For a biotech that had never before brought a drug to market, Moderna’s COVID-19 vaccine was a revelation. Not only did the vaccine validate the company’s focus on mRNA technology, it also led to huge profits, namely a net income of USD 12.2 billion in 2021 and vaccine sales adding up to USD 18.4 billion in 2022. Now Moderna has laid out ambitious plans to build on its mRNA platform for variant-adaptable vaccines and multi-shots, boost its manufacturing capacity and bring other respiratory vaccine candidates forward.
Lead up to COVID-19
Moderna has always been focused on modified mRNA, hence the company name. Created in 2011 with former Eli Lilly executive and bioMerieux CEO Stéphane Bancel as its founding CEO, the US-based company embarked on its journey at a time when several big pharmas were getting interested in mRNA —like Novartis, who established a vaccine mRNA research unit in 2008. At the same time, BioNTech and other start-ups came along, encouraged by the US Defence Advanced Research Projects Agency’s 2012 decision to fund research on RNA vaccines and drugs.
But Moderna stood out from the crowd by raising more than USD 1 billion for its prospect of using mRNA to induce cells in the body to make their own medicines. The plan, however, fell through and the firm decided to prioritize vaccines and by 2020 had advanced nine mRNA vaccine candidates. When COVID-19 struck the world, Moderna, based on its existing research, was able to create a prototype vaccine within days of the virus’s genome sequence becoming available.
Variant-Adapted and Multi Shots
We’ve shown that we are able to adapt to different variants very quickly
Stéphane Bancel, CEO
With the World Health Organization (WHO) declaring in September a foreseeable end to the COVID-19 pandemic, declining vaccination rates and government contracts reaching an end, the future of the COVID-19 vaccines market may be uncertain, but Moderna is still striving to improve on its key asset.
The company has proven its ability to adapt its Spikevax vaccine to new SARS-CoV-2 variants. “We’ve shown that we are able to adapt to different variants very quickly,” said Bancel speaking at the recent World Economic Forum State of the Pandemic panel discussion. To demonstrate the claim, Bancel explained how the FDA’s Center for Biologics Evaluation and Research (CBER) requested new vaccines for the BA.5 Omicron variant in June and the company was able to get these vaccines to US pharmacies within 60 days.
Beyond its capacity to adapt to new variants, the company is preparing for its COVID-19 vaccine to become more like a flu vaccine. “Like influenza and respiratory syncytial virus (RSV), which cause severe morbidity and mortality, many experts, including Moderna, expect COVID-19 to become a seasonal virus,” said Melissa J. Moore, Moderna’s Chief Scientific Officer in a recent interview. “I think there will have to be an improved vaccine combating such new variants annually, and people will likely have to get a booster shot every year before winter arrives,” she continued.
“To increase patient convenience, Moderna is trying to incorporate multiple mRNAs that combat respiratory diseases like influenza, RSV, and Covid-19, into one vaccine,” she said. Bancel confirmed this objective in a recent interview with Bloomberg, stating that Moderna could introduce combination shots as early as next year with the first combination vaccine likely to get to market being a combination shot for Covid-19 and flu. Bancel said this will most likely be followed by a trio jab that would include RSV, available by 2025 at the earliest.
Ramping up Production
Moderna has another key objective: increasing its manufacturing capacity. To this end, the company plans to lower production turnaround time using the technology from newly acquired Japanese biotech OriCiro Genomics. At the World Economic Forum, Bancel claimed the new technology, set to be ready in 2024, would “shrink the time to get from designing the sequence to having products ready by two more weeks.”
In addition, Moderna aims to set up new manufacturing facilities throughout the world. The company recently broke land on a new site in Canada as part of a 10-year partnership with the Canadian government to strengthen the company’s pandemic response. In a similar partnership with the UK government, Moderna will build an Innovation and Technology Centre able to produce up to 250 million vaccines a year. Construction on the site is set to start this year.
Moderna has also begun the construction of facilities in Australia and will soon set up a plant in Kenya with further facilities due in the US and Switzerland.
The ambition, Bancel said, is to have a manufacturing site on every continent, capable of producing not just COVID-19 vaccines. “We can use exactly the same machines in the same plant to make other vaccines, and so the flexibility is what gives me hope, not only for the variants that nature might throw at us, but also for other vaccines,” says Bancel.
Promising Candidates in the Pipeline
Moderna has an immunotherapy vaccine program and has been working with Merck for several years to develop personalized cancer vaccines that enable patients’ immune systems to recognize cancer
Melissa J. Moore, Chief Scientific Officer
Moderna’s pipeline is largely focused on mRNA vaccines for respiratory viruses. One of its star candidates is for a respiratory syncytial virus (RSV) vaccine for which it has reported promising results from its phase 3 trial. Yet Moderna is not alone in the race for an RSV vaccine as the virus runs rampant in the US. Competitors GSK and Pfizer have already filed for approval with the FDA for lower respiratory tract disease caused by RSV in people 60 and older and both companies have priority review status. Moderna expects to submit its application to global regulators in the first half of this year.
Apart from respiratory viruses, Moderna is also developing vaccines for so-called latent viruses, or viruses in the body that can be reactivated under stress. And beyond preventative vaccines, the company also has a broad treatment vaccine pipeline. “Notably, Moderna has an immunotherapy vaccine program and has been working with Merck for several years to develop personalized cancer vaccines that enable patients’ immune systems to recognize cancer,” said CSO Moore.
In short, Moderna is no longer the ambitious biotech with no proven concepts it was before the pandemic, but the company is not relying on its past achievements either.