Another Challenge for Vaccine Makers: Keeping It at Minus-112 Degrees

Sanofi Partner Takes On Vaccine Hurdle: Minus-112 Degree Storage

(Bloomberg) --

A little-known biotech is working to surmount a hurdle that may hinder global access to a coronavirus vaccine.

Translate Bio Inc., a 100-person company based outside Boston, has joined forces with French drug giant Sanofi to develop a vaccine based on similar technology being used by Moderna Inc. in its highly anticipated shot. This so-called messenger RNA platform has been lauded as a possible solution for the coronavirus pandemic, but it comes with one significant drawback: The vaccine must be stored at minus-112 degrees Fahrenheit (minus-80 degrees Celsius).

That means proving that such an immunization works is only a first step. After that, millions of shots will require specific transportation and storage facilities, a key hurdle in getting it to the masses⁠ -- a challenge shared by other predominant vaccine developers.

Translate Bio is “working feverishly” to develop a formulation that wouldn’t require freezers that go as low as minus-80 degrees Celsius, Chief Executive Officer Ron Renaud said in an interview. “We’re making this with the mindset of having it best-suited for everyone.”

Moderna spokeswoman Colleen Hussey said the company’s vaccine candidate permits for three-month storage at a much warmer temperature: 5 degrees Celsius (41 degrees Fahrenheit). For a longer shelf life, the shot could be freeze-dried or kept at freezing temperatures.

Pfizer, which also has an mRNA candidate, said it is continuing to work on temperature control.

Temperature Control

Having a vaccine that can be easily deployed under a variety of conditions is critical, especially to serve people in developing countries, Sanofi Chief Executive Officer Paul Hudson said in an interview last week.

A large part of the world’s population “simply doesn’t have a supply chain that can operate at that temperature,” Hudson said of the company’s experimental mRNA vaccine. “You need to be going to very, very specialized centers to get it.”

The vaccine candidate from Translate Bio, which is based in Lexington, Massachusetts, is currently being tested on animals, with a view to moving into human trials before the end of the year. Should that stage be successful, the company will seek to secure an approval before the end of 2021. It estimates it could, in partnership with Sanofi and other manufacturers, ultimately build out enough capacity next year to produce up to 360 million doses annually.

Still, it may be longer until Translate Bio can create a formulation that’s stable at higher temperatures, according to Renaud. Translate Bio and Sanofi are in talks with the U.S. and other government entities about securing additional funding to continue research, development and production efforts.

“For a small company like Translate to play a role in something as big as this is incredibly gratifying,” Renaud said. “It never loses its luster.”

Sanofi has also received funding for a different experimental shot that relies on a more traditional approach to vaccine-making.

Mass Production

Immunization is seen as the best way to end the Covid-19 pandemic, which has so far killed more than 300,000 people around the world. To achieve that, production of any vaccine that works and is found to be safe must be scaled up swiftly to meet global needs.

That’s where the messenger RNA technology -- a new approach that has yet to be approved for any drugs or vaccines -- could have an advantage. It works by injecting RNA into the body, which then slips into human cells and tells them to produce the viral proteins that prompt it to develop protective antibodies. The approach doesn’t involve brewing batches of protein or inactivated viral particles in living cells, which can take months.

However, “it would be short-sighted to think the only question is whether there is a good vaccine,” Mariângela Simão, assistant director-general for access to medicines and health products at the World Health Organization, said in an interview. Resources must quickly be deployed to health systems without proper cold-storage supply infrastructure to maintain such vaccines at such extreme temperatures, she said.

“This kind of challenge is why we will likely need more than one type of vaccine to succeed,” Simão said.

Moderna is the furthest ahead with the new vaccine technology: A phase 2 trial with 600 patients will begin shortly.

Pfizer says it should be able to make millions of doses this year and hundreds of millions in 2021, were it to succeed with one of its vaccine candidates.

“We are actively scaling up our manufacturing capacity and distribution infrastructure to support global supply of a potential COVID-19 vaccine in response to the pandemic,” Pfizer spokeswoman Amy Rose said in an emailed statement. “Among those things that we are preparing are drug product production, aseptic formulation and filling, and cold-chain distribution to ensure temperature control.”

The New York-based drugmaker and its German partner, BioNTech SE, started human trials of their mRNA vaccine in April.

“Being in the immediate rear-view mirror is not a bad place to be,” Translate Bio’s Renaud said. “Our colleagues are establishing the viability of a messenger RNA vaccine. It’s certainly a race, but it’s not a competition. We’re going to need more than one mRNA company to be successful.”

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