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 Apr 26 PTI Indias drug regulator has granted restricted emergency use authorisation for Biological Es COVID-19 vaccine Corbevax for those aged five to 12 years and Bharat Biotechs Covaxin for children in the age group of six to 12 years Union Health Minister Mansukh Mandaviya said on TuesdayThe approval by the Drugs Controller General of India DCGI for Corbevax and Covaxin for inoculating children below 12 years paves the way for giving protection to a majority of school going children and assumes significance ahead of Prime Minister Narendra Modis meeting with chief ministers on the emerging COVID-19 situation in the country on Wednesday through video conferencingThe DCGI has also granted emergency use authorisation EUA to Cadila for its ZyCoV-D for an additional dose of 3mg with a two-jab inoculation schedule 28 days apart for those aged above 12 yearsZyCoV-D is currently approved for a 2mg three-dose vaccination scheduleThe DCGI approval comes following recommendations by the Subject Expert Committee SEC on COVID-19 of the Central Drugs Standard Control OrganisationCDSCOThe SEC had last week reviewed the application of Biological E and Bharat Biotech seeking emergency use authorisation for Corbevax and Covaxin for use in children of five to 12 years and six to 12 years age group respectively It also reviewed Cadilas applicationBiological Es Corbevax is being used to inoculate children against COVID-19 in the age group of 12 to 14 years Covaxin has been granted Emergency Use Listing EUL by the DCGI for the age group of 12 to 18 years on December 24 2021India began inoculating children aged 12-14 years on March 16 So far more than 270 crore adolescents have been administered with the first dose of COVID-19 vaccineThe countrywide vaccination drive was rolled out on January 16 last year with healthcare workers getting inoculated in the first phase Vaccination of frontline workers started from February 2 last yearThe next phase of COVID-19 vaccination commenced on March 1 last year for people over 60 years of age and those aged 45 and above with specified co-morbid conditionsIndia launched vaccination for all people aged more than 45 years from April 1 last year The government then decided to expand its vaccination drive by allowing everyone above 18 years of age to be inoculated against the viral disease from May 1 last yearThe next phase of vaccination commenced on January 3 for adolescents in the age group of 15-18 yearsIndia began administering precaution doses of vaccines to healthcare and frontline workers and those aged 60 and above with comorbidities from January 10Precaution doses of COVID-19 vaccines to all aged above 18 years were allowed at private vaccination centres from April 10 The cumulative COVID-19 vaccine doses administered in the country has exceeded 18795 crore PTI PLB SRY

New Delhi Apr 26 PTI Indias drug regulator has granted emergency use authorisation for Biological Es COVID-19 vaccine Corbevax for those aged five to 12 years and Bharat Biotechs Covaxin for children in the age group of six to 12 years official sources said on TuesdayThe approval by the Drugs Controller General of India DCGI comes following recommendations by the Subject Expert Committee SEC on COVID-19 of the Central Drugs Standard Control OrganisationCDSCOThe SEC had last week reviewed the application of both the companies seeking emergency use authorisation for Corbevax and Covaxin for use in children of five to 12 years andsix to 12 years age group respectivelyBiological Es Corbevax is being used to inoculate children against COVID-19 in the age group of 12 to 14 years Covaxin has been granted Emergency Use Listing EUL by the DCGI for the age group of 12 to 18 years on December 24 2021India began inoculating children aged 12-14 on March 16 The countrywide vaccination drive was rolled out on January 16 last year with healthcare workers getting inoculated in the first phase Vaccination of frontline workers started from February 2 last yearThe next phase of COVID-19 vaccination commenced on March 1 last year for people over 60 years of age and those aged 45 and above with specified co-morbid conditionsIndia launched vaccination for all people aged more than 45 years from April 1 last year The government then decided to expand its vaccination drive by allowing everyone above 18 years of age to be inoculated against the viral disease from May 1 last yearThe next phase of vaccination commenced on January 3 for adolescents in the age group of 15-18 yearsIndia began administering precaution doses of vaccines to healthcare and frontline workers and those aged 60 and above with comorbidities from January 10 Precaution doses of COVID-19 vaccines to all aged above 18 years were allowed at private vaccination centres from April 10 PTI PLB NSD NSD

New Delhi Apr 26 PTI Indias drug regulator has granted emergency use authorisation for Biological Es COVID-19 vaccine Corbevax for those aged five to 12 years and Bharat Biotechs Covaxin for children in the age group of six to 12 years Union Health Minister Mansukh Mandaviya said on TuesdayThe Drugs Controller General of India DCGI has also granted emergency use authorisation EUA to Cadila for its ZyCoV-D for an additional dose of 3mg with a two-jab inoculation schedule 28 days apart for those aged above 12 yearsZyCoV-D is currently approved for a 2mg three-dose vaccination scheduleThe approval by the Drugs Controller General of India DCGI comes following recommendations by the Subject Expert Committee SEC on COVID-19 of the Central Drugs Standard Control OrganisationCDSCOThe SEC had last week reviewed the application of Biological E and Bharat Biotech seeking emergency use authorisation for Corbevax and Covaxin for use in children of five to 12 years and six to 12 years age group respectively It also reviewed Cadilas applicationBiological Es Corbevax is being used to inoculate children against COVID-19 in the age group of 12 to 14 years Covaxin has been granted Emergency Use Listing EUL by the DCGI for the age group of 12 to 18 years on December 24 2021India began inoculating children aged 12-14 on March 16 The countrywide vaccination drive was rolled out on January 16 last year with healthcare workers getting inoculated in the first phase Vaccination of frontline workers started from February 2 last yearThe next phase of COVID-19 vaccination commenced on March 1 last year for people over 60 years of age and those aged 45 and above with specified co-morbid conditionsIndia launched vaccination for all people aged more than 45 years from April 1 last year The government then decided to expand its vaccination drive by allowing everyone above 18 years of age to be inoculated against the viral disease from May 1 last yearThe next phase of vaccination commenced on January 3 for adolescents in the age group of 15-18 yearsIndia began administering precaution doses of vaccines to healthcare and frontline workers and those aged 60 and above with comorbidities from January 10 Precaution doses of COVID-19 vaccines to all aged above 18 years were allowed at private vaccination centres from April 10 PTI PLB NSD NSD

New Delhi Mar 20 PTI Indias apex body on immunisation NTAGI has recommended administering the second dose of COVID-19 vaccine Covishield between eight and 16 weeks after the first dose official sources said on Sunday Presently the second dose of Covishield is given between 12-16 weeks after the first dose under the National COVID-19 Vaccination Strategy The National Technical Advisory Group on Immunisation NTAGI has not yet suggested any change in the schedule of Bharat Biotechs Covaxin whose second dose is administered 28 days after the first dose The recommendation for Covishield is yet to be implemented in the national COVID-19 vaccination programmeThe latest recommendation of NTAGI is based on recent global scientific evidence derived from programmatic data said an official sourceAccording to it when the second dose of Covishield is given eight weeks onwards the antibodyresponse generated is almost similar when administeredat an interval of 12 to 16 weeks the source explainedThe decision will lead to accelerated administration of the second dose of Covishield to the remaining six to seven crore individuals amid rising cases in several countries the source said The government had on May13 2021 extended the gap between the first and seconddosesofthe Covishieldvaccinefrom 6-8 weeks to 12-16 weeks based on the recommendations by NTAGI NTAGI provides guidance and advice to the Union Health Ministry on immunisation services for the effective control of vaccine-preventable diseases in the country PTI PLB RT

New Delhi Feb 21 PTI Serum Institute of India has sought emergency use authorisation from Indias drug regulator for its COVID-19 vaccine Covovax for the 12 to 17 year age group official sources said on MondayThe government has not yet decided on vaccinating those aged below 15 The Health Ministry had recently said the additional need for vaccination and inclusion of population for inoculation is examined constantlyIn the application for emergency use authorisation EUA for the 12-17 year age group Prakash Kumar Singh Director Government and Regulatory Affairs at SII is learnt to have stated that data from two studies on about 2707 individuals aged 12 to 17 years show Covovax is highly efficacious immunogenic safe and well-tolerated in this age groupWe are submitting our application along with documents for grant of permission for restricted use in emergency situation for Covovax vaccine in children aged 12 to 17 years in addition to approved age of individuals 18 years and older an official source quoted Singh as having said in the applicationThis approval will not only be beneficial for the country but will also benefit the world fulfilling Prime Minister Narendra Modis vision of Making in India for the World Singh is learnt to have saidIn line with the philosophy of our CEO Dr Adar C Poonawalla we are sure that Covovax will play an important role in protecting the children of our country and the world against COVID-19 and will keep our national flag flying high globally Singh statedThe Drugs Controller General Of India has already approved Covovax for restricted use in emergency situations in adults on December 28Covovaxis manufactured by technology transfer from Novavax and is approved by the European Medicines Agency for conditional marketing authorisationIt has been granted emergency use listing by the World Health Organisation on December 17 2021India has been using Bharat Biotechs Covaxin to vaccinate adolescents between 15 and 18 years PTI PLB NSD NSD

New Delhi Dec 25 PTI The Drugs Controller General of India DCGI has granted emergency use authorisation to Bharat Biotechs Covaxin for children above 12 years with certain conditions sources saidon SaturdayThe Subject Expert Committee on COVID-19of the CDSCO on October 12 after deliberating Bharat Biotechs EUA application had recommended granting emergency use approval to Covaxin for use in the 12-18 years age group with certain conditionsThe recommendations of the SEC were evaluated by another experts committee after which DCGI had sought additional data from the firm a source saidThe DCGI gave its approval Friday the source said PTI PLB ZMN

New Delhi Oct 28 PTI India has proposed a mutually acceptable COVID-19 vaccine certification framework to its partner countries to ensure a simplified international travel regime and several of them have already agreed to it Foreign Secretary Harsh Vardhan Shringla said on Thursday The mechanism is based on reciprocal recognition of the integrity of the vaccine certification process by the partner countries and it will help in normalising international travel he said at a media briefing On the delay in the grant of Emergency Use Listing EUL for Bharat Biotechs Covaxin by the World Health Organisation Shringla said India is hopeful of getting the approval soon The foreign secretary said the regulatory body concerned of the WHO put some questions to Bharat Biotech and approval for the vaccine should come if the queries are responded to effectively India has proposed to its partner countries primarily countries that Indian citizens normally travel to that we should have a mutual mechanism that you recognise our vaccine certification and we will mutually recognise your vaccine certification Shringla said Now the advantage of this is that as we keep adding new vaccines to our stock of national vaccines you do not need to go to every country to try and get recognition You recognise the certification that we issue you recognise its integrity and we will give you mutual treatment he said The foreign secretary said a number of countries have already agreed to the proposal He however did not name the countries So we have achieved some reciprocal arrangements with a number of countries We are working with all of our partner countries to have similar arrangements It will simplify international travel it will normalise international travel Shringla said He said such a mechanism could be helpful in the G20s objective of recovering from the economic impact of the coronavirus pandemic Business travellers tourists which contribute to the recovery of economies will be greatly benefitted from this simplified international travel regime that we are proposing and we have taken it up with the G20 we have taken it up bilaterally we have taken it up in plurilateral forums he said We will continue to advocate this as a means of better and easier access to citizens travelling all over the world Shringla added To a question on delay in WHOs nod for Covaxin he said the regulatory committee of the global body in its meeting on October 26 asked certain questions to Bharat Biotech and the manufacturer will soon provide its response It is a technical and regulatory group The emergency authorisation by the WHO is based on technical considerations and we are carefully following up the discussions at the WHO We are hopeful that Covaxin will get approval soon Shringla said On India proposing waivers by the World Trade Organisation on Covid-related medical products including vaccines he said India is for ensuring affordable and equitable access to COVID-19 disease control tools We have advocated for technology transfer and diversification of supply chain and production hubs to ensure affordable and equitable access to COVID-19 disease control tools he said I am happy to share that G20 has recognised extensive vaccination as a global public good and I think that is where discussions in the G20 will be relevant he added PTI MPB ZMN ZMN

New Delhi Oct 28 PTI Bharat Biotechs Covaxin has been included to the approved list of COVID-19 vaccines for travel to Oman without quarantine In a tweet Bharat Biotech noted Covaxin has now been added to the approved list of COVID19 vaccines for travel to Oman without quarantine This will facilitate travelers from India vaccinated with Covaxin The vaccine major cited a press release issued by the Embassy of India Muscat in this regard Embassy of India Muscat is pleased to inform that the Government of the Sultanate of Oman has added Covaxin to the approved list of COVID-19 vaccines for travel to Oman The Civil Aviation Authority issued a notification on 27 October regarding this the release stated All passengers from India who have received two doses of Covaxin at-least 14 days before the estimated arrival date will now be able to travel to Oman without the requirement of quarantine it added All other COVID-19 related requirementsconditions such as pre-arrival RT-PCR test shall be applicable for such passengers the release stated This notification will significantly ease travel to Oman for Indian nationals who have taken Covaxin it noted Passengers who have taken AstraZenecaCovishield are already permitted to travel to Oman without quarantine PTI MSS ANS ANS

New Delhi Oct 25 PTI The Centre on Monday called on all panchayat leaders to play an active role in COVID-19 vaccination for children once it is approved while expressing hope that it will pave the way for the reopening of schoolsThe vaccination for those below 18 years of age is yet to be started in the country which has already crossed the 100-crore-dose mark in vaccinating adults against COVID-19As part of the Panchayati Raj webinar series under the Azadi Ka Amrit Mahotsav activities Panchayati Raj Secretary Sunil Kumar interacted with the elected representatives and functionaries of the Panchayati Raj institutions and appreciated their role in the countrys COVID-19 vaccination campaignKumar called on them for playing an active role in vaccinating children in the future and expressed hope that the availability of vaccines for children will pave the way for the reopening of school and related activities the Ministry of Rural Development and Panchayati Raj said in a statementCurrently three COVID-19 vaccines -- Covishield Covaxin and Sputnik V -- are being administered in the country to only those beneficiaries aged above 18 years All of these are two-dose vaccinesZydus Cadilas indigenously-developed needle-free Covid vaccine ZyCoV-D is set to become the first vaccine that will be available in the country for those in the age group of 12-18 years It has received the Emergency Use Authorisation EUA from the Drugs Controller General of India DCGIThe Subject Expert Committee SEC on COVID-19 has recommended that the DCGI grant emergency use authorisation to Bharat Biotechs Covaxin for children in the age group of two to 18 yearsThese two vaccines are yet to be included in the ongoing vaccination drive in the country PTI JTR RC