GOVT PANEL ASKS FOR MORE DATA ON SPUTNIK V
NEW DELHI: It will be some time before Sputnik V, the Russia-developed vaccine against the Coronavirus disease (Covid-19), is approval for use in India. The subject expert committee (SEC) of the national drug regulator asked Hyderabad-based Dr Reddy’s Laboratories, which is conducting clinical trials on it locally and had applied for emergency use authorisation (EUA) to the Central Drugs Standard Control Organisation (CDSCO) on February 19, to come back with more data.
NEW DELHI: It will be some time before Sputnik V, the Russia-developed vaccine against the Coronavirus disease (Covid-19), is approval for use in India. The subject expert committee (SEC) of the national drug regulator asked Dr. Reddy’s Laboratories, which is conducting clinical trials on it locally, to come back with more data.
Hyderabad-based Dr Reddy’s applied for emergency use authorization (EUA) to the Central Drugs Standard Control Organisation (CDSCO) on February 19 for the human adenoviral vector-based vaccine candidate.
The subject expert committee took up the application on Wednesday, but did not recommend that the vaccine be approved for use in India with the current data set that was produced before its members.
“The subject expert committee has sought more data such as the immunogenicity data from the company. The application has not been rejected, they will be given a chance to present their case once again after they have all the relevant documents,” said a senior government official with knowledge of the matter, requesting not to be identified. The company had presented the safety profile of Phase 2 clinical trials, and interim data from Phase 3 trials.
In September 2020, Dr Reddy’s partnered with the Russian Direct Investment Fund (RDIF) to conduct the clinical trials of the Sputnik V and for its distribution rights in India.
The vaccine is currently undergoing Phase 3 clinical trials in India. Sputnik V has demonstrated an efficacy rate of 91.6% in the interim analysis of the Phase 3 clinical trials, which included data on 19,866 volunteers in Russia, who received both the first and second dose of the vaccine.
BJP SAID WHILE THE STADIUM IS NOW NAMED AFTER MODI, LARGER SPORTS COMPLEX OF WHICH IT IS A PART CONTINUES TO BE NAMED AFTER SARDAR PATEL
NEW DELHI: The Bharatiya Janata Party defended the renaming of the cricket stadium at Motera as the Narendra Modi stadium but pointed out that while the stadium is now named after the PM, the larger sports complex of which it is a part continues to be named after Sardar Vallabhbhai Patel, India’s first home minister.
At a cabinet briefing, union ministers Prakash Javadekar and Ravi Shankar Prasad also hit out at the Congress and wondered if the top Congress leaders such as Sonia or Rahul Gandhi have even bothered to visit the world’s tallest statue, that of Sardar Patel, at Kevadcongress iya in Gujarat.
While Javadekar said the two Congress leaders have not even visited the statue, Prasad said, “A tourist place getting global praise has not been visited yet or praised by the two
leaders. What else is there to say?”
One BJP leader even flashed a list of 23 stadiums, one sports award and 17 tournaments named after members of the Nehru-gandhi family.
Earlier in the day, soon after the stadium was inaugurated by President Ram Nath Kovind, Congress leader Rahul Gandhi tweeted: “Beautiful how the truth reveals itself. Narendra Modi stadium Adani end. Reliance end. With Jay Shah presiding. #Humdohumaredo.”
The party spokesperson Pawan Khera alleged that Modi has insulted the two great sons of Gujarat and great international icons, Mahatma Gandhi and Sardar Vallabhbhai Patel while renaming the stadium.