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AstraZeneca’s COVID-19 vaccine candidate, AZD1222, currently being evaluated in phase 3 global trials, delivers a strong immune response, according to a new UK study. Read More
The FDA’s Vaccines and Related Biological Products Advisory Committee took no action Thursday after a lengthy discussion of the agency’s COVID-19 vaccine requirements, considerations for continuing blinded phase 3 trials after an Emergency Use Authorization (EUA) is issued and postmarket studies. Read More
More than two dozen researchers and experts have penned a letter to HHS Secretary Alex Azar, National Institutes of Health (NIH) officials and pharma company executives, imploring them to shed more light on the clinical trial designs for federally funded COVID-19 vaccine studies. Read More
Brazil’s health regulator ANVISA (Agência Nacional de Vigilância Sanitária) disclosed Wednesday that a participant had died in AstraZeneca’s Brazilian late-stage COVID-19 vaccine trial, though the UK drugmaker said the incident was not grounds for stopping the study. Read More
The British government has entered into a contract to conduct human challenge trials in which participants will be deliberately infected with COVID-19 to bolster development of a vaccine. Read More
The National Institutes of Health (NIH) is starting a late-stage trial of two existing drugs and one investigational agent to assess their potential to control cytokine storm, an immune system overreaction in COVID-19 patients. Read More
Pfizer will not be ready to submit an Emergency Use Authorization (EUA) application for its COVID-19 vaccine candidate until late in November, CEO Albert Bourla has announced, despite his previous projections of possibly filing for an EUA this month. Read More
Gilead Sciences has rejected early findings from the World Health Organization’s Solidarity trial showing four antivirals, including remdesivir, had “little or no effect” on hospitalized COVID-19 patients, criticizing the trial’s design and expressing concern that the data hadn’t gone through a peer review. Read More
UK-based contract research organization Open Orphan said it is in advanced negotiations with the British government and other partners for a human challenge trial of a COVID-19 vaccine. Read More