On Monday evening, the biotech unveiled commitments and programs that it said would prepare it to quickly produce doses of vaccines in the event of a future epidemic. He said that by 2025 he aims to begin early trials of vaccines targeting 15 high-priority pathogens identified by global health authorities.
(ticker: MRNA) CEO Stéphane Bancel said Barrons before the announcement, is to begin preliminary trials of each of the vaccines over the next three years to identify the appropriate dose level. This would allow Moderna to move quickly to further trials should the need arise.
“It’s a time saving of about four months,” said Bancel. “Think of what would have happened if the [Covid-19] the vaccine had been launched in the United States not in December , but in mid-September. We could have protected a lot of high-risk people before that terrible winter. So four months is a big deal.
Early-stage Phase 1 trials require relatively small numbers of subjects and are designed in part to identify the appropriate dose to test in larger trials. Large, later-stage trials would need to be conducted when a disease was already prevalent, so the company could test the effectiveness of the vaccine in prevention.
The company will seek partners on the programs, but said it would develop the vaccines itself for any diseases for which it cannot find partners.
Moderna also said it would never enforce its Covid-19 vaccine patent against manufacturers in 92 low- and middle-income countries. The company previously said it would not enforce its patent anywhere during the pandemic.
Outside of those 92 countries, Moderna said in a statement, “Vaccine supply is no longer a barrier to access. In these countries, the Company expects those who use Moderna-patented technologies to respect the Company’s intellectual property. »
The pledge not to enforce its vaccine patent in low- and middle-income countries has no immediate implications because no company is manufacturing or seeking to manufacture the Moderna vaccine there. Vaccine manufacturing in general is complicated, and the manufacturing of a messenger RNA vaccine in particular is a new, highly specialized field.
“The point for us was more of a policy point, a philosophy point, which is look, we want people to know that we’re not going to legally prosecute people who use our patent in those geographies. “, said Bancel. When asked if Moderna was engaged in so-called technology transfer, to share information on how to manufacture messenger RNA vaccines to manufacturers in those countries, Bancel replied that the company does not. was not.
“We’re open to anything that makes sense to do that,” he said.
In a separate announcement on Monday, Moderna said it would build a messenger RNA vaccine manufacturing plant in Kenya. The company previously announced plans to open a factory in Africa, but did not reveal where.
The announcements come as Moderna, and the vaccine industry in general, move toward a post-pandemic stance. Barrons has argued in recent months that the company can stand up to vaccine holders like
(PFE) over the long term. But so far the stock is down 50% so far this year, with its market value dropping to $55 billion from the $190 billion it approached last August.
The talk of future pandemic preparedness plans reminds investors of the extraordinary role Moderna has played in the current pandemic and the likelihood that Covid-19 will not be the last pathogen to threaten the world in our lifetime.
As part of the commitment to conduct phase 1 trials of vaccines against the 15 pathogens, drawn from a list maintained by the World Health Organization and another list compiled by the Coalition for Epidemic Preparedness Innovations , Moderna said academic and government labs around the world will be able to use a system that will enable rapid prototyping of mRNA vaccines.
The system, called mRNA Access, allows researchers developing a vaccine for a specific disease to upload an mRNA sequence to a Moderna website. Moderna’s automated systems will then manufacture a prototype vaccine at their factory in Norwood, Massachusetts, by wrapping the mRNA sequence in the same lipid nanoparticle used for the company’s Covid-19 vaccine, and send it to researchers.
The researchers would then test the prototype vaccine on animals on their own. When they were ready to put it through a phase 1 trial, they would come to an agreement with Moderna on who would conduct the trial.
Bancel said Moderna would jointly own the patent with the researchers.
“The research phase is very easy, very elastic,” says Bancel. “When they want to go to the clinic…we have to agree on how we’re going to do that on a case-by-case basis.”
In addition to working on vaccines against diseases like Nipah, Marburg virus and Lassa fever, Moderna will also work on preparing for disease X, the name the WHO uses to address the risks of epidemics caused by a currently unknown pathogen.
The idea is that if one of these pathogens, or a variant of one of these pathogens, causes a new epidemic, the world could be ready. “We want to enter humans in order to know what dose we need, that’s really the important thing, to save time, in the event of an epidemic with the same virus or with a variant of one of these viruses. “, said Bancel.
Write to Josh Nathan-Kazis at [email protected]