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COVID-19: J&J, AstraZeneca to resume late-stage virus vaccine trials

Johnson & Johnson and AstraZeneca Plc Photo: MedicalDialogues

*2 Top contenders to restart COVID-19 vaccine trials paused after illnesses

Alexander Davis | ConsumerConnect

Sequel to the stoppage of their Coronavirus vaccine trials earlier October 2020, Johnson & Johnson and AstraZeneca Plc plan to resume virus vaccine clinical trials which the United States regulators had halted.

ConsumerConnect learnt the resumption of the exercise now puts research into two of the leading candidates for a pandemic inoculation back on track.

Johnson & Johnson in a statement Friday, October 23, 2020, disclosed that it is preparing to resume recruitment in a late-stage trial of its vaccine after consultation with the US Food and Drug Administration (FDA).

The statement indicated that an independent data safety monitoring board recommended the trial continue.

It is recalled 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 stated that it had been cleared by the FDA to restart a trial that had been halted in the US after a volunteer participating in a United Kingdom (UK) 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.

It is believed 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 October 12.

The companies are among the front-runners in the quest for a vaccine, alongside rivals Pfizer Inc. and Moderna Inc.

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 US regulators for an emergency-use authorisation 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.

Paul Stoffels, J&J’s Chief Scientific Officer, said during the pause, besides its own careful review, J&J also had three independent outside medical consultants analyse what happened in detail.

“We have found no evidence it was linked to the vaccine,” Stoffels said.

He disclosed that pauses due to adverse events are quite common in big trials.

According to J&J’s Chief Scientific Officer, vaccine trial sites should be up and running again by Monday, resulting in only limited delay.

Even during the pause, the company was said to have continued with logistical work to get more trials sites supplied and ready.

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