Access to foreign Covid-19 vaccine a long haul, say Indian companies

US pharmaceutical associations feel that the decision to support the patent waiver would weaken already-strained supply chains

Indian vaccine makers feel that the decision of the US administration to support a patent waiver for Covid-19 vaccines is a welcome step, but it may mean very little in terms of giving immediate access unless innovator companies come forward to partner. Even if technology is made available immediately, it would take nine months to a year to develop the processes and commercialise the same, they say.

Vaccines are biological products using viruses, and manufacturing them involves an extremely complex process. Any change in that process can result in failure to get the right vaccine candidate, warns the Indian industry. US pharmaceutical associations, however, feel that the decision to support the patent waiver would weaken already-strained supply chains.

Sharvil Patel, managing director of Zydus Cadila, which is in the last leg of developing a Covid-19 vaccine candidate ZyCoV-D, explained, “Everyone has different cell lines, proprietary adjuvants, maybe proprietary equipment, different technologies. Intellectual properties (IPs) are very broad. One does not really know the exact process of manufacturing.”

Patel thus felt that waiving the IP would mean very little in terms of giving access unless the innovator company was willing to partner and help other companies to do the technology transfer and help develop the processes.

Biocon Chairperson Kiran Mazumdar Shaw too felt the same. Speaking to a television channel, Shaw said patents are not the stumbling blocks now, capacities are. If patents were waived and everything was immediately available, then also Shaw felt it would take at least nine months to a year to make an mRNA vaccine. “Pfizer and BioNTech were working on these technologies for years, and that is how they pivoted and made these vaccines,” she added.

Patel too felt the same. It would need capital investments and also around a year to develop the processes and everything to make these vaccines. Zydus would be open to partnering with any global firm, but it would be a time consuming process.

For vaccine manufacturing, one needs the drug substance. Capacities of making drug substances are a stumbling block in ramping up production.

India already has access to foreign vaccines like AstraZeneca (Covishield made by Serum Institute), Novavax (Covovax made by SII) and Johnson and Johnson (made by Biological E), Sputnik V (imported as well as made in India). It is the mRNA technology-based vaccines from Pfizer and Moderna that India does not have yet.

Biocon and its research arm Syngene have started work on the mRNA platform for vaccines and therapies. Pune’s Gennova Biopharmaceuticals has started human clinical on its mRNA platform based Covid-19 vaccine, and even the Council for Scientific and Industrial Research (CSIR) is working on the platform.

 “Vaccines are biological entities. For chemical processes, one can still attempt to make the drug if the IP is gone. The process of manufacturing is very sensitive, and complex. Minor changes in the process can change the product outcome. If we leave it in the fermentation for one more hour, it would fail. If we check the pH a bit late, it can fail. It is very important to know every nuance of a particular vaccine’s manufacture,” Patel explained.

Global pharma players’ alliances have not welcomed the move to waive patents for Covid19 vaccines.

Pharmaceutical Research and Manufacturers of America (PhRMA) President and CEO Stephen J Ubl has said, “In the midst of a deadly pandemic, the Biden Administration has taken an unprecedented step that will undermine our global response to the pandemic and compromise safety. This decision will sow confusion between public and private partners, further weaken already strained supply chains and foster the proliferation of counterfeit vaccines.” He also added that this decision does nothing to address the ‘real challenges’ to getting more shots in arms, including last-mile distribution and limited availability of raw materials.

The decision of the US administration to support a patent waiver for COVID-19 vaccines is disappointing, said the International Federation of Pharmaceutical Manufacturers & Associations that represents the research-based pharmaceutical companies and associations across the globe..

“Waiving patents of COVID-19 vaccines will not increase production nor provide practical solutions needed to battle this global health crisis. On the contrary, it is likely to lead to disruption; while distracting from addressing the real challenges in scaling up production and distribution of COVID-19 vaccines globally: namely elimination of trade barriers, addressing bottlenecks in supply chains and scarcity of raw materials and ingredients in the supply chain, and a willingness by rich countries to start sharing doses with poor countries,” the IFPMA said.