More than 21 months since the SARS-CoV-2 virus was first identified in Wuhan, China, the questions just keep coming, and the longer they go unanswered, the more divisive the opinions become. Controversies over the efficacy of current vaccines, over whether boosters are necessary for the general population, over the safety of COVID-19 vaccines for young children, over how to distribute the shrinking supply of highly effective monoclonal antibodies, and over how the virus originated in the first place – all of these looming questions have created a firestorm of uncertainty that will not stop burning.
When the SARS-CoV-2 virus first emerged in the U.S., the knee-jerk reaction by biopharma researchers was to make the best vaccines and therapeutics possible and to do so quickly. Since then, the number of those that have entered development has reached 1,001, more than for any other viral infection aside from HIV.
Merck & Co. Inc. and Ridgeback Biotherapeutics Inc. are planning a U.S. emergency filing for potentially the first oral antiviral for COVID-19, after a phase III trial showed molnupiravir cut risk of hospitalization or death by around 50%.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alzamend, Alzinova, Basilea, Bexion, Cantargia, Diamedica, Glenmark, Immix, Jubilant, Liscure, Mirum, Pfizer, Reata, Selecta, TG.
LONDON – Industry-sponsored clinical research in the U.K. took a big hit in the pandemic and is still struggling to catch up – and to capitalize on innovative trial designs and delivery approaches that were so successful in speeding up COVID-19 studies.
LONDON – It is both safe and effective for people to receive an influenza vaccine at the same time as a COVID-19 vaccine, with no negative impacts on the strength of the immune response produced by either vaccine and reported side effects mainly mild to moderate. Only nine of 679 participants in a U.K. study testing combinations of different flu and COVID-19 vaccines said they would not want to have two different vaccines at the same time in the future. Six of those were in the control arm of the trial, in which saline was injected as a placebo.