11 Jan, 2021
Moderna signs $11.7B in vaccine purchase agreements; will add flu, HIV trials
By Morgan Frey
Moderna Inc. has signed $11.7 billion in advance purchase agreements with different countries for the COVID-19 vaccine, money that will help fuel the company's research into three new development programs in its vaccine portfolio.
 U.S. National Institute of Allergy and Infectious Diseases Director Anthony Fauci before being vaccinated with Moderna Inc.'s COVID-19 vaccine. |
CEO Stéphane Bancel gave insight into the purchase agreements, which do not include options, during a panel at the J.P. Morgan Healthcare Conference. The conference brings together about 600 presenting companies and almost 13,000 attendees. The 39th annual conference in 2021 is being held virtually because of the COVID-19 pandemic.
Bancel said the company has already received $2.81 billion in deposits from countries that have signed advance purchase agreements.
During fiscal year 2021, Moderna expects to supply between 600 million and 1 billion doses of the COVID-19 vaccine mRNA-1273. Bancel expects the company will supply up to 1.2 billion doses during the following fiscal year.
The Cambridge, Mass.-based company has seen exponential growth over the past year with the success of its COVID-19 vaccine program, leading to major returns for leadership and investors. The vaccine was the second one to be granted an emergency use authorization from the U.S. Food and Drug Administration, behind Pfizer Inc. and BioNTech SE's vaccine, and the third to be approved by the U.K.'s Medicines and Healthcare products Regulatory Agency after Pfizer-BioNTech's and AstraZeneca PLC's shot.
"If you look at the totality of our programs, we believe that Moderna has the most innovative vaccine pipeline in the industry despite being one of the most recent players in vaccines," Bancel told media and investors.
The three new programs Moderna will add to its pipeline include potential mRNA vaccines against the seasonal flu, HIV and Nipah virus. The company is also expanding its respiratory syncytial virus program to include older adults.
Moderna's flu program, with experimental vaccines dubbed mRNA-1010, mRNA-1020 and mRNA-1030, will evaluate multiple antigen combinations against the four different seasonal influenza viruses recommended by the World Health Organization. The company also said it will be exploring the potential for combination vaccines against SARS-CoV-2, the flu, human metapneumovirus and RSV. Phase 1 clinical trials are expected to start in 2021.
Morgan Stanley analysts said in a Jan. 11 note that the seasonal flu program represents the highest potential market and potential for success.
Moderna also plans to begin phase 1 clinical trials for its planned HIV vaccines, mRNA-1644 and mRNA-1574, in 2021. The mRNA-1574 vaccine is being developed in collaboration with the National Institutes of Health, while mRNA-1644 is a collaboration with the Bill and Melinda Gates Foundation and the International AIDS Vaccine Initiative.
The NIH's Vaccine Research Center also co-developed Moderna's potential Nipah virus vaccine mRNA-1215. Nipah virus is a zoonotic virus transmitted to humans from animals that can cause severe neurological, including fatal inflammation of the brain, and respiratory complications.
'Just the beginning'
As the U.S. began distributing the mRNA vaccine in late 2020, investors and the public still had questions related to a new variant of the virus and the vaccine's effectiveness in younger populations.
The company began dosing adolescents aged 12 to 17 in December 2020, and Bancel said during the conference panel that Moderna hopes to have a label extension to include this group by the summer so that middle and high school students can be vaccinated before returning to school. Younger cohorts of 1 to 11-year-olds will take longer, however, Bancel said. He said a trial of younger children is expected to begin soon, and data can be anticipated for 2022.
Bancel also said a 1-year booster study in adults will begin in July 2021.
When it comes to the new variants of the virus that have been found in the U.K. and the U.S., Chief Medical Officer Tal Zaks said the company is keeping an eye on variants but is not too concerned at the moment. The variants, Zaks said, do not hinder neutralizing antibodies from the vaccine's ability to neutralize the virus. A time to be concerned, however, would be if significant rates of people who have been sick previously or have been immunized become reinfected.
Despite new challenges with variants of the virus and introducing new cohorts to the vaccine, Bancel said 2021 is going to be an inflection point for the company.
"Before, we believed that mRNA might work and might deliver a safe medicine approval. Now we know this is possible," Bancel said, adding, "I believe this is just the beginning."
The J.P. Morgan Healthcare Conference brings together about 600 presenting companies and almost 13,000 attendees. The 39th annual conference in 2021 is being held virtually to curb the rate of infection of the COVID-19 virus.