LONDON – The latest data from the large-scale randomized U.K. COVID-19 infection survey confirm vaccines are less effective against the Delta variant of SARS-CoV-2 that is now dominant across the U.S., Europe and elsewhere in the world.
The FDA’s emergency use authorization (EUA) program is still active in the area of tests and test kits, which is due in part by the emergence of the Delta variant of the SARS-CoV-2 virus and the associated warnings that the effectiveness of vaccines may be declining. One example of the sustained emphasis on testing is the EUA granted to Thermo Fisher Scientific Inc. for two PCR test kits that can detect the latest variants of the virus, a demonstration that the demand for these updated tests seems unlikely to ebb anytime soon.
Plans for offering COVID-19 vaccine booster shots in the U.S. took a big step forward Aug. 18, as Health and Human Services (HHS) public health and medical experts laid out their intention to offer booster shots across the country for people 18 and older beginning the week of Sept. 20 and starting eight months after an individual's second dose.
Exevir Bio NV is honing its attack on the crowded market for COVID-19 antibodies, beginning clinical development of a potential subcutaneously administered drug targeting outpatients with early symptoms who are at risk of further progression.
LONDON – Researchers at Birmingham University are looking for commercialization partners after finding a happy medium between the speed but limited accuracy of COVID-19 lateral flow antigen tests, and the use of slower but more accurate PCR and other RNA amplification diagnostics.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Globus Medical, Spectrum Solutions.
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