Left Menu
Development News Edition

EXCLUSIVE-AstraZeneca U.S. COVID-19 vaccine trial may resume as soon as this week -sources

The agency is requiring researchers conducting the trial to add information about the incident to consent forms signed by study participants, according to one of the sources. UK regulatory officials previously reviewed the illness and determined there was “insufficient evidence to say for certain” that it was or was not related to the vaccine.

Reuters | Updated: 20-10-2020 22:39 IST | Created: 20-10-2020 22:10 IST
EXCLUSIVE-AstraZeneca U.S. COVID-19 vaccine trial may resume as soon as this week -sources
Representative image Image Credit: Wikimedia

AstraZeneca Plc's COVID-19 vaccine trial in the United States is expected to resume as early as this week after the U.S. Food and Drug Administration completed its review of a serious illness, four sources told Reuters.

AstraZeneca's large, late-stage U.S. trial has been on hold since Sept. 6, after a participant in the company's UK trial fell ill with what was suspected to be a rare spinal inflammatory disorder called transverse myelitis. The sources, who were briefed on the matter but asked to remain anonymous, said they have been told the trial could resume later this week. It was unclear how the FDA would characterize the illness, they said.

The FDA did not respond to a request for comment. The agency is requiring researchers conducting the trial to add information about the incident to consent forms signed by study participants, according to one of the sources.

UK regulatory officials previously reviewed the illness and determined there was "insufficient evidence to say for certain" that it was or was not related to the vaccine. It permitted the trial to resume enrolling participants in the UK, according to a draft of the updated consent form shared with Reuters. "In this case, after considering the information, the independent reviewers and MHRA (Medicines and Healthcare products Regulatory Agency) recommended that vaccinations should continue," the draft consent form stated. "Close monitoring of the affected individual and other participants will be continued."

Regulators in Brazil, India and South Africa also previously allowed AstraZeneca to resume its vaccine trials there. Responding to a request, British regulators shared with Reuters a draft of a form letter to UK vaccine trial participants, dated Oct. 14 and signed by the Oxford COVID-19 Vaccine Team. It says the U.S. FDA had "completed their analysis" and said vaccination in the United States would resume shortly.

FDA "has come to the same conclusion as the other drug regulators including the MHRA," the letter states. The regulator, Health Research Authority, did not say if the letter had been sent or immediately respond to questions about it. An AstraZeneca spokeswoman said the communication is not from the company and it "cannot verify the content," referring to the draft letter to patients.

"We also cannot comment on a pending FDA decision," she said.


TRENDING

OPINION / BLOG / INTERVIEW

Turbulence surrounding tobacco control in Ghana

... ...

Refugee compassion and response: Ideas to mitigate disasters now and in their future

Their homeland becomes a forbidden territory for them and more likely than not, their journey to foreign soil is no less traumatizing, not to say deadly. It is crucial to help refugees live a life of dignity and purpose....

Inadequate water infrastructure causes a tidal wave of coronavirus in rural Alaska

... ...

Videos

Latest News

Chinese professor pleads guilty to lying to FBI in Huawei-related case

A Chinese professor accused by U.S. prosecutors of helping steal American technology to benefit Chinas Huawei Technologies Co Ltd on Friday pleaded guilty to lying to the FBI, but is expected to be allowed to return home after prosecutors d...

S Korea reports 583 more COVID-19 cases, 36,915 in total

Seoul South Korea, December 5 ANIXinhua South Korea reported 583 more cases of COVID-19 as of 000 a.m. Saturday local time compared to 24 hours ago, raising the total number of infections to 36,915. The daily caseload fell below 600 after r...

Rahul Gandhi hits out at Centre over MSP, APMC, urges people to support farmers

Congress MP Rahul Gandhi on Saturday hit out at Prime Minister Narendra Modi over the minimum support price MSP and Agricultural Produce Market Committee APMC Act and also urged citizens to support the protests led by farmers. Farmers of Bi...

Pakistani Rangers open fire on forward posts, villages in J&K's Kathua district

Pakistani Rangers opened fire on forward posts and villages along the International Border in Jammu and Kashmirs Kathua district, officials said on Saturday. Firing from across the border started around 9.50 pm on Friday in the Hiranagar se...

Give Feedback