FDA likely to issue Emergency Use Authorisation for J&J covid
vaccine on Saturday
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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.
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SELECTIONS FROM OUR ARCHIVES |
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Top Govt officer thrashed, kicked inside Bhubaneswar office: Incident sparks a debate
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The incident has triggered a debate on social media whether the officer refused to take orders from a party leader or he was accused of any corruption, some netizens justifying the handling in either case, that Ratnakar was blocking public welfare work! It is true the Govt machinery has been the enemy Number One of the people of this country, existing for itself and for these politicians, for well over seven decades. India will never make an inch of progress - real progress, not make-believe-progress - unless and until this machinery is eliminated.
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UK's House of Commons votes to legalise assisted dying: What it means | |
ANALYSIS: There have been cases of Britons going to Switzerland to get rid of a miserable life. Now once the House of Lords also passes the Terminally Ill Adults (End of Life) Bill, terminally ill Britons can call it quits with the help of a medical practitioner here itself. But the measure when comes into practice, will have very serious social consequences, it is feared. There won't be comparisons, even as tropes in Latin American folklores. The worst case scenario is of those who are not terminally ill also trying to misuse the provision to leave this world early when life with dignity is not available. But that is, in fact, a political question and not a moral imbroglio!
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What caused Air India Boeing 787 crash? Some questions, some answers | |
The CCTV footage and the video circulating on social media do not indicate any serious abnormalities in takeoff or descent, it has been confirmed. The disaster is becoming curiouser and curiouser. The flight path was not curvy. And the aircraft maintained a steady, gliding descent with its nose straight and the wings perfectly level. The pilot's distress call does not specify what prevented lift and climb-out. Here are some expert opinions. The sole purpose is to raise travellers' awareness about air travel.
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Udhampur-Srinagar-Baramulla line brings Kashmir Valley on India's rail map |
- The Udhampur-Srinagar-Baramulla line provides Kashmir with all-weather connectivity and integrates the Valley with the rest of India.
- The saying 'Kashmir to Kanyakumari' is now a dream come true.
- The Chenab bridge on the line, an engineering marvel, is the world's highest
railway bridge, taller than the Eiffel Tower. (Video: File)
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Work done, Elon Musk steps down from DOGE, leaves White House | |
Musk wrote: "My scheduled time as a Special Government Employee comes to an end... The @DOGE mission will only strengthen over time as it becomes a way of life throughout the government." Now on it will be on auto-pilot.
PROGNOSIS: DOGE was prematurely born to protect the country by aborting an impending socio-economic disaster which very few people could see coming.
Although its immediate job was to save American taxpayers billions by slashing waste, eliminating fraud, cutting Government bloat and ensuring utmost efficiency in administration for the good of the people.
(Today's headlines )
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Ailing Asiatic lion Pataudi too dies of bird flu at Kanpur zoo
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Originally from Junagadh, Gujarat, Pataudi was relocated to Etawah Lion Safari in September 2019 before being transferred to Gorakhpur Zoo in 2021. Recently it was receiving treatment for pancreatic and liver infections. After tigress Shakti died in the zoo on May 7 due to bird flu, Pataudi was shifted to Kanpur. Some birds are also reported to have died mysteriously around Gorakhpur. All zoos in UP are closed for fear of a bird flu outbreak.
Three other animals too had died - a tiger, a leopardess and a female wolf. Wolf Bhairavi died last Saturday, leopardess Mona died the Thursday before that and tiger Kesari died on March 30. Some of them had Shakti's symptoms but the cause of death has not been confirmed yet.
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48 tourist destinations closed in Kashmir following Pahalgam terror attack
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As tourist inflow is an indicator of normalcy returning to an erstwhile terrorist infested Valley, the Government has been trying hard to make everything travel-friendly, launching lot many projects and bringing Kashmir on the national rail map that physically completes the process of Kashmir's integration with the rest of India. And that defeats the designs of Pakistan eyeing Kashmir and simply explains a recrudescence of terrorism in J&K.
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Trump slaps ‘kind’, ‘reciprocal’ tariffs on trading partners; a 'lenient' 26% on India!
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ANALYSIS: There is a lot of hue and cry around the world over Trump's tariffs. But tariff, simply put, is a tax. But unlike tax, it affects the exporting country too. Domestic prices will go up for some time. Nothing more will happen, good or bad!
What motivated Trump's newfound policy, apart from being a stunt to justify his existence in the White House, is a false realisation that increased tariff will make foreign goods prohibitive, thereby boosting local production, and create more jobs, and more prosperity will ring in! If that is true, India would have been shining by now: Producing own Rolls-Royce La Rose Noire Droptail and Scotch Whiskies! And what about coconut and palm oil by America!
(Today's headlines )
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Trump signs order to shut Education Dept - And the contrast with India
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PROGNOSIS: It looks a Real New Trump is emerging - courageous, balanced, powerful and disinterested. Determined to save his country from the cliff, he has done quite a few draconian things that will reduce the burden of debts of the Federal entity, like the golden handshake, stopping senseless funding, pulling out of a worthless WHO. Shutting the Education Department is another. On the other hand, running it is also not the Centre's job either (We will convincingly elaborate it in the next chapter).
In India the scene is just the opposite. Centralisation is the core agenda and identity of the ruling dispensation without which it has no existence, or in other words, it exists for that set of schemes only. A realisation of this never dawned upon any Opposition party in 2014 or any time thereafter, what to talk of being able to see it coming 70 years ago! The consequence of all this violation of basic natural law of the universe we cannot predict.
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Sunita, Wilmore's Dragon splashes down in Gulf: What delayed their return? |
THE AMERICAN CONUNDRUM: Political venom has migrated to top echelons in the US. It was reported last year NASA has become politicised, vitiated. But NASA refuted the charge. How Boeing developed a glitch but its unmanned return was smooth. When Suni-Wilmore were stranded last June, why the return was set for February? Because that comes only after January 20! SpaceX called the shots, for itself and for Trump. Then the mission was manipulated for March for a better bargain! In between, what made Elon Musk 'predict' during campaign if Kamala Harris wins he would be in jail. In politics, it is said, "the only rule is there are no rules." Difficult times for Americans too.
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All 80k health workers in US offered $25,000 voluntary buyout: Administering wrong prescriptions!
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The terminations are part of a large-scale exercise going on all across Fed departments and organisations to reduce wasteful Government expenditure as decided by a Trump in a mess gone berserk, and improve administrative efficiency following the whims of billionaire and his associate Elon MusK and his DOGE. It has not been shared how terminations are going to raise the efficiency bar! It looks like Trump has stolen some of the prescriptions meant for India. But the American problems are quite different.
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