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Tag: SII

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

    By PTI

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

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

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

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

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

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

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

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

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

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

  • 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 |

  • 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.

  • Biocon and Serum Institute come together with strategic alliance to increase vaccine access for developing countries

    By Express News Service

    Two leading biotech players, Bengaluru based Biocon Biologics Limited and Pune based Serum Institute Life Sciences Private Limited have come together with a strategic alliance in a bid to increase vaccines and antibody therapeutics access for developing countries, for infectious diseases including Covid-19, dengue and HIV among others.

    As part of the deal, the BBL has offered 15% stake to SILS at a post money valuation of $4.9 billion in exchange for committed access to 100 million doses of vaccines per annul for 15 years.

    Announcing this at a joint press meet held on Friday, Biocon founder Kiran Mazumdar Shaw and SII chief executive Adar Poonawalla said, the partnership aims to complement the strengths and resources of the two leading players and make a significant impact on global healthcare through vaccines and biologics.

    “BBL will commercialise Serum institute’s vaccine portfolio including COVID 19 vaccines for global markets and this would also be an additional growth driving for BBL. Research and manufacturing infrastructure will also be leveraged by this partnership for various opportunities in infectious diseases, ” Shaw said.

    Speaking at the press meet, Poonawala said SII had to delay its plans to work on and produce monoclonal therapies for Covid due to the huge demand of Covishield vaccine production, and the new tie-up aims to address this. 

    More in the pipeline

    The duo stressed that the synergistic future oriented deal will help growth of both companies, as it will provide Biocon an opportunity to enter into the vaccine space, whereas Serum can leverage BBL’s expertise in areas like monoclonal antibodies (mABs), m-RNA technologies and biosimilars.

    Adding that there is more to the partnership than just the 100 million vaccines that has been talked about, Poonawala said that, “The opportunities are limitless and we will look at monoclonals and other therapeutics. Additional business partnerships and alliances in addition to the 100 million vaccines we have talked about will also be looked into,” Poonawala said.

    Biocon Biologics will also establish a vaccine research and development division to support the alliance in developing both vaccines and biologics for communicable diseases.

    Additionally, wherever possible, it will make available its cell culture and sterile fill and finish capacities for vaccine production under the alliance. 

    He also stressed that both the partners also wanted to make investments in strengthening the raw material chain, as many of these raw materials manufacturers are finding it hard to scale up and match the vaccine manufacturing supply.

    “We will make investment in raw material manufacturing as well — so that we are fully self-reliant,” Poonawala said, adding that these supply chains will be established in the country.

    Mazumdar-Shaw said the long term partnership will try to ensure that Indian drug manufacturers do not face supply chain disruptions in future. 

    Initial focus on COVID 

    Meanwhile Poonawala made it clear that the initial additional capacities will be focused on COVID vaccines for the obvious reason of demand to provide to not just India but other countries too.

    “Initially it would make sense that whatever firepower and additional capacity we can leverage from biocon biologics including the first 100 MN doses annually will be focused on COVID vaccines but there is a huge pipeline of vaccines for malaria, HPV etc, thereafter that will benefit from the partnership,” Poonawala explained.

    He added that Biocon has extensive marketing infrastructure in developed markets, an area Serum can explore to take its vaccines and other products to those markets through this alliance. At present most of Serum’s products are supplied across the world through public health agencies like WHO-UNICEF and other such agencies

  • 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.

  • Serum Institute of India writes to Union Health Minister proposing reforms in drug regulatory system

    By PTI
    NEW DELHI: World’s largest vaccine manufacturer by volume, Serum Institute of India (SII) has written to Union Health Minister Mansukh Mandaviya suggesting reforms in the existing drug regulatory system, including allowing manufacturing and stockpiling of non-Covid vaccines while undergoing clinical trial.

    According to official sources, Prakash Kumar Singh, Director, Government and Regulatory Affairs at Pune-based SII, in a letter, referred to a gazette notification by the Union Health Ministry on May 18, 2020.

    He said it allowed manufacturing and stockpiling of COVID-19 vaccine under clinical trial for marketing authorization for sale or distribution.

    “Because of this rule, it became possible for us to manufacture and stockpile the COVID-19 vaccine during clinical trial and we could make the vaccine available in such a short span of time period to protect millions of lives.

    “It will be a big help for the vaccine industry if this rule is implemented for non-COVID-19 vaccines also,” a source quoted Singh as having communicated in the letter to the minister.

    Singh also sought permission to use the remaining quantities of batches of Covid and non-Covid vaccines for commercial purposes which have been used in clinical trial.

    In this context, he said the Health Ministry had issued draft rules dated April 12, 2018, to allow remaining quantities of batches of vaccines which have been used in clinical trial for commercial use after granting of permission in form 46 (now it is form CT-23) and manufacturing licence in Form 28D.

    “However, the gazette notification in this regard has not been issued so far for the implementation of the same,” Singh said.

    He also sought the implementation of recommendations of a high-powered inter-ministerial committee for reforming the Drug Regulatory Systems in India.

    The letter stated that on the directions of the prime minister, a high-powered Inter-Ministerial Committee for reforming the drug regulatory systems in India was formed under the chairmanship of then OSD, Rajesh Bhushan who is presently the health secretary.

    “Recommendations of this inter-ministerial committee should be implemented immediately in line with ‘ease of doing business”.

    The letter highlighted few other points also related to regulatory reforms and stated, “If few rules/regulatory provisions are amended, it will be a great help and encouragement for the vaccine industry to grow faster.

  • Serum Institute gets DCGI’s nod to manufacture Covid jab Sputnik V in India

    By Express News Service
    NEW DELHI: India’s apex drug regulator on Friday granted permission to the Pune based Serum Institute of India (SSI) to manufacture the Russian Covid-19 vaccine Sputnik V in the country.

    It is the sixth firm in India, after Gland Pharma, Hetero Biopharma, Panacea Biotech, Stelis Biopharma, Virchow Biotech to enter into an agreement for the Russian Direct Investment Fund, the sponsor of Sputnik V, for the vaccine’s local production.

    Sources said that the Drug Controller General of India has granted approval SII to manufacture the vaccine in India for examination, test and analysis, apart from its manufacturing, at its licensed Hadapsar facility near Pune with certain conditions.

    SII is already producing AstraZeneca-Oxford University’s Covid-19 vaccine in India under the brand name of Covishield and is also in the process of manufacturing coronavirus vaccine by the US-based Novavax.

    Sources in the Central Drugs Standard Control Organisation meanwhile said that as per the conditions specified, the SII has been asked to submit copies of the agreement between it and the Gamaleya Research Institute of Epidemiology and Microbiology, the developer of the vaccine, for transfer of cell bank and virus stock and technology transfer.

    The firm has also been asked to submit proof of the permissions by the government’s Review Committee on Genetic Manipulation to import cell bank and virus stock and to initiate research and development of viral vector vaccine.

    SII, had last month, applied to the RCGM under the department of biotechnology seeking clearance for import of strains and seed lots and cell banks, and for carrying out research and development.

    Sputnik V was soft-launched in the country last month after nearly 2 lakh doses were imported by Hyderabad based Dr Reddy’s Lab from Russia but is expected to be available in significant quantities only after local production starts. Dr Reddy’s has said that it has the sole distribution rights of the first 250 million dose in India.

    This vaccine, based on an adenovirus vector, like Covishield, has a reported efficacy of over 90 % against preventing Covid-19 vaccine and is administered in two doses at a gap of 21 days.

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  • Poonawalla thanks Biden, Jaishankar for policy change to boost vaccine production

    By PTI
    NEW DELHI: Serum Institute of India CEO Adar Poonawalla on Friday thanked US President Joe Biden and External Affairs Minister S Jaishankar for a policy change that will boost the production of COVID-19 vaccines in India and globally.

    Confident of the availability of COVID-19 vaccines in the US, the Biden administration has removed Defense Production Act priority ratings on AstraZeneca, Novavax and Sanofi vaccines.

    While the firms will continue to make these three vaccines, this action will allow US-based companies that supply these vaccine manufacturers to make their own decisions on which orders to fulfil first.

    Sharing the link of a press briefing by White House COVID-19 response team and public health officials, Poonawalla said, “Thanks to the efforts of @POTUS, @WhiteHouse, & @DrSJaishankar, this policy change will hopefully increase the supply of raw materials globally and to India; boosting our vaccine production capacity and strengthening our united fight against this pandemic.”

    Earlier in April, Poonawalla had tweeted, “Respected @POTUS, if we are to truly unite in beating this virus, on behalf of the vaccine industry outside the U.S., I humbly request you to lift the embargo of raw material exports out of the U.S. so that vaccine production can ramp up. Your administration has the details”.

  • Will be able to manufacture, supply 10 crore Covishield doses in June: Serum Institute to Centre 

    By PTI
    NEW DELHI: Serum Institute of India (SII) has informed the government that it will be able to manufacture and supply nine to 10 crore doses of Covishield in June, official sources said on Sunday amid complaint by states about the shortage of anti-coronavirus vaccine jabs.

    In a recent letter to Union Home Minister Amit Shah, SII said its employees have been working round the clock in spite of various challenges because of the 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 the country as compared to our production capacity of 6.5 crore doses in May,” Prakash Kumar Singh, the Director of Government and Regulatory Affairs at SII, said in the letter.

    Singh also thanked Shah for his “valuable guidance and continuous support” at various stages of their endeavour to make India ‘aatmanirbhar’ (self-sufficient) in COVID-19 vaccines and making it available for the people of the country.

    “Serum Institute of India has always been sincerely concerned about the protection of the citizens of our country and world at large from COVID-19. Under the leadership of our CEO, Adar C Poonawalla, our team have been working relentlessly shoulder to shoulder with our government to fight the COVID-19 pandemic,” he said in the letter.

    “We assure you that with the support of the Government of India and under your kind guidance, we are trying our best by utilizing all of our resources to increase our production capacity of Covishield in the coming month also.

    ” In early May, SII had communicated to the Centre that production of Covishield would be ramped up to 6.5 crore in June, seven crore in July and 10 crore each in August and September.

    India is currently using made-in-India vaccines — Covishield manufactured by SII and Covaxin of Bharat Biotech — in its COVID-19 immunisation programme.

    The Russian Sputnik V is the third vaccine to get approval from the Drug Controller General of India (DCGI) for emergency use and is being used in a few private hospitals.