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Pfizer, Moderna vaccines are ready for distribution: First-ever use of mRNA technology
With Phase 3 trial data, Pfizer and Moderna vaccines are ready to apply for Emergency Use Authorization (EUA). Both will start distributing the vaccines next month. Both have been found safe and effective across a wide spectrum of volunteers. In Moderna, instances of verified reactogenicity occurred in a few instances but that should not necessarily feed vaccine hesitancy. It could as well be an immune response to the lipid nanoparticle, the vehicle, and not the vaccine molecule. Usual side-effects of these vaccines included fatigue, muscle pain, joint pain, fever and headache. But that is a small price.

In these vaccines, mRNA technology finds its first use. Unlike the conventional vaccines, mRNA makes the human body produce its own vaccine.

by RM NAIR

NEW YORK, Nov 19: The vaccines developed by Pfizer-BioNTech and Moderna based on mRNA technology have been found to be 95% effective against covid in Phase 3 trials. The efficacy of Pfizer's vaccine candidate, BNT162b2, was found consistent across age, gender, race and ethnicity, and the observed efficacy in adults over 65 years of age was over 94%, according to a statement issued by Pfizer.

It said that the vaccine was well tolerated across all populations with over 43,000 global participants enrolled and no serious safety concerns had been observed. Likewise, Moderna had released its findings last week.

Pfizer will produce 50 million vaccine doses by this December and up to 1.3 billion doses by the end of 2021. The UK has pre-ordered 40 million doses, Europe 200 million doses and the US 100 million doses. Moderna is also contracted to supply a large quantity to the US, which has financed the project heavily as it has been an initiative of the NIH.

Pfizer plans to use its existing cold-chain infrastructure. The vaccine needs to be stored at minus 70 deg C, the main drawback that has been cited as distribution in rural and remote areas will be challenging operation. The company says they have developed GPS-enabled thermal shippers using dry ice to maintain temperature conditions of -70°. Although Moderna vaccine can be stored in refrigerator temperature or minus 20 deg C.

Moderna and Pfizer plan to submit a request within days to the FDA for Emergency Use Authorization (EUA).

“The study results mark an important step in this historic eight-month journey to bring forward a vaccine capable of helping to end this devastating pandemic. We continue to move at the speed of science to compile all the data collected thus far and share with regulators around the world,” said Dr. Albert Bourla, Pfizer Chairman and CEO.

Both Pfizer and Moderna vaccines are given in two doses in a space of a few weeks.

What is mRNA technology

Their vaccines consist of a genetic code directing production of the coronavirus’ spike protein by the body's own cells. This spike protein makes immune system to produce antibodies without the presence of virus as in the conventional vaccine. The information is delivered in a fat bubble called lipid nanoparticle.

mRNA, a technology that has been in the works for several decades but never found its first use, is being deployed in these two vaccines. In this technology, human cells are instructed to produce its own vaccine by passing on a fabricated genetic code of the virus spike protein.

The technology has high potential for the future, even could be leading to groundbreaking developments in cancer research.

In the vaccine, a genetic coding for SARS-CoV-2 spike (S) protein is designed and the code is inserted into a messenger RNA molecule to be injected. The human cell produces the S-protein and displays the info on the cell surface, for the immune system to respond and produce antibodies. Thereafter the memory of the infection is stored which signals production of antibodies whenever the actual viral infection takes place.

The mRNA technology eliminates the traditional use of attenuated or inactivated virus or molecules or its fragments in the development of vaccines.

What happens when infection takes place? The virus enters the human cell. In the case of coronavirus, it uses its spikes to cling on to the cell membrane and that part is fused for the virus to enter the cell and using the cytoplasm and vitals it replicates, rendering the cell a mere shell. In covid, immune system responds very late such that it reacts very violently in order to eliminate the infection which has by now spread too deep. In the overdrive, various organs like kidneys, heart and brain are damaged by the very immune system, leading to death. This upheaval is called cytokine storm. In most cases death is not caused by the virus.

In conventional vaccines, the attenuated or inactivated virus signals the immune system to respond and antibodies are created and the memory stored in the helper cells for action when the actual infection occurs.

In the case of mRNA, no virus is injected but the body cells are made to produce harmless viral proteins which in turn signals on cell surface the presence of foreign object. The mRNA carries the genetic information code that makes the cell produce the viral protein. The new vaccine is a modified spike protein mRNA carried in a fat bubble.

The antibodies, helper cells and the T-cells all respond to the spike protein produced in response to the instructions the new vaccine delivers.

The new vaccine eliminates the risks of infection that the conventional vaccines might pose. And it continues to produce spike proteins for a couple of weeks. Pfizer and BioNTech are using the technology developed by Pennsylvania university, while Moderna has drawn its knowhow basically from NIH, which is officially assisting the pharma.

The mRNA technology came to fruition just last week when both Pfizer and Moderna announced the efficacy of the vaccines in final clinical trials as far above 90%. Both use synthetic messenger RNA. It does not contain any part of the virus, so the recipients will not get the infection from the injection.

Dr Drew Weissman, a professor of medicine at the University of Pennsylvania School of Medicine, has been working on mRNA for several decades now. He is the guide for BioNTech, the German biotechnology company, working with Pfizer.

Covaxin, Cadila, Novavax, AstraZeneca, Johnson & Johnson, Sinovax and Sputnik V are some of the conventional vaccines in the advanced stage.


SELECTIONS FROM OUR ARCHIVES

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.

  • Curfew was clamped on areas in Paris on Thursday lasting till Monday. The police apprehend an escalation of volence in the coming days. There will be "actions targeted at the forces of order and the symbols of the State", they said.
  • Under present law, the police have brute powers to deal with traffic violators. Young Nahel was shot point-blank by a cop for purported traffic violation and an anticipated crime.

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