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Tag: Covishield

  • Serum Institute of India restarts manufacturing of COVID-19 vaccine Covishield

    By PTI

    NEW DELHI: Serum Institute of India (SII) CEO Adar Poonawalla on Wednesday said it has restarted manufacturing of the Covid-19 vaccine Covishield amid rising numbers of cases of the virus infection.

    He said the company already has six million booster doses of the Covovax vaccine available and adults must take the booster shot.

    Reacting to reports of Covid-19 vaccine shortage, he said manufacturers are ready but there has been no demand.

    “Just as a precaution, at risk, we have done it so that people have a Covishield as a choice if they want it,” Poonawalla told PTI on restarting of manufacturing of the vaccine. The company stopped manufacturing Covishield in December 2021.

    On Covovax which has been approved as a booster dose for 18 years and above, he said, “We have six million doses ready but the demand is exactly zero. ” Covovax booster is now on the CoWin app, he said.

    NEW DELHI: Serum Institute of India (SII) CEO Adar Poonawalla on Wednesday said it has restarted manufacturing of the Covid-19 vaccine Covishield amid rising numbers of cases of the virus infection.

    He said the company already has six million booster doses of the Covovax vaccine available and adults must take the booster shot.

    Reacting to reports of Covid-19 vaccine shortage, he said manufacturers are ready but there has been no demand.googletag.cmd.push(function() {googletag.display(‘div-gpt-ad-8052921-2’); });

    “Just as a precaution, at risk, we have done it so that people have a Covishield as a choice if they want it,” Poonawalla told PTI on restarting of manufacturing of the vaccine. The company stopped manufacturing Covishield in December 2021.

    On Covovax which has been approved as a booster dose for 18 years and above, he said, “We have six million doses ready but the demand is exactly zero. ” Covovax booster is now on the CoWin app, he said.

  • Government nod for Corbevax as booster for adults vaccinated with Covishield, Covaxin soon

    By PTI

    NEW DELHI: The Union health ministry is expected to soon approve Biological E’s Corbevax as a precaution dose for people above 18 years who are double vaccinated with either Covishield or Covaxin, official sources said on Tuesday.

    The approval will be based on the recommendations made by the COVID-19 Working Group of the National Technical Advisory Group on Immunisation (NTAGI) last week, the sources told PTI.

    If approved by the government, this would be the first time a booster dose of a Covid vaccine different from the one used for primary vaccination would be allowed in the country.

    “Corbevax will be considered as a precaution dose after completion of 6 months or 26 weeks from the date of administration of the second dose of either Covaxin or Covishield vaccines for those aged above 18 years enabling use of Corbevax as a heterologous COVID-19 vaccine for precaution dose administration in this age group,” a source said.

    This will be in addition to the existing guidelines for homologous precaution dose administration of Covaxin and Covishield vaccines.

    India’s first indigenously developed RBD protein subunit vaccine Corbevax is currently being used to inoculate children in the age group of 12 to 14 years under the COVID-19 immunisation programme.

    The COVID-19 Working Group (CWG), in its July 20 meeting, reviewed data of the double-blind randomized phase-3 clinical study which evaluated the immunogenicity and safety of booster dose of Corbevax vaccine when administered to COVID-19-negative adult volunteers of age 18-80 years previously vaccinated with two doses of either Covishield or Covaxin.

    “Following the examination of the data, the CWG observed that Corbevax vaccine can induce significant increase in antibody titers when given to those who have received either Covaxin or Covishield, which is likely to be protective as per the neutralization data also,” the source said.

    The Drugs Controller General of India (DCGI) on June 4 approved Corbevax as a precaution dose for those aged 18 and above.

    India began administering precaution doses of vaccines to healthcare and frontline workers and those aged 60 and above with comorbidities from January 10.

    The country began inoculating children aged 12-14 from March 16 and also removed the comorbidity clause making all people aged above 60 eligible for the precaution dose of Covid vaccine.

    India on April 10 began administering precaution doses of COVID-19 vaccines to all aged above 18 years.

    NEW DELHI: The Union health ministry is expected to soon approve Biological E’s Corbevax as a precaution dose for people above 18 years who are double vaccinated with either Covishield or Covaxin, official sources said on Tuesday.

    The approval will be based on the recommendations made by the COVID-19 Working Group of the National Technical Advisory Group on Immunisation (NTAGI) last week, the sources told PTI.

    If approved by the government, this would be the first time a booster dose of a Covid vaccine different from the one used for primary vaccination would be allowed in the country.

    “Corbevax will be considered as a precaution dose after completion of 6 months or 26 weeks from the date of administration of the second dose of either Covaxin or Covishield vaccines for those aged above 18 years enabling use of Corbevax as a heterologous COVID-19 vaccine for precaution dose administration in this age group,” a source said.

    This will be in addition to the existing guidelines for homologous precaution dose administration of Covaxin and Covishield vaccines.

    India’s first indigenously developed RBD protein subunit vaccine Corbevax is currently being used to inoculate children in the age group of 12 to 14 years under the COVID-19 immunisation programme.

    The COVID-19 Working Group (CWG), in its July 20 meeting, reviewed data of the double-blind randomized phase-3 clinical study which evaluated the immunogenicity and safety of booster dose of Corbevax vaccine when administered to COVID-19-negative adult volunteers of age 18-80 years previously vaccinated with two doses of either Covishield or Covaxin.

    “Following the examination of the data, the CWG observed that Corbevax vaccine can induce significant increase in antibody titers when given to those who have received either Covaxin or Covishield, which is likely to be protective as per the neutralization data also,” the source said.

    The Drugs Controller General of India (DCGI) on June 4 approved Corbevax as a precaution dose for those aged 18 and above.

    India began administering precaution doses of vaccines to healthcare and frontline workers and those aged 60 and above with comorbidities from January 10.

    The country began inoculating children aged 12-14 from March 16 and also removed the comorbidity clause making all people aged above 60 eligible for the precaution dose of Covid vaccine.

    India on April 10 began administering precaution doses of COVID-19 vaccines to all aged above 18 years.

  • Amid rising COVID cases, Health Ministry seeks five crore free Covishield doses from GAVI under COVAX

    By PTI

    NEW DELHI: The Union health ministry has asked global vaccine alliance GAVI to supply 5 crore of the allocated 10 crore doses of Covishield to India under the COVAX facility free of cost, official sources said on Friday.

    Amid rising cases of coronavirus in the country, the government from Friday started providing precaution doses free of cost to those aged 18 years and above for the next 75 days under the ‘COVID vaccination Amrit Mahostava’.

    According to an official source, Prakash Kumar Singh, director (government and regulatory affairs) at Serum Institute of India, had written a letter to the health ministry in April for use of 10 crore doses of Covishield offered free of cost by GAVI.

    “As Covid cases are rising again in our country, using this immediately available 100 million (10 crore) free of cost Covishield vaccine doses by GAVI for our citizens at the earliest would be beneficial in controlling the upsurge of COVID-19.

    This will play a crucial role in taking forward the world’s largest vaccination drive under visionary leadership of our Prime Minister Narendra Modi Ji towards its successful completion,” Singh is learnt to have mentioned in his letter to ministry in April.

    Pune-based SII had stated that if these 10 crore free doses of Covishield are not taken by the Indian government timely, it will lead to wastage of the life saving vaccines amid the pandemic outbreak.

    According to sources, after utilisation of 5 crore doses of Covishield, the requirement will be reviewed and if needed, GAVI will be asked to supply the remaining 5 crore doses.

    Gavi, the vaccine alliance, is a public-private partnership that helps vaccinate half the world’s children against some of the world’s deadliest diseases.

    It is coordinating the COVAX Facility, which provides governments with the opportunity to benefit from a large portfolio of COVID-19 candidate vaccines using a range of technology platforms, produced by more manufacturers across the world, with a bigger market to provide security of demand.

    So far 75 higher-income economies have formally committed to join the facility, in addition to the 92 low- and middle-income economies that are eligible for support from the Gavi COVAX AMC.

    NEW DELHI: The Union health ministry has asked global vaccine alliance GAVI to supply 5 crore of the allocated 10 crore doses of Covishield to India under the COVAX facility free of cost, official sources said on Friday.

    Amid rising cases of coronavirus in the country, the government from Friday started providing precaution doses free of cost to those aged 18 years and above for the next 75 days under the ‘COVID vaccination Amrit Mahostava’.

    According to an official source, Prakash Kumar Singh, director (government and regulatory affairs) at Serum Institute of India, had written a letter to the health ministry in April for use of 10 crore doses of Covishield offered free of cost by GAVI.

    “As Covid cases are rising again in our country, using this immediately available 100 million (10 crore) free of cost Covishield vaccine doses by GAVI for our citizens at the earliest would be beneficial in controlling the upsurge of COVID-19.

    This will play a crucial role in taking forward the world’s largest vaccination drive under visionary leadership of our Prime Minister Narendra Modi Ji towards its successful completion,” Singh is learnt to have mentioned in his letter to ministry in April.

    Pune-based SII had stated that if these 10 crore free doses of Covishield are not taken by the Indian government timely, it will lead to wastage of the life saving vaccines amid the pandemic outbreak.

    According to sources, after utilisation of 5 crore doses of Covishield, the requirement will be reviewed and if needed, GAVI will be asked to supply the remaining 5 crore doses.

    Gavi, the vaccine alliance, is a public-private partnership that helps vaccinate half the world’s children against some of the world’s deadliest diseases.

    It is coordinating the COVAX Facility, which provides governments with the opportunity to benefit from a large portfolio of COVID-19 candidate vaccines using a range of technology platforms, produced by more manufacturers across the world, with a bigger market to provide security of demand.

    So far 75 higher-income economies have formally committed to join the facility, in addition to the 92 low- and middle-income economies that are eligible for support from the Gavi COVAX AMC.

  • Immunisation body likely to consider Corbevax as booster for those jabbed with Covishield, Covaxin 

    By PTI

    NEW DELHI: Allowing Biological E’s Corbevax as a booster for those fully vaccinated against COVID-19 with either Covishield or Covaxin is likely to be considered by the NTAGI, which is scheduled to meet on Tuesday, sources said.

    The Drugs Controller General of India (DCGI) on June 4 approved Corbevax as a precaution dose for those aged 18 and above.

    India’s first indigenously-developed RBD protein subunit vaccine, Corbevax, is currently being used to inoculate children in the age group of 12 to 14 years.

    “The National Technical Advisory Group on Immunisation (NTAGI) will discuss allowing Corbevax, which has been cleared by the DCGI, as a booster for those fully vaccinated with Covishield or Covaxin,” a source told PTI.

    The government advisory panel is also expected to review the trial data of the country’s first quadrivalent human papillomavirus (qHPV) vaccine against cervical cancer, developed by the Serum Institute of India.

    A separate HPV working group of the NTAGI had, on June 8, examined the vaccine’s clinical trial data and usefulness for inclusion in the national immunisation programme, sources had said.

    The recommendation of the Standing Technical Sub-Committee (STSC) of the NTAGI on reducing the gap between the second dose and the precaution dose of Covid vaccines from nine to six months may also also be ratified at the meeting to be chaired by the Union health secretary. 

  • Breakthrough infection with Delta, reinfection with Omicron in individual vaccinated with Covishield

    By IANS

    NEW DELHI: The Indian Council of Medical Research-National Institute of Virology (ICMR-NIV), Pune, has reported a case of three-time Covid infection in an individual who was vaccinated with the Covishield jab against the virus.

    The healthcare professional from Delhi had primary SARS-CoV2 infection, breakthrough infection with Delta and reinfection with Omicron over a period of around 16 months, researchers of Pune NIV said in a study.

    The findings of the study prove the immune evasion potential of the Omicron variant, even after infection and vaccination, said the researchers.

    The researchers in the report have said that the 38-year-old had tested positive with primary Covid infection during the first wave of the pandemic with symptoms like body ache, fever and a dry cough on October 9, 2020.

    ALSO READ: Serum Institute to give free Covishield vials to private vaccination centres to compensate for price difference

    However, there were no complaints of breathlessness, and post recovery, he experienced symptoms of long Covid, including generalised weakness for two to three weeks and insomnia for two to three months.

    The healthcare professional experienced body ache and headache again in November 2021. Subsequently, he tested positive for SARS-COV-2 and the body ache persisted for two to three days.

    However, during the third wave of the pandemic, the individual again developed a headache on January 24, 2022, after being asymptomatic for a period of two months.

    The researchers in the report said that the case represented a breakthrough infection post primary SARS-CoV-2 infection and two doses of Covishield vaccination.

    ALSO READ: Covishield & Covaxin prices cut, hospitals to pay Rs 225 per dose

    The patient received the first dose of Covishield vaccine on January 31, 2021, and the second dose on March 3.

    While vaccination reportedly reduces severity of disease and mortality in Covid-19, it cannot protect individuals from getting a breakthrough infection, said the researchers.

    The NIV scientists concluded the report saying that the fight against Covid-19 is far from over. Although vaccine boosters or third doses have shown an augmentation in the immune response against the Omicron variant, it has been found to wane over time.

    In such a situation, non-pharmacological interventions in the form of mask, hand hygiene and infection control remain the most reliable weapons to curb the direct transmission of SARS-CoV-2, researchers said in the report. The report was published in the Journal of Infection.

  • Serum Institute, Bharat Biotech cut COVID vaccine prices for private hospitals to Rs 225

    By PTI

    NEW DELHI: Vaccine majors Serum Institute of India (SII) and Bharat Biotech on Saturday said they have decided to cut prices of the precaution dose of their respective COVID-19 vaccines to Rs 225 per shot for private hospitals after discussions with the government.

    “We are pleased to announce that after discussion with the central government, SII has decided to revise the price of COVISHIELD vaccine for private hospitals from Rs 600 to Rs 225 per dose,” SII CEO Adar Poonawalla said in a tweet.

    On Friday, the company had said that the precaution dose of its Covishield vaccine against COVID-19 will be priced at Rs 600 per shot for eligible individuals.

    Bharat Biotech Co-Founder Joint Managing Director Suchitra Ella in a tweet said: “We welcome the decision to make available precautionary dose for all adults. In consultation with the Central Government, we have decided to revise the price of #COVAXIN from Rs 1,200 to Rs 225 per dose, for #privatehospitals.”

    SII and Bharat Biotech have been major suppliers of COVID-19 vaccines to the government so far.

    The Union Health Ministry on Friday announced that those above the age of 18 years who have completed nine months after the administration of the second dose will be eligible for the precaution dose.

    According to the health ministry, so far, about 96 per cent of all those above the age of 15 years in India have received at least one vaccine dose, while about 83 per cent have received both doses.

    More than 2.4 crore precaution doses have also been administered to healthcare workers, frontline workers and those aged above 60 years.

    Besides, 45 per cent of beneficiaries in the 12-14 years age group have received the first dose, the ministry said.

    The ongoing free COVID-19 inoculation programme through government vaccination centres for the first and the second dose to the eligible population as well as the precaution dose to healthcare workers, frontline workers and those above 60 years will be accelerated, the ministry stated.

  • Second Covishield dose can be given between 8-16 weeks after first: NTAGI

    The NTAGI has not yet suggested any change in the schedule of Bharat Biotech's Covaxin, whose second dose is administered 28 days after the first dose.

  • SII urges Mandaviya to reduce gap between 2nd, precaution dose of Covishield from 9 to 3 months

    By PTI

    NEW DELHI: Serum Institute has urged Union Health Minister Mansukh Mandaviya to consider reducing the gap between the second and the precaution dose of Covishield from current nine months to three, in line with Centre’s revised guidelines for officials on election duty, official sources said on Thursday.

    The Pune-based firm also requested the minister to allow it to administer Covishield’s precaution dose for all individuals aged above 18 years.

    In a letter to Mandaviya, Prakash Kumar Singh, director, Government and Regulatory Affairs at SII, is learnt to stated that the third dose of COVID-19 vaccine is being administered within 6 months of the second dose in various countries and this schedule is giving very good results to control the infection, an official source said.

    Singh also mentioned that private companies, educational institutions, social organisations, central government organisations as well as public undertaking companies etc are continuously requesting the firm for the third dose of Covishield for their staff members and families.

    He referred to Union Health Ministry’s letter dated January 21 according to which the precaution dose can be administered 3 months after the second dose of the vaccine was given to officials and staff deployed on election duty in the poll-bound states of Goa, Manipur, Punjab, Uttarakhand and Uttar Pradesh.

    For this, necessary changes have been made on the CoWIN portal to facilitate early administration of the precaution dose.

    Till January 28, more than one crore people were administered the third dose of the COVID-19 vaccine out of which more than 90 lakh doses were of Covishield.

    “In view of the above facts, we request for your kind intervention and consideration on our following submissions: The administration of third dose of our Covishield vaccine should be allowed for all individuals above the age of 18 years.”

    “The gap between second and third dose to be reduced and the administration of third dose of Covishield vaccine to be allowed after the completion of 3 months in line with revised guidelines of GoI for the officials and staff deployed on election duty,” the official source quoted Singh as having said in the letter.

    “Sir, it is need of the hour and in the interest of public at large. This will help to control unpredictable and fast spread of various strains of COVID-19 which is disrupting economy and social stability of our country,” Singh said in the letter.

  • Government expert panel recommends regular market approval for Covishield, Covaxin

    By PTI

    NEW DELHI: An expert panel of India’s central drug authority on Wednesday recommended granting regular market approval to Covid vaccines Covishield and Covaxin, which are currently only authorised for emergency use in the country, subject to certain conditions, official sources said.

    Pharma companies Serum Institute of India (SII) and Bharat Biotech had submitted applications to the Drugs Controller General of India (DCGI) seeking regular market authorisation for their respective COVID-19 vaccines Covishield and Covaxin.

    Prakash Kumar Singh, director (government and regulatory affairs) at SII, had submitted an application to the DCGI on October 25 on this matter.

    On that DCGI had sought more data and documents from the Pune-based company following which Singh recently had submitted a response along with more data and information.

    In addition to the successful completion of phase 2/3 clinical study in India, till now, more than 100 crore doses of Covishield vaccine have been administered to the people in this country and worldwide, Singh is learnt to have stated in the response.

    “Such a large-scale vaccination with Covishield and containment of COVID-19 infection is in itself a testimony of the safety and efficacy of the vaccine,” he had said.

    In an application sent to the DCGI a couple of weeks ago, V Krishna Mohan, whole-time director at the Hyderabad-based company, submitted complete information regarding chemistry, manufacturing and controls, along with the pre-clinical and clinical data while seeking regular market authorisation for Covaxin.

    Bharat Biotech International Limited (BBIL) took up the challenge to develop, produce and clinically evaluate a vaccine (Covaxin), from the SARS-CoV-2 strains isolated from COVID-19 patients in India, Mohan had said in the application.

    Covaxin and Covishield were granted Emergency Use Authorisation (EUA) on January 3.

    “The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) which reviewed SII and Bharat Biotech’s application for the second time on Wednesday has recommended granting regular market approval to Covishield and Covaxin subject to certain conditions,” an official source said.

    During last week’s meeting the SEC had sought more data and information from the two companies.

    Meanwhile, the cumulative COVID-19 vaccine doses administered in the country crossed 159.54 crore on Wednesday, the Ministry of Health and Family Welfare stated.

    More than 62 lakh (62,39,005) vaccine doses were administered in the day till 7 pm.

    Over 61 lakh precaution doses have been administered to frontline workers, healthcare workers, and citizens aged 60 and above, the ministry stated.

    A total of 3,82,93,986 doses have been given to adolescents in the age group of 15 to 18 years, according to the health ministry’s interim data.

    The government rolled out the countrywide vaccination drive on January 16 last year with healthcare workers getting jabbed in the first phase.

    From February 2, this was extended to frontline workers.

    The next phase of COVID-19 vaccination commenced from March 1, 2021, for people above 60 years, and those aged 45 and above but with specified co-morbid conditions.

    All citizens aged 45 and above were eligible for the jab from April 1.

    The government then decided to expand its vaccination drive by allowing all citizens above 18 years to get vaccinated from May 1.

    The next phase of COVID-19 vaccination commenced from January 3 this year for adolescents in the age group of 15-18 years.

    India began administering the precaution dose to healthcare workers, frontline workers, including personnel deployed for election duty, and those aged 60 years and above with co-morbidities from January 10 even as the country began witnessing a spike in infections fuelled by the Omicron variant of the virus.

  • Maharashtra: Centre denies Rajesh Tope’s vaccine shortage claim

    By Online Desk

    CHENNAI: The Centre on Friday described as “ill-informed and “incorrect” some media reports alleging vaccine shortage in Maharashtra, further stating that due to lack of vaccine the State Government is unable to increase the pace of vaccination in the state. 

    State health minister Rajesh Tope on Thursday said that Maharashtra is facing shortage of both Covaxin and Covishield vaccines.

    He told reporters that since vaccination drive for teenagers and precaution doses are being given to senior citizens, frontline and health workers, there is a shortage of vaccine. Tope said that the state has demanded an additional 50 lakh Covishield and 40 lakh Covaxin doses from the Centre.

    Meanwhile, a press statement issued by the Ministry of Health and Family Welfare chose to clarify that, as per the reports available today (January 14, 2022), Maharashtra has over 24 lakh unutilized doses of Covaxin available with it. An additional 6.35 lakh doses have been received today. As per their weekly consumption data available on Co-WIN, the average consumption by Maharashtra for Covaxin to cover the eligible beneficiaries for 15-17 years and for precaution dose is almost 2.94 lakh doses per day. Therefore, the State has adequate vaccine doses for about 10 days to cover the eligible beneficiaries with Covaxin.

    Furthermore, for Covishield, the state has 1.24 crore unutilized and balance doses available as on date. With an average consumption of 3.57 lakhs per day, this will sustain for more than 30 days for the beneficiaries to be vaccinated using the vaccine.

    “Hence, the media reports are not factually correct and do not reflect the correct picture of the available stock of balance and unutilized COVID vaccine doses with Maharashtra,” the Centre claimed.