New Delhi [India], September 6 (ANI): The Drugs Controller General of India (DCGI) rendered an emergency use authorization (EUA) to Bharat Biotech for the intranasal vaccine- iNCOVACC, said officials on Tuesday.

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

Hyderabad (Telangana) [India], April 26 (ANI): The Drugs Controller General of India (DCGI) on Tuesday granted an emergency use authorisation (EUA) to Bharat Biotech's Covaxin for the age group of 6-12 years.

New Delhi Apr 25 PTI A crucial meeting of the subject expert committee SEC of the CDSCO will be held on Tuesday to consider granting emergency-use authorisation EUA to Serum Institute of Indias SII recombinant BCG rBCG vaccine for the prevention of tuberculosis according to official sourcesThe Central Drugs Standard Control Organisation CDSCO is the drug regulator of IndiaThe EUA application was submitted to the Drugs Controller General of India DCGI on March 22 by Prakash Kumar Singh the director of government and regulatory affairs at the SIIIndias TB immunisation programme currently offers BCG vaccination at birth or as early as possible till one year of ageThe SII already supplies life-saving vaccines to the government under the Universal Immunisation Programme including Pneumococcal IPV and Rotavirus Singh mentioned in his letterThe Pune-based firm is one of the companies that supply BCG vaccines to the governmentOur government is committed to eliminate TB The vision of a TB-free India has been energised by the clarion call of the prime minister to end TB from our country by 2025 five years ahead of the Sustainable Development Goal of ending TB Singh mentioned in his letterUnder the leadership of CEO Adar C Poonawalla the SII is committed to making available a safe efficacious and high-quality world-class TUBERVAC-rBCG vaccine for newborns children adolescents and adults at an affordable price an official source had quoted Singh as having said in the applicationRecombinant BCG vaccines are manufactured through an advanced technology that allows the insertion of foreign genes or overexpression of native genes into a BCG vaccine an official explained PTI PLB RC

New Delhi Apr 21 PTI An expert panel of Indias central drug authority has recommended granting emergency use authorisation for Biological Es COVID-19 vaccine Corbevax for children in the five to 11 years age group with certain conditions official sources said on ThursdayThe Subject Expert Committee SEC on COVID-19 of the CDSCO has on the other hand sought more data from Bharat Biotech to review its emergency use authorisation EUA application for use of Covaxin among those aged two to 11 years they saidThe SEC has also recommended the grant of emergency use authorisation EUA to Cadila for their ZyCoV-D vaccine for an additional dose of 3mg with a two-jab inoculation schedule 28 days apart for those aged 12 years and above another source saidPresently ZyCoV-D is approved for a 2mg three-dose vaccination scheduleBiological 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 by the DCGI for the age group of 12 to 18 years on December 24 2021An official source on Thursday said Biological E had submitted updated safety data two to three months after the second dose in the proposed five to 11 years age group along with safety data available from the doses used uptil in the higher age groupIt has also submitted immunogenicity data and virus neutralising antibody data against variants of concern including Delta and Wuhan strains for its proposal for grant of restricted use in an emergency situation in the age group of five to 12 years the source saidBiological E has also presented updated safety data for vaccination in the age groupof 12 to 14 years from the immunisation programmeThe SEC noted that the interim safety and immunogenicity data of Phase 23 clinical trial in subjects of five to less than 12 years is comparable to that higher age groups It also noted the safety data of vaccination in the age group of 12 to 14 yearsAfter detailed deliberation it has recommended approval of the vaccine for 5 years and above for restricted use in an emergency situation with the condition to submit ongoing clinical trial data an official source saidIndia 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 10Precaution 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 21 PTI An expert panel of Indias central drug authority has recommended granting emergency use authorisation for Biological Es COVID-19 vaccine Corbevax for children in the five to 11 years age group official sources said on ThursdayThe Subject Expert Committee on COVID-19 of the CDSCO has however sought more data from Bharat Biotech to review its emergency use authorisation EUA application for use of Covaxin among those aged between two and 11 years they saidThe Drugs Controller General of India DCGI had approved Covovax for restricted use in emergency situations in adults on December 28 last year and in the 12 to 17 years age group subject to certain conditions on March 9 this yearBiological 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 12to 18 years on December 24 2021The Subject Expert Committee on COVID-19 of the CDSCO which deliberated on Biological EsEUA application has recommended granting emergency use authorisation for use of Corbevax in the age group of five to 11 years a source saidIndia 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 does of COVID-19 vaccines to all aged above 18 years was allowed at private vaccination centres from April 10 PTI PLB NSD NSD

Washington [US], March 18 (ANI/Xinhua): American biotechnology company Moderna submitted a request to the U.S. Food and Drug Administration (FDA) on Thursday for emergency use authorization (EUA) on a fourth dose of its COVID-19 vaccine for adults 18 years of age and older, who already received a booster dose of any approved or authorized shot.

New Delhi [India], March 9 (ANI): Hyderabad-based pharmaceutical company Biological E has applied for Emergency Use Authorisation (EUA) for its COVID-19 vaccine Corbevax for the 5-12 year age group, official sources said on Wednesday.

New Delhi Feb 21 PTI The Drugs Controller General of India has granted restricted emergency use authorisation EUA to Biological Es COVID-19 vaccine Corbevax for the 12 to 18 years age group subject to certain conditions official sources said on Monday However the government has not taken a decision yet on vaccinating those aged below 15 years This is the third vaccine to have received EUA from the Drugs Controller General of India DCGI for the age group of 12-18 years after Zydus Cadilas ZyCoV-D and Bharat Biotechs Covaxin At present India is using Covaxin to vaccinate adolescents in the 15 to 18 years age group The health ministry recently had said additional need for vaccination and inclusion of population for vaccination is examined constantly The DCGIs approval comes after the Subject Expert Committee on COVID-19 of the CDSCO on February 14 recommended granting restricted EUA to Corbevax for the 12 to 18 years age group after deliberating on Biological Es application The DCGI had approved Corbevax which is Indias first indigenously developed RBD protein sub-unit vaccine against COVID-19 for restricted use in emergency situations in adults on December 28 It has not been included in the countrys vaccination drive The DCGI on Monday granted restricted EUA to Corbevax for the 12 to less than 18 years age group subject to certain conditions an official source said Health Minister Mansukh Mandaviya tweeted The CDSCOINDIAINF has granted emergency use authorisation to COVID-19 vaccine CORBEVAX for 12-18 year age groupIt is Indias 1st indigenously developed Receptor Binding Domain Protein sub-unit vaccine against COVID-19This will further strengthen our fight against COVID19 In an application sent to the DCGI on February 9 Srinivas Kosaraju the head of quality and regulatory affairs at Biological E Limited had said the firm had received approval for conducting phase 23 clinical study of Corbevax among children and adolescents aged 5-18 years in September Based on the no-objection certificate Biological E has initiated the clinical study in October 2021 and has evaluated the available safety and immunogenicity results of the ongoing phase 23 study which indicated that the vaccine is safe and immunogenic The proposed application is for obtaining permission for restricted use in an emergency situation in adolescents aged 12 to less than 18 years based on interim results of the ongoing phase 23 clinical study considering the current pandemic and widespread of COVID-19 vaccine in India Kosaraju had said in the application The Corbevax vaccine is administered through the intramuscular route with two doses scheduled 28 days apart and is stored at two to eight degrees Celsius temperatures and presented as 05 ml single dose and 5 ml 10 doses vial pack According to the health ministry the company has conducted phase 12 and 23 clinical trials of its COVID-19 vaccine in the country Further it has conducted a phase 3 active comparator clinical trial to evaluate superiority against Covishield vaccine it said PTI PLB ANB ANB

New Delhi Feb 21 PTI The Drugs Controller General of India has granted restricted emergency use authorisation EUA to Biological Es COVID-19 vaccine Corbevax for the 12 to 18 years age group subject to certain conditions official sources said on Monday However the government has not taken a decision yet on vaccinating those aged below 15 years This is the third vaccine to have received EUA from the Drugs Controller General of India DCGI for the age group of 12-18 years after Zydus Cadilas ZyCoV-D and Bharat Biotechs Covaxin At present India is using Covaxin to vaccinate adolescents in the 15 to 18 years age group The health ministry recently had said additional need for vaccination and inclusion of population for vaccination is examined constantly The DCGIs approval comes after the Subject Expert Committee on COVID-19 of the CDSCO on February 14 recommended granting restricted EUA to Corbevax for the 12 to 18 years age group after deliberating on Biological Es application The DCGI had approved Corbevax which is Indias first indigenously developed RBD protein sub-unit vaccine against COVID-19 for restricted use in emergency situations in adults on December 28 It has not been included in the countrys vaccination drive The DCGI on Monday granted restricted EUA to Corbevax for the 12 to less than 18 years age group subject to certain conditions an official source said In an application sent to the DCGI on February 9 Srinivas Kosaraju the head of quality and regulatory affairs at Biological E Limited had said the firm had received approval for conducting phase 23 clinical study of Corbevax among children and adolescents aged 5-18 years in September Based on the no-objection certificate Biological E has initiated the clinical study in October 2021 and has evaluated the available safety and immunogenicity results of the ongoing phase 23 study which indicated that the vaccine is safe and immunogenic The proposed application is for obtaining permission for restricted use in an emergency situation in adolescents aged 12 to less than 18 years based on interim results of the ongoing phase 23 clinical study considering the current pandemic and widespread of COVID-19 vaccine in India Kosaraju had said in the application The Corbevax vaccine is administered through the intramuscular route with two doses scheduled 28 days apart and is stored at two to eight degrees Celsius temperatures and presented as 05 ml single dose and 5 ml 10 doses vial pack According to the health ministry the company has conducted phase 12 and 23 clinical trials of its COVID-19 vaccine in the country Further it has conducted a phase 3 active comparator clinical trial to evaluate superiority against Covishield vaccine it said PTI PLB ANB ANB