The U.S. FDA has given both AstraZeneca and Johnson & Johnson the green light to resume Phase 3 COVID-19 vaccine trials, both of which were paused after serious adverse events.
The Phase 3 trial for AstraZeneca’s vaccine candidate, AZD1222, developed with Oxford University, had been paused since September 6 when he company chose to halt the trial after a woman in the UK who took the vaccine came down with transverse myelitis. According to the drugmaker, following the resumption of trials in other countries in recent weeks, the FDA reviewed all safety data from trials globally and concluded it was safe to resume the trial.
J&J’s U.S. Phase 3 ENSEMBLE trial was paused two weeks ago after a participant suffered an unexplained serious medical evident. According to the drugmaker, while no clear cause for the illness has been determined, J&J found no evidence that the vaccine candidate caused the event. As such, J&J announced it will resume recruitment in the 60,000 person trial, which is evaluating a single dose of a vaccine versus placebo in adults, including significant representation from those who are over age 60.
Both potential vaccines are part of the government's Operation Warp Speed initiative. OWS leaders have pointed to the trial holds as reassurance to Americans that the highest standards are being followed.