Welcome development: The Hindu Editorial on the ICMR and Controlled Human Infection Studies
1 year, 8 months ago

Welcome development: The Hindu Editorial on the ICMR and Controlled Human Infection Studies

The Hindu  

With the Bioethics Unit of the Indian Council of Medical Research placing a consensus policy statement on Controlled Human Infection Studies for comments, India has taken the first step in clearing the deck for such studies to be undertaken here. CHIS, also called human challenge studies, where healthy volunteers are intentionally exposed to a disease-causing microbe in a highly controlled and monitored environment, has been carried out for hundreds of years, an example being the yellow fever study in the early 1900s to establish that mosquitoes transmit the virus. Importantly, human challenge studies are not done as an alternative to phase-3 efficacy trials, but to help select the best candidate for testing in a conventional phase-3 clinical trial. Phase-3 clinical trials that follow human challenge studies often require fewer volunteers, speeding up the development process.

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History of this topic

Is India ready for Controlled Human Infection Studies? | In Focus podcast
1 year, 6 months ago

Is India ready for Controlled Human Infection Studies? | In Focus podcast

The Hindu  

How do we understand how an infection affects the human body? One way scientists do this is through Controlled Human Infection Studies or CHIS, also known as human challenge studies. India has so far stayed away from such studies, because of the many ethical issues involved: the deliberate harm caused and the potential risk of exploitation since volunteers are paid …

Battling a deliberately-acquired infection to help find a cure
1 year, 7 months ago

Battling a deliberately-acquired infection to help find a cure

The Hindu  

One afternoon in April 2022, in the city of Baltimore, Maryland, U.S., I found myself lying on the floor in front of a toilet. Researchers at the University of Maryland had recruited me and about 15 others to join this study to test a new vaccine that one day may hopefully prevent Shigellosis. We were given the experimental vaccine, and …

Explained | Are human challenge studies effective?
1 year, 8 months ago

Explained | Are human challenge studies effective?

The Hindu  

The story so far: On July 17, the ICMR Bioethics Unit posted the consensus policy statement for the ethical conduct of controlled human infection studies, also known as human challenge studies, in India. The second major difference is that traditional clinical trials are undertaken to study the safety and efficacy of drugs and vaccines, whereas human challenge studies are carried …

India takes its first step towards opening door to Controlled Human Infection Studies
1 year, 8 months ago

India takes its first step towards opening door to Controlled Human Infection Studies

The Hindu  

India has taken its first step to introduce Controlled Human Infection Studies, used in many countries for vaccine and treatment development. “This paper is aimed at addressing a variety of ethical issues so that research can be conducted in India without compromising on ethical principles while ensuring the protection of human participants,” notes ICMR. ICMR notes that India has so …

Explained | What are the problems with India’s clinical trials registry?
1 year, 11 months ago

Explained | What are the problems with India’s clinical trials registry?

The Hindu  

The speedy approval of Covid-19 vaccines during the SARS-CoV-2 pandemic spotlighted the importance of clinical trials. Hosted with the Indian Council of Medical Research’s National Institute of Medical Statistics, the CTRI is a free, online public-record system to register clinical trials being conducted in India. The CTRI is one of 17 public trial registries under the International Clinical Trials Registry …

Unlike clinical trials, new Covid-19 study needed only a few volunteers
3 years, 7 months ago

Unlike clinical trials, new Covid-19 study needed only a few volunteers

Live Mint  

Medical studies often use thousands of volunteers. Researchers in the U.K. have deliberately infected 30 volunteers with the virus that causes Covid-19, in the first human challenge study of the disease. The volunteers are under 24-hour study in a hospital residential facility, allowing the researchers to, among other things, measure their viral load twice daily in the nose and throat, …

Bharat Biotech, ICMR publish Covaxin Phase 1 data showing safe, enhanced immunity to Covid-19 disease
4 years, 2 months ago

Bharat Biotech, ICMR publish Covaxin Phase 1 data showing safe, enhanced immunity to Covid-19 disease

Firstpost  

Almost three weeks after the COVID-19 vaccine candidate from Bharat Biotech and ICMR, Covaxin, was given emergency use approval by Indian authorities, the duo has published an interim report in leading medical peer-reviewed journal Lancet today. The study reports findings from the vaccine’s adaptive Phase 1 trials in 375 healthy volunteers at 11 different trial sites across India. However, the …

India prepares for COVID vaccine roll-out from Saturday
4 years, 2 months ago

India prepares for COVID vaccine roll-out from Saturday

Al Jazeera  

World’s second most populous nation hopes to inoculate 300 million people – equal almost to the US population – by July. In one of the world’s biggest roll-outs, the world’s second most populous nation hopes to inoculate 300 million people – equal almost to the population of the United States – by July. First to get one of two vaccines …

Politics drives India's fight against the COVID-19 pandemic even as questions over DCGI's approvals for vaccines persist
4 years, 2 months ago

Politics drives India's fight against the COVID-19 pandemic even as questions over DCGI's approvals for vaccines persist

The Hindu  

The Drug Controller General ofIndia’s rushed approval on January 3 for Restricted Emergency Use —also sometimes referred to as Emergency Use Authorisation —of two COVID-19 vaccines— Covishield of the Serum Institute of India, Pune, and Covaxin of Bharat Biotech, Hyderabad—has revealed once again that politics and not science continues to be in the driving seat in the fight against the …

Coronavirus | New challenges for COVID-19 vaccine trials in India
4 years, 2 months ago

Coronavirus | New challenges for COVID-19 vaccine trials in India

The Hindu  

On January 1, Pune-based Serum Institute’s Covishield vaccine was granted permission for restricted use, while Bharat Biotech’s Covaxin got a similar approval the next day with certain other riders. Effects of approval Now, with two vaccines approved for restricted use, how much more challenging will it be to enrol participants for clinical trials, particularly phase-3 trials that need 25,000–30,000 people? …

‘Bharat Biotech vaccine approved in clinical trial mode, consent of participants has to be taken’: ICMR
4 years, 2 months ago

‘Bharat Biotech vaccine approved in clinical trial mode, consent of participants has to be taken’: ICMR

Hindustan Times  

Balram Bhargava, chief of Indian Council of Medical Research, said on Tuesday that Bharat Biotech’s Covid-19 vaccine has been cleared in the clinical trial mode, which means consent of participants has to be taken. “Permission for restricted use in clinical trial mode has been allowed which means consent of participants has to be taken and there has to be a …

Safety concerns delay vaccine approval in India
4 years, 3 months ago

Safety concerns delay vaccine approval in India

The Hindu  

THE hype and hullabaloo over the availability and distribution of the COVID-19 vaccine in India have been gathering a lot of steam in recent days, with politicians, the Prime Minister in particular, making all kinds of assurances. On the basis of the data from Oxford-AstraZeneca’s phase I/II trials in the U.K. and recent phase III efficacy trials in the U.K. …

Harsh Vardhan Says India's Homemade Covid-19 Vaccine Could Complete Final Trials by 2 Months
4 years, 4 months ago

Harsh Vardhan Says India's Homemade Covid-19 Vaccine Could Complete Final Trials by 2 Months

News 18  

India's health minister said on Sunday a locally-developed COVID-19 vaccine candidate could complete its final trials in a month or two, raising hopes for a rapid roll-out in a country with the world's second highest number of infections. The state-run Indian Council of Medical Research and privately-held Bharat Biotech this month started third-stage trials of COVAXIN, in a process that …

India may end final trials of indigenous Covid vaccines in next two months: Vadhan
4 years, 4 months ago

India may end final trials of indigenous Covid vaccines in next two months: Vadhan

Live Mint  

New Delhi: India's health minister said on Sunday a locally-developed COVID-19 vaccine candidate could complete its final trials in a month or two, raising hopes for a rapid roll-out in a country with the world's second highest number of infections. The state-run Indian Council of Medical Research and privately-held Bharat Biotech this month started third-stage trials of COVAXIN, in a …

UK plans to infect healthy volunteers in COVID-19 research trials
4 years, 5 months ago

UK plans to infect healthy volunteers in COVID-19 research trials

Al Jazeera  

Controversial ‘human challenge’ technique aims to study the disease and potentially speed up vaccine development, but there are ethical and safety concerns. “However, such studies are enormously informative about a disease, even one so well studied as COVID-19.” ⚡We debunk some of the most common COVID-19 myths 🦠️ https://t.co/UHU14AnrPp — Al Jazeera English October 19, 2020 Tens of thousands of …

Infecting volunteers with coronavirus may be one way to test potential vaccines. But there are risks
4 years, 5 months ago

Infecting volunteers with coronavirus may be one way to test potential vaccines. But there are risks

ABC  

Researchers are considering using "human challenge studies" to accelerate COVID-19 vaccine research and development. However, if the first vaccines fail, or turn out to be only moderately effective, challenge studies could be used to select the next most promising candidates for future field trials. Members of WHO's science group agreed on a number of technical requirements for COVID-19 challenge studies …

India launches programme to strengthen clinical trial research capacity of vaccines in neighbouring countries
4 years, 6 months ago

India launches programme to strengthen clinical trial research capacity of vaccines in neighbouring countries

The Hindu  

Amid the coronavirus pandemic, India has kick-started a “science diplomacy” initiative by launching a programme to strengthen the capacity of clinical trial research of vaccines in neighbouring countries, the Department of Biotechnology said on Wednesday. “Keeping with the principles outlined by our science diplomacy initiatives, the DBT has initiated the first phase of the training programme to strengthen clinical trial …

Indian coronavirus vaccine race: 1,750 people now under testing for 3 candidates
4 years, 7 months ago

Indian coronavirus vaccine race: 1,750 people now under testing for 3 candidates

India Today  

As the world waits with bated breath for a vaccine against Covid-19, three vaccine candidates have reached advanced stages of testing, the ICMR said on Tuesday. Three Covid-19 vaccine candidates, including two indigenous ones, are in different phases of development in India. These three promising Covid-19 vaccine candidates are the Oxford University vaccine being produced by the Serum Institute in …

ICMR helping Serum Institute in conducting clinical trials for two vaccines
4 years, 7 months ago

ICMR helping Serum Institute in conducting clinical trials for two vaccines

Live Mint  

The Indian Council of Medical Research is supporting Serum Institute of India in conducting the phase 2 and 3 clinical trials for two vaccines for covid-19, one developed by University of Oxford and the other by US-based Novavax. Dr Balram Bhargava, Director-General ICMR, according to sources, told the parliament panel that the vaccine candidates developed by Oxford University handled by …

Covid-19 Vaccine May be Considered for Urgent Authorisation after Phase-3 Trial, to be a Political Call: ICMR
4 years, 7 months ago

Covid-19 Vaccine May be Considered for Urgent Authorisation after Phase-3 Trial, to be a Political Call: ICMR

News 18  

Top officials of the Indian Council of Medical Research and All India institute of Medical Sciences were present on Wednesday before the Standing Committee for Home Affairs called by Congress Deputy Leader of Rajya Sabha Anand Sharma. Committee chairman Anand Sharma, Bhupendra Yadav, Dr Anil Jain, Neeraj Chandrasekhar, Rakesh Sinha Ravneet Singh Bittu, Dr Satyapal Singh were some MPs present …

ICMR's COVID-19 vaccine symposium saw experts discuss challenge trials, vaccine distribution, preparedness
4 years, 8 months ago

ICMR's COVID-19 vaccine symposium saw experts discuss challenge trials, vaccine distribution, preparedness

Firstpost  

Many experts outlined that big investments in trials and vaccine development need to be accompanied by big investments in science. The Indian Council of Medical Research hosted an international symposium on 30 July, bringing global health and vaccine experts under one roof to discuss science & ethics around COVID-19 vaccines. “Our collaborations with both GAVI and WHO will enable not …

Human Challenge Trial Neither Essential Nor Ethically Justified at This Time, Says US Expert Anthony Fauci
4 years, 8 months ago

Human Challenge Trial Neither Essential Nor Ethically Justified at This Time, Says US Expert Anthony Fauci

News 18  

Human challenge trials to test Covid-19 vaccines are not necessary at this time as randomised controlled trials are quite feasible owing to the high incidence of the infectious disease, said Dr Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases in the US. These factors have led us to conclude that human challenge trials are not essential …

Coronavirus | India has key vaccine role: Anthony Fauci
4 years, 8 months ago

Coronavirus | India has key vaccine role: Anthony Fauci

The Hindu  

Anthony Fauci, top infectious disease specialist and senior adviser to U.S. President Donald Trump on COVID-19, on Thursday said that India would play a critical role in supplying the world with a COVID-19 vaccine. At a web conference organised by the Indian Council for Medical Research, he, however, underlined that though the threat posed by COVID-19 was grave, it was …

India Readies 5 Sites for Final Phase of Human Trials of Oxford-AstraZeneca Covid-19 Vaccine
4 years, 8 months ago

India Readies 5 Sites for Final Phase of Human Trials of Oxford-AstraZeneca Covid-19 Vaccine

News 18  

Five sites across the country are ready for the third and final phase of human trials of the Oxford-AstraZeneca COVID-19 vaccine, Department of Biotechnology Secretary Renu Swarup said on Monday. We have already started working on them and five sites are now ready to be available for Phase 3 trials," Swarup told PTI in a telephonic interview. The Pune-based SII …

Covid-19 vaccine update: AIIMS Delhi to start human trials of Covaxin from today
4 years, 8 months ago

Covid-19 vaccine update: AIIMS Delhi to start human trials of Covaxin from today

Live Mint  

The All India Institute of Medical Sciences Ethics Committee on Saturday gave its approval for conducting the human clinical trial of the indigenously developed Covid-19 vaccine candidate Covaxin. Volunteers needed for clinical trial of Covid-19 vaccine Covaxin in AIIMS Delhi Healthy volunteers having no comorbid conditions and without a history of COVID-19, aged more than 18 years and less than …

Volunteers needed for clinical trial of Covid-19 vaccine Covaxin in AIIMS Delhi
4 years, 8 months ago

Volunteers needed for clinical trial of Covid-19 vaccine Covaxin in AIIMS Delhi

Hindustan Times  

The All India Institute of Medical Sciences in Delhi will start enrolling healthy individuals from Monday for conducting the human clinical trial of Covaxin, the indigenously developed Covid-19 vaccine candidate. AIIMS’s Ethics Committee gave its nod for a human clinical trial of Covaxin on Saturday This comes after AIIMS’s Ethics Committee gave its nod for a human clinical trial of …

AIIMS panel gives nod to begin human clinical trial of COVID-19 vaccine Covaxin from 20 July
4 years, 8 months ago

AIIMS panel gives nod to begin human clinical trial of COVID-19 vaccine Covaxin from 20 July

Firstpost  

Covaxin, Bharat Biotech’s COVID-19 vaccine candidate, has been developed in collaboration with the ICMR and NIV New Delhi: The AIIMS Ethics Committee on Saturday gave its nod for a human clinical trial of the indigenously developed COVID-19 vaccine candidate Covaxin following which the premier hospital is likely to begin the exercise by enrolling healthy volunteers from Monday. “The AIIMS Ethics …

AIIMS panel gives nod to human clinical trial of anti-coronavirus drug Covaxin
4 years, 8 months ago

AIIMS panel gives nod to human clinical trial of anti-coronavirus drug Covaxin

India Today  

The AIIMS Ethics Committee on Saturday gave its nod for a human clinical trial of the indigenously developed Covid-19 vaccine candidate Covaxin following which the premier hospital is likely to begin the exercise by enrolling healthy volunteers from Monday. "The AIIMS Ethics Committee gave its approval for starting the human clinical trial of the indigenously developed Covaxin today. Covid-19 vaccine …

Coronavirus | Govt to set norms for vaccine trials
4 years, 8 months ago

Coronavirus | Govt to set norms for vaccine trials

The Hindu  

The government is readying a document that will chalk out guidelines for companies and institutions working on potential COVID-19 vaccines. The COVID-19 pandemic has prompted regulators across the world to issue emergency use authorisation for certain drugs and trials on potential vaccines to accelerate the approval process without compromising on objectively assessing whether the potential vaccine, or investigational drug, provides …

Surely, even if slowly: The Hindu Editorial on attempts to fast-track a COVID-19 vaccine
4 years, 8 months ago

Surely, even if slowly: The Hindu Editorial on attempts to fast-track a COVID-19 vaccine

The Hindu  

Yet again, the pandemic has revealed cracks in the conduct of the Indian Council of Medical Research. A letter by the agency’s head, Dr. Balram Bhargava, to doctors last week, preparing to test a vaccine for human trials, appeared to be coercing them into getting a vaccine ready by August 15. After public uproar the agency clarified that its intent …

Coronavirus vaccine update: Nod to human trial marks ’beginning of the end’, says govt
4 years, 8 months ago

Coronavirus vaccine update: Nod to human trial marks ’beginning of the end’, says govt

Live Mint  

The approval for human trails for two made-in-India COVID-19 vaccines, marks the 'beginning of the end,' the government said today. Two COVID-19 vaccine candidates — Covaxin, developed by the Hyderabad-based Bharat Biotech International Limited in collaboration with the ICMR and the National Institute of Virology and ZyCov-D vaccine by Zydus Cadila — had recently got the nod for human clinical …

ICMR says that expedited trial for Covaxin will not bypass any safety test
4 years, 8 months ago

ICMR says that expedited trial for Covaxin will not bypass any safety test

Op India  

The Indian Council of Medical Research has issued a clarification following criticism over its claim of plan to release a Coronavirus vaccine by 15 August while starting human trials for the same in July. ICMR has said that while it aims to expedite clinical trials of COVAXIN, developed in collaboration with Bharat Biotech, all globally accepted norms for vaccine development …

Fast-tracking Covid vaccine to cut red tape, don't second-guess our professionalism: ICMR
4 years, 8 months ago

Fast-tracking Covid vaccine to cut red tape, don't second-guess our professionalism: ICMR

India Today  

A day after experts raised concerns over the Indian Council of Medical Research's decision to fast-track vaccine development for Covid-19 and set a deadline for August 15, the ICMR has issued a clarification stating that it has decided to fast track the process to cut red-tapeism and it is in accordance with global practice. "Just as red tape was not …

WHO backs COVID-19 vaccine trials that deliberately infect participants
4 years, 10 months ago

WHO backs COVID-19 vaccine trials that deliberately infect participants

The Hindu  

In new guidelines issued on May 6, the World Health Organization has said that well-designed human challenge studies could not only accelerate coronavirus vaccine development but also make it more likely that the vaccines ultimately deployed will be far more effective. Around 30 Indian attempts at COVID-19 vaccine, says Principal Scientific Adviser In human challenge studies, healthy participants are first …

Vaccine research: Thousands of people want to be exposed to Covid-19 for science
4 years, 10 months ago

Vaccine research: Thousands of people want to be exposed to Covid-19 for science

CNN  

CNN — Abie Rohrig had just turned 18 when he told his mom he would be donating a kidney to save a stranger’s life. Co-authored by Nir Eyal of Rutgers, Marc Lipsitch of Harvard, and Peter Smith of the London School of Hygiene & Tropical Medicine, the piece concluded that while a human challenge study would not be without risks, …

Looking beyond just diagnosis and quarantine
5 years ago

Looking beyond just diagnosis and quarantine

The Hindu  

A pandemic is upon the world and coronavirus is not the last word. There was a suggestion in the article, “How is India containing COVID-19?”, that the virus in India is different from that in China on the basis of genome sequence made available by NIV, Pune. In any case, it is important to sequence the virus isolates in at …

Infecting healthy people with coronavirus can speed up vaccine trials
5 years ago

Infecting healthy people with coronavirus can speed up vaccine trials

The Hindu  

Even if everything goes to plan, it will take at least 12-18 months for a novel coronavirus vaccine to be tested if conventional clinical trial procedures are adopted. The human challenge study does not involve the conventional Phase-3 trial where thousands of healthy volunteers receive either a vaccine or a placebo and followed up for a long time to assess …

Coronavirus | India to join WHO’s COVID-19 trials
5 years ago

Coronavirus | India to join WHO’s COVID-19 trials

The Hindu  

India is all set to join World Health Organisation’s “Solidarity trial” aimed at rapid global search for drugs to treat COVID-19. The Solidarity Trial will test four different drugs or combinations — remdesivir, a combination of two drugs, lopinavir and ritonavir, the two drugs plus interferon beta, and chloroquine — and will compare their effectiveness to what is called standard …

ICMR tests vaccine to check spread of TB in households
5 years, 8 months ago

ICMR tests vaccine to check spread of TB in households

Live Mint  

The Indian Council of Medical Research has started a vaccine trial to prevent tuberculosis among those living close to patients suffering from the disease. The study will enrol more than 12,000 healthy members of households who are in contact with sputum smear-positive pulmonary TB patients, and are at high risk of contracting the disease, from seven locations across six states—Delhi, …

A challenge to protocol
6 years, 11 months ago

A challenge to protocol

The Hindu  

Members of a government ethics panel in the U.S. have renewed their criticisms of a controversial study in which volunteers are to be deliberately infected with the Zika virus. “When you’re asking someone to take a risk that won’t benefit them but may benefit others in the future, you need to know two things — that proper protections are in …

Collusion of the worst kind
11 years, 6 months ago

Collusion of the worst kind

The Hindu  

When regulators become violators, who is to regulate them? That perplexing question is what arises from the damning report of the Parliamentary Standing Committee that investigated alleged irregularities in the conduct of the human papilloma virus vaccine trial on nearly 23,500 girls in the 10-14 age group in Vadodara, Gujarat and Khammam, Andhra Pradesh. But an MoU was signed as …

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