Those programs cover mRNA vaccine candidates against seasonal flu, HIV and the Nipah virus. The US biotech also announced an expansion of its respiratory syncytial virus (RSV) vaccine program into older adults.
Moderna currently has 24 mRNA development programs in its portfolio with 13 having entered the clinic. It said its pipeline is organized into six modalities based on similar mRNA technologies, delivery technologies and manufacturing processes.
“The uniquely challenging year of 2020 for all of society proved to be an extraordinary proof-of-concept period for Moderna,” said Stéphane Bancel, the company CEO. “Even as we have shown that our mRNA-based vaccine can prevent COVID-19, this has encouraged us to pursue more-ambitious development programs within our prophylactic vaccines modality. Today we are announcing three new vaccine programs addressing seasonal flu, HIV and the Nipah virus, some of which have eluded traditional vaccine efforts, and all of which we believe can be addressed with our mRNA technology. Beyond vaccines, we are extending our mRNA development work to a total of 24 programs across five therapeutic areas.”
Bancel will be discussing the biotech's pipeline of mRNA development programs at the 39th Annual JP Morgan Healthcare conference today.
Moderna also informed the markets today about its financial status, saying it expects company cash, cash equivalents, and investments as of December 31, 2020 to be around US$5.25bn (unaudited), as compared to $1.26bn on that date the year prior. The US company also said the organization has strengthened its team in the past 12 months, finishing 2020 with 1,300 full time employees, a significant jump on the numbers employed by the biotech at the end of 2019, with it comprising 820 staff members back then.
European distribution of vaccine underway
Meanwhile, Moderna Switzerland GmbH, the international arm of the US biotech, has released an update regarding European distribution of its COVID-19 vaccine, announcing that deliveries to EU and EEA Member States are getting underway from today.
It said that international logistics group, Kuehne+Nagel, will be responsible for all shipments of the COVID-19 Vaccine Moderna in Europe, relying on its centralized pharma hub in Europe.
That logistics arrangement, which was announced last week, includes distribution and warehousing of the vaccine. Kuehne+Nagel will use its network of more than 230 operations worldwide to distribute the vaccine via road and air. In Europe alone, the company operates its own fleet of over 200 dedicated pharmaceutical transport vehicles.
This announcement does not impact timings of vaccine delivery in the UK, said Moderna.
The Switzerland headquartered Kuehne+Nagel’s clinical trial logistics subsidiary, QuickSTAT, has been an integral part of Moderna's vaccine supply chain as well, having supported Phase II and Phase III clinical trial supply logistics in the US.
Kuehne+Nagel has also signed partnerships with authorities in several countries for local storage and last-mile distribution, such in Germany’s most populous state, North Rhine-Westphalia.
Manufacturing of the COVID-19 Vaccine Moderna vaccine drug substance is performed by Lonza at its site in Switzerland, with aseptic drug product manufacturing and fill-finish performed by ROVI in Spain. Additional aseptic drug product manufacturing and fill-finish support will be provided by Recipharm in France within the first half of 2021.
On December 18, 2020, the EU Commission exercised its option to order an additional 80 million doses of Moderna’s vaccine against COVID-19, bringing its confirmed order commitment to 160 million doses in 2021.
The Commission granted a conditional marketing authorization (CMA) for COVID-19 Vaccine Moderna on January 6, 2021, based upon the recommendation of the European Medicines Agency (EMA) for use of the vaccine for active immunization to prevent COVID-19 in individuals over 18 years of age.
To date, COVID-19 Vaccine Moderna has also been authorized for distribution in the US, Canada, Israel, and the UK. Marketing authorizations have also been granted by Iceland and Norway.
