FDA okays Pfizer's covid vaccine after Trump threatens its chief:
Vaccination begins in US on Monday
Can Pfizer's mRNA vaccine be called a vaccine. It is not a vaccine in
the conventional sense. mRNA is a new technology being used in
human beings for the first time. It is a code that instructs cells in
the body to make the virus's distinctive 'spike' protein that serves
the purpose of vaccine. That is, our own cells are made to produce
the vaccine in our body. Are there any genetic issues?
WASHINGTON, Dec 12: The US will start vaccination against covid with the world's
first vaccine, Pfizer-BioNTech's mRNA vaccine, on Monday, it was officially
announced on Saturday. All high tech cold storage (minus 70 deg C) arrangements
required by this vaccine are in place.
The UK was the first country to launch covid vaccination with the world's first
vaccine, Pfizer's, last Tuesday. A few other countries have since given the
emergency use authorisation (EUA) for Pfizer vaccine although it has come to
light that four volunteers had developed Bell's palsy during trials.
On Monday, 145 sites in the US will have the vaccine, 425 more sites will get
it on Tuesday and the last 66 sites on Wednesday, according to Gustave Perna,
in-charge of distribution.
One person needs two doses with a gap of three weeks. It should start working
in seven days. This is the quantum required for all the upcoming covid vaccines
irrespective of the technology used, except Johnson & Johnson which needs only
one jab. Pfizer's needs to be stored under minus 70 deg C and this poses a challenge for distribution.
In the first phase in the US, 3 million people will be administered the vaccine,
healthcare workers and other vulnerable sections getting the top priority, although
the States will take the final decision.
Trump threat to FDA chief
The FDA had on Friday night given the emergency use authorisation. The approval
followed a nasty drama staged by President Donald Trump through White House
Chief of Staff Merk Meadows who threatened FDA Commissioner Stephen Hahn he
will lose his job if the vaccine is not approved immediately. So the approval
came by night, same Friday. On Thursday the expert panel had okayed it. December
10 was FDA's review date for EUA.
However, the FDA advised allergy patients to avoid the vaccine for the time
being. Common side-effects are fatigue and headache.
The vaccine is claimed to be 95% effective although there is no way to prove
a vaccine is effective unlike a medicine which cures a disease within a time
limit. Prevention is difficult to prove except by a process of deduction and
that is why it is said it takes usually a decade for a vaccine to be cleared.
The proof of the pudding is in the eating. A vaccine has to be safe (1) in
the first place, which can be proved in course of time, then it should have
the efficacy (2) for prevention, which is a deductive process taking a decade's
time, and then, thirdly, it should prevent transmission (3).
Is Pfizer's a vaccine
Enthusiasm and excitement will not stand in for a solution to health issues like
the current pandemic. Pfizer does not guarantee against transmission. It guarantees
the other two - safety and efficacy up to 95%. But actual proof is success in
the field over the years.
A basic question remains unanswered. Can Pfizer's mRNA vaccine be called a
vaccine. It is not a vaccine in the conventional sense. In conventional method,
an attenuated or deactivated virus or part thereof is injected into human beings
producing immunogenicity in the body, training the body to adequately respond
when the actual infection occurs.
mRNA is a new technology being used in human beings for the first time. Two
more pharmas are using this tech: US' Moderna (vaccination likely to begin in
the US after possible approval by FDA on December 27) and Gennova in India.
Pfizer's uses this technology, and so it is not a vaccine, it is a genetic
code of instruction taken from coronavirus. It is carried to the human cells. The cells in turn produce the "vaccine" which the immune system recognises as foreign body and responds and is thereby trained. "The (mRNA) code instructs cells in the body to make the virus's distinctive 'spike' protein," which works as the vaccine, the FDA said. Obviously this triggers functional changes in human cells.
What they call as engineered transcription. Will it go awry one day and set
off genetic changes? That will have catastrophic impact on the human race itself.
To rule out such adverse effects, mRNA technology needs be on clinical trials
for at least twenty years. It's something analogical to the GM technology of which
there is no final word yet.
Pfizer did not take funds from US Operation Warp Speed programme and it has
signed a deal with the US worth $2b for 100 million doses with option for 500
m more. The US also made a deal with Moderna on Friday for 100 m doses with
option for 300 m more. Moderna was working with the US National Institutes of
Health for the vaccine development.
Meanwhile, on Saturday the US recorded a toll of 3,309 covid deaths in the
24 hours, the highest for a day anywhere so far. The infection and death rates
are alarmingly going up in the US while elsewhere the situation is easing tremendously.
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.
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.
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.