LONDON – The SARS-CoV-2 variant first detected in India last year has joined those from the U.K., South Africa and Brazil as a “variant of global concern,” the World Health Organization said on May 10.
As expected, the FDA has expanded emergency use authorization (EUA) for Pfizer Inc. and Biontech SE’s COVID-19 vaccine, Comirnaty (tozinameran), to include adolescents 12 through 15 years of age, marking what Acting FDA Commissioner Janet Woodcock called "a significant step in the fight against the COVID-19 pandemic."
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biontech, Bold, Cerecor, Foghorn, Organicell Regenerative Medicine, Pfizer, Rocket, Samus.
With Monday's announcement that the U.S. FDA has expanded emergency use authorization for Pfizer and BioNtech's COVID-19 vaccine, Comirnaty (tozinameran), to include adolescents 12 through 15 years of age, and the EMA expected to follow suit in short order, the COVID vaccination campaign is expanding its age range.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bigfoot Biomedical, Conformis, Edge Surgical, Inova Diagnostics, Ortho Development, Orthofix, Think Surgical.
Novavax Inc. backed off its guidance of submitting an EUA for its COVID-19 vaccine in June, pushing the anticipated date to this fall. “We expect to complete regulatory filings in the third quarter,” Stan Erck, Novavax’s president and CEO, told investors on a May 10 conference call. “We hope to have market authorizations in multiple countries in the third quarter, as early in the quarter as possible.”
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amgen, Ampio, Astrazeneca, Biocorrx, Eagle, Kyowa Kirin, Liquidia, Merck, Mustang, Pfizer, Smart.
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