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BioWorld - Monday, January 26, 2026
Home » Topics » Infection » Coronavirus

Coronavirus
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Janssen COVID-19 vaccine vial

FDA adcom unanimously supports a booster for Janssen’s COVID-19 vaccine

Oct. 15, 2021
By Lee Landenberger
The FDA’s Vaccines and Related Biological Products Advisory Committee unanimously agreed to recommend a booster dose of Janssen Biotech Inc.’s COVID-19 vaccine for those age 18 years and older at least two months following the first dose. In the end, the vote swung on numbers from Janssen showing a booster significantly improved efficacy among study participants. Janssen’s data leaped to 94% protection after a booster dose, up from 70% efficacy following the first dose. That higher efficacy rate nearly matches that of the mRNA vaccines from Moderna Inc. and Pfizer Inc.-Biontech SE.
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Hands holding gears

BIA Autumn Forum: Keep collaboration, innovation momentum post-pandemic, new UK science minister urges

Oct. 14, 2021
By Nuala Moran
LONDON – After the hard, solitary slog through months of pandemic, U.K. biotech finally convened in person, buoyed by the contribution the sector has made to dealing with COVID-19, and evidently pleased to be face-to-face once more.
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Moderna COVID-19 vaccine

Unanimous booster vote more a desire to avoid confusion

Oct. 14, 2021
By Mari Serebrov
Given the FDA’s Vaccines and Related Biological Products Advisory Committee’s unanimous vote last month to recommend use of a booster dose of the Pfizer Inc.-Biontech SE COVID-19 vaccine in certain high-risk groups, it came as no surprise when the committee again voted unanimously Oct. 14 for a mirror use of Moderna Inc.’s proposed booster.
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Regulatory actions for Oct. 14, 2021

Oct. 14, 2021
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adocia, Algernon, Asieris, Beigene, Blade, Cantargia, Eli Lilly, Homology, Kadimastem, Lundbeck, Merck, Otsuka, Pharmather, Regeneron, Revance, Roche, Sanofi, Sorrento, Viridian.
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Other news to note for Oct. 14, 2021

Oct. 14, 2021
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aluda, Ardelyx, Augmenta, Aurigene, Biolinerx, Biomx, BMS, Eli Lilly, Emerald, Eqrx, Evotec, Exelixis, Graphite, Hemogenyx, HNF, Lixte, Maruho, NLS, Omega, Pasithea, Rarebase, Regulus, Skye, Stanford, Storm, Synlogic, Teva, Turning Point.
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In the clinic for Oct. 14, 2021

Oct. 14, 2021
Clinical updates, including trial initiations, enrollment status and data readouts and publications: 60 Degrees, Alimera, Anavex, Apnimed, Atara, Biogen, BMS, Brainstorm, Crispr, EMD, Eyepoint, Faraday, First Wave, Genentech, Horizon, I-Mab, Immune-Onc, Immunitybio, Neoimmunetech, Neurobo, Oncolytics, Oryzon, Outlook, Resverlogix, Rhizen, Sanofi, Smart Immune, TC, Tizona, Ultimovacs, Union, VBI, Veru, Vistagen.
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Syringe with Johnson & Johnson logo

FDA briefing docs build stronger case for 2nd J&J vaccine dose

Oct. 13, 2021
By Mari Serebrov
Should Johnson & Johnson’s (J&J) COVID-19 vaccine be a two-dose series? While not directly asked, that question almost lurks between the lines of the FDA’s briefing document for the Oct. 15 meeting of its Vaccines and Related Biological Products Advisory Committee. The document referred to J&J’s proposed second dose as a “booster,” but the FDA isn’t asking the committee the questions it posed for the Moderna Inc. and Pfizer Inc.-Biontech SE boosters. Instead, it is inviting VRBPAC to advise on whether the second J&J dose should be administered two months or six months following the first shot.
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ECTRIMS opens: Biogen therapies did not reduce COVID-19 antibody responses in MS patients

Oct. 13, 2021
By Lee Landenberger
Biogen Inc. opened the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) virtual meeting with data showing those treated with its multiple sclerosis (MS) therapies had an effective antibody response to COVID-19 vaccination.
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Regulatory actions for Oct. 13, 2021

Oct. 13, 2021
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Corium, Curevac, Deciphera, Gensight, Hoth, Intelgenx, Nrx, Ocular, Protara, Sofie, Viiv.
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Other news to note for Oct. 13, 2021

Oct. 13, 2021
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aavantibio, ABVC, Acceleron, Agenus, Albireo, Betterlife, Bionova, Biolite Japan, Bristol-Myers Squibb, Emmaus, Fosun, Helsinn, Jadeite, Kainos, Merck, Mission, Rxcell, Sapience, Sutro, Titan.
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