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Stop Covaxin Trials, Urge Bhopal NGOs In Letter To PM Modi

In the letters addressed to the Prime Minister and Union Health Minister Harsh Vardhan these NGOs have also asked for punishment for responsible parties.

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Covid 19 Vaccine

At least four NGOs working for the victims of the 1984 Bhopal gas tragedy wrote to Prime Minister Narendra Modi on Sunday demanding that the ongoing clinical trials for Covaxin, an indigenously developed Covid-19 vaccine, be stopped in Bhopal in view of the “gross violation of laws and guidelines”.

In the letters addressed to the Prime Minister and Union Health Minister Harsh Vardhan, these NGOs have also asked for punishment for the “responsible parties who were negligent in ensuring the safety, well being and the rights of the trial participants”.

They also demanded monetary compensation for “damages caused during the Covaxin trial in Bhopal”.

These letters have been written by Rashida Bee of Bhopal Gas Peedit Mahila Stationery Karmchari Sangh, Nawab Khan of Bhopal Gas Peedit Mahila Purush Sangharsh Morcha, Rachna Dhingra of Bhopal Group for Information and Action, and Nausheen Khan of Children Against Dow Carbide.

Covaxin is developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).

“We are writing to you to apprise you of the on ground situation with regard to the conduct of the trial. Evidence has emerged that the trial in Bhopal is being conducted in gross violation of laws and guidelines governing clinical trials in India,” the NGOs stated in the letters, copies of which were shared with media persons.

“This is leading to exploitation and harm to a community of people that are not just economically and socially deprived, but whose health is compromised owing to the destructive impact and its consequences,” they said.

The NGOs alleged that vulnerable people were being misguided and herded to participate in the trials, and the consent procedure and other protocol of the testing is being flouted.

“The (clinical) trial should be stopped immediately and an impartial probe be conducted,” they demanded.

Talking to reporters virtually, Rashida Bee said, “At least 700 of the 1,700 people on who this vaccine, with unknown efficacy, is being tested, are the people poisoned by Union Carbide (gas leak in 1984).

“One gas victim has already died within 10 days of getting the trial shot and many continue to have health complaints of serious nature,” Bee alleged.

A 42-year-old man, who had taken part in the clinical trial for Covaxin in Bhopal on December 12, died nine days later, with doctors suspecting that poisoning could be the cause.

Bharat Biotech had said in a statement that preliminary reviews indicated that the death was unrelated to Covaxin.

Bee claimed that nobody was punished for the “death of 13 gas victims during the trials by pharma companies at the Bhopal Memorial Hospital & Research Centre some 12 years ago”.

She demanded compensation of Rs 50 lakh for the people “who have died during the Covaxin trial, as being given in the case of deceased corona warriors”.

Alleging irregularities in the conduct of the Covaxin trials, Dhingra said, “People whose health is compromised due to Union Carbide’s poisons are being given the Covaxin trial shots without their knowledge or consent”.

She said audio and video consent should be taken of all the vulnerable people (before allowing them to volunteer for this clinical trial).

“No records are kept of the health problems the trial’s participants have had following the shots and several have been turned away without tending to the adverse effects of the shots. Trial participants who leave or are excluded halfway are denied care and are not followed up,” she alleged.

Shehzadi Bee of Bhopal Gas Peedit Mahila Purush Sangharsh Morcha said, “In addition to immediate stopping of the trial and awarding compensation for the gas victim who has died during this trial, we demand a thorough and impartial audit, criminal punishment to officials and institutions responsible for this public health disaster and compensation for injuries caused due to the trial vaccines”.

“By ignoring the ongoing criminal irregularities in the Covaxin trial in Bhopal, the Government is potentially unleashing a public health disaster on the 16th of this month,” said Nousheen Khan of the Children Against Dow Carbide.

The Drugs Controller General of India last week approved Oxford Covid-19 vaccine Covishield, manufactured by Serum Institute, and Covaxin of Bharat Biotech for restricted emergency use in the country.

The Central government on Saturday said India will launch its Covid-19 vaccination drive from January 16, with priority to be given to nearly three crore health care and frontline workers.

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No benefit from arthritis drug for severe Covid patients: Study

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Contrary to a few studies that earlier suggested benefits from an arthritis drug for patients with severe or critical Covid-19 infection, a new study indicates that it is not better than standard care alone.

According to the researchers, including Regis G Rosa from Hospital Moinhos de Vento in Brazil, there was an increased number of deaths at 15 days in patients receiving an arthritis drug — tocilizumab — that resulted in the trial being stopped early.

These results contradict earlier observational studies suggesting benefit from tocilizumab. However, observational effects are limited by a high risk that they may be due to other unknown (confounding) factors — and some studies have not yet been peer reviewed or published in a medical journal, the researchers said in a paper published in The BMJ journal.

Tocilizumab blocks a specific part of the immune system (interleukin 6) that can go into overdrive in some patients with Covid-19.

According to the team, doctors think this might help lessen the body’s inflammatory response to the virus and avert some of the more dire consequences of the disease, but its effects are not well defined.

To test this theory, researchers conducted a randomised controlled trial involving 129 Covid-19 patients with an average age of 57 years and compared tocilizumab plus standard care with standard care alone.

Patients were receiving supplemental oxygen or mechanical ventilation and had abnormal levels of at least two chemicals linked to inflammation in their blood.

The study participants were randomly divided into two groups — 65 received tocilizumab plus standard care and 64 received standard care alone. All patients were monitored for 15 days.

By day 15, 18 (28 per cent) patients in the tocilizumab group and 13 (20 per cent) in the standard care group were receiving mechanical ventilation or had died.

Death at 15 days occurred in 11 (17 per cent) patients in the tocilizumab group compared with 2 (3 per cent) in the standard care group.

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Male sex hormones may help treat breast cancer: Study

While endocrine therapy is standard-of-care for estrogen receptor positive breast cancer, resistance to these drugs is the major cause of breast cancer mortality.

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Sydney : Researchers have found new evidence about the positive role of androgens, commonly thought of as male sex hormones but also found at lower levels in women, in breast cancer treatment.

In normal breast development, estrogen stimulates and androgen inhibits growth at puberty and throughout adult life.

Abnormal estrogen activity is responsible for the majority of breast cancers, but the role of androgen activity in this disease has been controversial.

The new research published in the journal Nature Medicine showed that androgens have potential for treatment of estrogen receptor positive breast cancer.

A cancer is called estrogen receptor positive if it has receptors for estrogen, according to Breastcancer.org.

Using cell-line and patient-derived models, the global team, including researchers at the University of Adelaide and the Garvan Institute of Medical Research in Australia, demonstrated that androgen receptor activation by natural androgen or a new androgenic drug had potent anti-tumour activity in all estrogen receptor positive breast cancers, even those resistant to current standard-of-care treatments.

In contrast, androgen receptor inhibitors had no effect.

“This work has immediate implications for women with metastatic estrogen receptor positive breast cancer, including those resistant to current forms of endocrine therapy,” said lead researcher Theresa Hickey, Associate Professor at the University of Adelaide.

“We provide compelling new experimental evidence that androgen receptor stimulating drugs can be more effective than existing (e.g. Tamoxifen) or new (e.g. Palbociclib) standard-of-care treatments and, in the case of the latter, can be combined to enhance growth inhibition,” said Wayne Tilley, Director of the Dame Roma Mitchell Cancer Research Laboratories, Adelaide Medical School, University of Adelaide.

Androgens were historically used to treat breast cancer, but knowledge of hormone receptors in breast tissue was rudimentary at the time and the treatment’s efficacy misunderstood.

Androgen therapy was discontinued due to virilising side effects and the advent of anti-estrogenic endocrine therapies.

While endocrine therapy is standard-of-care for estrogen receptor positive breast cancer, resistance to these drugs is the major cause of breast cancer mortality.

“The new insights from this study should clarify the widespread confusion over the role of the androgen receptor in estrogen receptor driven breast cancer,” said Elgene Lim, a breast oncologist and Head of the Connie Johnson Breast Cancer Research Lab at the Garvan Institute.

“Given the efficacy of this treatment strategy at multiple stages of disease in our study, we hope to translate these findings into clinical trials as a new class of endocrine therapy for breast cancer.”

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Expert panel recommends Phase 1 trial of nasal Covid-19 vaccine

According to the firm, an intranasal vaccine stimulates a broad immune response at the site of infection, in the nasal mucosa, which is essential for blocking both infection and transmission of Covid-19.

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New Delhi, Jan 20: The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) on Tuesday recommended Bharat Biotech’s intranasal vaccine for coronavirus for phase 1 clinical trials. The final call will now be taken by the Drugs Controller General of India.

Days after getting the Drugs Controller General of India’s nod for restricted emergency use of India’s first indigenously-made coronavirus vaccine, Bharat Biotech had applied to the drug regulator for permission to start the clinical trials of their nasal coronavirus vaccine.

The nasal vaccine is different from the intramuscular vaccine which recently got approval, as it is non-invasive, needle-free, doesn’t require trained healthcare workers, eliminates needle-associated risks, suits children and adults and has scalable manufacturing.

Earlier on Tuesday, Dr VK Paul, Member, NITI (National Institution for Transforming India) Aayog had said, “A nasal vaccine candidate has been identified. It has come for consideration for phase 1 and phase 2 trials. If it works then it could be a game-changer.”

“Phase 1 has been recommended,” top government sources told IANS. Clinical trials of Bharat Biotech’s ‘BBV154’ — a novel adenovirus vectored, and intranasal vaccine for coronavirus — will be conducted at various locations. The vaccine will be single-dosed.

According to the firm, an intranasal vaccine stimulates a broad immune response at the site of infection, in the nasal mucosa, which is essential for blocking both infection and transmission of Covid-19.

The vaccine has demonstrated protective efficacy in mice and hamsters. Mice and hamsters immunized with its single-dose conferred superior protection against the SARS-CoV-2 challenge, “more so than one or two intramuscular immunizations of the same vaccine and dose.”

“Thus, intranasal immunization of ChAd-SARS-CoV-2-S can create an immune response in the nose, which is the point of entry for the virus, thereby protecting against disease, infection and transmission,” Bharat Biotech said in a statement.

On January 3, two intramuscular vaccines – Bharat Biotech’s Covaxin and Oxford-AstraZeneca’s Covishield manufactured by the Serum Institute of India were approved for restricted emergency use and have been administered to over four lakh people till now. Both are two-dose vaccines.

While the full efficacy of Covaxin is yet to be determined, it was given the go-ahead by the DCGI citing ‘public interest’. Covaxin is an indigenously developed vaccine by Bharat Biotech, in collaboration with the Indian Council of Medical Research (ICMR).

Public health experts believe that intranasal vaccines for coronavirus, administered through the nose rather than muscles, can be a potential game-changer in India’s fight against the coronavirus pandemic.

Last month, Pune-based Serum Institute of India and Codagenix Inc had announced that they have received regulatory approval in the United Kingdom to begin an early-stage trial of their single-dose, intranasal coronavirus vaccine.

(Aakanksha Khajuria can be contacted at [email protected])

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