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In a Senate hearing yesterday, National Institutes of Health Director Francis Collins applauded AstraZeneca’s decision to halt its phase 3 COVID-19 vaccine trial due to an unexplained illness — and said the incident should reassure the public that companies are not compromising when it comes to the safety of their vaccine candidates. Read More
Reports “are incorrect” that a participant in AstraZeneca’s COVID-19 vaccine trial that was paused Tuesday suffered from transverse myelitis, an AstraZeneca spokesperson told FDAnews Wednesday. Read More
Three House Democrat committee chairs are demanding that HHS Secretary Alex Azar detail how the department is gearing up for COVID-19 vaccine distribution, how it is working to increase public faith in a vaccine and how it will ensure its decisions aren’t influenced by politics. Read More
Sanofi’s chief in France, Olivier Bogillot, announced Tuesday that shots of the company’s COVID-19 vaccine candidate would likely cost below $11.80 (10 Euro) in Europe should it be approved, in the mid-range of prices that drugmakers are disclosing. Read More
After returning from a month-long congressional hiatus, Senate Majority Leader Mitch McConnell (R-Ky) unveiled a proposed coronavirus relief package on Tuesday that includes $31 billion for COVID-19 medical countermeasures. Read More
In prepared remarks at a Senate hearing today, National Institutes of Health Director Francis Collins is expected to say that there is “growing optimism” that one of the multiple COVID-19 vaccine candidates will prove safe and effective by late 2020 or early 2021. Read More
AstraZeneca has paused a late-stage trial of its promising COVID-19 vaccine candidate while it evaluates a single UK patient who may have experienced a serious adverse reaction. Read More
The pilot study will evaluate the drug’s effect on outcomes including facilitation of infection recovery, the improvement of clinical status, and the reduction in supplemental oxygen use and progression to mechanical ventilation. Read More
Multiple drugmakers have reportedly drafted a public pledge not to seek FDA approval of their COVID-19 vaccines until they meet certain safety and efficacy standards even as President Trump said a vaccine may be ready as soon as October. Read More