Dec. 21-23 COVID-19 roundup: U.S. secures 100M more doses of Pfizer-BioNTech vaccine; plus Merck, BioCryst, CureVac, NIH and Sputnik V
U.S. secures an additional 100M doses of Pfizer-BioNTech vaccine
Pfizer Inc. (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) entered an agreement to supply the U.S. government with an additional 100 million doses of BNT162b2 for $1.95 billion, bringing the total to 200 million doses. Because the vaccine requires two doses, that’s enough to vaccine 100 million people, less than a third of the U.S. population. The partners expect to complete delivery of all of the doses by July 31, 2021. The U.S. has an option to acquire up to an additional 400 million doses of the mRNA vaccine.
U.S. enters $356M supply agreement for Merck treatment
Merck & Co. Inc. (NYSE:MRK) received $356 million up front to manufacture and supply 60,000 to 100,000 doses of MK-7110 (formerly CD24Fc) to the U.S. government through June 30, 2021, should the therapy gain an approval or emergency use authorization from FDA. The recombinant fusion protein comprises the extracellular domain of CD24 linked to an IgG1 Fc domain and is in Phase III testing to treat patients with severe and critical COVID-19. Merck gained the program through its $425 million takeout of OncoImmune Inc. last month.
BioCryst’s galidesivir shows no clinical benefit in COVID-19
BioCryst Pharmaceuticals Inc. (NASDAQ:BCRX) said its broad-spectrum viral RNA polymerase inhibitor galidesivir did not demonstrate a clinical benefit versus placebo in a dose-ranging study in patients with moderate-to-severe COVID-19. The company expects the National Institute of Allergy and Infectious Diseases (NIAID) to discontinue support for the antiviral in COVID-19, but continue funding its development against other biodefense threats including Marburg virus disease.
CureVac begins Phase III testing of vaccine in healthcare workers
CureVac N.V. (NASDAQ:CVAC) began a Phase III trial of its COVID-19 vaccine, CVnCoV, in healthcare workers. The study will enroll more than 2,500 participants 18 years of age and older. The pivotal Phase IIb/III HERALD study of the two-dose mRNA vaccine is ongoing and will enroll more than 35,000 participants; initial data could come in 1Q21.
NIH RADx initiative awards more than $107M to support 49 testing projects
NIH’s Rapid Acceleration of Diagnostics (RADx) initiative awarded more than $107 million across 49 research projects to support “non-traditional approaches” and repurposed tools to address gaps in COVID-19 testing and surveillance, including biological or physiological markers of COVID-19, analytical platforms with novel chemistries or engineering, rapid detection strategies, point-of-care devices and home-based testing technologies. Of this, up to $20 million will go to academic groups developing approaches for identifying children at high risk for COVID-related multisystem inflammatory syndrome.
Sputnik V vaccine receives EUA in Argentina
Argentina has become the first Latin American country to grant emergency use authorization to the Sputnik V vaccine from Russia’s Gamaleya National Center of Epidemiology and Microbiology. The viral vector vaccine had 91.4% efficacy, based on 78 confirmed cases, in a Phase III trial in Russia; additional trials were not conducted in Argentina. On Dec. 10, the Russian Direct Investment Fund (RDIF) agreed to supply Argentina 10 million doses of the two-dose vaccine.