With the FDA’s granting of emergency use authorization (EUA) to Johnson & Johnson (J&J), there is now a third vaccine – and the first requiring only a single shot – against COVID-19 for adult Americans. Though it packs less of an efficacy punch, the EUA allows J&J’s Ad26.COV2.S to join mRNA vaccines from Moderna Inc. and Pfizer Inc./Biontech SE as protection against the virus.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Anokion, Boehringer Ingelheim, Chinook, Claritas, Clene, Enlivex, Evotec, Gubra, Homology, Hoth, Kalytera, Novartis, Uppthera.
A new study by Mayo Clinic and Nference Inc. researchers suggests that prior childhood and adult vaccinations for illnesses such as polio, measles and flu may provide protection against COVID-19 infection. The study, which analyzed patient data using Nference artificial intelligence (AI) software, underscores the critical role immunizations play in curbing the spread of diseases and preventing future pandemics. “What we discovered represents compelling evidence that vaccinations are a critical element in prevention of disease, even diseases one doesn’t anticipate,” said Venky Soundararajan, co-founder and chief scientific officer of the Cambridge, Mass.-based company.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aquarius Surgical Technologies, Healthmode, Htg Molecular Diagnostics, Inventiva, Materials and Machines, Medi-Tate, Mesa Biotech, Mind Medicine, Olympus, Picnichealth, Sirtex Medical, Surgical Lasers, Thermo Fisher, Vela Diagnostics.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Fusion Robotics, Roche.
China’s National Medical Products Administration granted conditional approval two Chinese-developed COVID-19 vaccines in less than 24 hours on Feb. 25. One of the vaccines approved was developed by Tianjin-based Cansino Biologics Inc., and the other by China National Pharmaceutical Group (Sinopharm) through its Wuhan Institute of Biological Products subsidiary.
As expected, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) looked favorably upon the latest COVID-19 entry: Ad26.COV2.S, a one-shot product that emerged from the same Johnson & Johnson (J&J) platform, AdVac, that let the firm devise an Ebola vaccine cleared in Europe last year.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biocryst, Biontech, BMS, Exelixis, GC, GW, Harbour, Incyte, Opko Health, Pfizer, PTC, Regeneron, Roche, Sarepta, Tricida.
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