FDAnews
www.fdanews.com/articles/200846-moderna-to-build-mrna-vaccine-portfolio-following-covid-19-success

Moderna to Build mRNA Vaccine Portfolio Following COVID-19 Success

January 12, 2021

Moderna is following up on the success of its messenger RNA-based COVID-19 vaccine with plans to develop inoculations for numerous other infectious diseases, the company said Monday.

Moderna’s vaccine was the early frontrunner among COVID-19 candidates — and the second to receive Emergency Use Authorization from the FDA last month (DID, Dec. 18, 2020). It has also received temporary or conditional authorization in the UK and in the EU (DID, Jan. 11).

The Cambridge, Mass.-based company has been in business for 10 years, but the COVID-19 vaccine was its first approved product. Using the same technology, it is now developing a seasonal flu vaccine program to cover four seasonal viruses recommended by the World Health Organization, with a phase 1 clinical trial scheduled to begin this year. It also has an HIV vaccine program, with separate phase 1 trials for two vaccines planned this year, and a program to develop a vaccine against the Nipah virus, which causes a range of illnesses, including fatal encephalitis.

“Beyond vaccines, we are extending our mRNA development work to a total of 24 programs across five therapeutic areas,” said CEO Stéphane Bancel. Of those two dozen programs, 13 are now in clinical trials.

The company is unlikely to run short of research funding this year. It has already received $2.8 billion from customers for the future supply of its COVID-19 vaccine, out of $11.7 billion expected from signed advance purchase agreements for fiscal 2021, Bancel said in a Monday call with investors. The company expects to supply 600 million to 1 billion doses of the vaccine in 2021 and 1.2 billion doses in 2022, he said. — Martin Berman-Gorvine