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Tag: Serum Institute of India

  • 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.

  • India’s first vaccine against cervical cancer to launch on September 1

    By ANI

    NEW DELHI: The Serum Institute of India (SII) and the Department of Biotechnology(DBT) are set to launch India’s first indigenously developed Quadrivalent Human Papillomavirus vaccine (qHPV) against Cervical Cancer on September 1, official sources told ANI.

    The most awaited vaccine will be launched by the Union Minister of State (Independent Charge) Science & Technology Jitendra Singh on Thursday.

    According to Dr N K Arora, Chairperson of the COVID working group, National Technical Advisory Group on Immunisation (NTAGI) said it is an exciting experience to launch a made-in-India vaccine.

    “It is very exciting and I must say it makes us very happy that our daughters and granddaughters will now be able to get this much-awaited vaccine.”

    ALSO READ | India produces nearly 60 per cent of all vaccines used worldwide: FM

    “In fact, this is one of the last major vaccines to be introduced. In fact, this is one of the last vaccines that will be launched in the programme. Now, Indian vaccines will be available and we hope that it will be launched in the National Immunisation programme for 9-14-year-old girls,” he added.

    “It is very effective and prevents cervical cancer because, 85 per cent to 90 per cent cases, cervical cancer is because of this particular virus and this vaccine is against those viruses. So, if we give it to our young children and daughters, they are protected from the infection and consequently probably 30 years later, cancer does not occur,” Dr Arora further explained.

    ALSO READ | Free medicine kits given to cancer patients in Bengaluru

    “There was a shortage in the global market. Now Indian vaccine has come. So, we will be able to take care of our requirements within our made-in-India vaccine,” he said.

    NEW DELHI: The Serum Institute of India (SII) and the Department of Biotechnology(DBT) are set to launch India’s first indigenously developed Quadrivalent Human Papillomavirus vaccine (qHPV) against Cervical Cancer on September 1, official sources told ANI.

    The most awaited vaccine will be launched by the Union Minister of State (Independent Charge) Science & Technology Jitendra Singh on Thursday.

    According to Dr N K Arora, Chairperson of the COVID working group, National Technical Advisory Group on Immunisation (NTAGI) said it is an exciting experience to launch a made-in-India vaccine.

    “It is very exciting and I must say it makes us very happy that our daughters and granddaughters will now be able to get this much-awaited vaccine.”

    ALSO READ | India produces nearly 60 per cent of all vaccines used worldwide: FM

    “In fact, this is one of the last major vaccines to be introduced. In fact, this is one of the last vaccines that will be launched in the programme. Now, Indian vaccines will be available and we hope that it will be launched in the National Immunisation programme for 9-14-year-old girls,” he added.

    “It is very effective and prevents cervical cancer because, 85 per cent to 90 per cent cases, cervical cancer is because of this particular virus and this vaccine is against those viruses. So, if we give it to our young children and daughters, they are protected from the infection and consequently probably 30 years later, cancer does not occur,” Dr Arora further explained.

    ALSO READ | Free medicine kits given to cancer patients in Bengaluru

    “There was a shortage in the global market. Now Indian vaccine has come. So, we will be able to take care of our requirements within our made-in-India vaccine,” he said.

  • Drug controller allows sale of Serum Institute’s cervical cancer vaccine

    By Express News Service

    NEW DELHI: The Drugs Controller General of India (DCGI) on Tuesday granted market authorisation to the Serum Institute of India (SII) to manufacture indigenously-developed India’s first Quadrivalent Human Papillomavirus vaccine (qHPV) against cervical cancer, officials said.

    Soon after the approval, SII CEO and owner Adar Poonawalla tweeted: “For the first time, there will be an Indian HPV vaccine to treat cervical cancer in women that is affordable and accessible.” 

    “We look forward to launching it later this year,” Poonawalla tweeted as he thanked the DGCI and ministry of health for approval.

    The DCGI’s approval came following a recommendation by the Subject Expert Committee (SEC) on Covid-19 of the CDSCO on June 15.

    SII’s director of government and regulatory Affairs, Prakash Kumar Singh, on June 8, applied to the DGCI for market authorisation of the qHPV vaccine after the phase 2/3 clinical trial was completed with the support of the Department of Biotechnology.

    Cervical cancer is the second most frequent cancer among women between 15 and 44 years of age, with a high death ratio in India. 

    In the application to the DCGI, Singh is learnt to have stated that qHPV vaccine CERVAVAC has demonstrated a robust antibody response that is nearly 1,000 times higher than the baseline against all targeted HPV types and in all dose and age groups.

    In the application, Singh mentioned that lakhs of women are diagnosed yearly with cervical cancer and a few other cancers, and the death ratio is also very high. Every year, 122,844 women are diagnosed with cervical cancer and 67,477 die.

    The government advisory panel National Technical Advisory Group on Immunisation (NTAGI) had recently also approved the qHPV after reviewing the clinical trial data of the vaccine.

  • Panel for emergency use approval to SII vaccination for 7-11 age group

    By Express News Service

    NEW DELHI:  An expert panel advising the Central Drugs Standard Control Organisation (CDSCO) has recommended granting emergency use authorisation to Serum Institute of India’s (SII) Covovax for use in children aged 7-11, official sources said Friday. Now, the Drugs Controller General of India (DCGI) will review the recommendation before granting final approval.

    Officials said the Subject Expert Committee deliberated upon the matter and recommended EUA for use in younger children. The process of data review was on for past few months. The application for emergency use authorisation was submitted by Prakash Kumar Singh, Director (government and regulatory affairs) at SII, on March 16. The expert panel in its last meeting in April had sought more data from the Pune-based firm.

    Covovax, the protein vaccine from US major Novovax, already has DCGI nod for use in adults as well as the 12-17 age group. Bharat Biotech’s Covaxin, too, has approval for use for 12-17-year olds. The government has procured Biological E’s Corbevax for adolescent vaccination but has not placed orders for Covovax, officials said.

    The expert panel had recommended the use of Corbevax for children as young as five in April, while it had sought more data from Bharat Biotech for kids in 2-11 group. India started vaccinating adolescents in the age group of 15-18 years in January, and expanded the drive to include children as young as 12 years from March.

  • Government panel recommends market authorisation for SII’s qHPV vaccine against cervical cancer

    By PTI

    NEW DELHI: An expert panel of India’s central drug authority on Wednesday recommended granting of market authorisation to Serum Institute of India (SII) to manufacture indigenously-developed India’s first Quadrivalent Human Papillomavirus vaccine (qHPV) against cervical cancer, official sources said.

    Prakash Kumar Singh, director (government and regulatory affairs) at SII had applied to Drugs Controller General of India (DCGI) on June 8 for market authorisation of qHPV after completing the phase 2/3 clinical trial with support of the Department of Biotechnology to ensure its early availability in the country.

    In the application, Singh is learnt to have stated that qHPV vaccine CERVAVAC has demonstrated robust antibody response that is nearly 1,000 times higher than the baseline against all targeted HPV types and in all dose and age groups.

    “The Subject Expert Committee (SEC) on COVID-19 of the CDSCO which deliberated on the application on Wednesday recommended granting market authorisation to Serum Institute to manufacture qHPV against cervical cancer,” an official source said.

    The SII is also learnt to have made a presentation before the working group of HPV constituted separately by the NTAGI to review the data and usefulness of this vaccine last Wednesday.

    In the application, Singh had mentioned that lakhs of women are diagnosed every year with cervical cancer as well as few other cancers and death ratio is also very high.

    Cervical cancer in India ranks as the second most frequent cancer among women between 15 and 44 years of age.

    “Also, it is noteworthy that presently our country is fully dependent on foreign manufacturers for the HPV vaccine. In line with the philosophy of our group & under leadership of our CEO, Dr Adar C Poonawalla, it has always been our endeavour to make available high quality ‘Made in India’ vaccines at affordable price for people of our country and world at large,” Singh said in the application.

    “Like many other indigenous life saving vaccines, we are committed to make our country ‘ATMANIRBHAR’ for India’s first indigenous life saving qHPV Vaccine also. This will fulfill the dream of our Prime Minister Narendra Modi – ‘vocal for local’ and ‘Making in India for the world’ and will ensure prevention of cancers caused by Human Papillomavirus (Type 6, 11, 16 & 18) vaccine recombinant,” Singh is learnt to have stated in the application.

  • Millions of COVID vaccines unsold; stopped production since December 2021: Adar Poonawalla

    By PTI

    MUMBAI: The Serum Institute of India has stopped producing the COVID-19 vaccine since the last day of December 2021 as it has been sitting on millions of unsold vaccines after the vaccination momentum has ebbed, its chief executive officer Adar Poonawalla said on Friday.

    Poonawalla also warned against the return to “the business as usual” approach of the administration in the national capital, saying “we can’t afford to put a price tag on the life of a citizen” as the pandemic is “not behind us yet nor we know by when it will be”.

    He also called for speeding up the decision to vaccinate young kids and said if they can be given other immunisation vaccines why not for the COVID-19, the end of which nobody knows as of now.

    “Since the vaccine intake has been coming down, there has been a lot of unsold inventories with us. We stopped production on December 31, 2021. Currently, we are sitting on over 200 million doses. I have offered this to anyone willing to pick them up for free. But there hasn’t been a good response to that also. Seems there is vaccine fatigue among the people now as even after the price was slashed to Rs 225, there has been no major uptake,” Poonawalla said at the Times Network India Economic Conclave.

    Defending his call for lowering the gap between second and third doses to six months from nine months at present, he said it’s needed for one “we can’t put a price tag on the life of a person be it an adult or a child. Another important reason is that after six months the antibodies come down so it is better to go for the third dose within six months”.

    ALSO READ| Public complacency responsible for low uptake of booster dose of vaccines: Experts

    “This is something many studies have verified and therefore many foreign governments have made the booster dose mandatory. Already, many counties have made booster doses mandatory for travel. This means those who were vaccinated by August or September last will not be able to travel outside the country. Therefore, my suggestion to the government for six months gap for the third dose,” he said.

    On the need for vaccinating kids in the 5-11 age bracket, he said, “My point is we can’t put a price tag on the life of a person. Also if an additional dose of vaccine can prevent a 1,000 hospitalisation, so let’s do that as was evident from the third wave.”

    On the delays in decision making, Poonawalla rued that it seems the urgency is no longer there. Unfortunately for the key people who are supposed to be taking decisions on time, the committees supposed to be meeting on time, it seems there is no urgency any longer.

    “The momentum of the past that brought us so far here is lost. As you said it seems for them, it’s business as usual. That’s why there is no decision on the emergency use of Covovax is coming in. What is more surprising is that the same vaccine has been approved by the regulator long ago and have also been in use in many European nations and in Australia,” he said.

    However, Poonawalla quickly added that the government at the highest level is fully seized of the matter, but “yes at the ground level there seems the urgency is lost”.

  • 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.

  • 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 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.