A large, Phase 3 study testing a Covid-19 vaccine being developed by AstraZeneca and the University of Oxford at dozens of sites across the U.S. has been put on hold due to a suspected serious adverse reaction in a participant in the United Kingdom.A spokesperson for AstraZeneca, a frontrunner in the race for a Covid-19 vaccine, said in a statement that the company’s “standard review process triggered a pause to vaccination to allow review of safety data.”
In a follow-up statement, AstraZeneca said it initiated the study hold. The nature of the adverse reaction and when it happened were not immediately known, though the participant is expected to recover, according to an individual familiar with the matter. The spokesperson described the pause as “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.” The spokesperson also said that the company is “working to expedite the review of the single event to minimize any potential impact on the trial timeline.”
LabCorp to Launch Single Home Swab Test Spanning COVID-19, Flu, RSV
LabCorp announced plans to launch a new at-home COVID-19 diagnostic that allows people to also get tested for the flu and respiratory syncytial virus from a single sample.The combined test is currently offered through doctors’ offices, hospitals and other healthcare providers, while the future, home-based version will be made available through LabCorp’s Pixel service, pending the FDA’s review and authorization.“The U.S. is facing the most challenging health crisis in a century and is about to enter flu season, which has the potential to put additional strain on our healthcare system and cost lives,” said Brian Caveney, LabCorp Diagnostics’ president and chief medical officer.
“Individuals infected with COVID-19, influenza A / B, or RSV, often experience similar symptoms of cough, fever, chest tightness, and body aches, providing a potential surge of patients seeking testing,” Caveney said.Last year’s flu season, spanning October 2019 through this past March, totalled between 39 million and 56 million cases and 18 million to 26 million medical visits, according to estimates from the Centers for Disease Control and Prevention. Today, the current U.S. total for COVID-19 infections stands at over 6.3 million, with nearly 190,000 deaths, while adding about 40,000 confirmed cases per day according to international health organizations.