SII’s Covovax gets EUA nod for 12-17 years age group

News Network
March 9, 2022

India's drug regulator has granted restricted emergency use authorisation to Serum Institute of India's Covid-19 vaccine Covovax for the 12-17 years age group subject to certain conditions, official sources said on Wednesday.

It is the fourth vaccine to receive the regulator's nod for use among those below 18 years.

The Drugs Controller General Of India's (DCGI) approval comes after the Subject Expert Committee on Covid-19 of the CDSCO last week recommended granting emergency use authorisation (EUA) to Covovax for those aged 12 to 17.

The government has still not not taken a decision on vaccinating those aged below 15 years. The health ministry has consistently said that additional need for vaccination and inclusion of population for vaccination are examined constantly.

In the EUA application to DCGI, Prakash Kumar Singh, director (government and regulatory affairs) at SII on February 21 had stated that the data from two studies on about 2707 children aged 12 to 17 years show that Covovax is highly efficacious, immunogenic, safe and well tolerated in this age group of children.

"This approval will not only be beneficial for our country alone, but will benefit the entire world, fulfilling our prime minister's vision of 'making in India for the world'. In line with the philosophy of our CEO, Dr Adar C Poonawalla, we are sure that Covovax will play an important role to protect children of our country and world at large against Covid-19 disease and will keep our national flag flying high globally," an official source had quoted Singh as having stated in the application.

The DCGI has already approved Covovax for restricted use in emergency situations in adults on December 28. It has not yet been included in the country's vaccination drive.

The DCGI on February 21 granted restricted EUA to Biological E's Covid-19 vaccine Corbevax for the 12 to less than 18 years age group subject to certain conditions.

Covovax is manufactured by technology transfer from Novavax and is approved by the European Medicines Agency for conditional marketing authorisation and also granted emergency use listing by WHO on December 2017, 2020. 

India has been using Bharat Biotech's Covaxin to vaccinate adolescents between 15-18 years.

ZyCov-D is the first vaccine cleared by India's drug regulator for inoculation of those aged 12 years and above in August last year. Indigenously-developed Covaxin received approval for emergency use in 12 to 18 in December last year.

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News Network
November 22,2024

Mangaluru: A man fell victim to an online scam, losing Rs 1.7 crore after fraudsters posed as officials from TRAI. According to a complaint filed at the CEN police station, the incident began on November 11, when the complainant received a call from an unknown number at 9:49 am.

The caller, claiming to represent TRAI, alleged that another mobile number registered under the complainant's name was involved in illegal activities in Andheri (East), Mumbai. The caller further stated that an FIR was lodged against the complainant for harassment under the guise of marketing. He was instructed to contact Andheri (East) police station immediately or risk his mobile service being deactivated within two hours.

The complainant was subsequently connected to an individual named Pradeep Sawant, who claimed the complainant was implicated in a money laundering scheme linked to the Naresh Goyal fraud case. Sawant alleged that a fraudulent bank account under the complainant's name was opened at Canara Bank, Andheri, and used to purchase a SIM card for illegal activities. He warned that the complainant could face arrest.

Later, the complainant was contacted via WhatsApp video call by individuals posing as Rahul Kumar (a police officer) and Akanksha (a CBI officer). They allegedly sent fabricated CBI documents to his WhatsApp number. The fraudsters demanded money to "resolve" the case. Fearing threats, the complainant allegedly transferred Rs 1.7 crore through RTGS in batches of Rs 53 lakh, Rs 74 lakh, and Rs 44 lakh between November 13 and 19. A case has been registered at the CEN police station and an investigation is ongoing.

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News Network
November 14,2024

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The UN special rapporteur for Palestine has slammed Israel’s parliament for passing a law authorizing the detention of Palestinian children, who are “tormented often beyond the breaking point” in Israeli custody.

Francesca Albanese, the UN special rapporteur on the rights situation in the Occupied Palestinian Territory, in a Thursday post on X, characterized the experiences of Palestinian minors in Israeli detention as extreme and often inhumane.

The UN expert highlighted the grave impact of this policy, noting that up to 700 Palestinian minors are taken into custody each year, a practice she described as part of an unlawful occupation that views these children as potential threats.

Albanese said Palestinian minors in Israeli custody are “tormented often beyond the breaking point” and that “generations of Palestinians will carry the scars and trauma from the Israeli mass incarceration system.”

She further criticized the international community for its inaction, suggesting that ongoing diplomatic efforts, which often rely on the idea of resuming negotiations for peace, have contributed to normalizing such human rights violations against Palestinian children and the broader population.

The comments by Albanese came in response to Israel’s parliament (Knesset) passing a law on November 7 that authorizes the detention of Palestinian children under the age of 14 for “terrorism or terrorist activities.”

Under the legislation, a temporary five-year measure, once the individuals turn 14, they will be transferred to adult prison to continue serving their sentences.

Additionally, the law allows for a three-year clause that enables courts to incarcerate minors in adult prisons for up to 10 days if they are considered dangerous. Courts have the authority to extend this duration if necessary, according to the Knesset.

The legislation underscores a shift in the treatment of minors and raises alarms among human rights advocates regarding the legal and ethical ramifications of detaining children and the conditions under which they may be held.

Thousands of Palestinians, including hundreds of children and women, are currently in Israeli jails—around one-third without charge or trial. Also, an unknown number are arbitrarily held following a wave of arrests in the wake of the regime's genocidal war on Gaza.

Since the onset of the Gaza war, the Israeli regime, under the supervision of extremist minister Itamar Ben-Gvir, has turned prisons and detention centers into “death chambers,” the ministry of detainees and ex-detainees’ affairs in Gaza says.

Violence, extreme hunger, humiliation, and other forms of abuse of Palestinian prisoners have been normalized across Israel’s jail system, reports indicate.

Over 270 Palestinian minors are being detained by Israeli authorities, in violation of UN resolutions and international treaties that forbid the incarceration of children, as reported by Palestinian rights organizations.

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News Network
November 11,2024

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Mangaluru: In a deeply tragic turn of events, a 28-year-old woman named Ranjitha, who had recently given birth but tragically lost her newborn, ended her life by suicide on Monday. She reportedly leapt from the fourth-floor window of Lady Goschen Hospital’s luggage room.

Ranjitha, whose strength and resilience had carried her through a difficult pregnancy, was scheduled for discharge on Monday. Her journey to Lady Goschen Hospital began on October 24, when she was transferred from Karkala. She was a high-risk patient, battling both hypertension and diabetes. At the time of her admission, she was just 27 weeks pregnant.

Due to the complexities of her health, doctors made the difficult decision to perform an emergency C-section on October 30. She delivered a baby girl, premature and weighing only 960 grams. The newborn was immediately moved to the Neonatal Intensive Care Unit, where doctors did all they could. Despite these efforts, the baby passed away on November 3.

Ranjitha’s sorrow was profound. She stayed under hospital care even after her initial recovery and was preparing to go home on November 9. She had even requested a couple more days at the hospital, seeking time perhaps to cope with her unimaginable grief.

On the day of her discharge, a discharge card ready and her family eagerly waiting to take her home, Ranjitha reportedly made her way to the luggage room in the early hours. There, standing on a cot placed for patients' family members, she climbed to a window and fell from the fourth floor. Despite the attempts of another visitor to intervene, tragedy was inevitable. She was rushed to Government Wenlock Hospital, where doctors confirmed the worst—she was no more.

Dr. Durgaparasad M R, the Medical Superintendent at Lady Goschen Hospital, shared his grief and spoke of the ongoing investigation. A post-mortem is to be conducted, and the local Tahsildar will complete the necessary inquest procedures. Ranjitha’s exact reasons for taking this step are yet to be confirmed, though the weight of her recent losses paints a sorrowful picture.

If you or anyone you know is struggling emotionally, please remember that help is available. Reach out to mental health experts who can provide support and guidance. The toll-free helpline number 9152987821 is available to assist anyone in distress.

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