Moderna, Inc has announced 3 new development programs in its vaccine pipeline,1 as well as temporary authorization in Switzerland for the company’s coronavirus disease 2019 (COVID-19) vaccine.2.3
According to Stéphane Bancel, Moderna’s CEO, the new vaccine programs address seasonal flu, HIV and the Nipah virus. Having eluded traditional vaccine efforts, he said the company will utilize mRNA technology that was used in creating its COVID-19 vaccine, mRNA-1273.1
The new infectious disease vaccine development programs are as follows:1
- Flu vaccine (mRNA-1010, mRNA-1020, mRNA-1030): Seasonal flu (type A and type B) epidemics occur seasonally and vary in severity each year, causing respiratory illnesses and placing substantial burden on health care systems. The World Health Organization (WHO) estimates globally approximately 3 million to 5 million severe cases of flu each year, and 290,000-650,000 flu-related respiratory deaths. Approximately 8% of the US population experiences symptoms from flu each year, with 140,000-810,000 hospitalizations and 12,000-61,000 deaths per year. The company plans to explore potential combination vaccines against flu, severe acute respiratory syndrome coronavirus 2, respiratory syncytial virus (RSV), and human metapneumovirus (hMPV). This first-generation flu program will evaluate multiple candidates comprising multiple antigen combinations against the 4 seasonal viruses recommended by the WHO. Phase 1 clinical trials for the program are expected to begin in 2021.
- HIV vaccine (mRNA-1644 & mRNA-1574): HIV, the virus responsible for AIDS, infects approximately 2 million new individuals worldwide every year and approximately 690,000 people die annually due to complications from HIV/AIDS. mRNA-1644, a collaboration with the International AIDS Vaccine Initiative and the Bill and Melinda Gates Foundation, is a novel approach to HIV vaccine strategy in humans designed to elicit broadly neutralizing HIV-1 antibodies (bNAbs). A phase 1 study for mRNA-1644 will use iterative human testing to validate the approach and antigens and multiple novel antigens will be used for germline-targeting and immuno-focusing. A second approach, mRNA-1574, is being evaluated in collaboration with the National Institutes of Health (NIH) and includes multiple native-like trimer antigens. Moderna expects to begin phase 1 clinical trials for both mRNA-1644 and mRNA-1574 in 2021.
- Nipah virus (NiV) vaccine (mRNA-1215): NiV is a zoonotic virus transmitted to humans from animals, contaminated food, or through direct human-to-human transmission and causes a range of illnesses including fatal encephalitis. Severe respiratory and neurologic complications of NiV have no treatment other than intensive supportive care. The case fatality rate among those infected is estimated at 40%-75%. NiV outbreaks cause significant economic burden to impacted regions due to loss of human life and interventions to prevent further spread, such as the slaughter of infected animals. NiV has been identified as the cause of isolated outbreaks in India, Bangladesh, Malaysia, and Singapore since 2000 and is included on the WHO R&D blueprint list of epidemic threats needing urgent R&D action. mRNA-1215 was co-developed by Moderna and the NIH’s Vaccine Research Center.
According to Moderna, the company accelerated its infectious disease portfolio based on the company’s experience with the COVID-19 vaccine, which continues to make inroads around the world.1 Today, Moderna announced it has added Switzerland to its list of countries and international agencies that have authorized mRNA-1273.2
Swissmedic, the Swiss Agency for Therapeutic Products, gave its temporary authorization according to the ordinary approvals procedure and based on a rolling submission of data and the totality of scientific evidence shared by Moderna, which includes a data analysis from the phase 3 COVE clinical study.2,3
"The rapid, but at the same time conscientious, review in the rolling procedure has proved very successful. This is another important step forward in enabling a large proportion of the population in Switzerland to be vaccinated quickly against COVID-19," said Raimund Bruhin, executive director, Swissmedic, in a prepared statement.3
The Swiss Federal Government has secured 7.5 million doses of the Moderna’s COVID-19 vaccine. Following today’s authorization, the first deliveries are expected to begin in Switzerland in the next week.2
Granted an Emergency Use Authorization by the FDA on December 18, 2020, for use in adults aged 18 years and older, mRNA-1273 has also been authorized by Canada, Israel, the United Kingdom, and the European Union, which has 27 member states. Additional authorizations are currently under review in other countries, including Singapore.1,2
In addition to Moderna’s advancement of the COVID-19 vaccine and its 3 new vaccine programs, the company has expanded its RSV vaccine program into older adults. According to Bancel, the company is also extending its mRNA development work to a total of 24 programs across 5 therapeutic areas 1
“The uniquely challenging year of 2020 for all of society proved to be an extraordinary proof-of-concept period for Moderna,” Bancel said in a press release. “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.”1
- Moderna Provides Business Update and Announces Three New Development Programs in Infectious Disease Vaccines [news release]. Cambridge, MA; January 11, 2021: Moderna. Accessed January 12, 2021. https://investors.modernatx.com/news-releases/news-release-details/moderna-provides-business-update-and-announces-three-new
- Swissmedic Authorizes COVID-19 Vaccine Moderna for Use in Switzerland [news release]. Cambridge, MA; January 12, 2021: Moderna. Accessed January 12, 2021. https://investors.modernatx.com/news-releases/news-release-details/swissmedic-authorizes-covid-19-vaccine-moderna-use-switzerland
- Swissmedic grants authorisation for the COVID-19 vaccine from Moderna [news release]. Bern, Switzerland; January 12, 2021: Swissmedic. Accessed January 12, 2021. https://www.swissmedic.ch/swissmedic/en/home/news/coronavirus-covid-19/zulassung-covid-19-impfstoff-moderna.html