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Tag: Serum Institute of India

  • Serum Institute seeks test licence from DCGI to manufacture Covid vaccine Sputnik V

    By PTI
    NEW DELHI: The Serum Institute of India (SII) has applied to the Drug Controller General of India (DCGI) seeking permission to manufacture the Sputnik V COVID-19 vaccine for examination, test and analysis at its licensed Hadapsar facility in Pune, official sources said on Thursday.

    The Pune-based firm has collaborated with the Gamaleya Research Institute of Epidemiology and Microbiology, Moscow for developing Sputnik V at its Hadapsar facility.

    On May 18, the SII had also applied to the Review Committee on Genetic Manipulation (RCGM), Department of Biotechnology seeking clearance for the import of strains or seed lots and cell banks and for carrying out research and development, the sources said.

    TheGM has raised certain queries over the SII’s application and sought a copy of the material transfer agreement between the Pune-based firm and the Gamaleya Research Institute of Epidemiology and Microbiology.

    Russia’s Sputnik V vaccine is currently being manufactured by Dr Reddy’s Laboratories in India.

    “The Serum Institute of India (SII) put up an application to the Drugs Controller General of India (DCGI) on Wednesday seeking permission to manufacture COVID-19 vaccine Sputnik V for examination, test and analysis at its licensed Hadapsar facility,” an official source said.

    Once these approvals are received, the SII plans to seek restricted emergency use permission for the vaccine in India.

    The SII has already told the government that it will be able to manufacture and supply 10 crore Covishield doses in June, while it is also manufacturing the Novavax vaccine, the regulatory clearance for which is awaited from the United States.

    The vaccine was given emergency use authorisation (EUA) by the DCGI in April.

    A consignment of 30 lakh doses of Sputnik V landed in Hyderabad on Tuesday.

  • After Pfizer, Serum Institute seeks indemnity over COVID-19 vaccine: Sources

    By ANI
    NEW DELHI: Amid discussions over possible legal protection to foreign vaccine manufacturers Pfizer and Moderna over their COVID-19 jabs in India, the Serum Institute of India (SII) has also sought protection against liabilities, sources said on Thursday.

    “Not just Serum Institute of India, all the vaccine companies should get indemnity protection against liabilities if foreign companies are granted the same,” sources added.

    Earlier last year, SII CEO Adar Poonawala had advocated for indemnity for all vaccine manufacturers.

    “We need to have the government indemnify manufacturers, especially vaccine manufacturers, against all lawsuits… Frivolous claims come up and you see in the media something being blown out of proportion. The government needs to step in with the right messaging,” he had said.

    Amid the nationwide COVID-19 vaccine crunch, US pharma giant Pfizer is seeking an indemnity bond that will exempt it from legal claims in case there are any adverse effects from the vaccine.

    NITI Aayog Member (Health) Dr VK Paul had said on May 27 that the government is still examining the American pharma company’s request for indemnity.

    “We are examining this request and will make a decision in the larger interest of people and on merit. This is under discussion and there is no decision as of now,” he had said.

    No company in India’s vaccination history has ever paid indemnity and the government, which is the biggest user of vaccines, has also not done it, Dr Nirmal K Ganguly, former ICMR chief had said on Wednesday.

    The Drugs Controller General of India (DCGI) had earlier exempted specific trials of COVID-19 vaccines that have been approved by some other international regulatory bodies. This is likely to clear the way of foreign COVID-19 vaccines such as Pfizer and Moderna.

    DCGI Chief VG Somani said in a letter that the decision will be applicable for vaccines that have already been approved for restricted use by the US FDA, EMA, UK MHRA, PMDA Japan or listed for Emergency Use by the World Health Organisation.

    Pfizer said in a statement that it continues to remain engaged with the Indian government towards making its coronavirus vaccine available for use in the government immunisation programme. 

  • 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.

  • HC seeks Uddhav government’s reply on plea seeking Z-plus security for Adar Poonawalla

    By PTI
    MUMBAI: The Bombay High Court on Thursday directed the Maharashtra government to respond to a petition filed by an advocate seeking Z-plus security for Adar Poonawalla, the CEO of the Serum Institute of India (SII) which manufactures the Covishield vaccine against COVID-19.

    The petitioner will have to bear in mind while arguing this matter that “India has a good reputation and such proceedings will have an international impact”, the HC said.

    A vacation bench of Justices S S Shinde and N R Borkar noted that Poonawalla was doing a great service to the nation.

    The Union government has already granted ‘Y’ category security to the Pune-based industrialist.

    The bench said, “He (Poonwalla) is doing a good job. As per our knowledge, he has been given Y-Plus security already. The petitioner is seeking Z-plus security. If it is necessary then the state will give (more security).”

    The HC directed the government to respond to the plea, filed earlier this month by advocate Datta Mane.

    It posted the petition for further hearing on June 1.

    ALSO READ | Serum Institute disassociates itself from its executive’s remarks on Covid vaccination drive 

    Mane in his petition had also sought a direction to police to register an FIR and carry out a probe into the alleged threat to Poonawalla over the supply of vaccine.

    If vaccine makers feel unsafe, it could affect the vaccine production, the petition had said.

    It said Poonwalla and his family left India and went to London due to the threats they had been receiving.

    Poonawalla had said in a recent interview to The Times that he has been receiving threats and pressure from ‘powerful people’ seeking vaccine doses on priority.

    The bench on Thursday also sought to know what locus (standing) did Mane have in filing the petition.

    To this, Mane’s advocate Pradeep Havnur said any person can set the criminal law in motion.

    The court noted that Poonawalla’s father in an interview said he has gone to London for a break.

    “The petitioner will have to bear in mind while arguing this matter that India has a good reputation and such proceedings will have an international impact,” the HC said.

  • Vaccine mix-up: Probe launched after 20 UP villagers get wrong second dose of jabs

    Express News Service
    LUCKNOW: The Uttar Pradesh health department’s vaccination staff has done the unimaginable in Siddharthnagar district – by administering a mix of Covishield and Covaxin vaccines to at least 20 villagers at a primary health centre, even as global researchers are yet to study the impact and effectiveness of mixing jabs from different vaccines.

    The faux pas happened at Badhni Primary Health Center (PHC) in the East UP district neighbouring Nepal, as 20 residents of Audahi Kalan village, who were given the first dose of Serum Institute of India’s (SII) Covishield vaccine on April 1, 2021 were administered the jabs of Bharat Biotech’s Covaxin as their second dose on May 14.

    The chief medical officer (CMO) of Siddharthnagar district, Dr Sandeep Chaudhary accepted that it’s a lapse, as there is no guideline from the union government’s ministry of health and family welfare for the use of cocktail of vaccines on a single beneficiary. 

    “Both, the first and second dose need to be of the same vaccine. After the lapse came to light, a team of senior doctors conducted an inquiry into the entire matter and based on their report, I sought explanation from all those who were found responsible for the lapse. Based on the explanation given by those found responsible in the enquiry, action will either be taken against them from our end or else we’ll recommend to the higher-ups in the state government for action,” the Siddharthnagar district CMO told The New Indian Express on Wednesday.

    “A team of doctors from the district headquarters was also sent to enquire about the health of the villagers who were given first dose of Covishield and second dose of Covaxin. All of them have been found healthy and normal on all important health parameters. We’re keeping a close watch on their health and expect that no health-related problems will happen to them even in future,” Chaudhary said.

    ALSO READ | Covishield seen preventing severe Covid even in breakthrough infections, finds study

    Ram Surat, one of the villagers vaccinated with a cocktail of the vaccines, said, “I got the first jab of Covishield on April 1, but six weeks later on May 14, instead of second dose of Covishield vaccine, the Covaxin jab was given at the PHC. Instead of enquiring about our details of the first dose, the staff at the vaccination center seemed busy in their own things. Till now, I’m fully fit, but also fear that a cocktail of vaccines could cause something wrong in my body in the long run.”

    It was Ram Surat only who brought the fact about him and 19 others getting first and second doses of their COVID vaccines mixed up to the notice of the health workers.

    Meanwhile, the Yogi Adityanath government said in an official statement on Wednesday that the pace of vaccination in UP has picked up significantly this month, hitting a daily record of around 2.66 lakh doses in the last 24 hours. 

    As per the official data, the state has reported more daily jabs than Maharashtra to become the state doing the highest daily vaccinations in the country. Maharashtra has just delivered 1.93 lakh daily jabs on May 25.

    The figures clearly reveal how UP has pushed ahead in providing a safeguard to the maximum number of people against Covid-19, the official statement added. UP has given more than 1.68 crore jabs so far, in which, over 1.34 crore people have been administered the first dose while around 33 lakh people got their second jab. 

    Since May 1, when registrations opened for the category of 18-44, around 13.61 lakh youths have so far been able to receive a jab in the state. In the last 24 hours, around 1,47,048 got their first dose administered in this category.  

  • Serum Institute disassociates itself from its executive’s remarks on Covid vaccination drive 

    By PTI
    NEW DELHI: The Serum Institute has disassociated itself from its executive director’s statement that the government began the COVID-19 vaccination of multiple age groups without taking into consideration the available stock, stating that this is “not the view of the company”.

    In a letter to the Union Health Ministry on May 22, Prakash Kumar Singh, Director of Government and Regulatory Affairs at the Pune-based Serum Institute of India (SII), clarified that the statement by its executive director Suresh Jadav at a recent event is not the view of the company, sources said.

    “On behalf of our CEO Adar C Poonawalla, I want to inform you that this statement is not issued on behalf of SIIPL (Serum Institute of India Private Limited) and the Company completely dissociates itself from this statement.

    It is reiterated that, this is not the view of the company at all.

    “SIIPL is committed to maximise its Covishield production and it stands shoulder to shoulder to strengthen the government’s fight against COVID-19,” he said in a communique.

    SII also clarified that Poonawalla is the only official spokesperson of the company.

    Amid an acute shortage of COVID-19 vaccines in the country, SII executive director Suresh Jadhav on Friday alleged that the government began inoculating people from multiple age groups without taking into account the available stock of vaccines and the WHO guidelines.

  • Government widened COVID vaccination drive without considering stock, WHO guidelines, says Serum Institute

    By PTI
    NEW DELHI: Amid an acute shortage of COVID-19 vaccines in the country, executive director of Pune-based Serum Institute of India (SII) Suresh Jadhav on Friday alleged that the government began inoculating people from multiple age groups without taking into account the available stock of vaccines and the WHO guidelines.

    Speaking at an e-summit organised by Heal Health, a health advocacy and awareness platform, Jadhav said the country should have followed the WHO guidelines and prioritised vaccination accordingly.

    “Initially, 300 million people were to be administered the vaccine for which 600 million doses were required. But before we reached the target, the government opened vaccination for all above 45 years followed by those aged 18 and above despite knowing well that so much vaccine is not available,” Jadhav said.

    “That is the greatest lesson we learnt. We must take into account the availability of the product and then use it judiciously,” added Jadhav.

    ALSO READ | India engaged with US entities for procurement of COVID-19 vaccines: MEA

    Jadhav stressed that vaccination is essential but even after getting jabbed, people are susceptible to the infection.

    “Therefore, be cautious and follow COVID preventive guidelines. Although the double mutant of Indian variants are neutralised, yet variants can create problems in vaccination,” he said.

    “As far as the selection of vaccine is concerned, as per CDC and NIH data, whatever vaccine is available can be taken provided it is licensed by the regulatory body. And it is too early to say which vaccine is efficacious and which is not,” he added.

    Meanwhile, the cumulative number of COVID-19 vaccine doses administered in the country has surpassed 19.32 crore, the Union Health Ministry said on Friday.

    ALSO READ | ‘Time for Modi government to act instead of giving speeches, advice’: Congress attacks PM, Harsh Vardhan

    It said 6,63,353 beneficiaries in the age group of 18-44 years received their first dose on Friday, and cumulatively 92,73,550 across 37 states and UTs since the start of phase-3 of the vaccination drive.

    The 92,73,550 beneficiaries include 11,83,124 from Rajasthan, 10,60,702 from Bihar, 8,85,881 from Delhi, 6,82,744 from Maharashtra, 9,60,032 from Uttar Pradesh, 6,71,800 from Haryana and 6,02,691 from Gujarat .

    The cumulative number of COVID-19 vaccine doses administered in the country stands at 19,32,97,222, according to the provisional report updated till 8 pm.

    The total of 19,32,97,222 include 97,37,237 healthcare workers (HCWs) who have taken the first dose and 66,89,893 HCWs who have taken the second dose.

    It also includes 1,48,63,770 frontline workers (FLWs) who have received the first dose, 83,05,152 FLWs who have taken the second dose, and 92,73,550 individuals in the 18-44 years of age group who have received the first dose.

    Besides, 6,01,86,416 and, 96,79,427 beneficiaries aged 45 to 60 years old have been administered the first and second dose respectively, while, 5,63,74,895 and 1,81,86,882 beneficiaries above 60 years have taken the first and second dose.

    ALSO READ | Two doses of AstraZeneca COVID-19 vaccine 85-90 per cent effective: Public Health England

    As on day-126 of the vaccination drive (21st May), a total of 13,83,358 vaccine doses were given.

    The ministry said 12,05,727 beneficiaries were vaccinated for the first dose and 1,77,631 beneficiaries received the second dose of vaccine as per the provisional report till 8 PM.

    Final reports would be completed for the day by late night.

    The vaccination exercise as a tool to protect the most vulnerable population groups in the country from COVID-19 continues to be regularly reviewed and monitored at the highest level, the ministry underlined.

  • Covishield vaccine supply for Maharashtra unlikely to start from May 20, state to approach Serum Institute

    By PTI
    MUMBAI: Even as the Maharashtra government had earlier said that the state would start getting Covishield vaccine doses May 20 onwards, that possibility appears to be dim as minister Rajesh Tope on Wednesday said they would come to know about the supply once SII CEO Adar Poonawalla returns to India from abroad.

    On May 13, Tope had said that the Serum Institute of India (SII) CEO had promised Maharashtra Chief Minister Uddhav Thackeray that 1.5 crore Covishield doses would be given to the state after May 20.

    When asked about it on Wednesday, Tope, the state Health Minister, said, “Once Poonawalla returns to India, we will come to know about the the availability of the vaccines.”

    The state government has some five lakh vials of Covishield and Covaxin, which is going to be used for completion of second dose as well as first dose of people in above 45 age group, he said.

    The government has also floated a global tender for vaccine procurement, which will remain open till May 25, the minister said.

    However, some of the approvals for procurement of vials need the Centre’s approval, he added.

    “Maharashtra has administered some 2.02 crore doses to people so far, which is the highest in the country. Various measures taken by the state to minimise the infection has resulted into the growth rate being 0.5 per cent. Among 36 states in the country, Maharashtra is at the 34th position (in terms of COVID-19 growth),” he said.

    The states recovery rate is above 90 per cent now, Tope added.

    When asked about recruitment in the health department, the minister said, “The state will finalise the recruitment agency in the next 4-5 days. We will expedite the procedure of recruitment. I have also held meetings with other state departments concerned such as general administration to fill the vacancies by promotion.”

    “Some posts have be filled throuogh promotions and the state government is expediting the process. We are trying to complete the entire exercise within the next two months,” he said.

    According to Tope, the state-run hospitals and medical colleges will have 100 per cent staff once the recruitment drive is over.

  • Covishield new rule tweaks won’t affect pre-booked slots: Government

    By Express News Service
    NEW DELHI: The Centre on Sunday clarified that already booked appointments for second dose of Covishield vaccine will remain valid and the same will not be cancelled on the Co-WIN platform.

    It, however, said requisite changes have now been done in the Co-WIN digital portal, as a result of which further online or on-site appointments will not be possible if the period after first dose date for a beneficiary is less than 84 days.

    The Centre had on May 13 extended the gap between the first and second doses of Covishield vaccine to 12-16 weeks based on the recommendations by the COVID Working Group chaired by N K Arora.​“The Government of India has communicated this change to states and UTs. The Co-WIN digital portal has also been reconfigured to reflect this extension of interval for two doses of Covishield,” the Union health ministry said.

    “However, there have been reports in a section of the media suggesting that people who had pre-booked their appointments for the second dose in less than 84 days on Co-WIN are being turned back from vaccination centres without getting the second dose of Covishield,” it said.

    “Additionally, already booked online appointments for second dose of Covishield will remain valid and are not being cancelled by Co-WIN. Further, the beneficiaries are advised to reschedule their appointments for a later date beyond the 84th day from the date of first dose of vaccination,” the ministry added.

  • COVID-19: Vaccination drive for 18-44 age group to begin in Himachal from Monday

    By PTI
    SHIMLA: The vaccination drive against COVID-19 for the 18-44 age group will begin in Himachal Pradesh from May 17, a health official said on Friday.

    The state recently received 1,07,620 doses of Covishield vaccine from the Serum Institute of India, Pune for this category, Special Health Secretary Nipun Jindal said.

    Vaccination for the 18-44 age group will be given only on Mondays and Thursdays, and slots will be visible on the COWIN portal two days prior to each scheduled session, he said.

    The state has already placed an order for more vaccines for this age group, Jindal added.

    All the eligible persons will have to register themselves and schedule their appointment for vaccination on the COWIN portal, he added.

    The health official said the available slots will be visible on the COWIN portal from May 15.

    HRTC conductors and drivers, fuel pump operators, PDS depot holders, teachers on COVID duty, banks and financial services, chemists, staff of Lok Mitra Kendra, employees in childcare institutions under the WCD department and the workers of pharma industry who are engaged in manufacturing process have now been declared as prioritised group for the anti-coronavirus vaccination, he added.

    These persons should get themselves certified from the departments concerned and they can avail vaccination in the priority group, he added.

    Meanwhile, a total of 21,08,857 people in the state have already been vaccinated till May 13.

    While 16,89,496 persons have been given the first dose, 4,19,361 persons have been administered the second dose.

    Of them, 81,822 healthcare workers got the first dose, while 68,608 HCWs were administered the second dose.

    Similarly, 53,761 frontline workers got the first dose, while 41,322 FLWs administered the second dose.

    In the same way, 8,61,509 persons between 45 and 60 years of age were administered the first dose while 63,939 got the second dose.

    Besides, 6,92,404 persons above 60 years were given the first dose, while 2,45,492 got the second dose.

    The COVID-19 death toll in Himachal Pradesh rose to 2,118 on Thursday with 63 more fatalities, while 4,937 new cases pushed the tally to 1,50,673, a senior official said.

    According to data updated till 7 pm, the number of active cases in the state stands at 40,008.

    The total recoveries in the state have risen to 1,08,503 with 3,817 more people recovering, the official said.