Johnson & Johnson, AstraZeneca to resume trial for Covid-19 vaccine

AstraZeneca Plc and Johnson & Johnson plan to resume Covid-19 vaccine clinical trials that had been halted by U.S. regulators, putting research into two of the leading candidates for a coronavirus inoculation back on track.
 

Johnson & Johnson said in a statement Friday it is preparing to resume recruitment in a late-stage trial of its vaccine after consultation with the U.S. Food and Drug Administration. An independent data safety monitoring board recommended the trial continue. The study was paused earlier this month after a patient became sick, but the company said no clear cause of the illness had been identified.

Earlier, AstraZeneca said it had been cleared by the FDA to restart a trial that had been halted in the U.S. after a volunteer participating in a U.K. trial of the shot had fallen ill. The company said the agency had reviewed data from global studies and decided it was safe to proceed.

Allowing the studies to go forward removes a shadow that had been hanging over the effort to find a vaccine in recent weeks. The AstraZeneca trial had been in limbo for more than a month, while J&J’s study had been paused since Oct. 12. The companies are among the front-runners in the quest for a vaccine, alongside rivals Pfizer Inc. and Moderna Inc.

In the meantime, the virus that has killed more than 1.1 million people worldwide is once again gathering steam, with case counts jumping in Europe and across the U.S. More than 1,000 people were in the hospital in New York as a result of the virus on Friday, the most since June.

Blinded Study

J&J is studying its candidate in a 60,000-person trial that is expected to read out data before the end of the year. The company has suggested it could approach U.S. regulators for an emergency-use authorization as soon as the outset of 2021.

The New Brunswick, New Jersey-based health-care giant paused the trial after learning about the volunteer’s serious illness. During the pause, in addition to its own careful review, J&J also had three independent outside medical consultants analyze what happened in detail, said Paul Stoffels, J&J’s chief scientific officer.

“We have found no evidence it was linked to the vaccine,” Stoffels said. Pauses due to adverse events are quite common in big trials, he said.

Stoffels said trial sites should be up and running again by Monday, resulting in only limited delay. Even during the pause, the company continued with logistical work to get more trials sites supplied and ready.

Stoffels said patient privacy rules prevented him from disclosing the nature of the serious adverse event. The company also declined to disclose whether the volunteer who got sick received the vaccine or not, because the trial is still blinded.

Disclosure Pressure

Questions have swirled around the AstraZeneca shot since an announcement in September that a participant in a U.K. study had developed an unexplained illness. Since then, the drugmaker and its partner, the University of Oxford, have faced pressure to disclose more information about the episode. While countries including Brazil, South Africa and the U.K. had let trials of the vaccine resume, the U.S. continued with its review.

The interruption raised concerns about the prospects of one of the fastest-moving shots and highlighted the hurdles researchers face when developing a vaccine. Moncef Slaoui, the head of the Operation Warp Speed program that is racing to develop shots in the U.S., said in an interview earlier this week that the trials could resume in the coming days.

AstraZeneca said in a statement Friday that it isn’t unusual for some participants to become unwell in large-scale vaccine trials. Results from its late-stage trials are anticipated later this year, the company said.

“We should be reassured by the care taken by independent regulators to protect the public and ensure the vaccine is safe before it is approved for use,” Chief Executive Officer Pascal Soriot said.