Jennifer Barrett is the senior editor for Drug Topics® and Total Pharmacy®.
The US government and Moderna are collaborating to produce 100 million doses of investigational COVID-19 vaccine candidate mRNA-1273.
The US Department of Health and Human Services and Department of Defense announced today an agreement with Moderna to purchase 100 million doses of mRNA-1273, Moderna’s coronavirus disease 2019 (COVID-19) vaccine candidate, for $1.5 billion, according to a press release.1
Under the terms of agreement, the US government will also have the option to buy up to an additional 400 million doses of mRNA-1273 from Moderna.1
mRNA-1273, which was co-developed by Moderna and investigators from the National Institute of Allergy and Infectious Disease’s (NIAID) Vaccine Research Center, is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein. The phase 3 COVE study of mRNA-1273, which is being conducted in collaboration with the National Institutes of Health and the Biomedical Advanced Research and Development Authority (BARDA), began on July 27, with enrollment on track to complete in September. Moderna will manufacture the vaccine doses while clinical trials are underway.1,2
Through Operation Warp Speed, the US government has now purchased initial batches of COVID-19 vaccine candidates from Moderna, GlaxoSmithKline and Sanofi, Pfizer, Novavax, Johnson & Johnson, and AstraZeneca. The goal of the program is to begin delivering 300 million doses of a COVID-19 vaccine to Americans by the end of 2020.1
“We appreciate the confidence of the US government in our mRNA vaccine platform and the continued support,” Stéphane Bancel, chief executive officer of Moderna, said in a statement.2 “We are advancing the clinical development of mRNA-1273 with the ongoing phase 3 study being conducted in collaboration with NIAID and BARDA. In parallel, we are scaling up our manufacturing capability with our strategic partners, Lonza, Catalent and Rovi, to address this global health emergency with a safe and effective vaccine.”
Moderna recently announced interim results from an ongoing phase 1 trial evaluating a 2-dose vaccination schedule of mRNA-1273 given 28 days apart across 3 levels in 45 healthy adult volunteers ages 18 to 55 years old. According to the analysis, mRNA-1273 elicited robust neutralizing antibody titers after 2 vaccinations. The vaccine was also shown to be generally safe and well tolerated in participants. According to Moderna, evaluation of the durability of the immune responses in recipients is ongoing, and participants will be followed for 1 year after the second vaccination.
For the phase 3 COVE study, investigators plan to enroll 30,000 adults to test the 100 µg dose level of the vaccine.
1. Trump Administration collaborates with Moderna to produce 100 million doses of COVID-19 investigational vaccine. News Release. HHS; August 11, 2020. Accessed August 11, 2020. https://www.hhs.gov/about/news/2020/08/11/trump-administration-collaborates-with-moderna-produce-100-million-doses-covid-19-investigational-vaccine.html
2. Moderna Announces Supply Agreement with US Government for Initial 100 Million Doses of mRNA Vaccine Against COVID-19 (mRNA-1273). News Release. Moderna; August 11, 2020. Accessed August 11, 2020. https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-supply-agreement-us-government-initial-100