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No external pressure to accelerate Covaxin development: Bharat Biotech

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 Vaccine-maker Bharat Biotech has denied that there was any external pressure to accelerate development of Covaxin, its vaccine for Covid-19.

“We condemn the targeted narrative against Covaxin put forth by a select few individuals and groups who have no expertise in vaccines or vaccinology. It is well known that they helped perpetuate misinformation and fake news throughout the pandemic. They are unable to comprehend global product development and licensure processes,” the Hyderabad-based company said in a statement on Thursday.

“The pressure was all internal to develop a safe, and effective vaccine for the Covid-19 pandemic, to save lives and livelihoods in India and globally,” it added.

The company claimed that Covaxin is one of the most highly studied covid-19 vaccines worldwide.

Covaxin was evaluated in about 20 preclinical studies, including three challenge trials and nine human clinical studies, more than any other Indian Covid-19 vaccine. These trials have clearly demonstrated safety and efficacy of Covaxin, Bharat Biotech said.

The vaccine-maker further claimed that with several hundred million doses administered worldwide, Covaxin has demonstrated an excellent safety record with minimal adverse events and no vaccine associated cases detected for myocarditis or thrombocytopenia.

“The entire product development and clinical studies were executed as per global guidelines and submitted worldwide. Data from Covaxin has resulted in more than 20 publications, documenting every aspect of its development.”

It termed as “incorrect and erroneous’ the recent media reports around the approvals for Covaxin.

“These few individuals and organizations were mostly involved in fake news and false information during the pandemic. They fail to understand product development and licensure pathways worldwide,” reads the statement.

It pointed out that the phase 1 study for Covaxin was one of the largest in the world, resulting in both the 3 and 6 mcg doses demonstrating safety and comparable immunogenicity.

The decision to proceed to phase III trials was taken based on data from phase I studies and results from successful animal challenge trials.

The phase II studies were designed to determine if the lower dose of 3 mcg would be effective, instead of the 6 mcg dose, which would have doubled our manufacturing capacity. In the interest of public health, it was decided to proceed with the 6 mcg dose for phase III clinical trials.

According to Bharat Biotech, vaccines against ebola and monkey pox, were approved by stringent regulatory agencies in developed countries based on phase I and II clinical data only and without phase III data.

“If such an approval was given by regulators in India, there would be an uproar, but the same people and organisations remain silent, demonstrating their hypocrisy.

“While these people and organizations were busy with false information and fake news during the pandemic, more than 1,000 personnel at Bharat Biotech across India were busy developing, testing, manufacturing and distributing Covaxin.

“Our diligent efforts have resulted in an universal Covid-19 vaccine for adults and children alike, which can be administered repeatedly as booster doses without safety concerns. The Bharat Biotech team is extremely proud of its efforts to develop a novel Covid-19 vaccine for India and the world. These efforts to discredit our work will not deter us,” it added.

Maharashtra

Maharashtra: Abu Asim Azmi presents bill in the House against religious hatred and blasphemy, application of MCOCA and UAPA also included in the draft bill

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Mumbai: Nagpur Samajwadi Party leader and MLA Abu Asim Azmi presented a private bill in the Maharashtra Legislative Assembly against those who spread blasphemy and religious hatred. The bill demands action against hate elements and calls for action under MCOCA and UAPA against those who spread religious hatred, in addition to ten years of imprisonment and a bail of Rs 2 lakh so that sectarians do not get bail and such cases of spreading religious hatred are banned. He told the House that there has been an increase in cases of blasphemy in the country and in such a situation, tension arises in the country. Action should be taken against such elements to maintain law and order. This will be possible only when action is taken against such sectarians who promote a hate agenda under the guise of freedom of expression. He said that the Supreme Court had also issued an order for strict action against hate elements and miscreants and has banned inflammatory and hate speech. In such a situation, Maharashtra The bill has been formally introduced in the House to take action against those who spread religious hatred and incite hatred against important people. The draft bill proposes to register a case against communalists under the section of the MCOCA UAPA, which carries a maximum sentence of ten years, so that such elements cannot be granted bail.

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Maharashtra

Mumbai fuel theft gang busted, 13 accused arreste, The gang of thieves had attempted to steal fuel in November

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Mumbai: Police claims to have busted a petrol theft gang. The accused were arrested for attempting to steal petrol from BPCL company on November 14 at around 3:30 am under the limits of RCF police station in Mumbai. A complaint was registered for attempting to steal fuel from the underground 18-inch Mumbai Manmade Multi-Product pipeline on Mumbai Gadkari Road. Vinod Devchand Pandit was arrested from Chembur on November 17 on the basis of technical investigation and information from an informant. His investigation revealed that the mastermind of this racket, Riaz Ahmed Ayub (59), Salim Mohammad Ali, Vinod Devchand Pandit had hatched a plan to steal fuel. 13 accused including Gopal Narayan, Mohammad Irfan, Vinay Shashikant, Ahmed Khan Juman Khan, Nishan Jagdish, Mustafa Manzoor, Nasir Shaukat, Imtiaz Asif have been arrested. All these accused have been arrested from various areas. Their arrests were made from Mumbai, Navi Mumbai and surrounding areas. This operation was carried out by Additional Commissioner Mahesh Patil and DCP Sameer Sheikh on the instructions of Mumbai Police Commissioner Deven Bharti.

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Maharashtra

Lack of general civic amenities in Mankhurd Shivaji Nagar, rehabilitation should be done after civic amenities are provided to the victims of Dharavi Rehabilitation Project: Abu Asim

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Abu Asim Azmi opposed the development of more waste management for waste disposal in Mankhurd Shivaji Nagar, Mumbai, in the winter session of Nagpur and said that Mankhurd Shivaji Nagar is a slum area. There is already a dumping ground here. There is also a waste management company, which is causing a lot of problems to the citizens. Pollution has increased due to waste disposal. The air here is toxic. On the one hand, a dumping ground is being shifted from Malind and a golf course is being built, and on the other hand, the residents of the slums of Dharavi are being rehabilitated here. There is a lack of civic amenities in Govindi. Until schools, colleges, grounds and religious places, mosques, temples and other places of worship are built, no one should be rehabilitated here. Along with this, the dumping ground and other waste management companies should be removed from here. There is already a waste management company here. Now more such companies are destroying human life. It should be banned immediately, this demand was made by Azmi.

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