It's mRNA or nothing

'It's game over. It's mRNA or nothing:' Expert on future of vaccines

Anjalee Khemlani

·Senior Reporter

Tue, September 7, 2021, 3:05 PM

Pfizer (PFE) and its partner BioNTech (BNTX) recently got FDA full approval for the most widely-approved and sought after COVID-19 vaccine in the world, to date.

It signals an important change in how vaccines of the future could look, according to Arnaud Bernaert, formerly head of Global Health and Healthcare at the World Economic Forum.

Bernaert, now head of Health Security Solutions at Swiss-based SICPA, told Yahoo Finance, "I think it's game over. I think it's mRNA or nothing. [Other technology] takes too long."

Pfizer, BioNTech and Moderna (MRNA) are invested in the tech, with announcements of pursuits of combination flu-covid shots as well as other diseases.

The potential for mRNA was recognized early. "mRNA vaccines represent a promising alternative to conventional vaccine approaches because of their high potency, capacity for rapid development and potential for low-cost manufacture and safe administration," according to a 2018 article in Nature.

Bernaert cited these reasons as well. "If success needs to be defined as a function of the agility of a manufacturer to be able to reposition the DNA template for combating the next variant, I don't think the U.S. and Europe will do anything else but buy mRNA vaccines" moving forward, he said.

"They [mRNA] will represent 60% or 70% of the market. The other guys will die," he added.

But the pandemic also arrived after early development hurdles had been overcome for the technology. That included the method of delivery, lipid nanoparticles. And within the timeframe of getting the vaccines authorized, Moderna was first to reduce the storage temperatures needed from ultra-cold to normal freezer temperatures.

Now, the next step to unlocking their potential as a dominant technology will be global manufacturing, Bernaert said.

"I think mRNA is going to be a highly decentralized manufacturing technology," he said.

Deals happening now could be viewed as early efforts. That includes the various manufacturing and fill/finish deals that Pfizer and Moderna have penned in the past year.

Moderna has forged relationships with Catalent (CTLT), Switzerland-based Lonza, Spain-based Rovi, and France-based Recipharm for manufacturing. The company also partnered with Takeda (TAK) in Japan, Magenta in the United Arab Emirates and Tabuk in Saudi Arabia for distribution. It has partnered with Thermo Fisher (TMO), Sanofi (SNY), Baxter BioPharma and Samsung Biologics, in South Korea, for fill/finish. In addition, Moderna is working with Canada to set up a new manufacturing facility for future products. That's all on top of investing in its Massachusetts plant to expand manufacturing.

By comparison, pharma giant Pfizer has largely relied on its own sites in the U.S. and Europe, along with BioNTech's capacity, but recently signed agreements for global efforts. That includes with the Biovac Institute in South Africa and Eurofarma in Brazil for manufacturing. It has also partnered with Sanofi for fill/finish.

But further in the future, Bernaert expects mRNA use will lead to a decrease in the need for large-scale manufacturing footprints, "with 20,000-liter bioreactors a story of the past."

Bernaert pointed to California-based Nutcracker Therapeutics, as an example.The company is working on a smaller instrument that could give doctors access to locally-produced mRNA doses.

Already, mRNA companies have achieved improving stability at warmer temperatures compared to ultra-cold temperatures for the first doses. For now, however, the process is "crude," Bernaert said.

"The cold chain challenges will reduce, I think, over time. There will be lots of investments in better encapsulation mechanism, better lipid nanoparticles. It was very crude in the first place. I mean, let's call a spade a spade. The template itself and the way you grow enzymes, I think it's fairly crude."

He foresees synthetic biology DNA templates on the front end and better encapsulation mechanisms (lipids) on the back end. Brought together, it leads to a much more stable manufacturing process, Bernaert said.

Whatever the future holds, mRNA is set to dominate. "Viral vector technologies are going to become obsolete," Bernaert said.

Above is from:  https://www.yahoo.com/news/its-game-over-its-m-rna-or-nothing-expert-on-future-of-vaccines-200508222.html