- AZN and Uni of Oxford COVID-19 vaccine late-stage trials paused
- "Suspected serious adverse reaction" in one participant reason for temporary halt
- Review could delay the launch or derail the efforts completely if vaccine to blame
- Dr Anthony Fauci says unlikely vaccine will be ready in time for U.S. election
British-Swedish pharma giant AstraZeneca, a frontrunner in the COVID-19 vaccine race, has made headlines by voluntarily pausing the global Phase 3 trial of the vaccine it developed with Oxford University. This was due to a "suspected serious adverse reaction" in one participant. The New York Times reported this person is part of the U.K. trials. The company said it is "a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials."
A source told STAT the finding is having an impact on the clinical trials being conducted by other vaccine manufacturers and researchers are now looking for similar cases of adverse reactions. What happens next depends on whether AZN finds the vaccine is to blame for the illness. The drug maker had expected to have a vaccine ready by the end of this year, and it's unclear how much this delay changes the timeline. Such delays are not unusual and don't mean the effort is doomed, but it's noteworthy when the whole world is waiting on a cure. Shares were 2% lower in pre-market trading.
The news of this safety review comes as concern is growing about vaccines potentially being rushed to the market prematurely for political or economic reasons. The U.S. CDC has advised states to prepare for distribution to health care workers and high-risk groups as soon as November 1. White House coronavirus advisor Dr. Anthony Fauci said Tuesday it’s more likely a vaccine will be ready by the end of the year. Almost three-quarters of healthcare industry leaders surveyed in early June believed it will not be widely available until the second half of 2021 or later. Investors can track drug and vaccine progress and updates using Goldman Sachs' chart below.
Yesterday CEOs at nine drug makers working on COVID-19 vaccines, AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax, Pfizer, and Sanofi, published a pledge they took to uphold the integrity of the scientific process and build public confidence in their efforts.
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