FDA likely to issue Emergency Use Authorisation for J&J covid
vaccine on Saturday
When the FDA approves Emergency Use Authorisation, J&J vaccine will become
the third one to be administerted to the Americans after Pfizer and Moderna.
How the J&J vaccine will be a game changer, and the pluses and minuses:-
SINGLE DOSE: The top advantage of J&J vaccine is that it is a single-dose
vaccine unlike all other vaccines produced so far
NO COLD STORAGE: J&J does not require ultra cold storage like in the
case of Moderna and Pfizer
PREVENTS ASYMPTOMATIC INFECTION: J&J is also majorly claimed to inhibit
asymptomatic infection, reducing the chances of transmission to a great extent,
apart from preventing the disease in the inoculated.
NO ANAPHYLACTIC REACTION: There were no reported cases of anaphylaxis
following vaccination.
NO DEATHS IN TRIALS: As of February 5, there were seven covid-related
deaths in the placebo group in the trial and no covid-related deaths in the
vaccine group.
BUT NO DATA ON THE ELDERLY: There were too few data generated by the
J&J Phase 3 study to determine if the vaccine works in people over the age of
75. Moderna and Pfizer did not have an age cap in their EUAs.
ALSO, NOT FOR CHILDREN: The J&J vaccine hasn’t been tested yet in children
under the age of 18, so it will not be authorized for use in them.
by RM NAIR
WASHINGTON, Feb 26: The US Food and Drug Administration (FDA) has said the
Johnson & Johnson covid vaccine has met the requirements for emergency use authorization (EUA) as per the data provided to them. The FDA was only releasing an analysis of the clinical trial data that the company had submitted. It has to be recommended by the advisory committee and then only the FDA will issue the EUA. When okayed, it will become the third vaccine to be administered in the US.
The efficacy of the Johnson & Johnson vaccine against moderate to severe covid
across all geographic areas was 66.9% at least 14 days after the single-dose
vaccination and 66.1% at least 28 days after vaccination, according to the analysis
which will be assessed by the advisory committee (VRBPAC) soon (which began the
session on Friday morning), and based on its recommendation
thereafter the FDA will issue the emergency use authorisation (EUA).
The final decision about the single dose vaccine is likely to be out on Saturday.
Johnson & Johnson has several advantages over the other two vaccines currently
being administered in the US - Pfizer and Moderna, both using the latest technology
of mRNA, which is an instruction to the human cell to produce the vaccine on
its own. And not in itself a vaccine as such. The new technology which has been
in the making for two decades is set to revolutionise the concept of curative
and preventive medicine.
"There were no specific safety concerns identified in subgroup analyses by
age, race, ethnicity, medical comorbidities, or prior SARS-CoV-2 infection,"
the Johnson & Johnson analysis said.
The Johnson & Johnson vaccine is claimed to work better than initial data showed
against the virus variants. The variants, which are more contagious, are behind
majority of cases in several countries like South Africa and the UK.
It was also claimed that the vaccine has a 72% efficacy rate in the US and
a more than 68% rte in Brazil in protecting people from mild to severe illness.
It offered nearly 86% protection against severe illness in the US and nearly
82% in South Africa and nearly 88% in Brazil.
The vaccine is also majorly claimed to inhibit asymptomatic infection, reducing
the chances of transmission to a great extent, apart from preventing the disease
in the inoculated. There were no reported cases of anaphylaxis following vaccination.
As of February 5, there were seven covid-related deaths in the placebo group
in the trial and no covid-related deaths in the vaccine group.
The US has ordered 100 million doses of the J&J vaccine, but supplies are not
likely before April.
It is likely the Vaccines and Related Biological Products Advisory Committee
(VRBPAC), currently in meeting, will recommend FDA authorisation (EUA) for the
J&J vaccine, and the FDA will do so as early as Saturday, according to sources
from the panel.
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.
A University of Florida Professor, Harrison Hove who was on the flight, posted
on social media that the incident was "terrifying." He said, "I've flown a lot. This
was scary ... The photos cannot capture the burning smell, loud bang or ear
pops ... Something failed midflight and depressurized the cabin."
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.
Let's Go! The legal immigrants should be allowed the flexibility
to change jobs and travel without obstacles. Doing away with the country cap
on Green Cards only can do this easily.
Bureaucratic delays in the US legal immigration system are also a drag on
the country's economy while leaving so many families in limbo, the Congressmen
argued.
In fact, the country cap was introduced to ensure diversity of immigrants
as well as to prevent monopoly by any one country like China leading to distortions
in the American culture and politics in course of time.
In any which case, it is high time the US straightened its convoluted immigration
laws for their own convenience and to allow the immigrants their basic rights!
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.
Way back when on June 20 EST after searches were launched, India Travel
Times had, on an analysis of the data available, indicated the probability of
Titan undergoing a sudden and massive implosion (inward collapse) at great
depths. (SEE: Titanic expedition goes missing: A ray of hope from
sounds of bang)
Now videos taken by a Canadian robot that reached the floor on
Thursday evening, June 22, has confirmed it. The fragments are lying
scattered. Horizon Arctic's ROV robot found the debris 1600 ft from Titanic
bow.
The submersible imploded at 500 metres above sea bed, if we go by our
calculations. The water pressure it had to withstand at that point was 2,345 kg
per sq inch. The hull was not built to take that, as per the court cases fought by
concerned people at the time of building the sub and going by the details revealed
in the cancellation of booking by at least one ocean expert.