News Analysis India

Tag: Serum Institute

  • 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.

  • 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

  • Current average monthly production capacity of Covishield 11 crore doses, Covaxin 2.5 crore doses: Government

    The procurement of COVID-19 vaccines by the Government of India, state governments and private hospitals is 36.01 crore doses of Covishield and 5.45 crore doses of Covaxin.

  • Govt panel recommends against allowing SII to conduct trial of Covovax on children aged 2-17 yrs

    By PTI
    NEW DELHI: An expert panel of the country’s central drug authority on Wednesday recommended against granting permission to the Serum Institute of India (SII) to conduct the phase 2/3 trial of COVID-19 vaccine Covovax on children aged two to 17 years, sources said.

    The SII applied to the Drugs Controller General of India (DCGI) on Monday seeking permission for conducting a trial of Covovax on 920 children, 460 each in the 12-17 and 2-11 age groups, at 10 sites.

    “The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO), which deliberated on the application, noted that the vaccine has not been approved in any country,” a source said.

    ALSO READ | Consider Covishield, Covaxin vaccines under Green pass scheme to avoid mandatory quarantine: India tells EU nations

    “It also recommended that the Pune-based company should submit the safety and immunogenicity data (of Covovax) from the ongoing clinical trial in adults for considering the conduct of a clinical trial in children,” the source said.

    The recommendations are learnt to have been approved by the DCGI.

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

    The clinical trials of Covovax began in India in March and the SII hopes to launch it by September for adults.

    In January, the SII had rolled out the Covishield vaccine in the country.

    It had entered into a collaboration with the University of Oxford and AstraZeneca to manufacture the vaccine.

    ALSO WATCH:

  • Good initiative of Goyal Group: 12 thousand vaccines ordered from Serum Institute, employees and relatives will be vaccinated

    Again in the midst of the Corona crisis, Goyal Group, Shree Bajrang Power and Ispat Ltd. have taken good initiatives. 12 thousand vaccines have been ordered from the Serum Institute for vaccination.
    The vaccine dose will be given to the employees of Goel Group. There will be vaccination of employees as well as their families. Vaccination of employees and their families will be done through Upadhyay Hospital.

  • Vaccine shortage: Serum Institute to produce 10 crore doses by August, Bharat Biotech promises 7.8 crore jabs

    By PTI
    NEW DELHI: Amid multiple states reporting a shortage of COVID-19 vaccine, Serum Institute and Bharat Biotech have submitted to the Centre their production plan for the next four months, informing they can ramp it up to 10 crore and 7.8 crore doses respectively by August, official sources said on Wednesday

    The sources said the Union Health Ministry and the office of Drugs Controller General of India had sought from both the firms their production plan for June, July, August and September.

    The Hyderabad-based Bharat Biotech’s indigenously developed Covaxin and Oxford-AstraZeneca’s Covishield, being manufactured by the Pune-based Serum Institute of India, are currently being used in India’s inoculation drive against coronavirus.

    Dr V Krishna Mohan, the Whole-time Director of Bharat Biotech, is learnt to have conveyed to the government that the production of Covaxin would be raised to 3.32 crore in July, and to 7.82 crore in August which will be maintained in September too.

    Similarly, Prakash Kumar Singh, Director, Government and Regulatory Affairs at Serum Institute of India, has communicated that the production of Covishield would be ramped up to 10 crore doses each in August and will be maintained at that level in September, the official sources said.

    “We confirm that the quantities mentioned will be fulfilled under all circumstances. Also, we are trying our best by utilising all our resources to increase our production capacity of Covishield. In view of this, the production during June and July may also increase by some quantity,” Singh said in a communique to the health ministry.

    An inter-ministerial group, comprising Rajneesh Tingal, Joint Secretary in the Department of Pharmaceuticals, Dr Mandeep Bhandari, Joint Secretary in the Ministry of Health, which was constituted for facilitating the capacity augmentation of domestic vaccine manufacturing, had visited the production facilities of both the Serum Institute of India and Bharat Biotech in April.

    Several states and UTs including Delhi, Maharashtra, Karnataka and Telangana have decided to opt for global tenders for procurement of anti-coronavirus shots with the domestic supply falling short to meet the rising demand.

    Meanwhile, Delhi’s Deputy Chief Minister Manish Sisodia on Wednesday said Bharat Biotech has informed the Delhi government that it cannot provide “additional” Covaxin doses to the national capital.

    The stock of Covaxin in Delhi has finished and as a result around 100 vaccination centres set up in 17 schools have been closed, he said.

    The Ministry of Science & Technology had said in a statement on April 16 that the production capacity of indigenously developed Covaxin will be doubled by May-June 2021 and then increased nearly 6-7 fold by July-August 2021.

  • ‘Philanthropic gesture’: Serum Institute cuts Covishield cost by Rs 100 for states

    By Express News Service
    NEW DELHI: The Serum Institute of India on Wednesday announced that the price of Covishield per dose for state governments has been reduced from Rs 400 to Rs 300. But there was no mention of its cost reduction to private hospitals indicating it will remain the same.

    As per the statement issued by the company earlier, it had said that states will have to pay Rs 400 per shot of the vaccines while it will cost Rs 600 per shot to private hospitals.

    “As a philanthropic gesture on behalf of Serum Institute of India, I hereby reduce the price to the states from Rs.400 to Rs.300 per dose, effective immediately; this will save thousands of crores of state funds going forward. This will enable more vaccinations and save countless lives,” said the company CEO Adar Poonawalla in a tweet.

    ALSO READ | First batch of Russia’s Sputnik V Covid vaccine to arrive in India on May 1

    Following the price announcement by SII last week, Bharat Biotech had announced that its Covid19 vaccine Covaxin will be available to states at Rs 600 per dose and to private hospitals at Rs 1200 per shot.

    The Centre however has said that it will keep procuring the two vaccines at Rs 150 per shot.

    As a philanthropic gesture on behalf of @SerumInstIndia, I hereby reduce the price to the states from Rs.400 to Rs.300 per dose, effective immediately; this will save thousands of crores of state funds going forward. This will enable more vaccinations and save countless lives.
    — Adar Poonawalla (@adarpoonawalla) April 28, 2021

    This differential pricing and the steep prices announced by the two companies have since triggered a torrent of criticism of the liberalised and decentralised Covid19 vaccination policy by the Centre.

    Under the new policy, from May 1, as vaccinations open to all adults, states and private entities can buy doses directly from manufacturers which will be used for people in the 18-44 age group.

    The Centre however will supply vaccines–50 % of the total vaccines supplied by these companies– only for the priority groups or those above 45 years, healthcare and frontline workers.

  • Government asks Serum Institute, Bharat Biotech to lower price of COVID vaccines: Sources

    Many states have objected to different prices for the vaccines, with Delhi Chief Minister Arvind Kejriwal saying this is not time for profiteering.

  • Four Congress-ruled states express inability to vaccinate for 18-45 group, say Centre hijacked stocks

    By PTI
    NEW DELHI: Fours states ruled by the Congress and its allies Sunday accused the Centre of “hijacking” vaccine stocks from manufacturers, and expressed doubts they would be able to launch the inoculation drive to cover those between 18-45 years of age from May 1.

    They also accused the Centre of meting out “step-motherly” treatment to them, and urged the Union government to provide them free vaccine doses to vaccinate all adults.

    Addressing a virtual joint press conference, the health ministers of Chhattisgarh, Rajasthan, Punjab and Jharkhand (ruled by Congress-JMM alliance) asked as to how they will vaccinate all adults when the Centre has already “taken away the stocks” and shots are not available to them.

    ALSO READ: Registration on CoWIN must for those between 18 and 45 years to get vaccine shot

    They said they are prepared for the next phase of vaccination drive from May 1, but the manufacturers have expressed inability to provide them vaccine shots.

    “How do we vaccinate adults of 18-45 years as Serum Institute has said they will not be able to provide vaccine till May 15,” Rajasthan Health Minister Raghu Sharma said.

    “We have the capacity, but not the vaccine,”he said.

    “States should get the supplies. The Government of India should provide vaccine as per their requirements.” The success of the drive depends on availability of shots, he said.

    Sharma said, “Our demand is that the Centre fully fund the vaccine. How can we fund it from our budget? No provision has been made by us in the budget.” Chhattisgarh Health Minister T S Singh Deo said, “There is no way shots can be administered if the vaccine is not available.

    How will we provide vaccination? We are ready to vaccinate, provided we have the vaccines.

    ” He also alleged politics is being played on vaccination the way prime minister’s photo is put on the certificate of vaccination.

    “The country is being misguided.

    The Centre has made a joke of this,” he said.

    Punjab Health Minister Balbir Singh Sidhu said, “We are being meted out step-motherly treatment.

    The Centre should provide the vaccine and essential life-saving medicines.

    ” “If the Centre does not support us, how can we roll out the vaccination drive? We are only hand-to-mouth on vaccines.

    The Centre should allot the vaccine and provide it to us,” Sidhu said.

    Jharkhand Health Minister Banna Gupta alleged the prime minister is trying to derive political advantage even during this raging pandemic.

    “Step-motherly treatment is being meted out to Congress-ruled states like us.

    The prime minister is politicising everything and we have to fight a dual battle of saving people from coronavirus and fighting politics,” he said.

    “The Centre has hijacked their production capacity (manufacturers’) and struck a deal for Rs 150 per dose.

    The government that talks of one constitution, one tax, are now trying to derive benefits out of pandemic by different pricing of vaccines,” he said.

    “How will we launch (the next phase of vaccination drive), when vaccine makers do not have vaccines, (and) how will they provide us supplies.

    People will ask us to vaccinate, we have set up vaccination centres,” he said, adding the Centre should allow them to purchase Remdesivir from Bangladesh, which is not being allowed.

    “On one side, we are being bound, on the other hand, an impression is being created that there is decentralisation of power to states,” he alleged.

    The Centre last Monday announced its liberalised vaccination policy, making all adults eligible for Covid19 vaccine from May 1 and has asked states to procure vaccines from makers of their own.

  • Modi govt’s vaccine policy allowing Serum Institute to earn ‘super profits’: Experts

    Express News Service
    NEW DELHI: The new Covid vaccination strategy, announced earlier this week, has allowed the Serum Institute of India (SII), a private firm, to dominate the vaccine pricing and policy and earn super profits, experts have pointed out.

    It is also in contradiction of an earlier stated stand by the National Expert Group on Vaccination Administration for Covid, which was in the favour of a single point of procurement for vaccines, many felt.

    The shift in the policy by the Centre now means that states and private hospitals can directly procure 50% of the supplies from vaccine makers while the Centre will aim its drive to fund jabs for those above 45 at select vaccination centres.

    SII, whose product, Covishield, has been the linchpin of India’s Covid vaccination drive so far with over 90% share in total 13 crore plus shots administered so far, has said that it will make available the vaccine at Rs 400 per dose to states and Rs 600 per shot to hospitals from May 1 when all adults in the country will qualify for inoculations.

    The company had signed an agreement to supply nearly 11 crore vaccine doses — between January to April — at Rs 150 per dose to the Centre and its CEO Adar Poonawalla in an interview earlier had indicated that it was recovering the production cost at that rate and was even making normal profit.

    The latest pricing announcement, however, makes it clear that the company is now looking to earn a greater margin on the vaccine, originally developed by AstraZeneca-Oxford University through 97% public funding by the UK government and the European Union.

    SII had earlier announced that it would want to sell Covishield at Rs 1,000 per dose in the private market, pointed out R Ramkumar, an economist with the Tata Institute of Social Sciences in Mumbai who has been closely following the development.

    “Perhaps it could not do it in one go but is clearly looking to maximise its profit and the Centre has succumbed under the pressure,” he said.

    He also stressed that the government, even considering that the vaccine will now cost Rs 400 per dose, will have to spend just Rs 53,000 crore—or 0.2% of the GDP—to incolutate the entire adult population with two doses.

    ALSO READ | Preliminary study shows Covishield protects against double mutant strain: CCMB director Rakesh Mishra

    “Why should the government shy away from doing that in the large public good and lead to a chaos that is about to unfold once states starting vying for the vaccine during a pandemic situation?” he asked.

    Epidemiologist Jammi N Rao dubbed the policy of having two or even 3 different prices for different purchasers as “mad”.

    “From a fiscal point of view state or central government makes no difference, it is ultimately the same taxpayer funded pot of money,” he said and made four points to argue against a system of multiple channels of procurement and differential pricing.

    Firstly, it breaches the principle of universality, Rao said.

    “There is now almost unanimous agreement that a quick and efficient programme of vaccinating the majority of the population offers the best, perhaps the only, means of escaping the chokehold exerted by waves of Covid-19 cases on normal life and economic activity,” he reckoned.

    Secondly, if states are forced to do their own procurement at an additional cost they may well be pushed into charging people for the service, Rao argued saying that it will create a new disincentive for people already impoverished by the economic slump and loss of livelihoods according to him.  

    Also, said Rao, by allowing manufacturers to set their own prices, the country loses the ability of bulk procurement and price negotiations to get the most cost-effective deal.

    The fourth argument put forth by him is that the new procurement policy subtly glosses over the cash injection that the Indian taxpayer has made into the two main vaccine manufacturers—the other one being Bharat Biotech.

     Finance Minister Nirmala Sitharaman had two days back announced that the Centre would fund capacity expansion to the tune of Rs 3000 crores to Serum Institute and Rs 1575 Rs crores to Bharat Biotech.

    “While this is absolutely to be welcomed, one should remember that this cash injection was on behalf of the Indian tax-payer. It is justified therefore to expect that the Indian government — it makes no difference whether it is Centre or states gets a preferential price for the vaccines that the extra capacity will produce,” Rao stressed.

    Some others meanwhile expressed dismay at the SII decision to introduce differential pricing for governments and the private market.

    “I strongly disagree with that unilateral decision,” said K V Babu of the Association of Doctors for Ethical Healthcare.