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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 Marathi Hindi Controversy: Strict action will be taken against those who take law into their hands: Chief Minister Devendra Fadnavis

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Mumbai: Maharashtra Chief Minister Devendra Fadnavis has made it clear on the Hindi-Marathi language dispute that linguistic discrimination and violence cannot be tolerated. If anyone instigates violence in the name of Marathi language or takes the law into his own hands, strict action will be taken against him because it is the government’s responsibility to maintain law and order. He said that in the Mira Road Hindi Marathi violence case, the police have registered a case and taken action.

A committee has been formed in the matter of Marathi and Hindi language. Whatever is better for the students on its recommendation, the government will implement it. No decision has been taken under anyone’s pressure. He said that the recommendation for Hindi language was made during the Maha Vikas Aghadi rule itself, but now these same people are opposing it. The public knows everything.

He said that in this election, BJP has got 51 percent Marathi votes. Violence and discrimination in the name of language cannot be tolerated. Marathi is a source of pride for us, but we do not oppose Hindi. What will happen if a Marathi businessman in another state is asked to speak his language? In Assam, he was asked to speak Assamese. He said that strict action will be taken against those who break the law.

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Maharashtra

Case registered for burning copy of Hindi Marathi dispute order

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Mumbai: Mumbai Police has registered a case against 200 to 300 activists including Deepak Pawar, Santosh Shinde, Santosh Kharat, Shashi Pawar, Yoginder Salulkar, Santosh Veer for protesting without permission, violating prohibitory orders and Police Act in the case of burning copy of order making Hindi language compulsory. The accused have been booked under Section 189(2), 190,223, Maharashtra Police Act at Azad Maidan Police Station. The case has been registered on the complaint of complainant Santosh Suraj Dhundiram Khot, 32 years.

According to the details, on June 29, between 2 and 3:30 pm, a copy of the government order against making Hindi i.e. third language compulsory in primary education was burnt without permission on BMC Road adjacent to Marathi Patkar Singh and the government order was violated. The accused had not taken any permission for this demonstration and had violated the prohibitory orders, following which a case has been registered against them, confirmed Mumbai Police. The case has been registered after recording the statement of the complainant.

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Maharashtra

Opposition protests against the government for declaring Wari as urban Naxal

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Mumbai: On the fourth day in the Maharashtra Legislative Assembly, the opposition created a ruckus over declaring Wari as urban Naxal and has made serious allegations against the government of insulting Wari. On the fourth day of the Maharashtra Legislative Assembly, the opposition has made several serious allegations against the ministers of the government while protesting on the steps of the Vidhan Bhavan. The ministers included in the cabinet of the state government are misusing their powers and occupying government lands in the state.

Just as the ruling front is trying to defame the holy pilgrimage of Hinduism, Wari, by calling Vitthurai and Warkars urban Naxalites and urban Maoists, in the same way it is insulting Wari Palkhi. This is reprehensible. Members of the Maha Vikas Aghadi staged a strong protest on the steps of the Vidhan Bhavan against the ruling front and accused the government of insulting Wari. In this demonstration, the members also raised slogans cursing the government and said that due to the scamster government, farmers are dying of hunger and the ministers are calling the laborers urban Naxalites. Shiv Sena leader of opposition Ambadas Danve, Vijay Varditwar, Sachin Ahir, Jitendra Ahawat etc. participated in this protest.

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