• Latest
  • Trending
FILE PHOTO: A health worker fills a syringe with a dose of the Oxford/AstraZeneca Covid-19 vaccine. (Photo credit: Reuters)

Around 1,500 Oxford Covid vaccine trial volunteers given wrong dose

February 2, 2021
India’s Covid-19 vaccine is found effective, boosting national efforts

India’s Covid-19 vaccine is found effective, boosting national efforts

March 4, 2021
India to cover 100 million in the second phase of COVID-19 vaccination

India to cover 100 million in the second phase of COVID-19 vaccination

March 3, 2021
Indian Air Chief in Sri Lanka for SLAF’s 70 th.anniversary celebrations

Indian Air Chief in Sri Lanka for SLAF’s 70 th.anniversary celebrations

March 3, 2021
Image credits - Meg Jerrard / Unsplash

Australia building world’s first platypus sanctuary

March 3, 2021
PothKade by Lanka Traders

PothKade makes stationery shopping easy with first of its kind door delivery app

March 3, 2021
Iranaitivu residents protest against COVID-19 burials

Iranaitivu residents protest against COVID-19 burials

March 3, 2021
Image credits - Sangga Rima Roman Selia / Unsplash

Global CO2 emissions bounce back to pre-COVID levels, study finds

March 3, 2021
Image credits - Tasnim News Agency; Mohammad Hassanzadeh

Iran’s only female Olympic medallist to compete under white flag in Tokyo

March 3, 2021
Image credits - Neven Krcmarek / Unsplash

Maezawa wants you: Japan billionaire seeks ‘crew’ for moon trip

March 3, 2021
Image credits - Dan Freeman / Unsplash

Australian economy storms ahead as COVID recovery turns ‘V-shaped’

March 3, 2021
Image credits - Hassan Ali @RealHa55an / Twitter

Cricket kind of gets forgotten in IPL; PSL, LPL more rewarding: Dale Steyn

March 3, 2021
Image credits - Hakan Nural / Unsplash

New data show vaccines reduce severe COVID-19 in older adults

March 3, 2021
  • About Us
  • Advertisements
  • Privacy Policy
  • Contact
Thursday, March 4, 2021
  • Login
  • Register
No Result
View All Result
NewsIn.Asia
  • Home
  • Around South Asia
    • All
    • Afghanistan
    • Bangladesh
    • Bhutan
    • China
    • India
    • Maldives
    • Myanmar
    • Nepal
    • Pakistan
    • Sri Lanka
    India’s Covid-19 vaccine is found effective, boosting national efforts

    India’s Covid-19 vaccine is found effective, boosting national efforts

    India to cover 100 million in the second phase of COVID-19 vaccination

    India to cover 100 million in the second phase of COVID-19 vaccination

    Indian Air Chief in Sri Lanka for SLAF’s 70 th.anniversary celebrations

    Indian Air Chief in Sri Lanka for SLAF’s 70 th.anniversary celebrations

    PothKade by Lanka Traders

    PothKade makes stationery shopping easy with first of its kind door delivery app

    Iranaitivu residents protest against COVID-19 burials

    Iranaitivu residents protest against COVID-19 burials

    Image credits - Hakan Nural / Unsplash

    New data show vaccines reduce severe COVID-19 in older adults

    COVID body being brought for cremation in Sri Lanka

    Sri Lankan government to go ahead with Iranaitivu Island for COVID-19 deceased burials

    Lanka takes three crucial decisions to garner Indian and Muslim support in UNHRC

    Lanka takes three crucial decisions to garner Indian and Muslim support in UNHRC

    Hope India votes in favour of Sri Lanka at UNHRC: Sri Lanka’s Foreign Secretary Jayanath Colombage

    Hope India votes in favour of Sri Lanka at UNHRC: Sri Lanka’s Foreign Secretary Jayanath Colombage

  • World
    • All
    • Japan
    • Russia
    • United States
    Image credits - Meg Jerrard / Unsplash

    Australia building world’s first platypus sanctuary

    Image credits - Sangga Rima Roman Selia / Unsplash

    Global CO2 emissions bounce back to pre-COVID levels, study finds

    Image credits - Tasnim News Agency; Mohammad Hassanzadeh

    Iran’s only female Olympic medallist to compete under white flag in Tokyo

    Image credits - Neven Krcmarek / Unsplash

    Maezawa wants you: Japan billionaire seeks ‘crew’ for moon trip

    Image credits - Dan Freeman / Unsplash

    Australian economy storms ahead as COVID recovery turns ‘V-shaped’

    Image credits - Mufid Majnun / Unsplash

    Tokyo asks China to stop anal swab tests for COVID-19 on Japanese citizens

    Image credits - Mark Paton / Unsplash

    One in four people will have hearing problems by 2050: WHO

    Disciplined societies may have tackled COVID better, but there is a downside in all

    China, U.S. should lift COVID-19 travel bans if herd immunity reached, Chinese epidemiologist says

    Image credits - Torstensimon

    Fauci urges Americans to get any of the three COVID-19 vaccines available

  • Business
  • Politics
  • Sports
  • Entertainment
    • All
    • Gaming
    • Movie
    • Music
    • Series
    Image credits - Joe Shlabotnik / Flickr

    Key winners at the 2021 Golden Globes

    Image credits - Gage Skidmore

    Chadwick Boseman Wins Best Actor at 2021 Golden Globes for Ma Rainey’s Black Bottom

    The film, a tale of an adolescent boy fighting human-eating demons, has amassed $313 million since opening on Oct. 16. © Koyoharu Gotoge/Shueisha, Aniplex, ufotable

    Japan anime movie ‘Demon Slayer’ lands in US cinemas

    Bengali Adhunik song Bela Hole Absan

    Bengali Adhunik song Bela Hole Absan

    Image credits - Steven Cordes / Unsplash

    Gotta catch ’em all: Pandemic sends prices soaring for Pokemon cards

    Image credits - Fixelgraphy / Unsplash

    Spotify to expand into more than 80 new markets including Sri Lanka, Pakistan and Maldives

    Image credits - AdamBMorgan / big-ashb

    Grammy-winning duo Daft Punk announces split after 28 years

    Image credits - LupEnd007 / rodrigoferrari

    Kim Kardashian files for divorce from Kanye West

    Nollywood meets Bollywood in love tale ‘Namaste Wahala’

    Nollywood meets Bollywood in love tale ‘Namaste Wahala’

  • Lifestyle
    • All
    • Fashion
    • Food
    • Health
    • Science
    • Travel
    Iranaitivu residents protest against COVID-19 burials

    Iranaitivu residents protest against COVID-19 burials

    Image credits - Neven Krcmarek / Unsplash

    Maezawa wants you: Japan billionaire seeks ‘crew’ for moon trip

    Image credits - Mark Paton / Unsplash

    One in four people will have hearing problems by 2050: WHO

    Disciplined societies may have tackled COVID better, but there is a downside in all

    China, U.S. should lift COVID-19 travel bans if herd immunity reached, Chinese epidemiologist says

    Image credits - Slash Gear

    Nestle expands plant-based products with new vegan KitKat bar

    India-made COVID-19 vaccine in Ghana

    India-made COVID-19 vaccine in Ghana

    Image credits - Stefan Spassov / Unsplash

    Japan appoints ‘minister of loneliness’ to help people home alone

    Image credits - freestocks / Unsplash

    Singapore trials Smartphone app offering mini check-ups

    First human case of H5N8 bird flu reported in Russia. Image credits - CDC

    First human case of H5N8 bird flu reported in Russia

    Image credits - LupEnd007 / rodrigoferrari

    Kim Kardashian files for divorce from Kanye West

    Trending Tags

    • Golden Globes
    • Mr. Robot
    • MotoGP 2017
    • Climate Change
    • Flat Earth
  • Tech
    Image credits - Benjamin Raffetseder / Unsplash

    China’s Xiaomi adds manufacturing muscle in India to boost phone production

    Image credits - freestocks / Unsplash

    Singapore trials Smartphone app offering mini check-ups

    Image credits - Fixelgraphy / Unsplash

    Spotify to expand into more than 80 new markets including Sri Lanka, Pakistan and Maldives

    Image credits - Nicole de Andrade

    Tech Tips: Signal lets users create groups with up to 1000 members, here is how to create one

    Whatsapp / Pic - India Today

    WhatsApp to switch off messages for all who reject new terms

    Image credits - Solen Feyissa / Unsplash

    Facebook news goes dark in Australia as content spat escalates

    Trending Tags

    • Sillicon Valley
    • Climate Change
    • Election Results
    • Flat Earth
    • Golden Globes
    • MotoGP 2017
    • Mr. Robot
  • Coronavirus
  • Home
  • Around South Asia
    • All
    • Afghanistan
    • Bangladesh
    • Bhutan
    • China
    • India
    • Maldives
    • Myanmar
    • Nepal
    • Pakistan
    • Sri Lanka
    India’s Covid-19 vaccine is found effective, boosting national efforts

    India’s Covid-19 vaccine is found effective, boosting national efforts

    India to cover 100 million in the second phase of COVID-19 vaccination

    India to cover 100 million in the second phase of COVID-19 vaccination

    Indian Air Chief in Sri Lanka for SLAF’s 70 th.anniversary celebrations

    Indian Air Chief in Sri Lanka for SLAF’s 70 th.anniversary celebrations

    PothKade by Lanka Traders

    PothKade makes stationery shopping easy with first of its kind door delivery app

    Iranaitivu residents protest against COVID-19 burials

    Iranaitivu residents protest against COVID-19 burials

    Image credits - Hakan Nural / Unsplash

    New data show vaccines reduce severe COVID-19 in older adults

    COVID body being brought for cremation in Sri Lanka

    Sri Lankan government to go ahead with Iranaitivu Island for COVID-19 deceased burials

    Lanka takes three crucial decisions to garner Indian and Muslim support in UNHRC

    Lanka takes three crucial decisions to garner Indian and Muslim support in UNHRC

    Hope India votes in favour of Sri Lanka at UNHRC: Sri Lanka’s Foreign Secretary Jayanath Colombage

    Hope India votes in favour of Sri Lanka at UNHRC: Sri Lanka’s Foreign Secretary Jayanath Colombage

  • World
    • All
    • Japan
    • Russia
    • United States
    Image credits - Meg Jerrard / Unsplash

    Australia building world’s first platypus sanctuary

    Image credits - Sangga Rima Roman Selia / Unsplash

    Global CO2 emissions bounce back to pre-COVID levels, study finds

    Image credits - Tasnim News Agency; Mohammad Hassanzadeh

    Iran’s only female Olympic medallist to compete under white flag in Tokyo

    Image credits - Neven Krcmarek / Unsplash

    Maezawa wants you: Japan billionaire seeks ‘crew’ for moon trip

    Image credits - Dan Freeman / Unsplash

    Australian economy storms ahead as COVID recovery turns ‘V-shaped’

    Image credits - Mufid Majnun / Unsplash

    Tokyo asks China to stop anal swab tests for COVID-19 on Japanese citizens

    Image credits - Mark Paton / Unsplash

    One in four people will have hearing problems by 2050: WHO

    Disciplined societies may have tackled COVID better, but there is a downside in all

    China, U.S. should lift COVID-19 travel bans if herd immunity reached, Chinese epidemiologist says

    Image credits - Torstensimon

    Fauci urges Americans to get any of the three COVID-19 vaccines available

  • Business
  • Politics
  • Sports
  • Entertainment
    • All
    • Gaming
    • Movie
    • Music
    • Series
    Image credits - Joe Shlabotnik / Flickr

    Key winners at the 2021 Golden Globes

    Image credits - Gage Skidmore

    Chadwick Boseman Wins Best Actor at 2021 Golden Globes for Ma Rainey’s Black Bottom

    The film, a tale of an adolescent boy fighting human-eating demons, has amassed $313 million since opening on Oct. 16. © Koyoharu Gotoge/Shueisha, Aniplex, ufotable

    Japan anime movie ‘Demon Slayer’ lands in US cinemas

    Bengali Adhunik song Bela Hole Absan

    Bengali Adhunik song Bela Hole Absan

    Image credits - Steven Cordes / Unsplash

    Gotta catch ’em all: Pandemic sends prices soaring for Pokemon cards

    Image credits - Fixelgraphy / Unsplash

    Spotify to expand into more than 80 new markets including Sri Lanka, Pakistan and Maldives

    Image credits - AdamBMorgan / big-ashb

    Grammy-winning duo Daft Punk announces split after 28 years

    Image credits - LupEnd007 / rodrigoferrari

    Kim Kardashian files for divorce from Kanye West

    Nollywood meets Bollywood in love tale ‘Namaste Wahala’

    Nollywood meets Bollywood in love tale ‘Namaste Wahala’

  • Lifestyle
    • All
    • Fashion
    • Food
    • Health
    • Science
    • Travel
    Iranaitivu residents protest against COVID-19 burials

    Iranaitivu residents protest against COVID-19 burials

    Image credits - Neven Krcmarek / Unsplash

    Maezawa wants you: Japan billionaire seeks ‘crew’ for moon trip

    Image credits - Mark Paton / Unsplash

    One in four people will have hearing problems by 2050: WHO

    Disciplined societies may have tackled COVID better, but there is a downside in all

    China, U.S. should lift COVID-19 travel bans if herd immunity reached, Chinese epidemiologist says

    Image credits - Slash Gear

    Nestle expands plant-based products with new vegan KitKat bar

    India-made COVID-19 vaccine in Ghana

    India-made COVID-19 vaccine in Ghana

    Image credits - Stefan Spassov / Unsplash

    Japan appoints ‘minister of loneliness’ to help people home alone

    Image credits - freestocks / Unsplash

    Singapore trials Smartphone app offering mini check-ups

    First human case of H5N8 bird flu reported in Russia. Image credits - CDC

    First human case of H5N8 bird flu reported in Russia

    Image credits - LupEnd007 / rodrigoferrari

    Kim Kardashian files for divorce from Kanye West

    Trending Tags

    • Golden Globes
    • Mr. Robot
    • MotoGP 2017
    • Climate Change
    • Flat Earth
  • Tech
    Image credits - Benjamin Raffetseder / Unsplash

    China’s Xiaomi adds manufacturing muscle in India to boost phone production

    Image credits - freestocks / Unsplash

    Singapore trials Smartphone app offering mini check-ups

    Image credits - Fixelgraphy / Unsplash

    Spotify to expand into more than 80 new markets including Sri Lanka, Pakistan and Maldives

    Image credits - Nicole de Andrade

    Tech Tips: Signal lets users create groups with up to 1000 members, here is how to create one

    Whatsapp / Pic - India Today

    WhatsApp to switch off messages for all who reject new terms

    Image credits - Solen Feyissa / Unsplash

    Facebook news goes dark in Australia as content spat escalates

    Trending Tags

    • Sillicon Valley
    • Climate Change
    • Election Results
    • Flat Earth
    • Golden Globes
    • MotoGP 2017
    • Mr. Robot
  • Coronavirus
No Result
View All Result
NewsIn.Asia
No Result
View All Result
Home Around The World

Around 1,500 Oxford Covid vaccine trial volunteers given wrong dose

Editor by Editor
February 2, 2021
in Around The World, Coronavirus, World
Reading Time: 5min read
5 0
FILE PHOTO: A health worker fills a syringe with a dose of the Oxford/AstraZeneca Covid-19 vaccine. (Photo credit: Reuters)

FILE PHOTO: A health worker fills a syringe with a dose of the Oxford/AstraZeneca Covid-19 vaccine. (Photo credit: Reuters)

Share on WhatsApp

February 2 (Reuters) – About 1,500 of the initial volunteers in a late-stage clinical trial of the Oxford/AstraZeneca Covid-19 vaccine were given the wrong dose, but weren’t informed that a mistake had been made after the blunder was discovered, documents obtained by Reuters show.

Instead, the dosing mishap was presented to the trial participants in a letter dated June 8 as an opportunity for University of Oxford researchers to learn how well the vaccine works at different doses. The letter was signed by the trial’s chief investigator, Oxford professor Andrew J. Pollard, and sent to the trial subjects.

As Reuters reported on Dec. 24, participants were given about a half dose due to a measuring mistake by Oxford researchers. The Pollard letter didn’t acknowledge any error. Nor did it disclose that researchers had reported the issue to British medical regulators, who then told Oxford to add another test group to receive the full dose, in line with the trial’s original plan.

There is no suggestion there was any risk to the health of trial participants.

Much is riding on the British-developed vaccine, which is being rolled out across the UK and has been touted as a low-cost weapon against the pandemic. The jab has come under scrutiny because of the dosing error in the Oxford trial and a paucity of data about its efficacy in older people who are most vulnerable to the virus.

Reuters shared the letter – which it obtained from the university through a Freedom of Information request – with three different experts in medical ethics. The ethicists all said it indicates the researchers may not have been transparent with trial participants. Volunteers in clinical trials are supposed to be kept fully informed about any changes.

“They are not clear at all about what they need to be clear about – what’s going on, what they knew, the rationale for undertaking further research,” said Arthur L. Caplan, founding head of the Division of Medical Ethics at New York University Grossman School of Medicine. “It is lost in a snowstorm of verbiage.”

Steve Pritchard, a spokesman for Oxford, told Reuters: “The half-dose group was unplanned, but we did know in advance that there was a discrepancy in the dose measurements and discussed this with the regulators before dosing and when the dosing was revised.”

Pritchard also said, “We have not stated that a dosing error occurred.”

Pollard didn’t respond to a request for comment.

The spokesman’s suggestion that no error was made is contradicted by documents produced last year by Oxford and its vaccine partner, drugs giant AstraZeneca PLC. In December, Reuters reported that a “Global Statistical Analysis Plan” by Oxford/AstraZeneca, dated Nov. 17 and later published in the scientific journal The Lancet, called the dosing discrepancy “a potency miscalculation.”

A spokesman for AstraZeneca declined to comment.

The Health Research Authority, a British government agency responsible for approving medical research and ensuring it is ethical, said in a statement that changes to the study design and the letter sent to participants were approved by one of its ethics committees.

The Oxford/AstraZeneca vaccine recently has received authorization for use in a growing number of countries, including the United Kingdom, the European Union and India. The UK became the first country to approve it, and began rolling out the vaccine on January 4.

But questions surrounding the clinical trials continue to plague the vaccine. Last week, Germany’s vaccine committee recommended it should only be given to people aged under 65, while the EU, which authorized it on Friday for people aged 18 and over, lowered its reported efficacy rate from 70.4% to 60%. In both cases, authorities cited a lack of sufficient data from the clinical trials. The EU also has sharply criticized AstraZeneca for cutting back its planned vaccine deliveries to the continent over the next few months. The company has said it is doing its best to boost supplies.

The mistaken half-dose – which prompted the letter in June to trial participants – continues to be a factor in the reported efficacy of the Oxford/AstraZeneca vaccine.

Oxford had reported interim results in November that showed the efficacy rate for trial subjects who mistakenly received a half-dose and a subsequent full-dose booster shot was 90%, and that the rate for those who received two full doses was 62%. Combining data from the two dosing regimens resulted in an efficacy of 70.4%.

In authorizing the vaccine, UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), accepted the pooled results, but didn’t approve administering the half-dose/full-dose regimen. “There is not persuasive evidence of a real difference in” vaccine efficacy between the two different dosing regimens, it said.

“RECENT CHANGES”

The vaccine’s late-stage clinical trial began on May 28. Within days, Oxford researchers realized trial participants had been given lower doses than planned after they displayed milder than expected side effects, such as fever and fatigue. They alerted British medical regulators.

On June 5, the researchers amended the trial protocol at the request of regulators to add a new group that would receive the correct full dose of the vaccine. Three days later, they alerted trial subjects to what they called “recent changes in the study” in a two-page letter attached to an updated 13-page “Participant Information Sheet.”

The letter, signed by chief investigator Pollard, stated that researchers “are not sure what dose of vaccine is most likely to be protective against Covid disease” and explained that doses “are measured using standard scientific test methods.” It said the late-stage trial participants received a dose measured using one method and that another group will receive a dose measured using a different test to match the dose given in another clinical trial of the vaccine.

It said the lower dose is “still in the normal range of doses that are used in clinical trials” and “if it can provide protection, it might be better for use in vaccine programmes.”

Caplan said the explanation would be of “no interest whatsoever to the subject because it’s too technical. To me, that qualifies as gobbledygook. What you want to know is, why are they doing this, we made an error, it involved dosing, we’re not worried about it.”

He and other ethicists interviewed by Reuters said researchers are obligated to be forthcoming with test subjects when things go wrong.

“As a letter purporting to explain a) an error and b) a change of protocol I find this entirely inadequate,” said Simon Woods, a professor of bioethics at Newcastle University, in an email. “It reads like a routine update (and a complex one at that).”

Emma Cave, a professor of healthcare law at Durham University’s law school, said: “Presenting the dosing variation as a planned change in the study is potentially a breach of trust if in fact the dosing resulted from an error. The letter makes clear the dosing change but not the reason for the change.”

Tags: Covid-19OxfordVaccine
SendShare3Tweet1ShareShare
Editor

Editor

Recommended Articles

  • All
  • Recommend
India to cover 100 million in the second phase of COVID-19 vaccination

India to cover 100 million in the second phase of COVID-19 vaccination

March 3, 2021
Iranaitivu residents protest against COVID-19 burials

Iranaitivu residents protest against COVID-19 burials

March 3, 2021
A conversation with Bertrand Russell (1952)

A conversation with Bertrand Russell (1952)

March 2, 2021
Lanka, India, Maldives set up Maritime Security Secretariat

Lanka, India, Maldives set up Maritime Security Secretariat

March 2, 2021
Imran Khan adds new dimensions to ties with Sri Lanka

Imran Khan adds new dimensions to ties with Sri Lanka

March 1, 2021
Nawam Perahera in Colombo was a colour fest, though with fewer elephants

Nawam Perahera in Colombo was a colour fest, though with fewer elephants

February 27, 2021

Advertorial

  • All
  • Advertorial
Visual and Textual Analysis for Images with Reverse Search Tools

Visual and Textual Analysis for Images with Reverse Search Tools

January 3, 2021

Popular Now

  • UNHRC debate: A majority of countries spoke in favour of Sri Lanka

    UNHRC debate: A majority of countries spoke in favour of Sri Lanka

    70 shares
    Share 53 Tweet 7
  • Background to Lanka’s decision to lift ban on burying COVID dead

    32 shares
    Share 21 Tweet 5
  • India tells UNHRC devolution of power is critical for reconciliation in Sri Lanka

    47 shares
    Share 38 Tweet 4
  • Tokyo asks China to stop anal swab tests for COVID-19 on Japanese citizens

    22 shares
    Share 14 Tweet 4
  • Lanka takes three crucial decisions to garner Indian and Muslim support in UNHRC

    31 shares
    Share 24 Tweet 3
  • About Us
  • Advertisements
  • Privacy Policy
  • Contact

© 2020 NewsIn.Asia - Lovingly maintained by DigitalArc.

No Result
View All Result
  • Home
  • Around South Asia
    • Afghanistan
    • Bangladesh
    • Bhutan
    • China
    • India
    • Maldives
    • Myanmar
    • Nepal
    • Pakistan
    • Sri Lanka
  • Around The World
  • Breaking News
  • Business
    • Exchange
  • Climate Change
  • Governance
    • Crime
    • Diplomacy
    • Defense
    • Human Rights
    • Politics
    • Strategic Affairs
  • Lifestyle
    • Books
    • Entertainment
      • Arts
      • Cinema
      • Gaming
      • Music
      • Movie
      • Series
      • TV
    • Health
    • Fashion
    • Food
    • Travel
  • Culture
    • Ethnicity
    • Gender
  • Development news
  • Economy
  • Education
  • Environment
  • Coronavirus
  • History
  • National
  • Offbeat
    • Media
    • Music and arts across South Asia
  • Recommended
    • Headlines
    • Highlights
    • Top Picture
    • Top Story
  • Religion
  • Science
  • Sports
    • Football
    • Cricket
      • LPL
      • IPL
    • Tennis
    • Formula 1
    • NBA
  • Tech
    • Instagram
  • United Nations
  • Weather
  • World
    • Japan
    • Russia
    • United States

© 2020 NewsIn.Asia - Lovingly maintained by DigitalArc.

Welcome Back!

Login to your account below

Forgotten Password? Sign Up

Create New Account!

Fill the forms below to register

All fields are required. Log In

Retrieve your password

Please enter your username or email address to reset your password.

Log In