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US health officials say AstraZeneca may have included 'outdated information' in coronavirus vaccine trial
3 years, 9 months ago

US health officials say AstraZeneca may have included 'outdated information' in coronavirus vaccine trial

ABC  

AstraZeneca may have included "outdated information" in touting the effectiveness of its COVID-19 vaccine in a US study, federal health officials have said, in an unusual public rift that could further erode confidence in the shot. Key points: AstraZeneca released the result of a 32,000-person study in the US to measure the effectiveness of its vaccine But an independent panel …

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New AstraZeneca report says vaccine was 76% effective in preventing Covid-19 symptoms
3 years, 9 months ago

New AstraZeneca report says vaccine was 76% effective in preventing Covid-19 symptoms

CNN  

CNN — Drug giant AstraZeneca updated its data on how well its coronavirus vaccine works, saying late Wednesday the vaccine showed 76% efficacy against symptomatic coronavirus disease and 100% efficacy against severe or critical disease or the need for hospitalization. On Tuesday, the independent Data and Safety Monitoring Board that reviews data from multiple Covid-19 vaccine candidates expressed concern over …

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AstraZeneca accused of cherry-picking vaccine study data
3 years, 9 months ago

AstraZeneca accused of cherry-picking vaccine study data

Associated Press  

WASHINGTON — AstraZeneca may have included “outdated information” in touting the effectiveness of its COVID-19 vaccine in a U.S. study, federal health officials said Tuesday in an unusual public rift that could further erode confidence in the shot. But shortly after midnight, the National Institutes of Health issued a statement saying the independent monitors that oversee the study had “expressed …

Vaccine Astrazeneca Nih Its Vaccine Dsmb Study Data
AstraZeneca vaccine: Independent review board raises concerns about trial data
3 years, 9 months ago

AstraZeneca vaccine: Independent review board raises concerns about trial data

CNN  

CNN — In an unusual statement released early Tuesday, the National Institute of Allergy and Infectious Diseases said the independent board that reviews data from multiple Covid-19 vaccine candidates has raised concerns about AstraZeneca’s announcement of efficacy data from its vaccine trial. “The DSMB expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided …

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AstraZeneca vaccine trial results may have included outdated info, U.S. officials say
3 years, 9 months ago

AstraZeneca vaccine trial results may have included outdated info, U.S. officials say

LA Times  

AstraZeneca may have included “outdated information” in touting the effectiveness of its COVID-19 vaccine in a U.S. study, federal health officials said Tuesday in an unusual public rift that could further erode confidence in the shot. But shortly after midnight, the National Institutes of Health issued a statement saying the independent monitors that oversee the study had “expressed concern that …

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Oxford-AstraZeneca Vaccine Effective Against Severe Covid-19, New Trial in US Confirms
3 years, 9 months ago

Oxford-AstraZeneca Vaccine Effective Against Severe Covid-19, New Trial in US Confirms

News 18  

A large trial in the US and two South American countries of the Oxford-AstraZeneca vaccine has shown 79 per cent efficacy rate at preventing symptomatic COVID-19 and 100 per cent effectiveness in stopping severe disease and hospitalisation, the biotech firm said on Monday. The vaccine’s efficacy was consistent across ethnicity and age, and in participants aged 65 years and over, …

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Serum Institute’s lawsuit against trial volunteer uncalled for; transparent approach needed, say experts
4 years, 1 month ago

Serum Institute’s lawsuit against trial volunteer uncalled for; transparent approach needed, say experts

Firstpost  

Even in the most well-developed drug or vaccines, where the odds of an adverse event may be slim, the redressal process for issues raised by volunteers is tricky. SII said that the volunteer’s illness had nothing to do with the vaccine trial – a statement that was validated by the Institutional Ethics Committee of the Covishield trials in India. It’s …

India Volunteer Volunteers Lawsuit Process Event Dcgi
Testing timeline: What is ahead for COVID-19 vaccines
4 years, 2 months ago

Testing timeline: What is ahead for COVID-19 vaccines

Live Mint  

Pfizer's surprising news that its COVID-19 vaccine might offer more protection than anticipated — an announcement right after a fraught US presidential election campaign — is raising questions about exactly how the different shots will make it to market. Late on Monday in a series of tweets President Donald Trump accused the US Food and Drug Administration and Pfizer of …

Safety Study Fda Vaccine Moderna Shots Side Effects
Testing timeline: What’s ahead for COVID-19 vaccines
4 years, 2 months ago

Testing timeline: What’s ahead for COVID-19 vaccines

The Independent  

For free real time breaking news alerts sent straight to your inbox sign up to our breaking news emails Sign up to our free breaking news emails Sign up to our free breaking news emails SIGN UP I would like to be emailed about offers, events and updates from The Independent. Read our privacy policy Pfizer's surprising news that its …

Safety Study Fda Vaccine Moderna Shots Side Effects
J&J Begins Final Study Of Single-shot Covid-19 Vaccine Among 60,000 Volunteers
4 years, 3 months ago

J&J Begins Final Study Of Single-shot Covid-19 Vaccine Among 60,000 Volunteers

News 18  

Johnson & Johnson on Wednesday kicked off a final 60,000-person trial of a single-shot COVID-19 vaccine that potentially would simplify distribution of millions of doses compared with leading rivals using two doses. The company expects results of the Phase III trial by year end or early next year, Dr Paul Stoffels, J&J’s chief scientific officer, said in a joint press …

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Johnson & Johnson kicks off final study of single-shot Covid vaccine in 60,000 volunteers
4 years, 3 months ago

Johnson & Johnson kicks off final study of single-shot Covid vaccine in 60,000 volunteers

India Today  

Johnson & Johnson on Wednesday kicked off a final 60,000-person trial of a single-shot Covid-19 vaccine that potentially would simplify the distribution of millions of doses compared with leading rivals using two doses. The company expects results of the Phase III trial by year-end or early next year, Dr Paul Stoffels, J&J's chief scientific officer, said in a joint press …

Trial Company Collins Covid Study Vaccine Dsmb
SII to restart COVID vaccine trials as India tally breaches 50L mark
4 years, 3 months ago

SII to restart COVID vaccine trials as India tally breaches 50L mark

Deccan Chronicle  

New Delhi: The Drugs Controller General of India has revoked its suspension and allowed Serum Institute of India to resume the Phase 2 and 3 of clinical trials of the Oxford COVID-19 vaccine candidate in the country. In another development, India’s Dr. Reddy’s Laboratories Limited and Russian Direct Investment Fund have decided to collaborate for the clinical trials and distribution …

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Serum Institute of India Gets DCGI Approval To Resume Oxford-AstraZeneca Covid-19 Vaccine Trials
4 years, 3 months ago

Serum Institute of India Gets DCGI Approval To Resume Oxford-AstraZeneca Covid-19 Vaccine Trials

ABP News  

The Serum Institute of India had got the green signal from the DGCI to restart the re-enrollment procedure for COVID-19 vaccine which is being developed by AstraZeneca and Oxford University following the recommendations made by Data Safety Monitoring Board. "You may recommence the clinical trial dated August 2, 2020, as recommended by the DSMB, India as per already approved protocol …

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Serum Institute of India gets DCGI's nod to resume clinical trial of Oxford COVID-19 vaccine
4 years, 3 months ago

Serum Institute of India gets DCGI's nod to resume clinical trial of Oxford COVID-19 vaccine

Firstpost  

SII has also been asked to submit to the DCGI’s office details of medication used in accordance with the protocol for management of adverse events New Delhi: Drugs Controller General of India Dr VG Somani on Tuesday gave permission to Serum Institute of India to resume clinical trial of the Oxford COVID-19 vaccine candidate in the country while revoking its …

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Vaccine by November 3? Halted AstraZeneca Study Explains Just How Unlikely
4 years, 4 months ago

Vaccine by November 3? Halted AstraZeneca Study Explains Just How Unlikely

News 18  

The suspension of a huge COVID-19 vaccine study over an illness in a single participant shows there will be “no compromises” on safety in the race to develop the shot, the chief of the National Institutes of Health told Congress on Wednesday. “When we say we are going to focus first on safety and make no compromises, here is Exhibit …

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