Updated January 4th, 2021 at 15:02 IST

Milind Deora questions both Centre & Opposition on COVAXIN, Asks PM & govt to 'come clean'

Drug Controller General of India (DCGI) on Sunday had approved the vaccines of Bharat Biotech (Covaxin) and Serum Institue of India (Covishield)

Reported by: Swagata Banerjee
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Congress leader and Member of Parliament (MP) Milind Deora has sought an answer from the Central Government and Prime Minister Narendra Modi on the approval of Bharat Biotech's COVID-19 vaccine 'Covaxin'. He took to Twitter and shared a news report that alleged that the efficacy data of the said vaccine is missing. He also questioned the opposition and his own party for opposing "for the sake of opposing", therefore, losing the credibility for asking genuine questions. In his tweet, The Congress MP urged the Prime Minister to restore the "eroding public faith" in the vaccine. 

READ | India Approves SII's Covishield & Bharat Biotech's Covaxin COVID Vaccines: DCGI Statement

He tweets:

READ | India's COVID Vaccines: With Covishield & Covaxin Nods, Cadilla's Phase 3 Also Approved

Bharat Biotech's Covaxin COVID Vaccine was approved on Sunday

Drug Controller General of India (DCGI) VG Somani on Sunday had announced that the vaccines of Bharat Biotech (Covaxin) and Serum Institue of India (Covishield)  have been granted permission for restricted use in an emergency situation. The massive development came a day after the Subject Expert Committee (SEC) of the Central Drugs Standards Control Organisation (CDSCO) made recommendations to the Drugs Controller General of India to grant permission for restricted emergency use of the Serum Institute of India (SII) and Bharat Biotech's vaccines. As per an official release, the SEC met on Friday and Saturday and made its recommendations in respect of the accelerated approval process request of the SII, Bharat Biotech International Ltd as well as about phase-III trials of Cadila Healthcare Ltd.

READ | Subramanian Swamy Slams Congress For Questioning DCGI Approval To Bharat Biotech's Covaxin

While making an official statement, the DCGI said, "Bharat Biotech has developed a Whole Virion Inactivated Corona Virus Vaccine (Covaxin) in collaboration with ICMR and NIV (Pune), from where they received the virus seed strains. This vaccine is developed on Vero cell platform, which has well established track record of safety and efficacy in the country & globally."

"The firm has generated safety and immunogenicity data in various animal species such as mice, rats, rabbits, Syrian hamster, and also conducted challenge studies on non-human primates (Rhesus macaques) and hamsters. All these data has been shared by the firm with CDSCO. Phase I and Phase II clinical trials were conducted in approx.800 subjects and the results have demonstrated that the vaccine is safe and provides a robust immune response.  The Phase III efficacy trial was initiated in India in 25,800 volunteers and till date, ~22,500 participants have been vaccinated across the country and the vaccine has been found to be safe as per the data available till date," DCGI added.

This came even as various Opposition leaders made questionable statements about the vaccines. While some asked pertinent questions about the approval to Bharat Biotech's Covaxin, others, such as Akhilesh Yadav have blatantly politicised the vaccine, calling it 'BJP's vaccine', while his party leader has alleged that it causes impotence. The remarks have been widely panned. 

READ | Bharat Biotech Recruits 23,000 Volunteers For 3rd Phase Trial Of Covaxin

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Published January 4th, 2021 at 15:02 IST