it is important to push for more licensing and tech transfer arrangements to expand production of COVID-19 vaccines.

The European Union (EU) too on Thursday said it is willing to discuss a proposal to waive intellectual property rights for COVID-19 vaccines.

"This is positive development, equitable distribution of vaccines around the world is very important to end the pandemic," said Sudarshan Jain, Secretary General of Indian Pharmaceutical Alliance (IPA).

IPA represents large domestic pharmaceutical companies.

Jain cautioned that while temporary patent waivers will help to get the best out of manufacturing capabilities available around the world, only patent waivers may not be sufficient.

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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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"We also need the technology to make it, patent waivers along with technology transfer would boost vaccine manufacturing," Jain added.

AstraZeneca-Serum Institute of India,  Johnson & Johnson - Biological E, RDIF-Dr Reddy’s are some of the examples of collaboration between innovators and Indian vaccine makers.

Experts say India has a considerable knowledge base on vaccine platforms such as whole virion vaccines (inactivated or live virus), viral vectors and recombinant proteins. Here the patent waiver may not be of much help.

"The patent waiver may be useful for mRNA vaccines, the technology that is something new for Indian developers. There are certain things that are not able to do now with mRNA vaccines will be possible," said Dr KV Balasubramaniam, a vaccine industry veteran and life science industry consultant.

Balasubramaniam says companies like Pune-based Gennova Biopharmaceuticals that's developing messenger RNA (mRNA) COVID-19 vaccine may possibly benefit by patent waivers.

But Balasubramaniam warns that things won't be that easy as patent holders try to fence their vaccine manufacturing know-how by broad patent claims.

"For Indian companies to understand the specifics, break the barrier of knowledge, experiment - it would take 2-3 years," Balasubramaniam

Dr Sanjay Singh, CEO of Gennova Biopharmaceuticals said the decision is a welcome one.

"In light such a difficult pandemic, right step to help humanity," he added.

Please read here  on how Gennova is trying to indigenise its mRNA vaccine.

"We still don't know the broad contours, but if the waiver is extended to manufacturing of adjuvants (the component that boost vaccine efficacy), some of the other key raw ingredients like certain enzymes, reagents, it would definitely help," said an executive of a vaccine company who didn't want to be named.

PhRMA, which represents America's leading innovative biopharmaceutical research companies, opposed the US government decision to support patent waivers for COVID-19 vaccines.

"(The) decision will sow confusion between public and private partners, further weaken already strained supply chains and foster the proliferation of counterfeit vaccines," PhRMA said.

PhRMA companies are devoted to discovering and developing medicines that enable patients to live longer, healthier and more productive lives. Since 2000, PhRMA member companies have invested nearly 1 trillion in the search for new treatments and cures, including an estimated USD83 billion in 2019 alone.
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 6, 2021 07:52 pm

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