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Tag: Covovax

  • 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.

  • COVID-19: Covovax to get approval as booster in 10-15 days, says SII CEO Adar Poonawalla 

    By PTI

    PUNE: Serum Institute of India chief executive officer Adar Poonawalla on Sunday said its Covovax vaccine will get approval as a booster in the next 10 to 15 days, adding it works very well against the Omicron variant of coronavirus.

    Speaking to reporters on the sidelines of an event at Bharti Vidyapeeth University here, Poonawalla, when asked about states and districts not getting Covishield vaccines, said there are ample stocks with the Union government for supply.

    “Covovax will be approved as a booster in the next 10-15 days. It is actually the best booster because it works very well against Omicron, more than Covishield,” said Poonawalla.

    He said everyone was looking at India, not just in terms of healthcare but because the country managed to take care of a huge and diverse population and also helped 70 to 80 nations during the COVID-19 pandemic.

    “This was all possible because of the leadership of our Central government, our state governments, healthcare workers, manufacturers, all of whom worked together with one common goal,” he said.

    On the occasion, Poonawalla was conferred with the first Dr Pantangrao Kadam Memorial Award at the hands of NCP Chief Sharad Pawar and Deputy Chief Minister Devendra Fadnavis in an event to mark the birth anniversary of the late minister and education baron from western Maharashtra.

    Appealing to students who wished to pursue education abroad, he said there was no place like India to fulfil dreams due to the presence of institutions like Bharti Vidyapeeth and others.

    “Even if you have to go abroad, come back as soon as possible,” he said.

    PUNE: Serum Institute of India chief executive officer Adar Poonawalla on Sunday said its Covovax vaccine will get approval as a booster in the next 10 to 15 days, adding it works very well against the Omicron variant of coronavirus.

    Speaking to reporters on the sidelines of an event at Bharti Vidyapeeth University here, Poonawalla, when asked about states and districts not getting Covishield vaccines, said there are ample stocks with the Union government for supply.

    “Covovax will be approved as a booster in the next 10-15 days. It is actually the best booster because it works very well against Omicron, more than Covishield,” said Poonawalla.

    He said everyone was looking at India, not just in terms of healthcare but because the country managed to take care of a huge and diverse population and also helped 70 to 80 nations during the COVID-19 pandemic.

    “This was all possible because of the leadership of our Central government, our state governments, healthcare workers, manufacturers, all of whom worked together with one common goal,” he said.

    On the occasion, Poonawalla was conferred with the first Dr Pantangrao Kadam Memorial Award at the hands of NCP Chief Sharad Pawar and Deputy Chief Minister Devendra Fadnavis in an event to mark the birth anniversary of the late minister and education baron from western Maharashtra.

    Appealing to students who wished to pursue education abroad, he said there was no place like India to fulfil dreams due to the presence of institutions like Bharti Vidyapeeth and others.

    “Even if you have to go abroad, come back as soon as possible,” he said.

  • Govt panel recommends inclusion of Covovax in national Covid vaccination drive for those aged 12 and above

    By PTI

    NEW DELHI: The COVID-19 Working Group of the NTAGI has recommended inclusion of the Serum Institute’s Covovax in the national vaccination programme for those aged 12 years and above, official sources said on Sunday.

    India’s drug regulator had approved Covovax for restricted use in emergency situations in adults on December 28 and in the 12-17 age group, subject to certain conditions, on March 9.

    The COVID-19 Working Group has now recommended to the Standing Technical Sub-Committee of the National Technical Advisory Group on Immunisation (NTAGI) that Covovax be included in the national vaccination programme for those aged 12 years and above, sources said.

    Serum Institute of India (SII) Director for Government and Regulatory Affairs Prakash Kumar Singh had written to the Union Health Ministry recently, requesting for Covovax’s inclusion in the immunisation drive.

    “A meeting of the COVID-19 Working Group of the NTAGI took place on April 1 during which data of Covovax was reviewed, after which it recommended that the vaccine can be included in the national COVID-19 vaccination programme for inoculating those aged 12 years and above,” one of the sources said.

    Singh had stated that the Pune-based firm wanted to provide Covovax to private hospitals at Rs 900 per dose plus GST and was waiting for directions to supply it to the Centre.

    However, the price of the vaccine for the government was not mentioned. India began inoculating children aged 12-14 from March 16. Biological E’s Corbevax is being used to inoculate them.

    In a letter to Union Health Secretary Rajesh Bhushan, Singh was learnt to have said that private companies, educational institutes, social organisations, central government organisations and public sector undertakings were making requests for Covovax to inoculate their staffers, families and children.

    “Under the visionary leadership of our CEO Adar C Poonawalla, we have developed, manufactured and obtained emergency use authorisation from our national regulatory authority for one more world-class COVID-19 vaccine, Covovax, for 18 years and above on December 28, and for children in the age group of 12 to 17 years on March 9, 2022,” an official source quoted Singh as having written in the letter.

  • DCGI’s EUA nod to SII’s Covovax for 12-17 years age group

    By PTI

    NEW DELHI: India’s drug regulator has granted restricted emergency use authorisation to Serum Institute’s COVID-19 vaccine Covovax for the 12-17 years age group subject to certain conditions.

    Confirming the DCGI approval, Serum Institute of India CEO Adar Poonawalla on Tuesday tweeted:”@SerumInstIndia’s brand Covovax has completed bridging studies in India and has been granted Emergency Use Authorisation by DCGI for adults and for children above the age of 12. Younger age groups will follow shortly.”

    It is the fourth vaccine to receive the regulator’s nod for use among those below 18 years.

    However, only one vaccine –Bharat Biotech’s Covaxin– is used for the 15-18 years age group in the vaccination drive in the country after the government approval.

    The Drugs Controller General Of India’s (DCGI) approval comes after the Subject Expert Committee on COVID-19 of the CDSCO last week recommended granting emergency use authorisation (EUA) to Covovax for those aged 12 to 17.

    The government has still not taken a decision on vaccinating those aged below 15 years and the health ministry has consistently said that additional need for vaccination and inclusion of population for vaccination are examined constantly.

    In the EUA application to DCGI on February 21, Prakash Kumar Singh, director (government and regulatory affairs) at SII had stated that the data from two studies on about 2707 children aged 12 to 17 years show that Covovax is highly efficacious, immunogenic, safe and well-tolerated in this age group of children.

    Singh in his application had said,”this approval will not only be beneficial for our country alone, but will benefit the entire world, fulfilling our prime minister’s vision of ‘making in India for the world’.

    “In line with the philosophy of our CEO, Dr Adar C Poonawalla, we are sure that Covovax will play an important role to protect the children of our country and the world at large against COVID-19 disease and will keep our national flag flying high globally”, according to an official source.

    The DCGI has already approved Covovax for restricted use in emergency situations in adults on December 28. It has not yet been included in the country’s vaccination drive.

    The DCGI on February 21 granted restricted EUA to Biological E’s COVID-19 vaccine Corbevax for the 12-18 years age group subject to certain conditions.

    Covovax is manufactured by technology transfer from Novavax and is approved by the European Medicines Agency for conditional marketing authorisation and also granted emergency use listing by WHO on December 2017, 2020.

    ZyCov-D is the first vaccine cleared by India’s drug regulator for inoculation of those aged 12 years and above in August last year.

    Indigenously developed Covaxin received approval for emergency use in 12 to 18 in December last year.

  • Government panel recommends EUA for vaccines Covovax, Corbevax and anti-Covid pill molnupiravir

    By PTI

    NEW DELHI: An expert panel of the country’s central drug authority has recommended granting emergency use authorisation to Serum Institute of India’s COVID-19 vaccine Covovax and Biological E’s vaccine Corbevax with certain conditions, official sources said on Monday.

    The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) on Monday also recommended granting permission to manufacture and market anti-Covid pill Molnupiravir for restricted emergency use for treatment of adult patients with SpO2 93 per cent and who have high risk of progression of the disease, including hospitalisation or death, subject to certain conditions.

    All the recommendations have been sent to the Drugs Controller General of India (DCGI) for final approval.

    The SEC on COVID-19 of the CDSCO, which reviewed the emergency use authorisation (EUA) applications of Serum Institute of India (SII) for the second time on Monday, after detailed deliberation has recommended granting EUA to Covovax.

    “The committee noted that the vaccine is manufactured by technology transfer from Novavax and is approved by the European Medicines Agency for conditional marketing authorisation and also granted emergency use listing by WHO,” an official source said.

    Prakash Kumar Singh, director, government and regulatory affairs at SII, had submitted an application to the DCGI in October for grant of market authorisation for Covovax for restricted use in emergency situations.

    The DCGI office had granted SII permission to manufacture and stock Covovax on May 17.

    Based on DCGI approval, till now, the Pune-based firm has manufactured and stockpiled the vaccine doses.

    In August 2020, US-based vaccine maker Novavax Inc had announced a licence agreement with SII for the development and commercialisation of NVX-CoV2373, its COVID-19 vaccine candidate, in low and middle-income countries and India.

    The World Health Organisation (WHO) had on December 17 issued emergency use listing for Covovax, expanding the basket of jabs validated by the global health body against the viral disease.

    As for Biological E’s Corbevax, in light of the recommendations of the SEC meeting held on December 10, the firm submitted proposal for grant of marketing authorisation to the vaccine for restricted emergency use in adults along with the updated interim safety and immunogenicity data of phase 2/3 clinical trial and updated interim safety and immunogenicity data of phase 3 active comparator trial.

    The committee noted that the firm has submitted six months safety follow up post second dose from phase-1 clinical trial, 90 days safety from the phase -2 part and 60 days safety data from phase 2/3 and phase 3 active comparator study.

    The firm has submitted interim immunogenicity data from phase-3 active comparator trial which showed superiority against the comparator with respect to viral neutralization antibody titres, the official source said.

    “After detailed deliberation, the committee recommended for grant of marketing authorisation permission of SARS-CoV-2 (Covid-19) Vaccine containing RBD antigen of SARS-CoV-2 for restricted use in emergency situation subject to various regulatory provisions,” the source said.

    The vaccine should be administered intramuscularly in two doses of 0.

    5 ml each with interval of 28 days (Day 0 and 28) and has to be stored between 2 degrees Celsius to 8 degrees celsius,the source added.

    The SEC on Monday also recommended granting permission to manufacture and market anti- Covid pill Molnupiravir for restricted emergency use for treatment of adult COVID-19 patients with SpO2 93 per cent and who have high risk of progression of the disease, subject to certain conditions.

    Dr Reddy’s Laboratories in consortium with Cipla, Mylan, Torrent, Emcure and Sun pharma had presented their proposal for approval of Molnupiravir 200mg capsules for approval in emergency situation along with various supporting documents.

    including clinical data in the country, official sources said.

    As per conditions, the drug should be sold by retail only under prescription of medical specialists.

    According to the conditions, the drug is not authorised for use in patients less than 18 years and for initiation of treatment in patients requiring immediate hospitalisation due to COVID-19 at that stage.

    However, if it was initiated before hospitalisation due to COVID 19, it may be continued, sources said.

    It is not authorsied for use for longer than five consecutive days and for pre-exposure or post exposure prophylaxis for prevention of COVID-19 for pregnant women.

    The US Food and Drug Administration recently authorised Merck’s Molnupiravir for treatment of mild-to-moderate COVID-19 cases in adults who are at risk for severe disease.

    Before that in November Britain granted conditional authorisation to Merck’s coronavirus antiviral, the first pill shown to successfully treat Covid-19.

    The pill is intended to be taken twice a day for five days by people at home with mild to moderate Covid-19.

    In a clinical trial of high risk people during the ealry course of illness,t he Merck’s drug was shown to reduce hospitalisations and deaths by around 30 per cent.

  • Serum Institute’s Covovax vaccine gets WHO emergency use nod, Poonawalla hails decision

    By PTI

    NEW DELHI: Serum Institute of India (SII) CEO Adar Poonawalla on Friday hailed WHO’s approval for emergency use of Covovax vaccine for children “as yet another milestone” in the fight against COVID-19.

    The World Health Organization (WHO) on Friday listed the Covovax as the ninth COVID-19 vaccine for emergency use with an aim to increase the access to vaccination in lower-income countries.

    It is produced by the Serum Institute of India under the licence from Novavax.

    Reacting to the development, Poonawalla tweeted, “This is yet another milestone in our fight against COVID-19, Covovax is now WHO approved for emergency use, showing excellent safety and efficacy. Thank you all for a great collaboration…..”

    He tagged Novavax, WHO, Gavi, the Vaccine Alliance, its CEO Seth Berkley and the Gates Foundation.

    Earlier this week, Poonawalla had said that SII planned to launch Covovax, a COVID-19 vaccine for children in the next six months.

    He had stated that Covovax which is under trial would offer protection to children all the way down to three years as it had shown excellent data during the trials.

    Currently, Covishield and other COVID -19 vaccines are approved for people above the age of 18.

    Poonawalla had asserted that there was enough data to show that the vaccine would work and protect children against the infectious disease.

    According to WHO, Covovax was assessed under its emergency use listing (EUL) procedure based on the review of data on quality, safety and efficacy, a risk management plan, programmatic suitability, and manufacturing site inspections carried out by the Drugs Controller General of India.

    “The Technical Advisory Group for Emergency Use Listing (TAG-EUL), convened by WHO and made up of experts from around the world, has determined that the vaccine meets WHO standards for protection against COVID-19, that the benefit of the vaccine far outweighs any risks, and that the vaccine can be used globally,” it said.

  • Covovax not yet been approved in country of origin: Govt panel seeks additional data from Serum Institute

    By PTI

    NEW DELHI: An expert panel of India’s Central Drug Authority, which recently reviewed Serum Institute’s application seeking emergency authorisation of COVID-19 vaccine Covovax, has sought additional data from the firm, while noting the jab has not yet been approved in the country of origin, official sources said.

    The Serum Institute of India (SII) had put in an application to the Drugs Controller General of India (DCGI) in October for grant of market authorisation of Covovax for restricted use in emergency situations.

    The Pune-based firm had submitted interim safety and immunogenicity data of phase 2/3 bridging clinical trials conducted in the country as well as interim clinical trial data of safety and efficacy from phase 3 clinical trials conducted in the UK and the US along with its application, official sources said.

    “The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO), which deliberated on the application on November 24, noted that the vaccine is technology transfer of Novavax vaccine and is not yet approved in the country of origin,” a source said.

    ALSO READ: Will Covaxin, Covishield be effective against Omicron? Here’s what experts say

    After detailed deliberation, the committee recommended that the firm should submit additional data and information.

    It has sought correct status of the phase 3 clinical trials in USA and UK along with up to date on the safety, efficacy and immunogenicity, comparative statement of immunogenicity parameters of the subjects from the US, UK and other overseas phase 3 studies with data from phase 3 study in India, besides review status of the application with regulatory authorities of the US and the UK, the source said.

    The government recently permitted the export of two crore doses of COVID-19 vaccine Covovax to Indonesia, produced in India by the SII, as the jab has not yet been approved for emergency use in the country, official sources had said.

    The DCGI office had granted SII permission to manufacture and stock Covovax on May 17.

    Based on the DCGI’s approval, till now, the Pune-based firm has manufactured and stockpiled vaccine doses, they said.

    In August 2020, US-based vaccine maker Novavax, Inc had announced a licence agreement with SII for the development and commercialisation of NVX-CoV2373, its COVID-19 vaccine candidate, in low and middle-income countries and India.

    ALSO READ |

  • Serum Institute seeks DCGI nod for Covid vaccine Covovax

    By PTI

    NEW DELHI: The Serum Institute of India on Friday sought permission from the Drugs Controller General of India (DCGI) to manufacture COVID-19 vaccine Covovax for restricted use in emergency situations at its Manjari manufacturing site, official sources said.

    The company has submitted interim phase 2/3 clinical study report on Indian adults, the interim report of Novavax UK and USA-Mexico phase-3 clinical study and response to the queries raised by the DCGI office, along with its application.

    There were no safety concerns arising from the study data and Covovax is safe and immunogenic in the adult population, Prakash Kumar Singh, Director, Government and Regulatory Affairs at the Serum Institute of India (SII), is learnt to have said in the application sent to the DCGI.

    “In our government’s endeavour to fight against COVID-19 pandemic, we have also been working shoulder to shoulder with the Government of India to make available one more safe and efficacious world class COVID-19 vaccine for our country and the world at large.

    “Approval of our COVOVAX and its availability will further strengthen India’s capability to fight COVID-19 pandemic and ensure vaccine security in line with our prime minister’s clarion call of Atmanirbhar Bharat,” an official source quoted Singh as having said in the application.

    In the phase 2/3 study in India, more than 1,400 participants have received at least first dose of the vaccine with no safety concerns reported so far, stated the application.

    In August 2020, US-based vaccine maker Novavax Inc had announced a licence agreement with SII for the development and commercialisation of NVX-CoV2373, its COVID-19 vaccine candidate, in low and middle-income countries and India.

    SII, which manufactures Covishield, plans to produce Covovax at its Manjari plant in Maharashtra.

    India has given emergency use permission to several COVID-19 vaccines, including Covishield, Covaxin of Bharat Biotech and Russian-made Sputnik V.

  • Recruitment of volunteers for trial of Covid vaccine Covovax on children begins

    By PTI

    NEW DELHI: Recruitment of volunteers for the phase 2/3 clinical trial of COVID-19 vaccine Covovax among children aged 2 to 17 years began on Sunday at the Hamdard Institute of Medical Sciences and Research here.

    The trial would be held across 10 sites and would cover 920 children — 460 each in the age groups of 12-17 and 2-11 — according to official sources.

    Indigenously developed Zydus Cadila’s needle-free COVID-19 vaccine ZyCoV-D has received emergency use authorisation from the drug regulator, making it the first vaccine to be administered in the age group of 12-18 years in the country.

    India’s drug regulator in July had granted permission to Serum Institute of India (SII) for conducting phase 2/3 trial of Covovax on children aged 2 to 17 years with certain conditions on the basis of the recommendations of the Subject Expert Committee (SEC) on COVID-19.

    In the application submitted to the Drugs Controller General of India (DCGI), SII’s director (government and regulatory affairs) Prakash Kumar Singh and director Prasad Kulkarni had stated that globally, all adults aged 18 and above are being vaccinated and after this population is protected against COVID-l9, children will remain the most susceptible group.

    “There have been reports of severe disease, including deaths in vulnerable children. It has also been predicted that the third wave of the pandemic may affect children in the country.”

    “Moreover, until all age groups, including children, are covered under vaccination, the SARS-CoV-2 virus may remain in circulation, thus keeping everyone at risk of severe disease,” the company had said in the application.

    Considering all these factors, several companies have already started evaluating the safety and immunogenicity of COVID-19 vaccines in the paediatric population, the Pune-based pharmaceutical company had stated.

    SII had informed that their collaborator, Novavax Inc. of the US, has already generated a large amount of data in adults in different countries and that the safety, efficacy and immunogenicity data on Novavax are very robust which includes a safety database of more than 50,000 adults from Australia, South Africa, the UK and the USA and preliminary safety data in 2,248 children.

    “Further in the ongoing Phase 2/3 study in India, more than 1,400 participants have received at least first dose of the vaccine with no safety concerns reported so far,” the application stated.

    In August 2020, US-based vaccine maker Novavax Inc had announced a licence agreement with SII for the development and commercialisation of NVX-CoV2373, its COVID-19 vaccine candidate, in low and middle-income countries and India.

  • Two more vaccines line up for regulatory nod

    By Express News Service

    NEW DELHI:  India’s pool of Covid-19 vaccines is set to receive a shot in the arm with two more approaching the apex drug regulator for approval. Vaccines which have applied to Central Drugs Standard Control Organisation for restricted use authorisation include Novavax, manufactured locally by the Serum Institute of India under the brand name of Covovax, and Johnson and Johnson’s single dose vaccine.

    Sources in CDSCO said the companies moved the application on Thursday and a meeting of an expert panel has been called to scrutinise their data. SII had started production of Covovax for stockpiling in June. This showed over 90% efficacy in Phase 3 trials in the US. It is looking to launch the vaccine in India by September. 

    Johnson and Johnson’s single dose is also seen as a crucial component in coming days as it may be logistically easy to administer and offer quick coverage. A bid by the Association of Healthcare Providers of India to procure Johnson and Johnson’s vaccines in private hospitals, had failed last month due to regulatory hurdles. 

    Nearly seven months since the launch of the nationwide Covid-19 vaccination programme, only about 8% of the adult population in India has been fully vaccinated yet.