Pfizer Inc. and Biontech SE have signed a deal with the U.S. government to supply up to 300 million doses of COVID-19 vaccines in a deal worth more than $3.2 billion. Depending on the U.S. FDA, the vaccine doses fulfilling the order may include the companies’ omicron-adapted candidate, which they reported June 25 demonstrated a high immune response against the omicron BA.1 subvariant of SARS-CoV-2, when given as a fourth booster.
South Korea’s Ministry of Food and Drug Safety has granted marketing authorization to SK Bioscience Ltd.’s COVID-19 vaccine, Skycovione (GB-510), marking the country’s first homegrown COVID-19 vaccine to be approved. The company has already signed an advanced purchase agreement with the Korea Centers for Disease Control for 10 million doses of the vaccine.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Intuitive, Siemens Healthineers.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akeso, Alx, Bristol Myers Squibb, Endevica, Freya, Inflarx, Ipsen, Obseva, Regeneron, Sanofi, Santhera, Teraimmune, Unibio.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Astellas, Biolinerx, Eli Lilly, Generian, Genfleet, Mitobridge, Novavax, Oyster Point, Scorpion.
Given that Novavax Inc.’s COVID-19 vaccine will be a latecomer to the U.S. scene if it gets FDA authorization, it’s been cast in a supporting role to the lead being played by the mRNA vaccines from Moderna Inc. and Pfizer Inc.-Biontech SE. But the data presented at the June 28 Vaccines and Related Biologic Products Advisory Committee meeting suggest the Novavax adjuvanted protein vaccine may have the chops to take on a larger role in taming the pandemic.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Moleculight, Seegene.
COVID-19 boosters for the fall should contain an omicron component, the FDA’s Vaccines and Related Biologic Products Advisory Committee (VRBPAC) said June 28, voting 19-2 to make that recommendation.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Astrazeneca, Bristol Myers Squibb, Curium, Cybin, Daiichi, Eli Lilly, Innovent, Jiangsu Recbio, Kiora, Kyowa Kirin, Merck, Noema, Prestige, Relay, Sinovac, Valneva.
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