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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

Ruckus created in Kurla over I Love Muhammad sticker, Soumya’s ultimatum, Soumya’s visit again after no progress in investigation, attempt to worsen the situation

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Mumbai: The controversy over I Love Muhammad has intensified in Mumbai, Maharashtra and Mumbai. BJP leader Kirat Soumya has objected to the pasting of I Love Muhammad stickers on vehicles at traffic stops in the Kurla area on the outskirts of Mumbai and demanded the registration of an FIR. After giving a 48-hour ultimatum to the Kurla police station, Kirat Soumya has again visited the Kurla police station today and demanded the registration of a case for the forcible pasting of stickers on vehicles. In this matter, the police have asked Kirat Soumya to consult the law department and seek time for progress in the matter until Tuesday. When Kirat Soumya was asked what he had against I Love Muhammad and why he opposed it, he denied it and said that everyone has the right to take the name of Prophet Muhammad (peace be upon him), but hooliganism will not be tolerated under the guise of this. The way the stickers were forcibly pasted on the roads without permission is the same. It is illegal. Kret Soumya said that the police have provided all the video footage and other documents, but the police have not registered a case yet. The police have given me time till Tuesday. Now the police will take some action after consulting the law department. When Kret Soumya was asked whether anyone had gone to the police station and complained about the forced sticker application, he said that since I am the complainant, the police should take action against this hooliganism. After Kret Soumya’s demand, attempts have been made to spoil the situation in Kurla, due to which the atmosphere is tense.

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Maharashtra

The streets echoed with the slogans of Takbir Allahu Akbar and Rasool, the Muslim youth arrested in the ‘I Love Muhammad’ controversy should be released, demand the scholars.

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Mumbai: The historic 71-year-old Ghausia procession was taken out from Madanpura Hari Masjid in Mumbai with great respect and dignity. The Ghausia procession was led by scholars, while the devotees of Ghaus Azam participated in the procession carrying the flag of the Prophet. The streets of Mumbai echoed with slogans like Takbir Allah Akbar, we will not leave the fold of Ghaus. The police had made strict security arrangements after the violence in Bareilly. After the controversy over I Love Muhammad, there was a high alert in Mumbai as well.

The scholars were seen in old and antique cars in the Ghausia procession, while all the scholars and devotees of Ghaus Azam, including students of madrasas, were part of the procession. The procession passed through traditional highways from Madanpura to Ghausia and ended with prayers at Mastan Talab. Success lies in following the teachings of Ghaus-e-Azam Dastgir (may Allah be pleased with him), therefore, it is essential for Muslims to observe prayers and follow Sharia. This advice was given by Maulana Maqsood Ali Khan while narrating the biography of Ghaus-e-Pak before the Ghausiya procession today.

He said that the Ghausiya procession has completed 70 years. It is the need of the hour for Muslims to maintain unity and agreement among themselves. The message of humanity has been spread by Ghaus-e-Azam Dastgir (may Allah be pleased with him). On the controversy over Come Muhammad, Maulana Maqsood Ali Khan said that Muhammad Mustafa (peace be upon him) has spread the message of love. He came as a mercy for humanity, but today in this fascinating era, the market of hatred is hot. Politics is also going on in the name of Come Muhammad and attempts are being made to spoil the situation, which is completely wrong. Maulana Maqsood Ali Khan said that Ghaus-e-Azam Dastgir has countless discoveries and miracles and he has advised to acquire knowledge.

He has also traveled from Jilani to Baghdad to acquire knowledge, so education is of great importance in Islam. He said that the first letter of the name of Muhammad (peace be upon him) is M, that is why everyone loves Muhammad (peace be upon him). On the Bareilly violence, Maulana Maqsood Ali Khan said that the Muslim youth arrested on charges of violence should be conditionally released. Muslims had protested peacefully in love with the Holy Prophet (peace be upon him). Along with this, Maulana Tauqeer Raza should also be released.

In all the monasteries, including Khwaja Gharib Nawaz (may Allah be pleased with him), there are more non-Muslim attendees than Muslims, and this is a manifestation of brotherhood and national unity. He said that opposing the name of Muhammad (peace be upon him) is absolutely not right. He (peace be upon him) loved even his enemies. A person who is devoted to him (peace be upon him) only spreads the message of love. Maulana Khalil-ur-Rehman said that the secret of success lies in following the teachings of Ghaus-e-Pak (may Allah have mercy on him).

Therefore, Muslims should hold firmly to the rope of Islam and follow the Holy Sharia. He said that in today’s fascinating era, sectarian forces are hatching conspiracies against Islam, along with which attempts are being made to commit atrocities on Muslims, but the grace of Ghaus-e-Pak will always remain with us Muslims. The government should immediately release the Muslim youth arrested in Bareilly and other cities of Uttar Pradesh and impose a ban on unnecessary arrests. Maulana Manan Raza Khan Manani Mian, Maulana Syed Kausar Rabbani, Alhaj Saeed Noori Raza Academy, Maulana Abdul Qadir Alvi, Maulana Farid-ul-Zaman, Maulana Khalil-ur-Rehman Noori, Maulana Ijaz Kashmiri, Maulana Amanullah Raza, Mufti Zubair Barkati, Hafiz Abdul Qadir, Qari Niaz Ahmed, Qari Nazim Ali Barkati, Qari Abdul Rehman Ziaei, Maulana Ibrahim Asi, Hafiz Shadab, Haji Barakat Ahmed Ashrafi and other scholars and intellectuals participated.

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Maharashtra

I am grateful to Uddhav Thackeray: Chief Minister Devendra Fadnavis

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Mumbai: Maharashtra Chief Minister Devendra Fadnavis targeted Uddhav Thackeray and said that Uddhav Thackeray did not say a single word about development works in the Dussehra rally. I am grateful to him because he saved me Rs 1,000. I had said that Uddhav Thackeray would not talk about development works and that is what happened, that is why I have saved Rs 1,000. Fadnavis said that instead of politicizing the floods in the state, there is a need for assistance. He said that the way the government has helped the flood-affected areas has definitely brought some relief. Along with this, Fadnavis called Rahul Gandhi a liar for targeting the country’s democracy abroad and said that Rahul Gandhi does not believe in democracy, that is why he lies. His grandmother Indira Gandhi had imposed emergency in the country. Now, democracy in the country is in danger.

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