The tenure of Dr V G Somani as the Drugs Controller General of India (DCGI) has been extended by three months for the second time, according to an order issued by the Union Health Ministry.

New Delhi [India], October 8 (ANI): A health expert from the Standing National Committee on Saturday asserted that there are several "missing links" that need to be probed in the World Health Organisation's (WHO) claim of over 66 deaths due to cold and cough syrup produced by the Maiden Pharmaceuticals Ltd.

Hyderabad (Telangana) [India], June 17 (ANI): Bharat Biotech International Limited (BBIL) on Thursday announced that Covaxin, its whole-virion inactivated COVID-19 vaccine has proven to be safe, well-tolerated, and highly immunogenic in paediatric subjects in phase II/III study, said a press release.

New Delhi Apr 26 PTI Bharat Biotech International Ltd BBIL on Tuesday said its COVID-19 vaccine Covaxin has received emergency use approval in children 6-12 years of age in India Earlier approved for children 12-18 years of age Covaxin has proven to be safe well-tolerated and immunogenic in paediatric subjects in phase IIIII study in children 2-18 years of age Bharat Biotech said in a statement The company said it conducted clinical trials in paediatric population between June 2021 to September 2021 and results have shown robust safety reactogenicity and immunogenicity The data readouts were submitted to the Central Drugs Standard Control Organisation CDSCO during October 2021 and received emergency use nod for children aged 12-18 from DCGI during December 2021 it added Bharat Biotech further said clinical trials in children documented seroconversion at 95-98 per cent four weeks after the second dose indicating superior antibody responses in children when compared to adults Commenting on the development Bharat Biotech Chairman and Managing Director Krishna Ella said We have established Covaxin as an universal vaccine for adults and children Safety of the vaccine is critical for children and we are glad to share that Covaxn has now proven data for safety and immunogenicity in children We have achieved our goal of developing a safe and efficacious COVID-19 vaccine for adults and children The company said fresh stocks of Covaxin are available and ready for supplies It has readily available more than 5 crore doses of Covaxin in vials and more than 20 crore doses as drug substance Additional production capacity is also available to meet product demand it added Earlier this month Bharat Biotech had announced that it was temporarily slowing down production of Covaxin across its manufacturing units for facility optimisation as it has already completed its supply obligations to procurement agencies and foresee decrease in demand The World Health Organization WHO had also confirmed the suspension of supply of Covaxin through UN procurement agencies and recommended countries that received the vaccine to take actions as appropriate WHO had said the suspension was in response to the outcome of WHO post Emergency Use Listing EUL inspection and the need to conduct process and facility upgrade to address identified GMP deficiencies The company after the WHO post Emergency Use Listing EUL inspection said it was working on further improvements and upgrades to ensure that the production of Covaxin continues to meet ever increasing global regulatory requirements PTI RKL MR

New Delhi Mar 23 PTI The Drugs Controller General of India DCGI granted permission on Wednesday for conducting the phase-3 clinical trial of COVID-19 vaccine Covovax as a booster dose in adults official sources saidThe Subject Expert Committee SEC on COVID-19 of the Central Drugs Standard Control Organisation CDSCO had on March 5 recommended permission for conducting the phase-3 clinical trial for Covovax as a booster dose in adults who have been fully vaccinated with either Covaxin or Covishield at least three months agoThe DCGI approved Covovax for restricted use in emergency situations in adults on December 28 last year and for inoculating the beneficiaries in the 12-17 years age group subject to certain conditions on March 9The vaccine has not been included in the countrys inoculation programme against COVID-19Director Government and Regulatory Affairs at the Serum Institute of India SII Prakash Kumar Singh submitted an application to the DCGI in February seeking permission to conduct a phase-3 observer-blind randomised controlled study to evaluate the safety and immunogenicity of Covovax for booster doses in adults who had received primary vaccination either with Covishield or Covaxin at least three months ago an official source had saidSingh had stated that many countries were administering booster doses to their citizens considering the uncertainties of the pandemicWe are sure that your approval for conducting this clinical trial will ensure an early availability of Covovax for booster-dose use for the people of our country as well as the world at large in line with our prime ministers vision of Making in India for the WorldOur firm is committed to providing world-class life-saving vaccines at an affordable price under the visionary leadership of our CEO Dr Adar C Poonawalla We request you to kindly grant us permission to conduct a phase-3 clinical trial for booster dose of Covovaxin Indian adults he had stated in the applicationCovovax is manufactured by technology transfer from Novavax and is approved by the European Medicines Agency for conditional marketing authorisation It was granted emergency-use listing by the World Health Organization WHO in December 2020In August 2020 US-based vaccine-maker Novavax Inc had announced a licence agreement with the SII for the development and commercialisation of NVX-CoV2373 its COVID-19 vaccine candidate in low-and-middle-income countries and in India PTI PLB RC

New Delhi [India], October 12 (ANI): After the evaluation of data Covaxin is yet to get approval by the Drugs Controller General of India (DCGI) for children between 2-18 years old, according to official sources.