AstraZeneca, the U.K.-based pharmaceuticals giant, said on Tuesday that it would pause the clinical trial of the coronavirus vaccine it is developing with the University of Oxford after a British subject became ill. The decision will affect the so-called Phase 3 trials the company just started by enrolling 30,000 volunteers in the U.S., after recruiting 10,000 subjects in the U.K. over the summer.
- AstraZeneca /zigman2/quotes/203048482/delayed UK:AZN +1.66% seemed destined to become the first company to deliver a vaccine it said it would be ready to manufacture in the fall, if the trials proved conclusive and the drug was approved. After the latest incident, an independent committee will now review safety data before the trials can resume.
- The U.K. company’s shares fell more than 1% on Wednesday on the news, in generally positive European markets as measured by the Stoxx 600 /zigman2/quotes/210599654/delayed XX:SXXP -0.57% index.
- U.K. health secretary Matt Hancock said on Wednesday in an interview that the pause in AstraZeneca’s trial would not necessarily be a “setback” and that it was a “normal part of a vaccine development.” Hancock added that “It’s not actually the first time it has happened to the Oxford vaccine and it’s a standard process in clinical trials.”
- Before the AstraZeneca announcement, its chief executive and the top executives of eight other big pharmaceutical companies — BioNTech /zigman2/quotes/214419716/composite BNTX +2.85% , GlaxoSmithKline /zigman2/quotes/209463850/composite GSK +1.54% , Johnson & Johnson /zigman2/quotes/201724570/composite JNJ +1.13% , Merck /zigman2/quotes/209956077/composite MRK -0.25% , Moderna /zigman2/quotes/205619834/composite MRNA -1.47% , Novavax /zigman2/quotes/202614340/composite NVAX +3.74% , Pfizer /zigman2/quotes/202877789/composite PFE +0.19% , and Sanofi /zigman2/quotes/209072534/delayed AT:SANO -0.54% — had pledged on Tuesday that they would “ unite to stand with science ” and only seek approval of a COVID-19 vaccine “after demonstrating safety and efficacy” through a Phase 3 clinical study.
- Big Pharma’s unusual statement comes amid concerns that the Trump administration may try to push one or more COVID-19 vaccines through the approval process, such as by granting an emergency-use authorization sooner than science might dictate, in order to gain an advantage in the presidential election.
The outlook: AstraZeneca’s setback is just one example of the type of cold showers that may pour on heightened vaccine hopes in the next few months. In a U.S. election year and as the virus is spiking again in Europe, the pharmaceutical companies want to ensure that politics won’t interfere with science — and safety. And that governments won’t try to rely on them as good-news providers in an otherwise gloomy autumn context.