DCGI approves market authorisation for SII's Covid vaccine Covovax as heterologous booster dose
New Delhi, Jan 16: The Drug Controller General of India (DCGI ) has approved market authorisation to COVID-19 vaccine Covovax as a heterologous booster dose for adults who have been administered two doses of Covishield or Covaxin, official sources said on Monday.
The DCGI's approval came following recommendation by the Subject Expert Committee of the Central Drugs Standard Control Organisation (CDSCO).
Prakash Kumar Singh, Director of Government and Regulatory Affairs at the Serum Institute of India (SII), had recently written to the DCGI for the approval of Covovax heterologous booster dose for those aged 18 years and above in view of escalating COVID-19 pandemic situation in some countries, an official source had said.
"The Subject Expert Committee of the CDSCO on Wednesday deliberated on the issue and had recommended for market authorisation of Covid jab Covovax as a heterologous booster dose for adults who have been administered two doses of Covishield or Covaxin," an official source said.
The DCGI had approved Covovax for restricted use in emergency situations in adults on December 28, 2021, in the 12-17 age group on March 9, 2022, and in children aged 7- 11 years on June 28 last year subject to certain conditions.
Covovax is manufactured through technology transfer from Novavax. It has been approved by the European Medicines Agency for conditional marketing authorisation. It was granted emergency-use listing by the World Health Organization (WHO) on December 17, 2021.
In August 2020, US-based vaccine maker Novavax Inc. had announced a licence agreement with the SII for the development and commercialization of NVX-CoV2373, its COVID-19 vaccine candidate in India and low-and-middle-income countries.
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PM must resign when TMC wins Bengal: Derek O'Brien
Kolkata (PTI): Trinamool Congress's Rajya Sabha MP Derek O'Brien on Wednesday expressed confidence that his party will come back to power in the state after the assembly elections and challenged Prime Minister Narendra Modi to resign when the results come.
In a video shared on microblogging site X, O'Brien accused the prime minister of making exaggerated political claims and urged him to "accept the challenge" instead of indulging in "big talk."
"Narendra, you had announced that you are the candidate on all 294 seats in West Bengal. Leave out the big talk and accept this challenge..." O'Brien wrote.
He asserted that if the Mamata Banerjee-led TMC wins the state, the prime minister should step down from his post. "When Mamata Banerjee and TMC win West Bengal, you will resign from your post as the prime minister," he said.
The remarks come amidst an intensifying political contest in West Bengal, where the ruling TMC and the Bharatiya Janata Party are engaged in a high-stakes electoral battle.
Polling is taking place in 142 constituencies in the second and final phase of the assembly elections on Wednesday, amid unprecedented security arrangements and a high-intensity contest that could decide whether the ruling TMC retains its dominance over the southern districts or the BJP can force open the gates of power in the state.
