News Analysis India

Tag: Covaxin

  • 50 million doses of Covaxin set to expire in early 2023 due to poor demand

    By PTI

    HYDERABAD: Nearly 50 million doses of Bharat Biotech’s COVID-19 vaccine, Covaxin lying with the firm are set to expire early next year as there are no takers owing to poor demand, company sources said.

    Due to lack of product demand, production stoppage of Covaxin- a two dose jab, was initiated by Bharat Biotech earlier this year, though the vaccine maker has established manufacturing to reach an annualised capacity of 1 billion doses at the end of 2021.

    “Bharat Biotech has more than 200 million doses of Covaxin in bulk form and approximately 50 million doses in vials ready to use. Due to lack of product demand, production stoppage of Covaxin was initiated several months ago, earlier this year,” sources told PTI.

    “Covaxin doses in vials are set to expire during early 2023, resulting in losses for the company,” sources further said.

    However, the quantum of loss that the Bharat Biotech would incur in the event of all the 50 million doses expiring next year is not known.

    India reported 1,082 fresh COVID-19 cases on Saturday, while the number of active cases declined to 15,200, according to Union health ministry data.

    ALSO READ | China launches a COVID-19 vaccine inhaled through the mouth

    So far, 219.71 crore doses of COVID-19 vaccines, including Covaxin have been administered under the nationwide vaccination drive. As the infection rate has been sturdily declining globally, exports of Covaxin were negatively impacted with poor off take by foreign countries.

    “COVID-19 is not considered a threat anymore globally,” sources added. In April this year, the World health Organization (WHO) said it confirmed the suspension of supply of Covaxin through UN procurement agencies and recommended that countries using the vaccine take action as appropriate.

    A statement issued by WHO then said the suspension is in response to the outcome of its post EUL (emergency use authorisation) inspection held between March 14- 22, 2022 and the need to conduct process and facility upgrade to address recently identified GMP (good manufacturing practice) deficiencies.

    When the COVID-19 infection was at its peak during 2021, the Brazil government suspended its decision to import 20 million doses of Covaxin following a controversy that attracted investigation by authorities in that country.

    Bharat Biotech on July 23, 2021 said it terminated the MoU it entered into with Precisa Medicamentos and Envixia Pharmaceuticals LL.C for its COVID-19 vaccine Covaxin for Brazilian market.

    In December 2021, Bharat Biotech said, the Central Drugs Standard Control Organisation (CDSCO) has approved the extension of its COVID-19 vaccine Covaxin’s shelf life up to 12 months from the date of manufacture.

    HYDERABAD: Nearly 50 million doses of Bharat Biotech’s COVID-19 vaccine, Covaxin lying with the firm are set to expire early next year as there are no takers owing to poor demand, company sources said.

    Due to lack of product demand, production stoppage of Covaxin- a two dose jab, was initiated by Bharat Biotech earlier this year, though the vaccine maker has established manufacturing to reach an annualised capacity of 1 billion doses at the end of 2021.

    “Bharat Biotech has more than 200 million doses of Covaxin in bulk form and approximately 50 million doses in vials ready to use. Due to lack of product demand, production stoppage of Covaxin was initiated several months ago, earlier this year,” sources told PTI.

    “Covaxin doses in vials are set to expire during early 2023, resulting in losses for the company,” sources further said.

    However, the quantum of loss that the Bharat Biotech would incur in the event of all the 50 million doses expiring next year is not known.

    India reported 1,082 fresh COVID-19 cases on Saturday, while the number of active cases declined to 15,200, according to Union health ministry data.

    ALSO READ | China launches a COVID-19 vaccine inhaled through the mouth

    So far, 219.71 crore doses of COVID-19 vaccines, including Covaxin have been administered under the nationwide vaccination drive. As the infection rate has been sturdily declining globally, exports of Covaxin were negatively impacted with poor off take by foreign countries.

    “COVID-19 is not considered a threat anymore globally,” sources added. In April this year, the World health Organization (WHO) said it confirmed the suspension of supply of Covaxin through UN procurement agencies and recommended that countries using the vaccine take action as appropriate.

    A statement issued by WHO then said the suspension is in response to the outcome of its post EUL (emergency use authorisation) inspection held between March 14- 22, 2022 and the need to conduct process and facility upgrade to address recently identified GMP (good manufacturing practice) deficiencies.

    When the COVID-19 infection was at its peak during 2021, the Brazil government suspended its decision to import 20 million doses of Covaxin following a controversy that attracted investigation by authorities in that country.

    Bharat Biotech on July 23, 2021 said it terminated the MoU it entered into with Precisa Medicamentos and Envixia Pharmaceuticals LL.C for its COVID-19 vaccine Covaxin for Brazilian market.

    In December 2021, Bharat Biotech said, the Central Drugs Standard Control Organisation (CDSCO) has approved the extension of its COVID-19 vaccine Covaxin’s shelf life up to 12 months from the date of manufacture.

  • 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.

  • Covaxin booster safe, necessary as it ensures persistent immunity: ICMR study

    By Express News Service

    NEW DELHI: The Covaxin booster dose is safe and necessary as it ensures persistent immunity that minimises breakthrough Covid infections, said a new Indian Council of Medical Research (ICMR) study.

    Published in the Nature – Scientific Reports Journal, the study said no serious adverse events were observed, except pain at the injection site, itching and redness.

    With the government pushing for precaution doses in the country, as only eight per cent of the population in the over 18 years of age group has taken booster doses, the study said it is well known that neutralising antibodies induced by Covid-19 vaccines wane within six months of vaccination leading to questions on the effectiveness of the two-dose vaccination against breakthrough infections.

    The study said that the administration of the third dose of BBV152 increased neutralisation titers against both homologous (D614G) and heterologous strains (Alpha, Beta, Delta, Delta Plus and Omicron) with a slight increase in B cell memory responses.

    The study said that a booster dose of Covaxin, India’s indigenous Covid-19 vaccine developed by Hyderabad-based Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV), showed an 18.5-fold increase in neutralisation antibody titers against the Omicron variant, as compared with the non-booster does recipient.

    ALSO READ | Covid vaccine protects people of all body weights: Lancet

    “Thus, seroconversion rate remains high in boosted recipients compared to non-booster, even after six months, third post dose against variants,” said Dr Pragya Yadav, one of the authors of the study, ‘persistence of immunity and impact of the third dose of inactivated Covid‐19 vaccine against emerging variants’.

    Seroconversion rates are one of the methods used for determining the efficacy of a vaccine. “Hence, these results indicate that a booster dose of BBV152 is safe and necessary to ensure persistent immunity to minimise breakthrough infections of COVID-19 due to newly emerging variants,” the study added.

    The report said that, in addition, sera collected after six months post a third dose was also evaluated for neutralisation efficiency. Results showed that Covaxin generated higher neutralisation efficiency against D614G, Delta and Omicron variants, and the antibody titers are persistent even after 12 months of primary vaccination.

    Yadav, a top scientist at ICMR-NIV who was also awarded for her work on vaccine development, said that the emergence of SARS-CoV-2 variants of concern had raised questions about the durability of the neutralising antibody responses.

    “Diminished vaccine effectiveness against variants of concern such as Alpha, Beta, Delta and Omicron has been reported for several authorised vaccines with two doses of vaccination,” she said.

    Understanding the persistence of neutralising antibody responses against variants of concern has become vital to assess the need for additional booster doses, said the lead author, Krishna Mohan Vadrevu, director with Bharat Biotech International Limited (BBIL).

    The researchers assessed the persistence of immunogenicity up to six months after two or three doses of Covaxin and the safety of a booster dose in an ongoing phase 2, double-blind, randomised controlled trial.

    For the booster dose trial, around 184 from the parent study were re-enrolled to receive the preventive dose or placebo.

    A decline in antibody levels after the second dose of Covaxin was found.

    However, more than 75 per cent of participants who followed up six months after the amount still had detectable neutralising antibody responses to the homologous SARS-CoV2 strain D614G, the study said

    NEW DELHI: The Covaxin booster dose is safe and necessary as it ensures persistent immunity that minimises breakthrough Covid infections, said a new Indian Council of Medical Research (ICMR) study.

    Published in the Nature – Scientific Reports Journal, the study said no serious adverse events were observed, except pain at the injection site, itching and redness.

    With the government pushing for precaution doses in the country, as only eight per cent of the population in the over 18 years of age group has taken booster doses, the study said it is well known that neutralising antibodies induced by Covid-19 vaccines wane within six months of vaccination leading to questions on the effectiveness of the two-dose vaccination against breakthrough infections.

    The study said that the administration of the third dose of BBV152 increased neutralisation titers against both homologous (D614G) and heterologous strains (Alpha, Beta, Delta, Delta Plus and Omicron) with a slight increase in B cell memory responses.

    The study said that a booster dose of Covaxin, India’s indigenous Covid-19 vaccine developed by Hyderabad-based Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV), showed an 18.5-fold increase in neutralisation antibody titers against the Omicron variant, as compared with the non-booster does recipient.

    ALSO READ | Covid vaccine protects people of all body weights: Lancet

    “Thus, seroconversion rate remains high in boosted recipients compared to non-booster, even after six months, third post dose against variants,” said Dr Pragya Yadav, one of the authors of the study, ‘persistence of immunity and impact of the third dose of inactivated Covid‐19 vaccine against emerging variants’.

    Seroconversion rates are one of the methods used for determining the efficacy of a vaccine. “Hence, these results indicate that a booster dose of BBV152 is safe and necessary to ensure persistent immunity to minimise breakthrough infections of COVID-19 due to newly emerging variants,” the study added.

    The report said that, in addition, sera collected after six months post a third dose was also evaluated for neutralisation efficiency. Results showed that Covaxin generated higher neutralisation efficiency against D614G, Delta and Omicron variants, and the antibody titers are persistent even after 12 months of primary vaccination.

    Yadav, a top scientist at ICMR-NIV who was also awarded for her work on vaccine development, said that the emergence of SARS-CoV-2 variants of concern had raised questions about the durability of the neutralising antibody responses.

    “Diminished vaccine effectiveness against variants of concern such as Alpha, Beta, Delta and Omicron has been reported for several authorised vaccines with two doses of vaccination,” she said.

    Understanding the persistence of neutralising antibody responses against variants of concern has become vital to assess the need for additional booster doses, said the lead author, Krishna Mohan Vadrevu, director with Bharat Biotech International Limited (BBIL).

    The researchers assessed the persistence of immunogenicity up to six months after two or three doses of Covaxin and the safety of a booster dose in an ongoing phase 2, double-blind, randomised controlled trial.

    For the booster dose trial, around 184 from the parent study were re-enrolled to receive the preventive dose or placebo.

    A decline in antibody levels after the second dose of Covaxin was found.

    However, more than 75 per cent of participants who followed up six months after the amount still had detectable neutralising antibody responses to the homologous SARS-CoV2 strain D614G, the study said

  • 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. 

  • DCGI to review Serum Institute’s applications for Covovax use in kids aged 2 to 7 yrs, 7 to 11 yrs 

    By PTI

    NEW DELHI: The subject expert committee on COVID-19 of India’s drug regulator will on Friday review the applications of Serum Institute of India seeking emergency use authorisation to use Covovax among those aged two to seven years and seven to 11 years, official sources said.

    The two applications were submitted by Prakash Kumar Singh, Director, Government and Regulatory Affairs at Serum Institute of India (SII) on March 16 and June 1.

    The expert panel in its last meeting in April had sought more data from SII following its application seeking the emergency use authorization of Covovax for seven to 11 years.

    Drugs Controller General of India (DCGI) had approved Covovax for restricted use in emergency situations in adults on December 28 and in the 12 to 17 years age group subject to certain conditions on March 9.

    India 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 year.

    The 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 conditions.

    India 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 year.

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

    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 administering precaution doses of COVID-19 vaccines to all aged above 18 years at private vaccination centres on April 10.

  • Covaxin booster dose enhances vaccine effectiveness against Delta, Omicron variants, says ICMR study

    By PTI

    NEW DELHI: The administration of Covaxin as a booster dose enhances vaccine effectiveness against COVID-19’s Delta variant and gives protection against Omicron variants BA.

    1.1 and BA.2, a study by ICMR and Bharat Biotech has found. The protective efficacy of Bharat Biotech’s Covaxin following two and three-dose immuniszations against the Delta variant and the efficacy of the Covaxin against Omicron variants were studied in a Syrian hamster model (animal model to study human-associated diseases), it said.

    The antibody response, clinical observations, viral load reduction and lung disease severity after virus challenge were observed, it added.

    The findings of the study have been published on Tuesday on bioRxiv, a pre-print server and have not been peer reviewed.

    “In the Delta infection study, where we compared the protective response between the two and three-dose regimens, we could observe the advantage of the booster dose vaccination in the protection.

    Although the neutralising antibody levels were comparable among the groups, lung disease severity was found more reduced after the three dose vaccination.

    “The virus shedding and viral organ load were considerably reduced in both the two dose and three-dose immunised animals indicating the vaccine efficacy against Delta variant,” the study by Indian Council of Medical Research and Bharat Biotech said.

    In the second study in which the protective response was assessed against Omicron variants i.e. BA.1 and BA.2, following three-dose vaccinations, lesser virus shedding, lung viral load and lung disease severity were observed in the immunised groups in comparison to the placebo groups.

    “The evidence from the present study shows that Covaxin booster immunisation tends to broaden the protective immune response and reduces disease severity against the Delta and Omicron variant infection,” it further said.

  • Bharat Biotech’s Covaxin gets emergency approval for 6-12 age group

    By PTI

    NEW DELHI: 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 II/III study in children 2-18 years of age, Bharat Biotech said in a statement.

    The company said it conducted clinical trials in the 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 a 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 a 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 the production of Covaxin across its manufacturing units, for facility optimisation as it has already completed its supply obligations to procurement agencies and foresees a decrease in demand.

    The World Health Organization (WHO) had also confirmed the suspension of the supply of Covaxin through UN procurement agencies and recommended countries that received the vaccine take action as appropriate.

    WHO had said the suspension was in response to the outcome of the WHO post-Emergency Use Listing (EUL) inspection and the need to conduct process and facility upgrades 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.

  • DCGI grants EUA to Corbevax for those aged 5-12, Covaxin for 6-12 age group

    By PTI

    NEW DELHI: India’s drug regulator has granted emergency use authorisation for Biological E’s COVID-19 vaccine Corbevax for those aged five to 12 years and Bharat Biotech’s Covaxin for children in the age group of six to 12 years, official sources said on Tuesday.

    The 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 Organisation(CDSCO).

    The 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 and six to 12 years age group, respectively.

    Biological E’s 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, 2021. India 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 year.

    The 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 conditions. India 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 year. The next phase of vaccination commenced on January 3 for adolescents in the age group of 15-18 years.

    India 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.

  • Covaxin’s phase 2/3 clinical trials put on hold in the US

    Express News Service

    NEW DELHI: The US Food and Drug Administration (FDA) has put on hold the phase 2/3 clinical trials of Bharat Biotech’s Covid-19 vaccine Covaxin in the US.

    According to the statement issued by Ocugen Inc, Bharat Biotech’s partner for US and Canada for Covaxin, the biotechnology company was informed by the US FDA that the agency placed its phase 2/3 immuno-bridging and broadening study for Covaxin (BBV152), OCU-002, on clinical hold.

    “This is a result of the company’s decision to voluntarily implement a temporary pause in dosing participants of OCU-002 while it evaluates statements made by the WHO following their inspection of Bharat Biotech International Limited’s (BBIL) manufacturing facility,” Ocugen said in the statement issued on April 12. OCU-002 is Ocugen’s Phase 3 immuno-bridging study of Covaxin.

    On April 2, the WHO had said it suspended the supply through United Nations agencies of Covid-19 vaccine Covaxin by India’s Bharat Biotech after its inspectors identified good manufacturing practice deficiencies in the pharma company’s pharma plants.

    The WHO also asked countries that have received India’s indigenous Covid-19 vaccine to take appropriate actions; however, it did not specify the proper actions. We will work with the FDA to address any questions.

    After the WHO inspection, the Hyderabad-based company said it is temporarily slowing down the production of Covaxin, which is used in India’s Covid vaccination programme, across its manufacturing units for facility optimisation as it has already completed its supply obligations to procurement agencies and foresees a decrease in demand.

    The company also said after the recent WHO post-Emergency Use Listing (EUL) inspection, it is working on further improvements and upgrades to ensure that the production of Covaxin continues to meet ever-increasing global regulatory requirements.

    The WHO had, however, said the vaccine is effective, and no safety concerns exist, but the suspension of production for export will result in the interruption of the Covaxin supply.

    The central government has clarified that the suspension will not impact travel by people who have taken the vaccine, as it still continues to be recognised under the EUL.

  • US FDA puts Covaxin’s second phase trials in US on hold after fallout on WHO’s observations

    By PTI

    HYDERABAD: The US Food and Drug Administration has put on hold the phase 2/3 clinical trials of Bharat Biotech’s COVID-19 vaccine Covaxin, in USA.

    According to a press release by Ocugen Inc , Bharat Biotech’s partner for US and Canada for Covaxin, the FDA’s decision was based on the US firm’s decision to voluntarily implement a temporary pause in dosing participants of the jab, following the World Health Organisation’s observations on Covaxin manufacturing plants in India.

    “This is a result of the company’s decision to voluntarily implement a temporary pause in dosing participants of OCU-002 while it evaluates statements made by the World Health Organization following their inspection of Bharat Biotech International Limited’s (BBIL) manufacturing facility,” Ocugen said on April 12.

    WHO had earlier suspended the supply of Covaxin through US procurement agencies, after its inspectors identified GMP (good manufacturing practice) deficiencies in the Bharat Biotech’s manufacturing plants.

    Sources had said the city-based firm however, said it had not supplied the Covid vaccine to any UN agency and no impact of the suspension would be felt. OCU-002 is Ocugen’s Phase 3 immuno-bridging study of Covaxin.

    The company said it will work with the FDA to address any questions. The FDA, in February, lifted its clinical hold on Ocugen’s Investigational New Drug application (IND) to evaluate the Covaxin.

    After WHO inspection, Bharat Biotech had said it is 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 foresees decrease in demand.

    The company further said after the recent WHO post Emergency Use Listing (EUL) inspection, it is working on further improvements and upgrades to ensure that the production of Covaxin continues to meet ever increasing global regulatory requirements.