Group items tagged

French drugmaker Sanofi said on Monday (June 13) an upgraded version of the Covid-19 vaccine candidate it is developing with GSK showed potential in two trials to protect against the virus's main variants of concern, including the Omicron BA.1 and BA.2 strains, when used as a booster shot. While the two companies' first experimental Covid shot is undergoing review by the European Medicines Agency, Sanofi and GSK have continued work on a vaccine that is moulded on the now-supplanted Beta variant, hoping still that it will confer broad protection against future viral mutations. Sanofi said this new vaccine candidate was shown to significantly boost antibody levels against a number of variants of concern, when given to trial participants who had an initial course of mRNA vaccines, a type made by BioNTech-Pfizer and Moderna. In a separate trial conducted by a French hospitals network, Sanofi's Beta-adapted booster shot triggered a higher immune response than Sanofi's first-generation shot or Pfizer-BioNTech's established vaccine in previously vaccinated volunteers.

Pharmaceutical giant GlaxoSmithKline aims to get its respiratory syncytial virus (RSV) vaccine to regulators for review later this year, after interim data showed the vaccine was effective in a keenly-watched late-stage study involving older adults. RSV is a leading cause of pneumonia in toddlers and the elderly, but the complex molecular structure of the virus and safety concerns have stymied efforts to develop a vaccine since the virus was first discovered in 1956. Companies including Pfizer, J&J, Sanofi, Moderna and AstraZeneca are also racing to get an RSV therapy or vaccine approved. The latest GSK trial is the first to show statistically significant efficacy for RSV in adults aged 60 years and older, the British drugmaker said of the ongoing study on Friday (June 10). If approved, the RSV vaccine is expected to generate billions for GSK, which is already the world's biggest vaccine maker by sales but has faced pressure from activist investors such as Elliott Management who have urged the London-based company to shore up its drug pipeline.

GlaxoSmithKline and Sanofi said on Wednesday (December 15) they expect data from late-stage clinical trials of its booster dose of their Covid-19 vaccine candidate in the first quarter, instead of this year, another delay for the potential shot. The news came as two companies said preliminary data from trials showed the single-dose booster provided strong immune responses. They added that they need more time to test the booster on more people who have not been infected by the virus before they can submit data to regulators. The Phase III trial for the recombinant adjuvanted Covid-19 vaccine recruited most participants in the third quarter, coinciding with a significant increase in the number of people infected globally due to the Delta variant, it said. "To provide the necessary data to regulatory authorities for the booster vaccine submission, the trial will continue to accrue the number of events needed for analysis, with results expected in Q1, 2022." No safety concerns were identified. This is the latest delay for the vaccine's development, putting the companies further behind rivals in the race for Covid-19 shots.