AstraZeneca, Johnson & Johnson Vaccine Trials Back on Track in US

The Quint
·2-min read

Even as the COVID-19 pandemic continues across the world, the clinical trials for two major vaccine candidates by drugmakers AstraZeneca as well as Johnson & Johnson got back on track in the United States on Friday, 23 October.

AstraZeneca announced that the trial of its vaccine candidate, developed with the UK’s University of Oxford, had resumed in the US where it remained suspended after a volunteer fell sick over a month ago, AFP reported.

“The Food and Drug Administration (FDA) today authorised the restart in the US, following the resumption of trials in other countries in recent weeks,” AstraZeneca said in a statement on Friday, adding that the body had reviewed all safety data from trials globally and concluded resuming the trial was safe.

The trial had been suspended across the world on 6 September but resumed shortly afterwards in the UK after the Medicines Health Regulatory Authority (MHRA) certified that it was safe to do so.

Also Read: FAQ: Why Oxford-AstraZeneca Trials Were Halted & Restarted?

Other countries such as South Africa, Brazil and Japan followed suit soon after, as authorities concluded that the illness was not linked to the vaccine, AFP reported.

The AstraZeneca vaccine is at one of the most advanced stages of development compared to other vaccines in the world.

Johnson & Johnson to Resume Trial

Meanwhile, Johnson & Johnson also said on Friday that it was preparing to resume recruitment for its clinical trial. The trial for the Johnson & Johnson COVID-19 vaccine had been temporarily halted after a participant became ill, reports had said on 13 October.

"After a thorough evaluation of a serious medical event experienced by one study participant, no clear cause has been identified," the drugmaker said in a statement, according to AFP.

"“The company has found no evidence that the vaccine candidate caused the event.”" - Johnson & Johnson statement

The trial was in Phase 3, and had started recruiting participants in late September. A company statement had said last week that the patient's condition was being reviewed and evaluated by the ENSEMBLE independent Data Safety Monitoring Board as well as internal clinical and safety physicians.

(With inputs from AFP.)

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