Celltrion Inc. recently received FDA emergency use authorization (EUA) for its Diatrust COVID-19 Ag home test. “With the FDA approval, we will now prioritize getting the test kits to the U.S. and into users’ hands as soon as possible,” a spokesperson for the Incheon, South Korea-based Celltrion told BioWorld. The test kits will be distributed through Celltrion’s U.S. arm, Celltrion USA Inc. Celltrion is currently in the final stage of negotiations with the U.S. government, as well as online and offline distributors.
The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 17-0, with one abstention, that the benefits of Pfizer Inc.-Biontech SE pediatric formulation of its two-dose COVID-19 vaccine outweigh its risks for children ages 5 through 11. Many of those votes came with caveats, as the VRBPAC members struggled with the unknowns of the vaccine and the fear that schools would mandate its use, even though it would still be considered experimental if the FDA grants it an emergency use authorization.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alkermes, Arrowhead, Avenue, Bausch, Cardiol, Clearside, Eyenovia, Merck & Co., PTC, Recce, Ridgeback.
LONDON – A U.K. study following up 32.5 million people for 28 days after their first dose of a COVID-19 vaccine has shown an increased risk of hemorrhagic stroke after receiving the Pfizer Inc./Biontech SE product, and confirmed case reports of an increased risk of developing Guillain-Barré syndrome after the Astrazeneca plc vaccine.
Interim data from a phase II/III study of Moderna Inc.’s COVID-19 vaccine show a robust antibody response in children ages 6 through 11, stronger than the one the company found in adolescents. Two 50-mcg doses given 28 days apart also produced a favorable safety profile that nearly mirrored that of adolescents and adults.
The race for a Japan-made COVID-19 vaccine is heating up as players make progress with their trials. Daiichi Sankyo Co. Ltd. recently shared the results from its phase I/II trial for DS-5670, its mRNA vaccine. The mRNA vaccine candidate initiated studies in March 2021. The findings showed that in terms of immunogenicity, both neutralizing activity and IgG titer increased after the vaccination.
LONDON – The U.K. Health Security Agency (UKHSA) has designated an offspring of the Delta variant of SARS-CoV-2 as a “variant under investigation” after uncovering some early evidence it may have an increased growth rate.
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