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DCGI approves Bharat Biotech’s Covaxin clinical phase II, III trials for those aged between 2 to 18

The Indian drugs regulator, the Drugs Controller General of India (DCGI) has granted approval to indigenously developed Covid-19 vaccine Covaxin developed by Bharat Biotech for conducting Phase II/III clinical trials on those aged between 2 to 18 years.

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The Indian drugs regulator, the Drugs Controller General of India (DCGI) has granted approval to indigenously developed Covid-19 vaccine Covaxin developed by Bharat Biotech for conducting Phase II/III clinical trials on those aged between 2 to 18 years.

In a press note, the government said that after careful examination the drug regulator has accepted the recommendation of an expert committee on vaccines.The DCGI, after careful examination, has accepted the recommendation of the Subject Expert Committee and accorded permission to conduct the Phase II/III clinical trial of Covaxin in the age group 2 to 18 years, to its manufacturer Bharat Biotech, said the statement.

The Subject Expert Committee on Covid-19 of the Central Drugs Standard Control Organization (CDSCO) had on Tuesday deliberated upon Bharat Biotech’s application seeking permission to conduct phase II/III clinical trials to evaluate the safety, reactogenicity and immunogenicity of Covaxin jabs in children aged 2 to 18 years. The committee after detailed deliberation recommended grant of permission to conduct proposed Phase II/III clinical trials to certain conditions, added the statement.

The vaccine maker Bharat Biotech said its phase II and III trials would be carried out on 525 healthy children volunteers. The trial will involve two vaccine doses given by intramuscular route on Day 1 and Day 28. The trial will take place at various sites including AIIMS centres in Delhi, Patna, and Meditrina Institute of Medical sciences, Nagpur.

The approval for clinical trial of Covaxin on children comes even as the US drug regulator USFDA gave its nod for use of Pfizer-BioNTech’s Covid-19 vaccine on children in the 12-15 years age group earlier this week. Bharat Biotech has developed Covaxin in collaboration with the Indian Council of Medical Research (ICMR), which is being used in adults in India’s ongoing Covid-19 vaccination drive.

Read Also: Rahul Gandhi says PM Modi missing like oxygen, Covid vaccine in India

Covaxin was the first Covid-19 vaccine globally to begin testing on children as young as 12 years of age. In September 2020, the clinical Phase II trials had tested the vaccine on 380 volunteers in the 12-65 years age bracket.

India News

Salman Khan house firing case: Mumbai crime branch recovers gun, cartridges from Tapi River in Surat

One gun and some cartridges have been recovered from the Tapi river in Surat by the Mumbai Crime Branch in the firing case outside Salman Khan’s residence, as per reports.

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The Mumbai Crime Branch on Monday, April 22, found a gun and some live cartridges, which was used for firing outside Salman Khan’s house, from Tapi River in Gujarat’s Surat.

This is a fresh update related the gunfire incident outside Salman Khan’s apartment at the Galaxy Apartment in Bandra on April 14. According to the crime branch, they are currently looking for another gun.

It is interesting to note that the accused, after performing the crime, dropped the gun into the Tapi River in Surat.

As to the Mumbai Crime Branch, the shooters who opened fire outside Salman Khan’s residence have two guns and were instructed to shoot 10 rounds of fire.

Outside the actor’s apartment at the Galaxy Apartments in the early hours of April 14, two people arrived on a motorcycle and fired four rounds.The attackers left the location shortly after the event. Both individuals were wearing headgear and carrying backpacks, according to surveillance footage.

The Mumbai Crime Branch has taken the accused Vicky Gupta with them to the Surat Tapi river, where they had thrown the gun. The police can add more sections to this case. More than ten people’s statements have been recorded in the Salman Khan case, and the recording process is still ongoing.

The Mumbai Crime Branch announced on April 20 that three more sections have been added to the FIR against the offenders in an effort to step up the investigation into the shooting incident at Bollywood actor Salman Khan’s home.

The case has been appended with the extra sections under IPC 506(2) (threatening), 115 (abetment), and 201 (tampering with evidence). Gangster Lawrence Bishnoi and his brother Anmol Bishnoi have been named as wanted suspects in connection with the crime, according to Mumbai Crime Branch police.

Shortly after the shooting, Anmol Bishnoi, the younger brother of criminal Lawrence Bishnoi, who is currently incarcerated, allegedly claimed responsibility for the incident on Facebook.

Notably, Salman’s security level has been increased to Y-Plus since November 2022 because to threats from gangsters Lawrence Bishnoi and Goldy Brar. The actor also obtained a new armored vehicles for increased protection and was given permission to carry a handgun on his person.

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Arvind Kejriwal given insulin in Tihar jail after sugar levels touch 320

Finally, the BJP and its jail administration came to their senses and gave insulin to CM Arvind Kejriwal in jail, AAP tweeted.

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Delhi Chief Minister Arvind Kejriwal received insulin on Tuesday, April 23, after days of battling, according to the Aam Aadmi Party.

Arvind Kejriwal, however, received a low dose of insulin, according to Tihar jail officials, following a rise in his blood sugar. Around 7:00 p.m., his blood sugar level was found to be 217, and the medical staff at Tihar who were attending to him then made the decision to give him insulin, according to an official.

Taking to social media X, formerly Twitter, AAP tweeted, CM Arvind Kejriwal received insulin in jail after the BJP and its jail administration finally had a change of heart. CM Kejriwal’s blood sugar level was 320. Only the graces of Lord Hanuman and the perseverance of the Delhi community have made this possible. The AAP announced in a tweet on X that they have succeeded in delivering insulin to our Chief Minister.

According to the Tihar official, Kejriwal was given two units of low dose insulin on Monday evening on the advice of AIIMS doctors.

Low-dose insulin was given to Delhi Chief Minister Arvind Kejriwal at Tihar Jail yesterday. Yesterday, his sugar levels were 217. When the level surpasses 200, the AIIMS experts had stated that he could receive low-dose insulin, according to a Tihar Jail official.

He said Tihar’s doctors had been informed by AIIMS specialists in a video conference with the chief minister on April 20 that insulin could be given to him if his blood sugar level exceeded a specific threshold.

The incident took place just one day after a Delhi court ordered the AIIMS to set up a medical board to evaluate Arvind Kejriwal in order to determine whether or not he requires insulin to regulate his blood sugar levels. The court further said that the food prepared at home by the AAP national convenor differs from the diet plan prescribed by his doctor.

The order was issued by special judge Kaveri Baweja for CBI and ED cases, who turned down Arvind Kejriwal’s request for a video consultation with his doctor in front of his wife Sunita Kejriwal.

Delhi health minister Saurabh Bharadwaj  said on Monday that Arvind Kejriwal has been detained in Tihar for almost 22 days. He has been complaining for several days that his blood sugar is rising and that the jail does not have a diabetes specialist. He has been requesting insulin. It is evident from the court’s ruling today that Tihar jail does not have a diabetes specialist.

Since insulin is the only option available to control his blood sugar levels, Arvind Kejriwal has been requesting it nonstop for the past ten days, according to AAP leader Atishi.

The Enforcement Directorate (ED) arrested Arvind Kejriwal on March 21 in relation to a money-laundering investigation involving the Delhi government’s now-scrapped excise policy. The CM has been logged in Tihar jail since April 1.

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Lok Sabha elections: BJP candidate Mukesh Dalal wins from Surat after opponents remain out of fray

BJP’s Surat Lok Sabha candidate Mukesh Dalal has won the seat unopposed

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Bharatiya Janata Party (BJP) candidate Mukesh Dalal is elected unopposed from Gujarat’s Surat Lok Sabha constituency after all other contenders withdrew their candidature.

Gujrat BJP chief CR Paatil took to hi social media account X, formerly Twitter, and congratulated Dalal for being elected unopposed.

This latest developmnet comes after the cancellation of two Congress candidates’ nominations on Sunday and the withdrawal of eight more on Monday.

The Congress candidate for the Surat Lok Sabha constituency, Nilesh Kumbhani, had his nomination form canceled since he was unable to produce even one of his three proposers before the election commissioner.

The differences in three proposers’ signatures on Kumbhani’s nomination form had drawn scrutiny from the BJP.

The Congress’s replacement candidate from Surat, Suresh Padsala, had his nomination form nullified as well, which eliminated the party from the race in the city.

Returning Officer Sourabh Pardhi issued an order stating that the four nomination forms that Kumbhani and Padsala had presented were refused because there were initially found differences in the proposers’ signatures, making them seem fake.

Pardhi’s order also mentioned that the proposers acknowledged having signed the forms themselves in their affidavits. It should be noted that Kumbhani’s three proposers were related to him.

Nilesh Kumbhani was given a day by the Returning Officer to submit his response following the proposers’ claim. The congressional candidate arrived at the polling place with his representative; however, none of his three proposers showed up.

According to the order, the Congress candidate’s attorney had requested that the camera tape be checked, and even their presence was not discovered.

Meanwhile, the Congress said that everyone was afraid of the government’s threat and accused the ruling BJP of being involved in dirty play.

Congress leader and activist Babu Mangukiya said that Kumbhani’s three proposers had been abducted, and he suggested that the Returning Officer look into this matter rather than the validity of the signed form.

According to Mangukiya, it was improper to cancel the form without first telechecking the signatures and determining whether or not the proposers’ signatures were accurate.

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