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Tag: Serum Institute of India

  • 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.

  • Government allows Serum Institute to export 50 lakh Covishield doses under COVAX

    By PTI

    NEW DELHI: The Union government has allowed the Serum Institute of India to export 50 lakh doses of COVID-19 vaccine Covishield under the UN-backed COVAX global vaccine programme to Nepal, Tajikistan and Mozambique, official sources said on Sunday.

    In addition to these three countries, the SII will also export Covishield to Bangladesh under COVAX, they said.

    The SII will commence Covid vaccine export under the COVAX programme from November 23 and Nepal will receive the first lot of Covishield on November 24.

    The government, earlier in October, had permitted the SII to export 10 lakh Covishield doses each to Nepal, Myanmar and Bangladesh under the ‘Vaccine Maitri’ programme.

    In a recent communication to the Union Health Ministry, Prakash Kumar Singh, Director, Government and Regulatory Affairs at Serum Institute of India (SII) is learnt to have informed that the Pune-based firm has manufactured stock of 24,89,15,000 doses of Covishield and that the stock is increasing day by day.

  • SII urges government to fast-track movement of increasing Covishield stock

    By PTI

    NEW DELHI: Serum Institute of India (SII) has urged the government to fast-track Covishield movement citing the difficulties being faced in production and cold chain space planning for other vaccines because of the increasing stock of its COVID-19 jab, official sources said on Sunday.

    Prakash Kumar Singh, Director, Government and Regulatory Affairs at SII, is learnt to have recently communicated to the Union Health Ministry that it has a manufactured stock of 24,89,15,000 Covishield doses and it is increasing every day.

    In addition to the Covishield vaccine, the Pune-based firm also manufactures and supplies various life-saving vaccines to EPI, UNICEF and different countries, Singh is learnt to have told the ministry.

    “To fulfil our domestic and global supply commitments, we have to plan our production/cold chain space/human resource well in advance. In view of continuous increase in the stock of Covishield, we are facing a lot of difficulties in production/cold chain space/human resource planning for other life-saving vaccines,” an official source quoted Singh as having stated in the letter.

    “In view of these facts, genuine difficulties and as this matter is directly concerned with the availability of various other life-saving vaccines in our country and the world at large, we request for your kind intervention for fast-track movement of our Covishield vaccine domestically and globally,” Singh is learnt to have stated.

    The Centre has allowed SII to export 50 Lakh doses of Covishied under the UN-backed COVAX global vaccine sharing programme to Nepal, Tajikistan and Mozambique.

    SII will also export Covishield to Bangladesh under COVAX, an official source said.

    The Serum Institute will commence its Covid vaccine export under the COVAX programme from November 23 and Nepal will receive the first lot of Covishiled on November 24.

    The government had in October permitted SII to export 10 lakh Covishield doses, each to Nepal, Myanmar and Bangladesh under the ‘Vaccine Maitri’ programme.

  • Serum Institute of India seeks regular marketing authorisation from DCGI for Covishield

    By PTI

    NEW DELHI: Pointing out that over 100 crore doses of Covishield have been supplied in India and many other countries, Serum Institute of India on Monday sought regular marketing approval for the COVID-19 vaccine, which is currently authorized for emergency use in the country, official sources said.

    The application sent to the Drugs Controller General of India (DCGI) by Prakash Kumar Singh, Director, Government and Regulatory Affairs at Serum Institute of India (SII) comes just a couple of days after Prime Minister Narendra Modi held a meeting with domestic COVID-19 vaccine manufacturers.

    If the DCGI grants regular marketing authorisation, Covishied will be the second vaccine in the world to receive such approval.

    Pfizer-BioNTech’s COVID-19 vaccine has received full US FDA approval for use in individuals 16 years of age and older.

    The cumulative COVID-19 vaccines administered in the country has exceeded 102.27 crore. Of all the vaccine doses administered, around 90 per cent are Covishield and close to 10 per cent are Bharat Biotech’s Covaxin.

    Less than one per cent of the doses given are Sputnik V. The Pune-based SII has submitted the final phase 2/3 clinical study report of India with its application for grant of regular market authorization for Covishield, an official source said.

    According to the application by Singh, the firm has already submitted phase-3 clinical study results of 24,244 subjects from the UK, Brazil and South Africa on June 8, 2021, to the Central Drugs Standard Control Organisation (CDSCO).

    Also, phase-3 clinical study results of 32,379 subjects from the US, Chile and Peru were submitted on July 9.

    “In addition to the successful completion of our phase 2/3 clinical study in India, till now more than 100 crore doses of our Covishield has been administered to people in our country and worldwide.

    “Such a large-scale vaccination with our Covishield vaccine and containment of COVID-19 infection is in itself a testimony to the safety and efficacy of Covishield,” the official source quoted Singh as having stated in the application.

    Singh thanked the DCGI office and Subject Expert Committee for granting restricted emergency use approval to Covishield on January 3, because of which, he said, the vaccine played a crucial role in the pandemic control and has been the mainstay of India’s Covid inoculation drive.

    “It is a matter of pride for us that we have been a part of the world’s largest vaccination drive under the dynamic and visionary leadership of our Prime Minister Narendra Modi Ji,” Singh is learnt to have said in the application.

    Under the kind guidance of Union Health Minister Mansukh Mandaviya, Team Government of India and leadership of CEO Adar C Poonawalla, Team Serum Institute of India has been working relentlessly to manufacture and supply Covishield vaccine for making the world’s largest Covid vaccination drive successful, he said.

    “In line with our prime minister’s clarion call of Aatmanirbhar Bharat, we have made our country Aatmanirbhar for COVID-19 vaccine. In view of the above-mentioned facts, we request for your kind approval for regular market authorization of Covishield,” Singh is learnt to have written in the application.

  • Australia says looking forward to welcoming Indian students after Covishield approval

    By PTI

    NEW DELHI: Australia on Friday said it was looking forward to welcoming Indian students after its top medical regulator approved the Covishield vaccine manufactured by the Serum Institute of India for incoming international travellers.

    Australian Prime Minister Scott Morrison’s office said the Therapeutic Goods Administration (TGA) has advised that Coronavac (Sinovac) and Covishield should be considered as “recognised vaccines” for the purpose of determining incoming international travellers as being appropriately vaccinated against COVID-19.

    During a media interaction, visiting Australian Minister for Trade, Tourism and Investment Dan Tehan said it is a wonderful news that his Prime Minister has announced that the international border will be reopening.

    “It means that the pathway for our Indian international students to return to Australia is there again and with semester one starting in February, March next year, those international students will be able to start returning towards the end of this year and the beginning of next year,” he said.

    Australia had imposed very strict travel restrictions on people travelling in and out of the country.

    To a query regarding approval to Bharat Biotech’s Covaxin, Tehan said: “I think it’s still before the World Health Organization, as I understand it. So obviously there’s that step that needs the approval process, and then our Therapeutic Goods Administration will look at it.”

    The Australian PMO said the government will finalise in the coming weeks the processes for people to be able to show their vaccination status if they have had a TGA recognised vaccine.

  • SII to supply nearly 22 crore doses of Covishield vaccine to Centre in October

    By PTI

    NEW DELHI: The Serum Institute of India has informed the Centre that it will be able to supply around 22 crore doses of Covishield in October as the Union government has announced resuming export of surplus Covid vaccines in the coming fourth quarter under the ‘Vaccine Maitri’ programme, official sources said.

    In a communication to the Centre on Monday, Prakash Kumar Singh, Director, Government and Regulatory Affairs at Serum Institute of India (SII), said the firm has enhanced its production capacity of Covishield and it will be able to supply 21.90 crore doses in October to Government of India and private hospitals.

    The Pune-based pharmaceutical company has enhanced the manufacturing capacity of Covishield to more than 20 crore doses per month.

    “Starting from January 2021, we have supplied 66.33 crore doses of Covishield to MoHFW, Government of India in addition to supply of more than 7.77 crore doses to state governments and private hospitals till 19th September 2021 evening.

    “All this has become possible under the dynamic leadership and kind direction of our Prime Minister Narendra Modi Ji, continuous support from team Ministry of Health and GoI, visionary leadership of our CEO, Dr Adar C Poonawalla, along with untiring efforts of Team SIIPL,” a source quoted Singh as having communicated.

    Singh futher assured that by December 31, keeping with the timeline, the firm will complete the recent supply order of 66 crore doses.

    “At this juncture, I can assure you that by December 31, 2021, we will complete supply of 66 crore doses of Covishield against the recent order and will touch supplies of more than 130 crore doses of Covishield in the year 2021. We are working relentlessly to fulfill our prime minister’s dream for successful completion of world’s largest vaccination drive so that our country overcomes COVID-19 pandemic,” the communication stated.

    Union Health Minister Mansukh Mandaviya on Monday announced that India will resume export of surplus COVID-19 vaccines in the fourth quarter of 2021 under the ‘Vaccine Maitri’ programme and to meet its commitment to the COVAX global pool, but vaccinating its own citizens remains the topmost priority of the government.

    Talking about the expected production and supply trends in the coming months, the minister said the government will receive over 30 crore doses of COVID-19 vaccines in October and over 100 crore doses in the coming quarter from October-December.

    The cumulative doses administered in the country so far under the nationwide COVID-19 vaccination drive has crossed 82 crore.

    Of all the vaccine doses administered, around 88.45 per cent are Covishield, around 11.44 per cent are Bharat Biotech’s Covaxin and less than one per cent are Sputnik V.

    India on September 17 administered a record number of over 2.50 crore COVID-19 vaccine doses on the occasion of Prime Minister Narendra Modi’s 71st birthday.

    The daily COVID-19 vaccination in the country was over 1 crore on September 6, August 31 and August 27.

    India took 85 days to touch the 10-crore vaccination mark, 45 more days to cross the 20-crore mark and 29 more days to reach the 30-crore mark, according to the ministry.

    The country took 24 days to reach 40 crore from 30 crore doses and then 20 more days to cross the 50-crore vaccination mark on August 6, it said.

    It took 19 more days to go past the 60-crore mark and took only 13 days to reach 70 crore from 60 crore on September 7.

    It then took just 11 days to reach 80 crore from 70 crore.

    According to official sources, over 22 per cent of India’s adult population have received both doses of COVID-19 vaccine and nearly 65 per cent have got at least one dose.

  • SII to supply Inactivated Polio Vaccine to Centre for Universal Immunisation Programme

    By PTI

    NEW DELHI: Serum Institute of India (SII) will start supplying Inactivated Polio Vaccine (IPV) to the Union government for the Universal Immunisation Programme from this month, becoming the first indigenous company to do so, official sources said on Tuesday.

    The Union Health Ministry has recently placed a purchase order with SII for 54 lakh doses of IPV vaccine. So far, the government was dependent on Sanofi, a foreign pharmaceutical company for supplying IPV to the universal immunisation programme.

    “I wish to inform you that our firm, Serum Institute of India has become the first Indian manufacturer to supply Inactivated Poliomyelitis Vaccine (IPV) to MoHFW which will protect children of our country from Poliomyelitis disease,” Prakash Kumar Singh, Director, Government and Regulatory Affairs at SII communicated to the Health Ministry recently.

    The IPV of SII is World Health Organisation pre-qualified for supplies to various countries worldwide also. The Union Health Ministry has also placed an order with Sanofi for the supply of 36 lakh doses of IPV.

    “It is a matter of pride for all of us that in addition to many other life-saving vaccines as well as COVID-19 vaccines, our country is now ‘Atmanirbar’ (self-reliant) for Inactivated Poliomyelitis Vaccine (IPV) also and we are moving ahead on the lines of the clarion call of our Prime Minister ‘ATMANIRBHAR BHARAT’,” Singh said in his letter.

    The first lot of IPV will be supplied to GMSD (Government Medical Stores Depot) this month shortly for the vaccination programme as per the requirement of the Health Ministry. “The supply of IPV from first Indian company i.e. Serum Institute of India has become possible because of your kind guidance, support of Team MoHFW, farsighted vision of our CEO, Dr Adar C Poonawalla along with relentless efforts of team SIIPL during COVID-19 pandemic,” Singh stated in the communication.

    India was officially declared polio-free in 2014, but the immunisation programme continues in the country. IPV has been introduced in the Universal Immunisation Programme as part of the Global Polio end-game strategy, to mitigate the risk associated with the trivalent oral polio vaccine to bivalent oral polio vaccine switch.

    IPV was introduced in November 2015 initially in six states, which was expanded across the country by April 2016.

  • Centre places 66 crore Covishield doses order with SII to be supplied by December: Sources

    Serum Institute of India has enhanced the manufacturing capacity of Covishield to more than 20 crore doses per month.

  • Serum Institute informs Centre it will supply around 20 crore Covishield doses in September

    By PTI

    NEW DELHI: Serum Institute of India (SII) has informed the Centre that it will be able to supply around 20 crore doses of COVID-19 vaccine Covishield in September itself to Government to India and private hospitals, official sources said.

    The Pune-based SII has already supplied 12 crore doses of the COVID-19 vaccine in August, they said.

    Director, Government and Regulatory Affairs at SII, Prakash Kumar Singh has communicated to the Union Health Ministry that the firm has further enhanced its production capacity and it will be able to supply approximately 20 crore doses of Covishield in September itself to Government of India and private hospitals, an official source said.

    In a production plan submitted to the Centre in May, SII’s director had communicated that the production of Covishield would be ramped up to 10 crore each in August and September, sources had said.

    Later in May-end, Singh communicated to Union Home Minister Amit Shah that Covishield production would be ramped up to 10 crore doses in June.

    “We are committed to enhancing the production capacity of our Covishield vaccine and have been working round-the-clock in spite of various challenges being faced by us because of COVID-19 pandemic.

    “We are pleased to inform that in the month of June we will be able to manufacture and supply nine to 10 crore doses of our Covishield vaccine to our country as compared to our present production capacity of 6.5 crore doses in May,” he had said in a communication to Shah.

  • COVID vaccine export ban ‘very bad’ move; son warned not to speak against it: SII’s Cyrus Poonawalla

    By PTI

    PUNE: Cyrus Poonawalla, chairman of the Serum Institute of India (SII), on Friday termed the ban on COVID-19 vaccine exports imposed by the Union government a “very bad move”, saying it put his company, the world’s largest vaccine-maker, in a difficult situation.

    He also said that his son Adar Poonawalla, the chief executive of the SII which makes the Covishield vaccine, had asked him not to speak about the issue.

    “It is a very bad move by the Modi government. My son asked me not to open my mouth. But it is my view that exports ought to be opened,” Poonawalla said here.

    He was speaking to reporters after receiving the prestigious Lokmanya Tilak Award.

    Over 150 countries are dependent on the SII for vaccines and are blaming the company for stopping the supply during a crucial period, he said.

    These countries have paid “crores” in advance to the company, Cyrus Poonawalla said, adding that the Bill and Melinda Gates Foundation and World Health Organisation (WHO) have also given it Rs 5,000 crore.

    He had offered to return the money to the Gates Foundation and WHO, he said, but hinted that they declined his offer in the hope that the Indian government will lift the ban on exports soon.

    India banned vaccine exports in April when the second wave of the pandemic began to peak and the need to vaccinate people in the country at a greater pace was felt acutely.

    The move led to concerns being expressed from various quarters as the Pune-based SII is one of the biggest suppliers globally and had taken advance orders.

    About a shortage of vaccines in Pune itself, Poonawalla again voiced disappointment with the Union government.

    “We told them (the government) that data says that the infections are highest in Pune and requested them to release more (vaccines) for Pune…but the Modi government is unwilling to even reply. The government says it will do what it feels,” he said.