Hyderabad Dec 20 PTI The Central Drugs Standard Control Organisation CDSCO has approved the extension of Bharat Biotechs COVID-19 vaccine Covaxins shelf life up to 12 months from the date of manufacture the vaccine-maker said This approval of shelf life extension is based on the availability of additional stability data which was submitted to CDSCO With the shelf life extension hospitals can now utilise the stock to avoid vaccine wastage a press release said Covaxin is approved for use under the 28-day multi-dose vial policy from Drug Controller General of India and the WHO Emergency Use Listing WHO EUL Covaxin Open Vial is stable at 2 to 8 degrees Celsius for 28 days and not required to be discarded immediately in a day or at the end of immunisation session Bharat Biotech said it believes in doing a bit for the environment The multi-dose vial policy saves money for procurement agencies by reducing the cold chain logistics and management thereby reducing the carbon footprint costs related to open vial wastage cold chain distribution cold chain storage and biomedical waste disposal among others Most importantly we believe in being environmentally friendly by reducing the quantum of packing materials and single-use plastics that are utilised in vaccines manufacturing storage distribution and disposal the company said PTI GDK NVG NVG

Hyderabad Oct 27 PTI Ocugen Bharat Biotechs US partner for COVID-19 vaccine Covaxin on Wednesday said it has submitted Investigational New Drug Application IND to the US Food and Drug Administration to conduct clinical trials The development comes a day after the World Health Organisation sought more details from Bharat Biotech to consider its COVID-19 vaccine Covaxin for Emergency Use Listing The US firm in a press release said the Phase 3 trial proposed in the IND is designed to establish whether the immune response experienced by participants in a completed Phase 3 efficacy trial in India is similar to that observed in a demographically representative healthy adult population in the USA The US drug regulator earlier in June recommended Ocugen Inc to go for Biologics Licence Application BLA route with additional data instead of Emergency Use Authorisation EUA The proposed trial can be to people who either have not been vaccinated for COVID-19 or who already received two doses of an mRNA vaccine at least six months earlier in the USA We are very excited to take this next step in the development of Covaxin which we hope will bring us closer to introducing a different type of COVID-19 vaccine to the American public We are hopeful that the study conducted under the IND if allowed to proceed will help demonstrate that the data from India will be applicable to the US population Dr Shankar Musunuri Chairman of the Board Chief Executive Officer and Co-Founder of Ocugen said If the study is allowed to proceed Ocugens Phase 3 immuno-bridging study OCU-002 will seek to enroll several hundred healthy adults in the US Subjects will be randomized to receive either two doses of Covaxin or placebo 28 days apart The Phase 3 study conducted in India by Ocugens business partner Bharat Biotech involved 25798 participants receiving two doses of Covaxin or placebo 28 days apart Ocugen has already sought regulatory approval from Health Canada for Covaxin to be used in that country Covaxin is a whole-virion inactivated COVID-19 investigational vaccine candidate that uses the same vero cell manufacturing platform that has been used in the production of polio vaccines for decades PTI GDK BN BN

Chennai Oct 26 PTI Tamil Nadu would conduct the seventh edition of the COVID mass vaccination programme through 50000 camps across the state on October 30 State minister Ma Subramanian said on Tuesday The health department has conducted six mass vaccination programmes inoculating 133 crore people the Minister for Medical and Family Welfare said Briefing reporters after inspecting the vaccines at the storage facility of the Directorate of Medical and Rural Health Services DMS in the city he said till date 568 crore people have been vaccinated in the state Coming Saturday October 30 the seventh edition of mega vaccination camp will be held through 50000 campsthose who are waiting to receive the second dose should make use of the exercise he said Noting that more than 60 lakh people in the state have not received their second dose he said of the 60 lakh two lakh people need to receive the second dose of Bharat Biotechs vaccine -- Covaxin Subramanian said along with health secretary J Radhakrishnan he would make a request to the Union Health Minister Mansukh Mandaviya to allot 10 lakh doses of Covaxin to the state during his visit to New Delhi tomorrow as a large number of people were waiting to receive the dose We will also urge the Minister to allot funds to set up safe vaccine storage facilities in every district of the state he said Subramanian said he would also make a request to the Union Minister on the necessity to set up government hospitals at 19 locations in the State We need about Rs 950 crore for this purpose We will also take up this matter with the Union Minister he said Stating that there was no ban to celebrate festivals Subramanian said people should strictly follow the Covid-19 protocols at least for a year and celebrate the festivals PTI VIJ BN BN

Hyderabad Oct 17 PTI The technical advisory group of the World Health Organisation WHO will meet on October 26 to consider emergency use listing for Bharat Biotechs COVID-19 vaccine Covaxin tweeted Soumya Swaminathan chief scientist of the global health body on Sunday The technical advisory group will meet on Oct 26th to consider EUL for Covaxin WHO has been working closely with BharatBiotech to complete the dossier Our goal is to have a broad portfolio of vaccines approved for emergency use to expand access to populations everywhere she tweeted The Strategic Advisory Group of Experts on Immunization SAGE of the WHO which held a meeting on October 6 to make its recommendations on Covaxin on EUL among other issues had earlier said it will take a call on granting EUL status to Covaxin in a week time The EUL process being carried out by the WHO and the Technical Advisory Group of independent experts - is centered on determining if a manufactured product such as vaccine is quality-assured safe and effective WHO earlier saidThe WHO is currently reviewing the data submitted by the vaccine maker and the date for a decision on the jab is October 2021 according to the update available on the WHO websiteCovaxin is one of the three vaccines that have received emergency use authorisation from Indias drug regulator and is being used in the nationwide inoculation programme along with Covishield and Sputnik V PTI GDK GDK NVG NVG