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Vaccine: Bangladesh approves Sinovac’s final-stage human trial

Health minister Zahid Maleque on Thursday said the International Centre for Diarrhoeal Disease Research, and Sinovac would jointly conduct the trial on uninfected healthcare employees

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COVID-19 Vaccine

The Sheikh Hasina government on Thursday granted approval for the final-stage human trial in Bangladesh of a candidate Covid-19 vaccine developed by China’s Sinovac Biotech Ltd.

The development surprised diplomats in New Delhi and Dhaka since Indian foreign secretary Harsh Vardhan Shringla had during a Dhaka visit last week told his counterpart Masud Bin Momen that India would offer any Covid-19 vaccine it develops to Bangladesh as a priority.

Bangladesh health minister Zahid Maleque on Thursday said the International Centre for Diarrhoeal Disease Research, Bangladesh, and Sinovac would jointly conduct the trial on healthcare employees uninfected by the new coronavirus.

“We have approved the human trial of the Covid-19 (candidate) vaccine, developed by Sinovac, in Bangladesh after examining all necessary research protocols,” Maleque said at a media briefing.

Some within Bangladesh’s foreign policy establishment described the development as a failure on the part of India’s “vaccine diplomacy”, which had brought Shringla to Dhaka.

“India had conveyed its reservations about Bangladesh allowing the human trial of the Chinese vaccine…. That’s why the trial was put on hold although the Bangladesh Medical Research Council had cleared it in mid-July,” said a source who asked not to be identified. “But the ministry’s go-ahead to it now means India’s reservations have been ignored.”

The source added that the clearance to the vaccine trial had followed a meeting between Maleque and the Chinese ambassador to Bangladesh, indicating Beijing had elbowed Delhi out of the vaccine race in Bangladesh.

Others, however, felt that an approval to the human trial of a candidate vaccine to fight a pandemic could not be seen as a diplomatic failure.

“It’s a humanitarian issue involving the lives of people…. This narrative about India’s reservations about candidate vaccines from another country is misplaced and exaggerated,” a source from the Indian side said.

He added that Momen had during his briefing after a lunch with Shringla last week categorically said that Bangladesh was in touch with China, Russia, the US and other countries for a possible Covid-19 vaccine.

“A nod for one company doesn’t mean that they have shut the door on other candidate vaccines…. Like all other countries, they too are in a hurry to get the vaccine,” the source said.

Maleque had during his media interaction taken care to explain why the Chinese company had been allowed to conduct the trial, which would involve more than 4,200 people in Bangladesh.

“We will get 1 lakh vaccines free of cost. Besides, Bangladesh will get priority in the purchase of an adequate number of vaccines from the Chinese company,” he said.

A source in the Bangladesh Medical Research Council, the country’s apex body for medical research, said the organisation had cleared the Chinese proposal for a trial as it was convinced about the safety and efficacy of the candidate vaccine.

“We believe that research has no geographical boundaries. Clinical trials are research; that’s why we have given the go-ahead,” the source said.

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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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Covid-19 vax: WHO warns of ‘catastrophic moral failure’

He said over 39 million vaccine doses had been given in 49 richer states – but one poor nation had only 25 doses.

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Tedros Adhanom Ghebreyesus WHO

Geneva, Jan 19 : The world faces a “catastrophic moral failure” because of unequal Covid-19 vaccine policies, the head of the World Health Organization (WHO) has warned.

WHO chief Tedros Adhanom Ghebreyesus said it was not fair for younger, healthy people in richer nations to get injections before vulnerable people in poorer states, the BBC reported.

He said over 39 million vaccine doses had been given in 49 richer states – but one poor nation had only 25 doses.

Meanwhile, both the WHO and China were criticised for their Covid response.

An independent panel commissioned by the WHO said the UN public health body should have declared an international emergency earlier, and also rapped China for not taking public health measures sooner.

So far, China, India, Russia, the UK and the US have all developed Covid vaccines, with others being made by multinational teams – like the American-German Pfizer vaccine.

Almost all of these nations have prioritised distribution to their own populations.

Speaking at a WHO executive board session on Monday, Tedros said: “I need to be blunt: the world is on the brink of a catastrophic moral failure – and the price of this failure will be paid with lives and livelihoods in the world’s poorest countries.”

Tedros said a “me-first” approach would be self-defeating because it would push up prices and encourage hoarding.

“Ultimately, these actions will only prolong the pandemic, the restrictions needed to contain it, and human and economic suffering,” he added.

The WHO head called for a full commitment to the global vaccine-sharing scheme Covax, which is due to start rolling out next month.

“My challenge to all member states is to ensure that by the time World Health Day arrives on April 7, Covid-19 vaccines are being administered in every country, as a symbol of hope for overcoming both the pandemic and the inequalities that lie at the root of so many global health challenges,” Tedros said.

So far, more than 180 countries have signed up to the Covax initiative, which is supported by the WHO and a group of international vaccine advocacy groups. Its aim is to unite countries into one bloc so they have more power to negotiate with drug companies.

Ninety-two countries – all of them low or middle-income – will have their vaccines paid for by a fund sponsored by donors.

“We have secured two billion doses from five producers, with options of more than one billion more doses, and we aim to start deliveries in February,” Tedros said.

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