Yesterday media were informed that the US Department of Health and Human Services and Department of Defense will purchase 100 million doses of mRNA-1273, COVID-19 vaccine candidate, from Moderna. According to general estimates, the purchase of such a quantity of vaccine will cost $1.5 billion.
Moderna COVID-19 Vaccine
Moderna is an American biotechnology company focused on drug discovery, drug development, and vaccine technologies based exclusively on messenger RNA (mRNA). It is headquartered in Cambridge, Massachusetts. Moderna specializes at mRNA (messenger RNA). We should to remember that earlier a few pharmaceutical and biotechnology companies refused to use mRNA, because were unable to overcome the side effects of inserting RNA into cells. Need to be added that in May 2020, no mRNA drug has been approved for human use.
As stated in the press release, “Americans will receive mRNA-1273 at no cost for the vaccine itself. As is customary with government-purchased vaccines, healthcare professionals could charge for the cost of administering the vaccine”.
To date, mRNA-1273, which was co-developed by Moderna and investigators from the National Institute of Allergy and Infectious Disease’s (NIAID) Vaccine Research Center the first 2 phases continue to be tested.
The Phase 3 COVE study of mRNA-1273, being conducted in collaboration with the National Institutes of Health and the Biomedical Advanced Research and Development Authority (BARDA), began on July 27; enrollment is on track to complete in September.
Results from a non-human primate pre-clinical viral challenge study evaluating mRNA-1273 were recently published in The New England Journal of Medicine.
According to preliminary agreement the US government a ready to buy up to an additional 400 million doses of mRNA-1273 from Moderna.
Besides Moderna the US government were purchased vaccines from companies such as: GlaxoSmithKline and Sanofi, Pfizer, Novavax, Johnson & Johnson, and AstraZeneca, according to Warp Speed Operation.
Warp Speed Operation
Operation Warp Speed (OWS) aims to deliver 300 million doses of a safe, effective vaccine for COVID-19 by January 2021, as part of a broader strategy to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics (collectively known as countermeasures).
Stéphane Bancel, Moderna’s Chief Executive Officer said “We appreciate the confidence of the U.S. government in our mRNA vaccine platform and the continued support. 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.”
At the press-relies were also announced results from an ongoing phase 1. According to this study volunteers need to use a 2-dose vaccination schedule of mRNA-1273 given 28 days apart across 3 levels. The vaccine was tested on 45 healthy adult people ages 18 to 55 years old.
Results said mRNA-1273 elicited robust neutralizing antibody titers after 2 vaccinations. The vaccine was also shown to be generally safe and well tolerated in participants. 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.