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‘Raw material shortages could hit vaccine supplies’

Even as Nobel laureates and public health voices call for a waiver of intellectual property on Covid-19 technologies, including vaccines, global vaccine industry representatives point to export bans as a key barrier to access.

‘Bumpy road ahead’

Collaborations between companies, competitors, countries and regulators has helped deliver multiple Covid-19 vaccines, but the road ahead is “bumpy”, said an industry panel that reflected Big Pharma and companies from the developing world, speaking in a single voice.

On the IP waiver, Sai Prasad, Executive Director, Quality Operations, Bharat Biotech, said that the big picture was to deliver healthcare solutions during the pandemic and that can be done through technology transfer. But then again, technology can be transferred only to companies with the expertise to deliver a quality product, he said. Prasad is also President at the Developing Countries Vaccine Manufacturers’ Network (DCVMN).

Technology-transfer is an important tool that needed to be encouraged, he said. But vaccines were complex to make and the recipient company needed to have the expertise to make the product innovation. Over 100 components come from different parts of the world and it would be difficult to get the recipient company to speed up in three months, he said, adding that it required much hand-holding. Bharat Biotech has a check-list of about 50 indicators, he said, before sealing a tech-transfer alliance. His company was exploring alliances with another company in India, Brazil and the US, he said.

Consumables in short supply

On the raw-material shortage hampering vaccine supplies, he said, single use materials, plastic consumables were in short supply, and “there was no solution in sight”. The ban on raw materials by the US, following the invocation of its Defense Production Act, had been flagged recently by Serum Institute’s chief.

Michelle McMurry-Heath, President & Chief Executive, Biotechnology Innovation Organization (BIO) said the US DPA was “well intentioned, but misguided.” She added, that it needed to be resolved to get more supplies on the road. On IP transfer, she said, it was not similar to an alliance for a small drug molecule, as vaccines were way more complex.

Moderna Chief Executive Stéphane Bancel, pointed out, that a vaccine’s IP was available on the internet, the key really was the people and expertise involved in producing it. Companies should focus on getting enough vaccines out this year, he said, as the next year would have too much capacity and many vaccines. Companies need to stay agile, he said, as the virus was not “still” and variants were emerging. Moderna was working on a multi-valent, single dose booster.

Roger Connor, President (Global Vaccines), GlaxoSmithKline, pointed out that technology-transfers were difficult as they involved shifting the technology to different equipment, ensuring that it behaved the same and making sure the sterile product was of the highest quality.

Rajinder Suri, Chief Executive with DCVMN, opined that the raw material shortage would affect vaccine-makers’ efforts to ramp-up capacities.

Thomas Cueni, Director General, International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) pointed to the 275 partnerships in place, of which 214 were technology transfers. On the WHO’s recent suggestion for tech-transfer on mRNA vaccines, he said, it may not be for this pandemic, but more for the long term.

The three entities, IFPMA, BIO and DCVMN said, the one billion Covid-19 vaccine production milestone had been reached, and projections are to get to 10 billion doses by end of 2021. According to a World Bank report, this would be sufficient to achieve global equity in the distribution of vaccines and attain worldwide herd immunity by March 2022, they pointed out. But much hinged on keeping the supply lines flowing, they added.

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