An ongoing evaluation of heart muscle inflammation risk, a key concern with mRNA COVID-19 vaccines globally, could delay through January 2022 completion of an FDA review of Moderna Inc.'s vaccine in adolescents 12 to 17 years of age. The side effect, called myocarditis, has been a particular concern with regulators, especially for adolescents and young men.

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, ANI, Antengene, Bionomics, Biontech, Cocrystal, Coherus, Gannex, Hyloris, Incyte, Immutep, Junshi, Medac, Medexus, Moderna, Novartis, Novavax, Orphazyme, Pfizer, Sesen, Sio Gene, Sorrento, Synthekine, Theseus.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alzheon, Astrazeneca, Atai, Cabaletta, Calithera, Centessa, Corium, Daiichi, Eiger, Hutchmed, Idorsia, Janssen, Merck, Neurocrine, Novatek, Rhizen, Rivus, Teva, Todos.

The FDA has granted emergency use authorization (EUA) to the COVID-19 vaccine created by Pfizer Inc.-Biontech SE for use in children ages 5 through 11. This is the first EUA for a COVID-19 vaccine to be awarded for this group of roughly 28 million children in the U.S. and it comes after weeks of lengthy debate among experts about the wisdom of targeting the young demographic.

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Agilent, Detect, Renovia.

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: ADC, Akebia, Boehringer, Cytodyn, HCW, Huya, Immunoforge, Immutep, Impact, Kite, Neuroene, Novavax, Oramed, Pfizer, RDIF, Reata, Regeneron, Sanofi, Spero, TFF, Vertex, Viiv.

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aivita, Awakn, Biontech, Bridgebio, Curacle, Eton, Gilead, Innovent, Merck, Neocura, Pfizer, Polyphor, PF Argentum, Trillium.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abbvie, Alnylam, Alphamab, Alzinova, Arca, Candel, Context, Edgewise, Hutchmed, Immunic, Inventiva, Landos, Meissa, Optinose, Rafael, Paxmedica, Revolo, Sorrento, Talaris.

Plants could be an alternative vaccine platform for both COVID-19 and future pandemics, shaking up a biologics sector that is currently mostly protein-based. South Korean company Bioapplications Inc., for example, is aiming to have a plant-derived booster shot for COVID-19 in the clinic in 2022.