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Bharat Biotech submits Covaxin phase 3 trial data to Drug Controller General of India, expert panel meet today

Hyderabad-based Bharat Biotech is also expected to hold a ‘pre-submission meeting on Wednesday with the World Health Organization for international emergency use listing (EUL) and approval of its Covid vaccine.

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Bharat Biotech

Bharat Biotech, the Hyderabad-based drugmaker has submitted data from phase 3 trials of the Covaxin, the Covid vaccine to the Drugs Controller General of India (DCGI), according to the news agency ANI.

The development comes nearly five months after Covaxin was authorized for emergency usage in the country.

The Hyderabad-based vaccine maker had stated that its coronavirus vaccine was 81 percent effective in preventing the infection, according to early analysis of the results from late-stage trials.

However, the drug regulator’s SEC (subject expert committee) is expected to meet around noon to discuss the results of Phase 3 data of Covaxin, the country’s first indigenous Covid vaccine.

Hyderabad-based Bharat Biotech is also expected to hold a ‘pre-submission meeting on Wednesday with the World Health Organization for international emergency use listing (EUL) and approval of its Covid vaccine. The company would be submitting a summary of its report at the WHO meeting. For it to supply the Covid vaccine to other countries, approval from WHO is necessary.

A ‘pre-submission meeting will provide an opportunity to receive guidance from WHO authorities before final submission. EULs involve rigorous assessment of clinical trial data – as well as data on safety, efficacy, and quality – and a risk management plan.

The company also told news agency ANI, it is critical to understand that Phase III data will first be submitted to CDSCO (the Central Drugs Standard Control Organisation)… followed by peer-reviewed journals with a timeline of approximately three months for publication.

Read Also: 86 lakh people jabbed on Day 1 of Centre’s new vaccination policy

In a press briefing a few days ago by the Union Health Ministry, Dr VK Paul, who is a member (Health) Niti Aayog and also the head of the COVID task force of the country, said that the company would be submitting the data within seven to eight days. 

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Jammu & Kashmir: 5 soldiers killed after Army vehicle plunges into gorge in Poonch

“Today at around 17:40 hrs (5.40 pm), an Army vehicle of 11 Maratha Light Infantry, which was on its way from from Nilam headquarters to Balnoi Ghora Post along the LoC, met with an accident near Ghora Post,” said officials.

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Five soldiers lost their lives and several others were injured when an Army vehicle veered off the road and fell into a deep gorge in the Balnoi area of Mendhar, Poonch district, Jammu and Kashmir, on Tuesday, according to officials.

The incident occurred as the vehicle, part of the 11 Madras Light Infantry (11 MLI), was traveling from Nilam Headquarters to Balnoi Ghora Post. Reports indicate that the vehicle plunged approximately 350 feet into a steep gorge near its destination.

Upon learning of the accident, the Quick Reaction Team from 11 MLI rapidly mobilized to the scene to initiate rescue operations. The injured personnel received immediate medical attention, and efforts are currently underway to evacuate them for further treatment.

In a message on X, the White Knight Corps expressed their deep condolences for the tragic loss of five courageous soldiers, stating, “All ranks of #WhiteKnightCorps extend their deepest condolences on the tragic loss of five brave soldiers in a vehicle accident during operational duty in the #Poonch sector. Rescue operations are ongoing, and the injured personnel are receiving medical care.”

“Today at around 17:40 hrs (5.40 pm), an Army vehicle of 11 Maratha Light Infantry, which was on its way from from Nilam headquarters to Balnoi Ghora Post along the LoC, met with an accident near Ghora Post,” said officials.

This incident follows a similar accident last month, where one Army personnel died and another was injured when their vehicle skidded off the road and fell into a gorge in Rajouri district, Jammu and Kashmir. This crash, which occurred on November 4 near Badog village in Kalakote, resulted in Naik Badri Lal and Sepoy Jai Prakash suffering critical injuries; Lal ultimately succumbed to his injuries while in treatment.

On November 2, another tragedy struck when a vehicle skidded off a hilly road in Reasi district, claiming the lives of a woman and her 10-month-old son, while three others sustained serious injuries.

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Over 350 Himachal Pradesh roads shut amid snowfall, 4 dead

Meanwhile, post-monsoon rainfall from October 1 to December 24 has shown a deficit of 92% of the normal level of 70.4 mm.

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In Himachal Pradesh, a significant snowfall in the past 24 hours has resulted in four fatalities and the shutdown of approximately 700 electric transformers along with over 350 roads, including three national highways. This has left around 500 vehicles stranded, among which are more than 300 buses.

The snowfall, which began yesterday, has been recorded in various districts such as Kinnaur, Lahaul and Spiti, as well as the higher elevations of Shimla, Kullu, Mandi, Chamba, and Sirmaur.

On a positive note, the situation has attracted a large number of tourists heading to Shimla and nearby areas in hopes of enjoying a white Christmas. According to MK Seth, president of the Shimla Hotel and Tourism Stakeholders’ Association, hotel occupancy in the historic town has exceeded 70%, 30% higher than usual.

Tragically, four individuals lost their lives in accidents over the last day, with several others injured due to vehicles skidding in hazardous conditions. Key national highways connecting Attari to Leh, Sanj to Aut in Kullu, and Khab Sangam in Kinnaur to Gramphoo in Lahaul and Spiti are currently blocked.

Among the affected areas, Shimla has the highest number of closed roads, totaling 89, followed by Kinnaur with 44 and Mandi with 25. The State Emergency Operation Centre reported that 683 transformers are inactive, leaving some regions without electricity.

Authorities have urged tourists to follow the advice of district officials and police, heed local guidance, and avoid driving on snowy roads. Khadrala experienced the highest snowfall, receiving 24 cm, followed by Sangla with 16.5 cm, and Shillaro at 15.3 cm. Other areas such as Chopal and Jubbal recorded 15 cm each, while Kalpa received 13.7 cm, Nichar 10 cm, Shimla 7 cm, Pooh 6 cm, and Jot 5 cm.

Manali and Dalhousie suburbs also saw snowfall since Monday, with light rain experienced in parts of the mid and lower hills. An intense cold wave is affecting the lower hills of Mandi, while cold conditions are noted in Una and Chamba.

The Meteorological Office reported dense, moderate, and shallow fog in Bilaspur, Sundernagar, and Mandi. An ‘orange’ warning has been issued for severe cold in Bilaspur, Una, Hamirpur, and Mandi, and a ‘yellow’ warning for dense fog in areas around the Bhakra dam reservoir and Balh Valley in Mandi until Thursday.

The coldest recorded temperature was in Kukumseri, Lahaul and Spiti, at minus 6.9 degrees Celsius. Meanwhile, post-monsoon rainfall from October 1 to December 24 has shown a deficit of 92% of the normal level of 70.4 mm.

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Delhi Pollution: GRAP 4 revoked in capital, NCR as air quality improves

The GRAP 4 measures were implemented in Delhi after the air quality index (AQI) hit alarming levels on 16th December 2024

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Delhi Pollution: GRAP 4 revoked in capital, NCR as air quality improves

The Commission for Air Quality Management (CAQM) today revoked Stage 4 of the Graded Response Action Plan (GRAP) across Delhi and the National Capital Region (NCR). Nonetheless, measures under stages 1, 2, and 3 will remain in force to manage pollution levels. The GRAP 4 measures have been in effect in the entire NCR since December 16 after deterioration in air quality. 

This move follows after the Central Pollution Control Board (CPCB) reported an Air Quality Index (AQI) of 401 at 8 AM. The AQI on Monday fell into the severe category, measuring 403 at 7 am. Reportedly, AQI in several areas of the national capital was also recorded as ‘severe.’

Reports said, Anand Vihar recorded an AQI at 439, 456 at Ashok Vihar, 473 at Bawana, 406 at CRRI Mathura Road and 430 at Narela. Notably, an AQI between 0-50 is considered good, 51-100 is satisfactory, 101-200 is moderate, 201-300 is poor, 301-400 is very poor, and 401-500 is severe.

The GRAP 4 measures were implemented in Delhi after the air quality index (AQI) hit alarming levels on 16th December 2024. The Air Quality Index breached the 350 mark during the day, prompting the GRAP Sub-Committee to implement Stage-III measures. On the same day, by 10 PM, the AQI soared to 401, surpassing the severe plus category threshold. According to the Supreme Court instructions, Stage-IV measures were immediately introduced to tackle the crisis.

The apex court had earlier mandated precautionary measures, requiring Stage-III actions for AQI above 350 and Stage-IV for AQI exceeding 400. These directions were reiterated on 5th, 12th, and 19th December 2024, underlining the urgency to address Delhi’s air pollution.

As Delhi continues to battle hazardous air quality, the intensified measures under GRAP Stages I, II, and III will focus on curbing pollution sources and improving monitoring. Furthermore, residents are urged to remain cautious and adhere to guidelines issued by the authorities to mitigate the impact of air pollution on health and daily life.

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