COVID-19 Vaccine Update: Covaxin yet to get DCGI's nod for emergency use in children

Asia's Tech News Daily

#coronavirus, #Current Affairs, #Health, #India, #Sanjeevani

If approved by the drugs regulator, Bharat Biotech’s Covaxin will be the second COVID-19 vaccine after Zydus Cadila’s needle-free ZyCoV-D to receive EUA for use in those below 18 years.

Bharat Biotech’s COVID-19 vaccine Covaxin is yet to get approval by the Drugs Controller General of India (DCGI) for emergency use authorisation in children and adolescents in the two to 18 years age group, as it is seeking additional technical opinion on it, reported Hindustan Times citing sources.

The vaccine received a recommendation Subject Expert Committee (SEC) on COVID-19 for granting emergency use authorisation earlier this week.

“The drugs controller general of India (DCGI) is taking more technical opinion on vaccinating children even though the expert panel has recommended its use,” a senior official in the union health ministry told the publication.

The official further noted, “We will have to be extremely careful when talking about COVID-19 vaccination in children as even the developed countries that have begun vaccinating their children, are treading cautiously. The whole world is watching and we cannot afford to slip.”

If approved by the drugs regulator, it will be the second COVID-19 vaccine after Zydus Cadila’s needle-free ZyCoV-D to receive EUA for use in those below 18 years.

Also read | Over 8.36 lakh doses of COVID-19 vaccine given on October 15

Hyderabad-based Bharat Biotech, which completed the phase 2/3 trials of COVID-19 vaccine Covaxin for use in children aged between two and 18 years, had submitted the data to the Central Drugs Standard Control Organisation (CDSCO) for its verification and subsequent approval for emergency use authorisation (EUA) for the jab in the beginning of this month. The Subject Expert Committee (SEC) on COVID-19 examined the data and deliberated on the EUA application.

The committee noted that the interim safety data of the phase 2/3 clinical trial was reviewed in a meeting on August 26, sources said. The overall geometric mean titre (GMT) for the paediatric population is comparable with GMT of the adult population in phase -3 efficacy study, the recommendations stated.

Also read | India records 15,981 COVID-19 cases, 166 fatalities in a day

After detailed deliberation, the committee recommended the grant of market authorisation of the vaccine for the two to 18 years age group for restricted use in emergency situations subject to certain conditions, they stated. According to the conditions, the firm should continue the study as per the approved clinical trial protocol and provide updated prescribing information/package Insert (Pl), Summary of Product Characteristics (SmPC) and Factsheet.

Internet Explorer Channel Network
Asia's Tech News Daily
News Related

OTHER NEWS

Fed's Jerome Powell weighs earlier end to bond tapering amid hot inflation

By Craig Torres and Matthew Boesler Federal Reserve Chair Jerome Powell said it’s appropriate to consider finishing the U.S. central bank’s tapering of asset purchases a few months earlier than ... Read more »

Delhi's air quality this November worst for the month in seven years

Delhi air pollution. (Image: ANI) Delhi’s air quality this November was the worst for the month in seven years with the city witnessing severe pollution on 11 days and not ... Read more »

Bayern Munich face playing behind closed doors again due to Germany Covid spike

Bayern Munich are set to play their upcoming home matches behind closed doors after Covid cases soared in the state of Bavaria. The decision means the German giants will have ... Read more »

India summons Pakistan Charge d'Affaires over model's photoshoot at Kartarpur gurdwara

India on Tuesday summoned the Charge d’Affaires at the Pakistan High Commission and conveyed its deep concern over a Pakistani model’s photoshoot at Gurdwara Darbar Sahib in Kartarpur, describing it ... Read more »

Govt constitutes panel to revisit criteria for determining economically weaker sections

The government has constituted a committee to revisit the criteria for determining the economically weaker sections to provide them reservation. The government had informed the Supreme Court last week that ... Read more »

Mallikarjun Kharge writes to RS chairman urging him to revoke suspension of 12 MPs, points to anomalies

Leader of Opposition in Rajya Sabha Mallikarjun Kharge on Tuesday wrote to Chairman M Venkaiah Naidu, urging him to revoke his decision of suspending 12 opposition MPs. In his letter, ... Read more »

Parliamentary panel on Data Protection Bill to seek extension for report submission

Representative image The Joint Committee of Parliament (JCP) on the Personal Data Protection Bill will move a motion in Lok Sabha on December 1 seeking extension of time for presentation ... Read more »

Delhi government extends validity of learner's license till January 31

The Delhi government on Tuesday extended the validity of learner’s licenses that expired between February 2020 and November 2021 till January 31, 2022, according to an official order. The decision ... Read more »

NTA panel finds no discrepancy in Hindi version of Physics paper in NEET-UG exam, SC dismisses plea

The Supreme Court Tuesday dismissed a plea by students alleging discrepancy in a question in the Hindi version of Physics paper in NEET (UG) 2021 after the NTA-appointed expert panel’s ... Read more »

FIR registered in Kanpur against Sahara chief Subrata Roy, family members and group officials

An FIR has been registered against Sahara chief Subrata Roy and 17 of his family members and group officials on charges of cheating, forgery and criminal conspiracy at a police ... Read more »

Bird flu confirmed in dead crows in MP's Agar Malwa; govt asks bordering districts to be vigilant

The presence of the H5N8 virus (bird flu) has been confirmed after at least 48 crows were found dead in Agar Malwa district of Madhya Pradesh, a senior official said ... Read more »

Over 124 crore vaccine doses administered in India so far: Health Ministry

The total COVID-19 vaccine doses administered in the country crossed 124 crore on Tuesday, the Union Health Ministry said. Over 72 lakh vaccine doses was administered on Tuesday till 7 ... Read more »

Voices: India's farmers have exposed Modi's BJP – will the party learn its lesson?

Voices: India’s farmers have exposed Modi’s BJP – will the party learn its lesson? Indian prime minister Narendra Modi’s decision to repeal three controversial farm laws that had been the ... Read more »

Punjab polls | Amarinder Singh in talks with PM Modi, Amit Shah on alliance: Report

Former Punjab Chief Minister Amarinder Singh (Illustration: Moneycontrol) Former Punjab Chief Minister Captain Amarinder Singh said on November 30 that he is in talks with Prime Minister Narendra Modi and ... Read more »

Declining trend in Covid cases, but surge cannot be ruled out as virus continuously evolving: Govt

There has been a declining trend in COVID-19 cases in the country for the past few months, but a surge in infections cannot be ruled out as the virus is ... Read more »

Russian coronavirus-denying monk given prison sentence

MOSCOW (AP) — A rebel Russian monk who castigated the Kremlin and denied that the coronavirus existed was convicted Tuesday on accusations of encouraging suicides and given a 3½-year prison ... Read more »

Bulk deals: Kingsman Wealth Management buys stake in Diggi Multitrade

MUMBAI: Kingsman Wealth Management today bought 60,000 shares of Diggi Multitrade at Rs 11.7 apiece through a bulk deal on the BSE. Shares of Diggi Multitrade ended 4.2 per cent ... Read more »

Assam CM Himanta Biswa Sarma orders probe into student lynching

Following mob lynching of a student leader, Assam chief minister Himanta Biswa Sarma has assigned Special DGP GP Singh to personally supervise the inquiry of the incident and stated that ... Read more »

Air Pollution in Delhi: Plea filed before HC seeking Rs 15 lakh compensation, medical insurance

A petition has been filed before the Delhi High Court seeking Rs 15 lakh as compensation and medical insurance of Rs 25 lakh in view of the poor air quality ... Read more »

Large corporates going back to banks amidst signs of capex pick up

Another indicator that the economy is slowly getting back on track and signs of pick-up in private sector capex. After 14 months of contraction, loan growth to large corporates turned ... Read more »

Unwise for India to place bans on private crypto assets: Report

A new monograph by the Observer Research Foundation, in collaboration with the Esya Centre, presents a deep-dive into the growth of cryptocurrency in India and proposes a balanced regulatory approach. ... Read more »

Centre gives 3-member committee three weeks to review criteria for EWS reservation

Representative image The Central government has formed a three-member committee to review the criteria for reservation for the Economically Weaker Sections (EWS) category, the Ministry of Social Justice and Empowerment ... Read more »

ICICI Venture divests partial stake in Go Fashion

ICICI Venture, the alternative asset arm of ICICI Bank , on Tuesday said it has divested half of its 13.5 per cent stake in the recently concluded IPO of Go ... Read more »

Mandatory RT-PCR test for int'l travellers arriving in Karnataka amid growing concern over Omicron

Amid growing concerns over Omicron, the new variant of coronavirus, the Karnataka government on Tuesday said international travellers arriving in the state will have to mandatorily undergo RT-PCR test and ... Read more »

Not yet 'V-shaped' recovery, sectors of economy still 'crippled': P Chidambaram

With India’s GDP growth at 8.4 percent in the second quarter of 2021-22, senior Congress leader P Chidambaram on Tuesday said it was not yet a V-shaped recovery and there ... Read more »

Wall Street opens lower as Omicron fears grow after vaccine warning

U.S. stocks opened sharply lower on Tuesday after a warning from vaccine maker Moderna’s chief executive on the effectiveness of COVID-19 shots against the Omicron variant hammered travel, energy and ... Read more »

SAT quashes NSE's directive to Axis Bank in Karvy case

New Delhi, In a relief to Axis Bank, the Securities Appellate Tribunal (SAT) has quashed a direction issued by NSE that funds lying in the bank account of Karvy Stock ... Read more »

Covaxin for 2-18 yrs: Centre examining Expert Committee recommendations, informs Health Ministry in Rajya Sabha

The Central government is examining the recommendation of the Subject Expert Committee (SEC) regarding the grant of market authorization of Covaxin for the age group of 2 to 18 years ... Read more »

Sebi to auction realty firm's properties to recover investors money

New Delhi: Capital markets regulator Sebi on Tuesday said it will auction four properties of Ravi Kiran Realty India Ltd and its promoters on December 16 to recover investors’ money. ... Read more »

Government seeks names of farmer leaders for panel on MSP, other issues; SKM to decide in December 4 meet

To constitute a committee for discussion on MSP and other issues, the Centre has sought five names from the Samkyukt Kisan Morcha (SKM) and it will be decided by the ... Read more »

Stricter norms for international passengers to be effective from Tuesday midnight

The strict norms for arriving international passengers, especially from ‘at-risk’ countries, will come into effect from Tuesday midnight and authorities are stepping their vigil for effective surveillance amid mounting concerns ... Read more »

Munster rugby confirms nine new positive Covid cases as South Africa exit plan set back

Irish provincial outfit Munster have suffered further disappointment after confirming nine new positive coronavirus cases among their squad. The club is currently isolating in Cape Town, having travelled to South ... Read more »

Ashok Leyland's stock may continue to underperform amid shrinking market share

ET Intelligence group: The stock of Ashok Leyland has underperformed the benchmark Nifty 50 for the past six months after posting significant gains since the March 2020 lows. The subdued ... Read more »

India could become a poster boy for EMs in this decade

Looking beyond the home bias, there are strong fundamental reasons to believe India will be the beacon of growth in the emerging markets’ (EM) space in this decade, and will ... Read more »

India reported 1.64 lakh dengue cases during 2021 against 2.05 lakh cases in 2019: Govt to Rajya Sabha

India reported 1,64,103 dengue cases during 2021 as against 2,05,243 cases in 2019 and has maintained a case fatality rate of less than one per cent since 2008, Union Health ... Read more »

Non-food bank credit grows at 6.9% in Oct: RBI data

Non-food credit growth of banks accelerated to 6.9 % in October as against 5.2 % in the same month of last year, the RBI data showed. Loans to agriculture and ... Read more »

S&P keeps India's GDP growth forecast unchanged at 9.5% in FY22

S&P Global Ratings on Tuesday kept India’s economic growth forecast in the fiscal year to March 2022 unchanged at 9.5 per cent but raised its predictions for the subsequent year ... Read more »

Omicron latest: At least 17 countries, territories record cases of new variant

A police officer gets a booster vaccination against COVID-19 in Germany, as cases of the Omicron variant continue to rise. © Moritz Frankenberg/dpa via ZUMA Press At least 17 countries ... Read more »

Dow futures drop 300 points amid Omicron COVID concerns

Futures tied to the Dow Jones Industrial Average fell as much as 500 points at one point. Brendan McDermid/REUTERS Global stock markets were reeling once again Tuesday morning due to ... Read more »

Nov auto sales: Tata Motors likely to emerge winner; CVs in spotlight

NEW DELHI: Tata Motors , along with other commercial vehicle (CV) players, are likely to steal the limelight as the monthly sales data for November starts pouring in from Wednesday ... Read more »
On free-english-test.com you will find lots of free English exam practice materials to help you improve your English skills: grammar, listening, reading, writing, ielts, toeic