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

... ...

Smart healthcare: IoT redefining the way healthcare is delivered

As the world is embracing the new wave of digitalization triggered by the pandemic and the arrival of 5G, the adoption of IoT devices will further boom. With adoption set to soar, IoT security issues and other challenges cant be ignored any...

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

Two killed, five injured in early-hour road accident in Bulandshahr: Police

Two men of a family were killed and five others seriously injured when the car they were travelling in was hit by an unidentified vehicle near here on early Saturday morning, said police. Those killed in the accident were identified as Hari...

PM reviews vaccine work in Ahmedabad, Hyderabad and Pune

Prime Minister Narendra Modi on Saturday visited Ahmedabad, Hyderabad and Pune to review coronavirus vaccine development work there. The Prime Ministers Office PMO said the day-long visit was aimed at getting a first-hand perspective of the...

India, Lanka and Maldives agree to bolster maritime security cooperation

Top security officials of India, Sri Lanka and the Maldives on Saturday agreed to further strengthen cooperation and ensure peace in the region for common benefit as they took stock of the current maritime security environment in the region...

Chirag downplays BJP fielding Sushil Modi for seat won by Ram Vilas Paswan

Cold-shouldered by the BJP in the by-election to a Rajya Sabha seat in Bihar, LJP president Chirag Paswan said on Saturday that it belonged to the saffron party which was free to take a decision about whom to field. The seat had fallen vaca...

Give Feedback