Exclusive: US trial of AstraZeneca Covid-19 vaccine may resume this week | The Business Standard
Skip to main content
  • Home
  • Economy
    • Aviation
    • Banking
    • Bazaar
    • Budget
    • Industry
    • NBR
    • RMG
    • Corporates
  • Stocks
  • Analysis
  • World+Biz
  • Sports
  • Features
    • Book Review
    • Brands
    • Earth
    • Explorer
    • Food
    • Habitat
    • In Focus
    • Luxury
    • Mode
    • Panorama
    • Pursuit
    • Wheels
  • Epaper
    • GOVT. Ad
  • More
    • Subscribe
    • Multimedia
    • TBS Graduates
    • Thoughts
    • Splash
    • Bangladesh
    • Supplement
    • Infograph
    • Archive
    • COVID-19
    • Long Read
    • Interviews
    • Offbeat
    • Tech
    • Magazine
  • বাংলা
The Business Standard

Friday
December 08, 2023

Sign In
Subscribe
  • Home
  • Economy
    • Aviation
    • Banking
    • Bazaar
    • Budget
    • Industry
    • NBR
    • RMG
    • Corporates
  • Stocks
  • Analysis
  • World+Biz
  • Sports
  • Features
    • Book Review
    • Brands
    • Earth
    • Explorer
    • Food
    • Habitat
    • In Focus
    • Luxury
    • Mode
    • Panorama
    • Pursuit
    • Wheels
  • Epaper
    • GOVT. Ad
  • More
    • Subscribe
    • Multimedia
    • TBS Graduates
    • Thoughts
    • Splash
    • Bangladesh
    • Supplement
    • Infograph
    • Archive
    • COVID-19
    • Long Read
    • Interviews
    • Offbeat
    • Tech
    • Magazine
  • বাংলা
FRIDAY, DECEMBER 08, 2023
Exclusive: US trial of AstraZeneca Covid-19 vaccine may resume this week

Coronavirus chronicle

Reuters
21 October, 2020, 10:40 am
Last modified: 21 October, 2020, 10:46 am

Related News

  • Yemen's Houthis say they launched ballistic missiles at Israel
  • US restricts visas for Uganda, Zimbabwe officials, citing repression
  • Man stabs four to death in New York, police shoot him dead
  • Bangladesh could be target of US labour policy, warns Washington mission
  • Minnesota students exchange with Bangladeshi students about US education opportunities

Exclusive: US trial of AstraZeneca Covid-19 vaccine may resume this week

AstraZeneca’s large, late-stage US trial has been on hold since September 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

Reuters
21 October, 2020, 10:40 am
Last modified: 21 October, 2020, 10:46 am
Britain's Medicines and Healthcare products Regulatory Agency (MHRA) started an accelerated "rolling review" of the vaccine at the start of this month as data comes in on safety and efficacy. Photo: Reuters
Britain's Medicines and Healthcare products Regulatory Agency (MHRA) started an accelerated "rolling review" of the vaccine at the start of this month as data comes in on safety and efficacy. Photo: Reuters

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

AstraZeneca's large, late-stage US trial has been on hold since September 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 characterise the illness, they said.

The Business Standard Google News Keep updated, follow The Business Standard's Google news channel

US signs agreement with AstraZeneca to develop, supply Covid-19 antibody treatment

An FDA spokeswoman declined to 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 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.

AstraZeneca, which is developing the vaccine with Oxford University researchers, had been seen as a frontrunner in the race to produce a vaccine for Covid-19 until its trials were put on hold to investigate the illness. Early data from large-scale trials in the United States of vaccines from Pfizer Inc PFE.N and Moderna Inc MRNA.O are expected some time next month.

Johnson & Johnson JNJ.N last week paused its Phase III Covid-19 vaccine trial to investigate an unexplained illness in a study participant. At the time of the announcement, the company did not know whether the volunteer had been given its vaccine or a placebo.

A J&J spokesman on Tuesday said the study remains on pause as the company continues its review of medical information before deciding to restart the trial. J&J noted last week that its "study pause" was voluntary. By contrast, AstraZeneca's trial is on "regulatory hold," which is imposed by health authorities.

Vaccines are seen as essential to helping end the pandemic that has battered economies around the world and claimed more than 1 million lives - over 220,000 of them in the United States.

Responding to a request about the AstraZeneca trial, British regulators shared with Reuters a draft of a form letter to UK vaccine trial participants, dated October 14 and signed by the Oxford Covid-19 Vaccine Team. It says the US FDA had "completed their analysis" and said vaccination under the study 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 Health Research Authority, which helps oversee UK medical research, said in an email to Reuters that it vetted the communication to make sure it was suitable to ensure informed consent among study volunteers. It could not confirm that the letter had been issued.

An AstraZeneca spokeswoman said the communication is not from the company and it "cannot verify the content," referring to the draft letter to study participants.

"We also cannot comment on a pending FDA decision," she said. The Oxford study team did not respond to requests for comment.

Not Enough Evidence

In another of the documents directed at trial participants, the Oxford vaccine study team noted that there was not enough evidence to link the neurological problem seen in the UK trial to the vaccine.

Dr Paul Offit, director of the Vaccine Education Center at Children's Hospital of Philadelphia, who reviewed the document, said it can be difficult to link a rare side effect specifically to a vaccine to the exclusion of other potential causes.

Transverse myelitis, which the study volunteer is believed to have developed, typically occurs at a rate of 1-in-200,000 people, Offit said, so it would be unusual to see it in a trial of 9,000 individuals.

Other viruses including those that cause West Nile and polio can trigger the condition, as can physical trauma.

The regulators have to weigh whether a rare side effect is vaccine-related and could occur again against the sickness and deaths linked with Covid-19, Offit said. "That's always the line that you walk."

Top News / World+Biz

AstraZeneca Covid-19 Vaccine / Oxford Covid-19 Vaccine / US

Comments

While most comments will be posted if they are on-topic and not abusive, moderation decisions are subjective. Published comments are readers’ own views and The Business Standard does not endorse any of the readers’ comments.

Top Stories

  • US sanctions could threaten SDG financing: Economists
    US sanctions could threaten SDG financing: Economists
  • A pile of onion. File Photo: Mumit M/TBS
    Onion price goes up in Bangladesh after India extends export restrictions
  • Mixed prices in Dhaka's beef market despite set rate
    Mixed prices in Dhaka's beef market despite set rate

MOST VIEWED

  • File photo of metro rail during its trial run. Photo: Mumit M/TBS
    Metro rail Dhaka University, Bijoy Sarani stations to start operations from 13 December
  • What is causing dollar crisis in Bangladesh
    What is causing dollar crisis in Bangladesh
  • Photo: UNB
    Unique Group MD Noor Ali's daughter Nahida dies in US road crash
  • Buyer's rep removes sanction clause from RMG LC
    Buyer's rep removes sanction clause from RMG LC
  • Photo: Collected
    Dhaka expressway construction crane hits train; rail link with capital snapped
  • 'Anima;' poster. Photo: Collected
    Ranbir Kapoor starrer 'Animal' to release on Netflix

Related News

  • Yemen's Houthis say they launched ballistic missiles at Israel
  • US restricts visas for Uganda, Zimbabwe officials, citing repression
  • Man stabs four to death in New York, police shoot him dead
  • Bangladesh could be target of US labour policy, warns Washington mission
  • Minnesota students exchange with Bangladeshi students about US education opportunities

Features

Bangladesh now has 19 GI-certified products. What changed?

Bangladesh now has 19 GI-certified products. What changed?

13h | Panorama
Illustration: TBS

How financial institutions can help transition to net zero

13h | Panorama
Sketch: TBS

The looming populist dystopia

13h | Panorama
Hamas-Israel war: What really happened on 7 October?

Hamas-Israel war: What really happened on 7 October?

1d | Panorama

More Videos from TBS

Israeli troops surround home of Hamas chief: Netanyahu

Israeli troops surround home of Hamas chief: Netanyahu

23h | TBS World
For the first time, Bangladesh tops the list of knitwear exports to Europe

For the first time, Bangladesh tops the list of knitwear exports to Europe

5h | TBS Economy
Is the tobacco business in US really declining?

Is the tobacco business in US really declining?

36m | TBS World
Revenue arrears of 28 govt. institutions is Tk 23,800 crore

Revenue arrears of 28 govt. institutions is Tk 23,800 crore

3h | TBS Economy
EMAIL US
[email protected]
FOLLOW US
WHATSAPP
+880 1847416158
The Business Standard
  • About Us
  • Contact us
  • Sitemap
  • Privacy Policy
  • Comment Policy
Copyright © 2023
The Business Standard All rights reserved
Technical Partner: RSI Lab

Contact Us

The Business Standard

Main Office -4/A, Eskaton Garden, Dhaka- 1000

Phone: +8801847 416158 - 59

Send Opinion articles to - [email protected]

For advertisement- [email protected]