Home / News / World /  Coronavirus vaccine: AstraZeneca resumes Phase-3 trial in US, J&J prepares for the same

AstraZeneca has resumed the Phase-3 trial of its experimental coronavirus vaccine in US, said the US Food and Drug Administration (FDA), putting research into two of the leading candidates for a Covid-19 inoculation back on track.

Meanwhile, Johnson & Johnson is also preparing to resume its late-stage trial on Monday or Tuesday, the company said in a statement.

The development signalled progress against the deadly virus that has infected 42,952,534 people across the world, including 8,568,625 in the US and comes 10 days before a presidential election in the country that may hinge on plans to fight the novel coronavirus pandemic.

Why AstraZeneca paused its US trial

AstraZeneca -- one of the leading vaccine developers -- paused its US trial on 6 September after a report of a serious neurological illness, believed to be transverse myelitis, in a participant in the company's UK trial.

Johnson & Johnson paused its large, late-stage trial last week after a study participant became ill.

Both the firms have contracts to provide vaccine to the US and other governments if they are cleared by regulators.

Officials and experts have expressed concern that the regulatory approval process overseen by the FDA will be undermined by political pressure, and around a quarter of Americans say they are hesitant to take a coronavirus vaccine.

"As this trial resumes, I am hoping the message communicated to the public is that we are following procedures to highest ethical standard and not interfering with the FDA regulatory process," said Matthew Hepburn, head of vaccine development for Operation Warp Speed, a public-private partnership to speed inoculation efforts.

J&J said on Friday that the safety panel, called a Data and Safety Monitoring Board, has recommended that the drugmaker resume trial recruitment after finding no evidence that the vaccine caused the volunteer to fall ill.

J&J expects to resume its trial in the United States on Monday or Tuesday and remains on track to produce data from the trial on the vaccines' effectiveness by the end of 2020 or early 2021, J&J's chief scientific officer Paul Stoffels said.

J&J is also in discussions with other regulators to resume a trial outside of the United States, the company said.

So far, the medical board has not identified a clear cause for the patients' illness. J&J cannot reveal any details about the patient's sickness because of patient privacy rules, Stoffels said.

AstraZeneca said that it is not unusual for some trial participants to fall ill during large scale vaccine trials but that the U.S. Food and Drug Administration has reviewed all safety data from the trials globally and deemed it safe to continue testing the vaccine.

AstraZeneca vaccine trials, which is being developed along with researchers at Oxford University, in the United Kingdom, Brazil and South Africa resumed last month even as the US FDA continued its probe into the case.

Reuters earlier this week reported that the FDA had completed its review and that the AstraZeneca U.S. trial was set to resume as early as this week, citing four sources familiar with the situation.

Global Covid cases top 42.5 mn

The overall number of global coronavirus cases has topped 42.5 million, while the deaths have soared to more than 1,148,940, according to the Johns Hopkins University.

As of Sunday morning, the total number of cases stood at 42,532,198, while the death toll surged to 1,148,943, the University's Center for Systems Science and Engineering (CSSE) revealed in its latest update.

The US is the worst-hit country with the world's highest number of cases and deaths at 8,571,943 and 224,771, respectively, according to the CSSE.

India comes in second place in terms of cases at 7,814,682, while the country's death toll soared to 117,956.

With agency inputs

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