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Why is the world going slow on intranasal vaccine development for coronavirus
Union Health Minister Dr Harsh Vardhan has indicated that Bharat Biotech and Serum Institute of India will pursue clinical trials of intranasal vaccines for Covid-19 in India and that they are seeking regulatory approval. While Serum Institute of India in a tieup with US' Codagenix started producing CDX-005 for trial purpose last month, Bharat Biotech has entered into an agreement with Washington University School of Medicine for another vaccine. Both are expected to go into the final stage by year-end. Yet there is a stepmotherly delay in producing this simple, effortless nasal vaccination. Because, it looks, that does not involve billions in this golden age of the pharmas. The intranasal vaccine, when made available, will truly revolutionalise covid treatment.

by RM NAIR

NEW DELHI, Oct 19: Union Health Minister Harsh Vardhan has said that Bharat Biotech and Serum Institute of India will pursue clinical trials of intranasal vaccines for Covid-19 in India in collaboration with foreign vaccine developers on receipt of regulatory approval. They will conduct trials, produce and market the intranasal vaccines.

The Minister said in his Sunday Samvaad that at present in India there is no intranasal covid vaccine under clinical trial.

However, he said, the Serum Institute of India has begun manufacturing US' Codagenix's CDX005 which is an intranasal live attenuated vaccine candidate for SARS-CoV-2. (The manufacturing is for large-scale safety and efficacy studies, in addition to preparing to meet global vaccine supply requirements, the company had said.)

The pre-clinical animal studies had already been completed last month and Codagenix expects to initiate Phase I human clinical trial in the UK by the end of 2020.

Serum Institute of India also plans to undertake the clinical development of this in India.

CDX-005 is a single dose intranasal vaccine made with a live attenuated version of the virus.

“Our live-attenuated vaccine approach is in sharp contrast to many of the more common COVID-19 immunisation strategies currently undergoing human testing, such as mRNA or virus-like-particle candidates, which only target the spike protein, or the adenovirus vectored approaches that could cause off-target effects. Moreover, CDX-005 is delivered intranasally rather than via an injection, which allows for more efficient, patient-friendly administration,” Codagenix had said.

Codagenix, Inc., is a New York-based clinical-stage biotechnology company developing prophylactic vaccines and oncolytic virus therapies.

Vardhan said, Bharat Biotech has entered into an agreement with Washington University School of Medicine as part of which Bharat Biotech will conduct trials, produce and market an intranasal vaccine for Covid-19. The Phase I trials will take place in St Louis University's vaccines and treatment evaluation unit and Bharat Biotech on receipt of regulatory approval will pursue further stages of clinical trials in India.

Of the vaccines currently in Phase 3 trials in India, all are administered by injection and in two doses.

The prognosis

Nasal vaccine is less invasive and is quickly absorbed by the nasal mucosa. There is no fear of diseases transmission through needles and anaphylactic response associated with injections. Manufacture, distribution and administration (by self) will be easy and very cheap and quick and smooth. It will be an effortless step to stop coronavirus transmission instantly. If not sabotaged! Presently, billions and billions are siphoned off for medicines that are no cure.

Nasal vaccine has several more advantages. It will ensure systemic as well as local immunity as it directly impacts the nasal mucosa which is corona's primary breeding ground. Engaging local immunity will have immediate effect of reducing the viral load. A reduced load moving through airways by inhalation will delay replication in the lungs with the result that by then the 'sleeping' immune system would have woken up to strike down the viral invasion before it is late. A delayed human immune response to coronavirus has been found to be why the virus is so lethal. Some scientists believe the virus has the ability to evade detection by the primary immune layer and that gives it time to get entrenched before the larger immune system responds. This late immune response goes into an overdrive like a panic reaction that damages organs like kidney, heart, liver, brain etc. in what is called cytokine storm. It is not the virus that is doing the organ damage as much, its habitat being only the airways and the lungs. This is otherwise called the corona's asymptomatic advantage, which the nasal spray will break.

During the current crisis the world is passing through, coronavirus calls for a logical approach to prevention and cure as there is no medicine. Let us keep in mind one thing that this virus is not a living thing to fly into our nostrils on its own! Else, let us turn to the doctor who has gathered enough experience in the last ten months as our only Saviour.


SELECTIONS FROM OUR ARCHIVES

Five people were arrested from a banquet hall in Sector 51 Noida on Thursday where they were called to hold a rave party in a trap laid by the animal rights group, PFA. They named Yadav but he was not present.

Betting through Dubai-based Mahadev Book in India is conducted through a countrywide network. Probes reveal that the online gambling is worth several millions and top politicians, officials and celebs have been beneficiaries.

TAILPIECE: Polling dates for some States are round the corner. Top politicians have begun their acrimonious debate who looted more, even as Mahadev is washing their dirty laundry in the open ghat. Come what may, one needs to seize power to amass "thy wretched pelf!" One simple question is, why else one should spend lakhs or crores to get elected! A question every Indian should ask to oneself at least once a day!

His inaction amounts to defeating the rights of the people of the State to welfare measures sought to be implemented through the Bills, the Kerala Government's petition submitted, while the State of Tamil Nadu remarked that its "Governor is acting as a political rival."

Tailpiece: Coming up back to back, the petitions in their totality seem to question the provision of Raj Bhavan, and not motives of a Governor as a person.

Hundreds of cars piled up behind the wreckage of crashes occurring one after other in backing up - continuous crashes to the rhythm of metallic clanks and bangs back to back. According to reports, some ops required 'Jaws of Life' to pull apart the mangled cars to save lives inside.

The pilots struggled with Emerson to thwart a shut-off as he reached for the T-handles (see pix). Later he admitted to police he had taken psychedelic mushrooms and had a "nervous breakdown."

Doctors reasoned how the incidence of heart attacks is spiking over time and advise the simple way to play safely is to take a break and rehydrate yourself.

But how come ten people, including children, die of cardiac arrest at Garba in 24 hours, and that at different places of Gujarat? Garba had been going on for six days, and every year it is celebrated.

The killing of a teacher in France by an Islamic radical last Friday is linked to the Israel-Hamas war in West Asia, say authorities.

Shocking news from the UK: Leading grocers have started bribing policemen with free food and drinks to persuade them to take action against shoplifters.

Shoplifting has risen by about 27 per cent in 10 major cities across the UK this year. The cost of retail crime last year was $2.15 billion. Besides, “We are seeing organised gangs threatening staff with weapons and emptying stores," Helen Dickinson, chief executive of the British Retail Consortium, said. Data shows that the police failed to respond to 73 per cent of serious retail crimes that included assault and abuse of workers, apart from shoplifting.

Isar Mohammad allegedly picked up a banana offered to Ganesh idol on Chaturthi at a makeshift temple in Delhi and consumed it.

Harris said hip-hop is “the ultimate American art form” that “shapes every aspect of American popular culture.” “Hip-hop culture is American culture,” she said in a talk at her official residence at the US Naval Observatory in Washington, D.C.

The social media had mixed reaction. There was much appreciation that she dances better than any VP in American history. But some called her "moves" as “cringe” while others did not like her pink pants - "pink pants don’t look good.” In fact, her ensembles have always been incongruous.

"Let’s see how the (Governor's) Vice-Chancellors are given salary." Mamata's extreme statements will put the Marxist Government in Kerala, which is also facing similar issues, to shame. Has she begun the countdown for a war on the streets?

It's true Mamata has come to see a conspiracy to demolish the established systems across the country, but lacks the ability to foresee what exactly is being pushed.

Brandishing a sword, Mahant Paramhans told reporters on Tuesday he himself will behead MK Stalin's son for his remarks against Sanatan Dharma in case nobody came forward to accept his offer he made in his video. Udhayanidhi reacted to the saint's Monday video, "I will speak more. I am the grandson of the artist who put his head on the rail track for Tamil Nadu."

Somanath elaborated, "I am an explorer. I explore the Moon. I explore the inner space. So it's a part of the journey of my life to explore both science and spirituality. So I visit many temples and I read many scriptures. So try to find the meaning of our existence and our journey in this cosmos. So it's a part of the culture that we are all built to explore, find out the inner self as well as outer self. So for the outer, I do science, for the inner I come to temples." (See videos)

Rao the mathematical legend had fathered the path-breaking Rao-Blackwell theorem, one of the most important theorems in mathematical statistics, at the age of 25. That brought him global fame. He is also famous for his Cramér-Rao Bound inequality theorem relating to quality of estimators in statistics which has had a profound bearing on applications of modern economics and several other diverse fields. Simply put, with the pioneering statistician computation became a tool to analyse even socio-economic challenges of modern times.

The alleged incident has received such a flash publicity that a standardised city's hugely middle class population will have second thoughts about eating outside for some time. Now everything on the table looks suspicious!

“All subjects directly connected to the people should be shifted to the State List. Particularly the subject of education. Only if this is done can cruel exams like NEET be abolished,” Stalin said. Education was moved from the State List to the Concurrent List with the 42nd Constitution Amendment made by the Central Government in 1976.

Decentralisation has been at the core of Tamil politics since the times of CN Annadurai. Stalin indicated there will be political changes in the offing.

TAILPIECE: While the Centre and the States are at loggerheads, it takes a different cognitive acumen to know that entrance tests are not the way for students' admission to courses.

As recently as Tuesday Craig Robertson had posted on Facebook: "Perhaps Utah will become famous this week as the place a sniper took out Biden the Marxist." Biden was scheduled to make his first visit to Utah as President Wednesday afternoon.

Maruti is recalling 87,599 S-Presso and Eeco vehicles to inspect and possibly replace parts in the steering system. All reputed companies around the world do recall their products when a defect comes to light.

Meanwhile, a question arises why just in about a year so many accidents have taken place involving Mercedes sent to India while the car has won safety awards abroad? In most cases, the vehicle collided with divider, while manoeuvring a turn. Was there a split second delay in the steering system coming to a grip when at high speed? Did anybody in India bother to study a pattern in several of these accidents that took place one after other?

Former Tata Sons chairman Cyrus Mistry died when his Mercedes-Benz-SUV hit a divider in Gujarat. Cricketer Rishabh Pant's Mercedes-Benz-SUV rammed a divider in Uttarakhand and smashed. It went up in flames but he escaped with injuries. Brother of PM Narendra Modi, Prahlad Modi's Mercedes-Benz-SUV met with a similar accident in Mysuru. And many more.

  • Experts blame violation of the Visual Flying Rules (VFR) for most of the chopper crashes in the mountains as the leading cause. VFR means fly only visually - because of the lack of navigation aids in remote areas or unreliability of GPS-like aids in hilly terrains or a remote manipulation of instruments in cases of sabotage - as the topography plays havoc especially in the monsoon (mid-June to September).
  • Even when VFR is followed, most crashes occur due to CFIT (Controlled Flight into Terrain) - that is, everything else is OK but the aircraft collides with hills or trees hidden by the clouds. This also occurs mostly in the monsoon.
  • On Tueday with Manang, the chopper was brand new, pilot was highly experienced. But it hit an 'invisible' tree and then crashed against a hillside. This CFIT occurred when the pilot tried to dodge patches of clouds even as he was following the VFR.
  • Simply put, everyone knows flying in the hills during the monsoon is risky, but the companies want to make more money in any which case. This type of tragedy is very frequently invited in the Indian hill State of Uttarakhand as well, where pilots are even made to fly without the mandatory rest.
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