DCGI authorisation for Covaxin for children of 2-18 years likely this week
|

The Subject Expert Committee (SEC) of the DCGI has recommended approval for Bharat Biotech's Covaxin for children and the DCGI authorisation for emergency use is expected to come in days. The Covaxin meant for children will have a different mode of inoculation than of the adult's. It will also be administered in two doses, but in a gap of only 20 days. Although Zydus Cadila had received the emergency use authorisation early, it is yet to reach the market.
|
NEW DELHI, Oct 12: After Zydus Cadila got the authorisation, Bharat Biotech
is awaiting immediate regulatory approval for emergency use of its indigenous
Covaxin for children of 2 to 18 years as it was cleared by the Subject Expert
Committee (SEC) on Tuesday. Although Zydus Cadila had received the emergency
use authorisation early, it is yet to reach the market.
The Covaxin for children will have a different mechanism of inoculation other
than its adult vaccine. It will also be administered in two doses, but with
a gap of only 20 days.
The Hyderabad-based Bharat Biotech had submitted the data of Phase 2 and 3
trials to the Drugs Controller General of India (DCGI) for authorisation early
this month. After SEC recommendation the authorisation is a formality and it usually
takes only a few days.
“After detailed deliberation, the committee recommended for grant of market
authorization of the vaccine for the age group of 2 to 18 years for restricted
use in emergency situation,” the SEC said in a statement.
"This represents one of the first approvals worldwide for Covid-19 vaccines
for the 2-18 age group. Bharat Biotech sincerely thank the DCGI, Subject Expert
Committee, and CDSCO for their expedited review process. We now await further
regulatory approvals from the CDSCO prior to product launch and market availability
of Covaxin for children," the Bharat Biotech said.
ZyCov-D of Zydus Cadila was the first vaccine approved for emergency use in
children aged 12 and above in India. The DNA- based, three-dose, needle-free
vaccine can also be administered to adults. However, it is yet to reach the
market. The price, not yet fixed, is likely to be high.
Novavax called Covovax in India is another vaccine for children aged 2 to 18
but it is yet to get the drug regulator's permission for emergency use as the
Serum Institute of India (SII) has not completed second and third phase trials
. There is also yet another called Corbevax, for children aged 5 to 18 years.
The Hyderabad-based Biological E Limited is conducting the second and third
phase clinical trials.
As the schools have opened in most States and more children were were found
infected during the second wave of the covid pandemic, parents as well as teachers
are concerned about vulnerability of children while getting exposed to the bustle
of school life. The sero surveys have detected high levels of covid antibodies
among children. especially in the States of Maharashtra, Kerala and Mizoram.
|
|
|
|
|
SELECTIONS FROM OUR ARCHIVES |
|
Top Govt officer thrashed, kicked inside Bhubaneswar office: Incident sparks a debate
| |
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.
|
|
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!
|
|
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.
|
|
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)
|
|
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 )
|
|
Ailing Asiatic lion Pataudi too dies of bird flu at Kanpur zoo
| |
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.
|
|
48 tourist destinations closed in Kashmir following Pahalgam terror attack
| |
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.
|
|
Trump slaps ‘kind’, ‘reciprocal’ tariffs on trading partners; a 'lenient' 26% on India!
|
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 )
|
|
Trump signs order to shut Education Dept - And the contrast with India
|
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.
|
|
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.
|
|
All 80k health workers in US offered $25,000 voluntary buyout: Administering wrong prescriptions!
| |
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.
|
|
|
|
|
Previous Files
|
|
|
|
ARCHIVES
|
|
Visit Indian Travel Sites
Goa,
Kerala,
Tamil Nadu,
Andhra Pradesh,
Delhi,
Rajasthan,
Uttar Pradesh,
Himachal Pradesh,
Assam,
Sikkim,
Karnataka,
Madhya Pradesh,
Jammu & Kashmir
Gujarat
Puducherry
|
|
|
|
Neighbours Calling
Bhutan
Nepal
Malaysia
Dubai
|
|
|
|
|
|
|
Visit Indian Travel Sites
Goa,
Kerala,
Tamil Nadu,
Andhra Pradesh,
Delhi,
Rajasthan,
Uttar Pradesh,
Himachal Pradesh,
Assam,
Sikkim,
Karnataka,
Madhya Pradesh,
Jammu & Kashmir
Gujarat
Puducherry
|
|
|