Clinical Trials Chennai

2 Billion Doses of Oxford’s Unproven Coronavirus Vaccine Will Soon Be Ready to Produce

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The global supply of a potential coronavirus vaccine being developed at Oxford University has been doubled to 2 billion after a deal including $US750 million from the Bill and Melinda Gates Foundation.

The vaccine is being produced by AstraZeneca British drug maker, drawing on work by researchers from Oxford University.

It announced Thursday that it had signed agreements with the Coalition for Epidemic Preparedness Innovations (CEPI) and Gavi the Vaccine Alliance to boost its supplies.

The company has committed to mass-producing the vaccine before it has been proved effective, an unusual step designed to compress the long timeline of vaccine production.

CEPI and Gavi are both charities supported the Bill and Melinda Gates Foundation and the World Health Organisation. The US$750 million agreement with CEPI and Gavi will support manufacturing, procurement, and distribution for 300 million of the 2 billion doses.

The statement also said that AstraZeneca struck a licensing partnership with the Serum Institute of India (SII), the world’s largest manufacturer of vaccines by volume, for 1 billion doses of the vaccine earmarked for low- and middle-income countries.

The deal includes “a commitment to provide 400 million of them by the end of 2020,” according to the statement.

The company had already announced the manufacture of 1 billion doses last month, according to the BBC.

300 million of the potential vaccines are already pledged to the US and 100 million to the UK, the BBC said. If clinical trials prove the vaccine works, the first doses could be ready by September.

In the statement, AstraZeneca Chief Executive Pascal Soriot said: “We are working tirelessly to honour our commitment to ensure broad and equitable access to Oxford’s vaccine across the globe and at no profit.”

It remains unclear whether the vaccine, named AZD1222, will work. Soriot said the company should know by August, the BBC reported.

Richard Hatchett, chief executive of CEPI, admitted there was a “substantial risk” in investing in manufacturing a product that may ultimately not deliver, The Guardian reported.

Around 10,000 adult volunteers are currently testing the Phase II/III versions of the vaccine in the UK, according to the AstraZeneca statement.

This article was originally published by Business Insider.

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India mulls at four types of vaccines to prevent COVID-19, DBT’s shortlisted proposal has 10 candidates

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India is looking at four types of vaccines to prevent COVID-19. These vaccines are mRNA, attenuated, inactivated and adjuvant. There are around 50 groups evaluating the categories of vaccines covering biopharma and academic research centres.

DBT’s National Biomedical Resource Indigenization Consortium (NBRIC) in a public private partnership model to advance indigenous innovation will look vaccines and therapeutics for COVID-19. This is in partnership with ABLE (Association of Biotech Led Enterprises) and CII (Confederation of Indian Industry) and is being hosted by the Centre for Cellular and Molecular Platform (C-CAMP), Bengaluru.

There is a review mechanism of the proposals for vaccine candidates among others which is recommended for receiving financial support. The shortlisted proposals include 10 vaccines candidates. Under the research consortium, DBT and BIRAC are assessing applications of COVID-19 vaccine.

The department has also accepted institutes to provide animal models to test pre-clinical efficacy. It is here IIT-Indore will produce Pseudovirus SARS CoV-2 to develop in-vitro assays. The portfolio of vaccine candidates has further been enhanced by extending support to develop the next-generation mRNA vaccine candidate by Gennova and also separately to CMC-Vellore for a lipid encapsulated mRNA based vaccine. Early work to develop an intranasal vaccine candidate for COVID-19 has also been awarded to Indian Institute of Chemical Technology.

The companies engaged in vaccine and drugs include Serum Institute, Bharat Biotech, Indian Immunologicals Limited (IIL), Biocon and Zydus. Serum Institute plans to produce 60 million doses of a potential Oxford vaccine: ChAdOx1 nCoV-19 which is yet to be proven to work against COVID-19. Zydus is exploring a biologic drug to treat COVID-19 with Inteferon alpha-26. Biocon too has indicated that its old immunomodulator drug is showing its effectiveness in treating COVID-19 patients.

Hyderabad’s IIL has entered into a research collaboration agreement with Australia’s Griffith University to develop a lead vaccine candidate for coronavirus. As part of the cross-continental collaboration, scientists from IIL and the University will develop a ‘Live Attenuated SARS – CoV-2 vaccine’ or COVID-19 vaccine using the latest codon de-optimization technology.

Bharat Biotech, also Hyderabad-based has inked a pact with Thomas Jefferson University to develop a new vaccine candidate for COVID-19. It will make use of an existing deactivated rabies vaccine as a vehicle for coronavirus proteins. The vaccine development in its early phase has indicated an antibody response in mice. The company indicated that by the year-end, it would be ready for human studies.

According to Kiran Mazumdar-Shaw, executive chairperson, Biocon, vaccine development is a complex process. Developing a vaccine in a year’s time is a very daunting task. It will take time to have safe vaccine which takes at least 4 years. It is a complex process but we are being asked to do it in just one year.

The industry observers noted that vaccines constitute the largest component of the Indian biopharma segment. In addition to manufacturing, India has indigenously researched and developed novel vaccines for various diseases. Vaccines are public health tools that eradicated smallpox. The country’s Universal Immunization Programme (UIP) has also eliminated polio. Currently, India is managing one of the largest mass immunization programmes in the world. The country’s has made a mark in the international arena.

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Cluster Headaches Are More Than ‘Just a Headache’. But They’re Often Misdiagnosed

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Cluster headache is more than just a headache. It is a severe neurological condition, sometimes known as a “suicide headache” because many patients have suicidal thoughts during attacks.

The pain experienced during a cluster headache attack is excruciating and is said to be comparable to the pain of childbirth. Such attacks can last from 15 minutes to three hours and can occur several times per day.

The pain is almost always on one side and typical features of an attack may include bloodshot or teary eyes, droopy eyes and a runny nose or blocked nostrils.

Around one in 1,000 people experience cluster headache. It’s perceived as a rare disease, but in fact is as common as well-known neurological conditions such as multiple sclerosis or Parkinson’s disease. Getting the right treatment for this condition is difficult, as our recent study showed.

We found that many healthcare professionals do not know cluster headache or how to diagnose the condition. This has serious consequences for those suffering. Our research also shows patients regularly face long delays and undergo unnecessary procedures and referrals to specialist care before receiving the correct diagnosis and treatment.

Our team examined the understandings and experiences of cluster headache and the impact of the condition. GPs and neurologists who work in the north of England, were interviewed by a medical sociologist.

We explored their knowledge around the diagnosis and treatment of cluster headache, how they usually refer patients to a specialist, and the ways they communicate with other clinicians.

Our main finding is that cluster headache is neglected among health professionals. Many healthcare professionals do not know what a cluster headache is. This frequently leads to misdiagnosis of the condition and huge delays in receiving the correct diagnosis.

Some clinicians interviewed in the study were not aware of cluster headache, while others thought that cluster headache is the same as “cluster migraine“, which can cause nausea and sensitivity to light alongside severe head pain.

Our interviewees gave plenty of examples of the consequences a patient faces when they don’t receive a timely and correct diagnosis. Cluster headache is often misdiagnosed as migraine or trigeminal neuralgia (a severe, sudden form of face pain), but also as sinusitis or dental problems.

Patients occasionally undergo unnecessary procedures, such as teeth extraction, sinus washouts and intracranial surgery because they are in despair.

The condition has a huge impact on sufferers’ everyday life and they try all kinds of treatments hoping to find some relief from the excruciatingly painful attacks. Indeed, cluster headache can have significant influence on a patient’s mental health and on their ability to remain in employment.

People with cluster headache often suffer from severe mental health conditions, such as chronic depression, suicidal thoughts and may self-harm. Family, friends and employers often don’t grasp the severity of the condition and the enormous impact it has.

Challenges with treatment

Due to the nature of the attacks, cluster headache is treated differently compared to other headache conditions, like migraine or a tension-type headache. These are normally treated with painkillers – but if these occur frequently they will require regular preventive treatment. Cluster headache attacks are treated with nasal sprays or injectable medication (triptans) and inhalation of oxygen.

Our study also highlights tensions between primary and secondary care around prescribing these treatments because of the cost. Sometimes GPs don’t follow the treatment instructions received from neurologists in secondary care. This is especially the case if GPs think the suggested medication is not cost effective.

For example, the injectable triptans were often not prescribed because of their high cost. Some GPs instead prescribed cheaper oral triptans. But these are not effective for cluster headache patients. Many interviewed clinicians were not aware of the prescription policies for oxygen, which is an effect treatment for cluster headache.

GP participants in our study rarely referred patients with cluster headache symptoms to neurologists. When patients get referred, it is more likely to provide the patient with reassurance that their condition is not life-threatening.

In some cases, patients with cluster headache get referred to neurologists to begin specialised treatments for cluster headache, such as the drugs verapamil and lithium.

Our study shows an urgent need to increase awareness of cluster headache among health professionals and the general public. This will prevent misdiagnosis and delays in diagnosis.The Conversation

Lisa Dikomitis, Professor in Anthropology and Sociology of Health, Keele University; Alina Buture, PhD researcher, Hull York Medical School, University of Hull, and Fayyaz Ahmed, Professor of Clinical Neurology, University of Hull.

This article is republished from The Conversation under a Creative Commons license. Read the original article.

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IMA urges health ministry to reduce regulatory control on healthcare sector

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The Indian Medical Association (IMA) has urged the Union health ministry to bring down the regulatory control on healthcare sector and to ease the guidelines, so that healthcare industry in the country can revive itself and help the nation overcome this pandemic.

In a memorandum to Union health secretary Preeti Sudan, the IMA stated that all policies have served to over regulate the healthcare profession and increase the cost of healthcare delivery. Private healthcare has been providing more than 80 per cent of the total healthcare services in the country as the government services are inadequate in the country at present.

“We represent approximately 3.5 lakh doctors of modern medicine and a majority of them are entrepreneurs who have set up small nursing homes in tier II and tier III towns. Most of the times these are being run by the couples who stay in the premises of their own hospitals and are available 24X7. Unfortunately for us, the successive policies are strangulating us leading to closure of nursing homes and people looking for alternate professions after spending a lifetime caring for the sick,” said Dr Rajan Sharma, national president, IMA.

IMA stated that these single, couple and multiple doctors owned nursing homes are one of the biggest employers in both the organized and unorganized sector whose presence and importance has never been taken into account.

“As you all are aware, the healthcare sector is facing severe shortage of trained healthcare staff. Even in the government sector, there are so many vacancies. We will overcome it by recruiting untrained manpower and their training takes years of effort, needless to say, to suitably reward them to elevate the financial and social status in the society,” added IMA president.

Sharma added, “This sector has never shirked its responsibility and will never do so. Poor or rich everyone prefers to go to the friendly neighbourhood doctors who have been providing the most economical health care in the most humane way giving relief to the population at large and sharing the burden of the overburdened government facilities. Most of the patients are known to the doctor personally and have a faith in him. A private sector doctor upgrades his knowledge by attending CMEs, workshops and conferences. These efforts should be seen as an effort not to stagnate, but to deliver the best according to his knowledge and for the patients’ betterment.”

Dr R V Asokan, honorary secretary general, IMA, said, “We need to seriously introspect why the entire medical fraternity is fighting on various issues like protection against violence, as it lead to unnecessary legal harassments which take long to settle, which may entail penal action against this vital links of healthcare providers. It is time to revisit this important and significant section of healthcare delivery system of modern medicine which is already there Pan-India and needs protections not creation. We are a regular and trusted partner in delivering various national health policies like end-TB and vaccination programme, etc.”

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Physicist Proposes a Pretty Depressing Explanation For Why We Never See Aliens

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The Universe is so unimaginably big, and it’s positively teeming with an almost infinite supply of potentially life-giving worlds. So where the heck is everybody?

At its heart, this is what’s called the Fermi Paradox: the perplexing scientific anomaly that despite there being billions of stars in our Milky Way galaxy – let alone outside it – we’ve never encountered any signs of an advanced alien civilisation, and why not?

It’s a decent question, and one that generations of scientists and thinkers have grappled with since the paradox was formulated decades ago.

Some suggest aliens might be hibernating, or that something mysterious is preventing their evolution from taking place. Or maybe they just don’t want anything to do with us?

In 2018, theoretical physicist Alexander Berezin from the National Research University of Electronic Technology (MIET) in Russia put forward his own explanation for why we’re seemingly alone in the Universe, proposing what he calls his “First in, last out” solution to the Fermi Paradox.

According to Berezin’s pre-print paper, which hasn’t as yet been reviewed by other scientists, the paradox has a “trivial solution, requiring no controversial assumptions” but may prove “hard to accept, as it predicts a future for our own civilisation that is even worse than extinction”.

As Berezin sees it, the problem with some proposed solutions to the Fermi Paradox is they define alien life too narrowly.

“The specific nature of civilisations arising to interstellar level should not matter,” he writes.

“They might [be] biological organisms like ourselves, rogue AIs that rebelled against their creators, or distributed planet-scale minds like those described by Stanislaw Lem in Solaris.”

Of course, even with such a wide scope, we’re still not seeing evidence of these things out there in the cosmos.

But for the purposes of solving the paradox, Berezin says the only parameter we should concern ourselves with – in terms of defining extraterrestrial life – is the physical threshold at which we can observe its existence.

“The only variable we can objectively measure is the probability of life becoming detectable from outer space within a certain range from Earth,” Berezin explains.

“For simplicity let us call it ‘parameter A’.”

If an alien civilisation doesn’t somehow reach parameter A – whether by developing interstellar travel, broadcasting communications across space, or by other means – it might still exist, but not help us solve the paradox.

The actual “First in, last out” solution Berezin proposes is a grimmer scenario.

“What if the first life that reaches interstellar travel capability necessarily eradicates all competition to fuel its own expansion?” he hypothesises.

As Berezin explains, this doesn’t necessarily mean a highly developed extra-terrestrial civilisation would consciously wipe out other lifeforms – but perhaps “they simply won’t notice, the same way a construction crew demolishes an anthill to build real estate because they lack incentive to protect it”.

So is Berezin suggesting that we are the ants, and the reason we haven’t encountered aliens is because we simply haven’t had our own civilisation unthinkingly demolished by such unimaginably superior life forms yet?

No. Because we are probably not the ants, but the future destroyers of the very worlds we’ve been looking for this whole time.

“Assuming the hypothesis above is correct, what does it mean for our future?” Berezin writes.

“The only explanation is the invocation of the anthropic principle. We are the first to arrive at the [interstellar] stage. And, most likely, will be the last to leave.”

Again, such potential destruction wouldn’t need to be wilfully designed or orchestrated – it could just play out like a completely unrestricted system, bigger than any individual’s attempts to control it.

One example Berezin gives is free market capitalism, and another could be the dangers of an artificial intelligence (AI) untethered by constraints on its accumulation of power.

“One rogue AI can potentially populate the entire supercluster with copies of itself, turning every solar system into a supercomputer, and there is no use asking why it would do that,” Berezin writes.

“All that matters is that it can.”

It’s a pretty terrifying outlook on Fermi – basically, we may be the winners of a deadly race we didn’t even know we were competing in, or as Andrew Masterson at Cosmos put it, “we are the paradox resolution made manifest”.

Even Berezin admits he hopes he is wrong about this, and it’s worth noting that many other scientists have much more optimistic views about when we can expect to hear from advanced alien life.

But the physicist’s views are just the latest scientific statement of why we may be destined to gaze at the stars alone in time and space, much as we might wish it were otherwise.

The paper is available at arXiv.org.

A version of this story was first published in May 2018.

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