News Analysis India

Tag: Covishield

  • Covid-19 vaccination coverage above 60% in 13 states, below 40% in 12 others

    Express News Service
    NEW DELHI: As the number of Covid-19 vaccinations crossed the 56 lakh mark on Saturday, Union Health Secretary Rajesh Bhushan reviewed the status and progress of the immunisation drive and urged states to improve the number of average vaccinations per session.

    Of the total figure, 52,66,175 beneficiaries are healthcare workers and 3,70,693 are frontline workers. There are 13 states and UTs in India now where at least 60% of the targeted healthcare workers have received the first jabs while this percentage is less than 40 in 12 states and UTs.

    In the review meeting, the state health secretaries were asked to analyse the daily variation in the number of average vaccinations and take necessary steps to increase them.

    Health secretary Rajesh Bhushan also asked states to ensure 100% saturation of people who have already been registered on CoWin digital platform and also advised them to organise simultaneous vaccination sessions every day in the health facility wherever possible. 

    ALSO READ | 25 countries in queue for ‘Made in India’ COVID-19 vaccine: EAM Jaishankar

    Every state was directed to ensure that all healthcare workers should be scheduled for vaccination at least once before February 20 and immediately thereafter mop-up rounds should be organised for them.

    Similarly, all frontline workers must be scheduled for vaccination at least once before March 6 and immediately thereafter organise mop-up rounds for them, states were told.

    The failure of potential beneficiaries to get vaccinated in the mop-up round would automatically push them to the age-appropriate vaccination category, said Bhushan.

    The Centre is looking to launch Covid-19 vaccination for people above 50 in March and administration of the second and final shots of the vaccines for beneficiaries, who have got the first jabs, will begin on February 13.

    The Union Ministry of Health and Family Welfare said in a statement that India is the fastest country to reach the five million Covid-19 vaccination mark — in 21 days. “Several other countries which have had a head start have taken a longer time, some as much as 60 days, to reach this target,” it said. 

  • 165 lakh COVID vaccine doses procured so far at cost of Rs 350.25 crore: MoS Health Ashwini Choubey

    By PTI
    NEW DELHI: A total of 165 lakh doses of COVID-19 vaccines – Covishield and Covaxin – have been procured so far at a cost of Rs 350.25 crore, Minister of State for Health Ashwini Choubey told Lok Sabha on Friday.

    Giving out the details of the number of vaccines already procured by the government, Choubey, in a written reply, said only two vaccines namely Covishield manufactured by the Serum Institute of India and Covaxin manufactured by Bharat Biotech International Limited have so far been granted permission for restricted use in emergency situation by the Drugs Controller General of India.

    “Therefore, only these two vaccines have been procured for COVID-19 vaccination drive in the country. A total of 165 lakh doses of COVID-19 vaccine have been procured so far, of which 110 lakh doses are of Covishield and 55 lakh doses are of Covaxin vaccine. The total cost of procurement of above mentioned doses of vaccines is Rs 350.25 crore,” he said.

    Choubey clarified that no pre-procurement agreements have been entered into.

    In response to a question on the logistical hurdles in deployment of these vaccines, including storage and transportation, the minister said there are no logistical hurdles in the deployment of these vaccines, including storage and transportation.

    The existing infrastructure under Universal Immunization Programme is being used and simultaneously strengthened for deployment of vaccines, including storage and transportation.

    A National Expert Group on Vaccine Administration for COVID-19 (NEGVAC) has been established, which provides guidance on all aspects of COVID-19 vaccination, including prioritisation of population groups, procurement and inventory management, vaccine selection, vaccine delivery and tracking mechanism.

    The introduction of the vaccine is being taken up in a phased manner starting with priority groups of healthcare workers and frontline workers, subsequent to this, NEGVAC recommends covering prioritised groups of persons aged 50 years and above and those aged less than 50 years with comorbidities.

    A ‘Task Force on Focused Research on Corona Vaccine and other Science and Technology Issues’ chaired by Principal Scientific Advisor (PSA) is facilitating research and development of vaccines, drugs, diagnostics and other related issues.

    The Central Drugs Standards Control Organization (CDSCO) has granted permission to manufacture both Covishield and Covaxin as per the New Drugs and Clinical Trials Rules, 2019 under the Drugs and Cosmetics Act, 1940.

    As far as Covaxin is concerned, Bharat Biotech had submitted interim safety and immunogenicity data of phase I and II clinical trials carried out in the country along with safety data, including Serious Adverse Event (SAE) data, of the ongoing phase III clinical trial in the country.

    The data was reviewed by the Central Drugs Standard Control Organisation (CDSCO) in consultation with Subject Expert Committee (SEC) comprising domain knowledge experts. The committee noted that this vaccine is inactivated whole virion coronavirus vaccine having potential to target mutated coronavirus strains.

    The data demonstrated a strong immune response (both antibody as well as T cell) and in-vitro viral neutralisation. The ongoing clinical trial is a large trial on 25,800 Indian subjects in which all the subjects have already been enrolled.

    ALSO READ| COVID vaccine: Pfizer withdraws Emergency Use Authorisation application in India

    Moreover, the firm presented the safety and efficacy data from non-human primate challenge study also to CDSCO, where the vaccine has been found to be safe and effective. “After detailed deliberations, SEC recommended grant of permission for restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode, to have more options for vaccinations, especially in case of infection by mutant strains,” Choubey said in response to another question.

    Based on the recommendations of SEC, CDSCO has granted permission to Bharat Biotech International Limited, Hyderabad to manufacture Covaxin vaccine for restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode with various conditions/restrictions.

    The Serum Institute of India, Pune has submitted safety immunogenicity and efficacy data of phase II/III clinical trials of AstraZeneca vaccine carried out in the UK, Brazil and South Africa along with the safety and immunogenicity data from the ongoing phase II/III clinical trial in the country.

    The Subject Expert Committee (SEC) of CDSCO reviewed the proposal of restricted emergency use along with above details and the data received. The Medicines and Healthcare products Regulatory Agency (MHRA) approval for AstraZeneca vaccine on December 30 last year along with its conditions/restrictions was also reviewed by the committee.

    The committee noted that the safety and immunogenicity data presented by the firm from the Indian study is comparable with that of the overseas clinical trial data.

    Based on the recommendations of SEC, CDSCO granted permission to Serum Institute of India to manufacture Covisheild vaccine for restricted use in emergency situation with various conditions/restrictions.

    Furthermore, CDSCO has granted permission to conduct clinical trials of COVID-19 vaccines either manufactured in the country or outside the country. So far, as Serious Adverse Events (SAE) are concerned, 51 SAEs have been received by CDSCO from various clinical trials of COVID-19 vaccine.

  • Government places second purchase order with SII for one crore doses of Covishield

    By PTI
    NEW DELHI: The Centre on Wednesday placed a second purchase order with the Serum Institute of India for the supply of one crore doses of Oxford-AstraZeneca COVID-19 vaccine ‘Covishield’, each costing Rs 210, including GST, sources said.

    The HLL Lifecare Limited, a public sector undertaking, on behalf of the Union health ministry issued the supply order in the name of Prakash Kumar Singh, Director, Government and Regulatory Affairs at Serum Institute of India (SII), Pune.

    The government had on January 11 placed an order for 1.1 crore doses of Covishield at a cost of Rs 231 crore, which has now risen to Rs 441 crore with the second order placed on Wednesday, a source said.

    The government had on January 11 also committed to buy from the Serum Institute 4.5 crore doses of the vaccine, in addition to the first order of 1.1 crore doses.

    India has approved two COVID-19 vaccines–Covishield manufactured by SII and indigenously developed Covaxin of Bharat Biotech–for restricted emergency use in the country.

  • No data generated with Covishield, Covaxin on ‘European’ strain of coronavirus, Rajya Sabha told

    By PTI
    NEW DELHI: No data has been generated with Covishield and Covaxin vaccines specifically on the new “European” COVID-19 virus strain, Union Minister Ashwini Choubey said on Tuesday.

    Two strains of the coronavirus that originated in the United Kingdom and South Africa have already spread in several countries around the globe.

    To a question on whether the Covishield and Covaxin are able to provide protection from the new coronavirus variant that was traced in the UK, Choubey told Rajya Sabha, “At present, there is no data generated with the above vaccines specifically on new European COVID-19 virus strain.”

    The Oxford-AstraZeneca COVID-19 vaccine Covishield is being produced in this country by Serum Institute of India while Covaxin has been developed indigenously by Bharat Biotech.

    “However, in the case of the proposal of Bharat Biotech International Limited, during consultation, the Subject Expert Committee (SEC) of the CDSCO noted that the Inactivated Whole Virion Coronavirus vaccine has potential to target mutated coronavirus strains,” the Union minister of state for health said in a written reply.

    The Central Drugs Standard Control Organisation (CDSCO) under the Ministry of Health has given approval to Serum Institute of India for manufacture of its COVID-19 vaccine for restricted use in emergency situation with various conditions and restrictions.

    It has also granted permission to Bharat Biotech for manufacturing its COVID-19 vaccine for restricted use in emergency situations in public interest as an abundant precaution in clinical trial mode with various conditions and restrictions.

    Choubey said many countries in Europe and the Americas are witnessing a resurgence in the number of COVID-19 cases.

    The United Kingdom reported a new variant of SARS-CoV-2 to the World Health Organization on December 14.

    Currently in the UK this new variant has become the dominant circulating virus, he said.

    As on January 29, about 61 countries (including the United Kingdom) have reported this variant of the virus, Choubey said.

    According to the health ministry, India till January 29 reported 166 cases of the UK strain.

    Elaborating on the steps taken by the government to prevent spread of coronavirus in the country, Choubey said all flights to the UK were banned from December 23 to January 7.

    Resumption of limited international flight services to and from the UK has been allowed with effect from January 8 in a calibrated manner by initially allowing flight movement to and from Delhi, Mumbai, Bengaluru, Hyderabad and Chennai only.

    “All passengers arriving from the UK should carry negative RT-PCR test report for which the test should have been conducted within 72 hours prior to undertaking the journey,” he said, adding all international passengers who arrived in India from UK or transit through UK are again mandatorily tested for COVID-19 by RT-PCR at the airport.

    “All passengers and their contacts who tested positive for RT-PCR are isolated, their samples are sent for whole genome sequencing to detect UK variant. All international passengers who test negative at airports are quarantined for 14 days,” Choubey said.

  • Relief for SII as court rejects trademark-violation plea over ‘Covishield’ 

    By PTI
    PUNE: A local court has rejected an application seeking injunction against the use of `Covishield’ as brandname by the vaccine-maker Serum Institute of India (SII), the company said on Saturday.

    SII is producing a coronavirus vaccine named Covishield, co-developed by the University of Oxford and British-Swedish company AstraZeneca.

    The Indian government has purchased 11 million doses of Covishield vaccine.

    While the court order was not available immediately, the lawyer of Cutis-Biotech, which had filed the suit, said it would file an appeal in the high court.

    On January 4, Cutis-Biotech, a pharmacertical firm, filed a suit in the civil court claiming it was a prior user of the brandname Covishield, and sought to restrain SII from using the name.

    SII had told the court that the two companies operate in different product categories and there is no scope for confusion over the trademark.

    “Court has rejected the application,” said SII’s lawyer Hitesh Jain.

    Advocate Aditya Soni, lawyer of Cutis-Biotech, said the order copy was not yet available, but operative order was read out in the court.

    “We will file an appeal against the order in the high court,” he said.

  • Serum Institute applies for trials of another COVID-19 vaccine

    By PTI
    PUNE: Serum Institute of India (SII) CEO Adar Poonawalla on Saturday said his company has applied to start the trials of another COVID-19 vaccine and that it hopes to launch it by June 2021.

    The city-based firm has already produced Covishield vaccine, co-developed by the University of Oxford and British-Swedish company AstraZeneca.

    The Centre has purchased 11 million doses of Covishield vaccine for the ongoing inoculation drive.

    ALSO READ: Inside the world’s biggest vaccine factory, India’s Serum Institute

    In a tweet, Poonawalla said, “Our partnership for a COVID-19 vaccine with @Novavax has also published excellent efficacy results.

    We have also applied to start trials in India. Hope to launch #COVOVAX by June 2021!”

    Our partnership for a COVID-19 vaccine with @Novavax has also published excellent efficacy results. We have also applied to start trials in India. Hope to launch #COVOVAX by June 2021!
    — Adar Poonawalla (@adarpoonawalla) January 30, 2021

    The country launched its COVID-19 vaccination drive from January 16 in what Prime Minister Narendra Modi has called the world’s largest inoculation programme with priority to be given to nearly three crore healthcare and frontline workers.

  • Let’s have a duel: Amit Shah slams COVID-19 vaccine critics in Assam event

    By PTI
    GUWAHATI: Union Home Minister Amit Shah on Saturday lambasted those who have been criticising the efficacies of COVID-19 vaccines, saying that there should be no politics on public health.

    At a function in Guwahati to extend the benefit of the central health insurance programme to all the armed police forces in India by launching ‘Ayushman CAPF’, Shah urged the personnel to get inoculated when their turn comes.

    “There are some people who are spreading misinformation on vaccine. Come to another platform and let’s have a duel. But why are you creating doubt over people’s health and doing politics? There are other issues for that,” he said.

    Shah said the vaccines developed by Indian scientists are fully safe and the personnel from all forces will be vaccinated after health workers are covered.

    “I appeal to all of you to go for the vaccine when your turn comes. Do not have any doubt over its efficacy. We’ve already launched the world’s biggest vaccination drive,” he said.

    Shah ceremoniously distributed the ‘Ayushman CAPF’ health cards among some personnel from the seven Central Armed Police Forces here.

    He said that the personnel of the CAPFs had three prime concerns — the existing health coverage was not comprehensive, the satisfaction of housing was not there and long duty hours without leaves.

    “Our government is addressing all three concerns. For the health issue, we’ve launched the Ayushman CAPF today. This will give health insurance to around 50 lakh people in 24,000 hospitals, including 14,000 private ones, across the country,” Shah said.

    By May 1, the Ayushman CAPF process will be completed by offering health cards to all the personnel of the seven Central police forces, he added.

    The Union minister said that the government and authorities of forces are trying to increase the satisfaction ratio of the personnel to 55 per cent by 2022 from 36 per cent two years ago, and further take it to 65 per cent by 2024.

    “We’ve completed the examination process for 50,000 recruitments. Now, we’ll start the process again to hire another 50,000 persons in the CAPFs. Our target is one hiring against one departure in five years. With this, everyone will be able to stay at home for 100 days in a year,” he added.

    An MoU was signed between the National Health Authority (NHA) and Union Home Ministry in presence of Shah, Assam Chief Minister Sarbananda Sonowal, Union Minister of State for Home Affairs Nityanand Rai and state Health Minister Himanta Biswa Sarma at the CRPF Group Centre in Guwahati.

    Shah said that launching the ambitious scheme on the 125th birth anniversary of Netaji Subhash Chandra Bose is a matter of big satisfaction for him and the union government.

    “Prime Minister Narendra Modi has decided that we’ll celebrate Netaji’s birthday as ‘Parakram Diwas’ every year. And today, we’re launching a new scheme for the ‘parakrami’ jawans of the CAPFs. We can’t have a better day than this,” he said.

    Under the initiative ‘Ayushman CAPF’, around 28 lakh personnel from Central Armed Police Force (CAPF), Assam Rifles and NSG and their families will be covered by ‘Ayushman Bharat: Pradhan Mantri Jan Arogya Yojana’ (AB PM-JAY).

    CRPF Director General A P Maheshwari expressed his gratitude for bringing the CAPFs under AB PM-JAY scheme.

    The Union home minister also virtually inaugurated Sashastra Seema Bal’s (SSB) 168 quarters, a 10-bedded hospital and an administrative building located at different places of Assam.

  • Seven more states to administer Covaxin from next week: Health Ministry

    By PTI
    NEW DELHI: Seven more states will be administering the indigenously-developed Covaxin from next week, the health ministry said on Saturday.

    The Drugs Controller General of India (DCGI) had earlier this month approved Oxford COVID-19 vaccine Covishield, manufactured by the Serum Institute of India, and indigenously developed Covaxin of Bharat Biotech for restricted emergency use in the country, paving the way for a massive inoculation drive.

    Addressing a media briefing, Additional Secretary in the Union health ministry Manohar Agnani said that as on January 23, a total of 15,37,190 beneficiaries have been vaccinated for COVID-19 in 27,776 sessions.

    The inoculation drive was launched on January 16 with over three crore healthcare and frontline workers prioritized to get the jabs initially.

    In addition to the 12 states currently using Covaxin, seven new states — Chhattisgarh, Gujarat, Jharkhand, Kerala, Madhya Pradesh, Punjab and West Bengal — will be administering the vaccine from next week, Agnani said.

    “The orientation of all programme managers of these seven states was conducted today by the ICMR (Indian Council of Medical Research) and the health ministry covering all aspects of implementation protocols,” he said.

    Giving updates on the ongoing COVID-19 vaccination drive, he said that “1,46,598 beneficiaries were vaccinated till 6 pm today and 123 adverse event following immunisation were reported till 6 pm on the eighth day of the vaccination drive.”

    No case of serious or severe adverse event following immunisation or death attributable to vaccination has been reported till date, the official said.

    “Total six deaths have been reported so far (post-vaccination). In the last 24 hours, a person aged 56 years, a resident of Gurgaon, has died. The postmortem confirms that cardio-pulmonary disease was the reason for her death and it was not related to vaccination. None of these deaths have been causally linked with COVID-19 vaccination,” he said.

    Agnani said 11 hospitalisations post vaccinations have been reported till date.

    “About 0.0007 per cent people have recorded hospitalisation against vaccinations. In the last 24 hours, one person has been hospitalised at a government hospital in Guntur in Andhra Pradesh who was vaccinated on January 20,” he said.

    Agnani said training of Immunization Programme Managers of 13 countries — Bahrain, Bangladesh, Bhutan, Brazil, Maldives, Mauritius, Mongolia, Morocco, Myanmar, Nepal, Oman, Seychelles and Sri Lanka — using Indian vaccines was conducted by the health ministry, covering all aspects of vaccine roll-out, over two days.

    Of the 1,46,598 vaccinations carried out on Saturday, the highest number of people were inoculated in Gujarat (22,063) followed by Maharashtra (21,751), Odisha (14,892), Bihar (12,165) and Andhra Pradesh (11,562), according to ministry data.

  • Inside the world’s biggest vaccine factory, India’s Serum Institute

    By AFP
    PUNE: The tiny clinking vials supervised by silent PPE-wearing technicians belie the excitement inside the world’s largest vaccine manufacturer, the Serum Institute of India, a major player in the fight against coronavirus.

    The firm, founded in 1966 in the western city of Pune, is producing millions of doses of the Covishield vaccine, developed by AstraZeneca and Oxford University, for India and much of the developing world.

    Unlike the rival Pfizer-BioNTech vaccine, Covishield can be stored and transported using standard refrigeration. 

    It is also significantly cheaper than the vaccines developed by Pfizer or the US firm Moderna, making it better suited for countries with poorer populations and rusty infrastructure.

    Even before the pandemic, the Indian firm was a world leader in vaccines, producing 1.5 billion doses a year and inoculating two out of three children in 170 countries against diseases such as polio, mumps, meningitis and measles.

    Its journey kicked off on a stud farm, where the firm’s owners, the Poonawalla family, began breeding horses in 1946, before a conversation with a vet sparked the realisation that anti-toxin serum extracted from the animals could be used to make vaccines.

    The Serum Institute soon became a market leader thanks to its cheap and effective drugs, which were eagerly sought after by price-conscious governments and consumers, prompting the company to expand at a dizzying rate.

    Adar Poonawalla, its 40-year-old CEO, has spent nearly a billion dollars in recent years enlarging and improving the sprawling Pune campus.

    As a result, when the coronavirus pandemic began to sweep across the world, the company, which recorded annual revenues of over $800 million in 2019-20 and is debt-free, was in pole position to reap the rewards.

    ‘Used to pressure’

    The palm-fringed Pune campus, whose grounds boast horse-shaped topiaries in a playful nod to the firm’s origins, is home to several buildings where vaccines are manufactured and scrutinised for quality before being deposited into sterilised vials and stored for delivery.

    From Brazil to South Africa, there is no shortage of customers, with governments clamouring to buy Covishield.

    With Poonawalla vowing to reserve 50 percent of Covishield stocks for the Indian market, New Delhi, which intends to immunise 300 million people by July, is engaging in a bout of vaccine diplomacy, planning to supply 20 million doses to its South Asian neighbours.

    The Serum Institute also plans to supply 200 million doses to Covax, a World Health Organization-backed effort to procure and distribute inoculations to poor countries. 

    If all this sounds overwhelming, the firm’s bosses are not worried.

    “We are used to these kinds of pressures because even in the past there were situations when we were required to step up the production to meet individual countries’ requirements,” Suresh Jadhav, Serum Institute’s executive director, told AFP.

    Even a deadly fire at an under-construction building this week failed to dent confidence, with Poonawalla promptly tweeting that “there would be no loss of #COVISHIELD production due to multiple production buildings that I had kept in reserve to deal with such contingencies”.

    The pandemic has transformed Poonawalla’s public profile, from a jet-setting billionaire known for his expensive taste in cars and fine art to a pharma-tycoon applauded for his willingness to take risks and his commitment to affordable vaccines.

    Unsurprisingly, the father-of-two has not held back from taking so-called anti-vaxxers to task, including berating US rapper Kanye West for spreading conspiracy theories.

    “Though we enjoy your music very much @KanyeWest, your views on #vaccines come across as irresponsible and borderline dangerous, considering the influence you have today and may have in the future; vaccines save lives,” Poonawalla tweeted in July.

  • Court order in ‘Covishield’ trademark lawsuit likely on January 30

    By PTI
    PUNE: A Pune court hearing a suit filed by a pharmaceutical firm over the brand name ‘Covishield’, used by the Serum Institute of India (SII) for its COVID-19 vaccine, is likely to deliver its order in the case on January 30.

    Cutis-Biotech had filed the suit in the civil court on January 4, seeking to restrain the SII from using the trademark Covishield or any other similar names for its COVID-19 vaccine and claimed the pharma firm is a prior user of the brand name.

    On Tuesday, the SII had filed its response to the lawsuit, stating that both the firms operate in different product categories and there is no scope for confusion over the trademark.

    Advocate S K Jain, representing the SII, said he argued in the court on Friday that Cutis-Biotech had filed another application before the trademark registry for a vaccine in the name of Covishield in December 2020.

    “However, SII applied for the trademark in June 2020. Thus, SII becomes the prior and first user of the trademark Covishield,” said Jain, adding that he also presented some material which showed that the work of printing the material having the name of Covishield had begun in March last year itself.

    “In such a scenario, SII becomes the first user of the trademark,” Jain said.

    Jain said the case filed by the plaintiff should be dismissed as it had cheated the court by not revealing all the information related to the second application of December last year before the trademark registry for a vaccine under the name Covishield.

    Advocate Aditya Soni, representing Cutis-Biotech, countered the SII lawyer’s argument about product distinction, and said it was not necessary that the products should be identical and it was sufficient if the goods are similar, he said.

    Soni said he had cited some judgements to counter the SII’s lawyer’s point that the plaintiff firm did not reveal the details about their December 2020 application.

    “It is irrelevant to attach the documents (related to the application made by Cutis-Biotech to trademark registry for a vaccine under the name Covishield) to the present case,” Soni said.

    After hearing both sides, Additional Sessions Judge A V Rotte kept the hearing on January 30 when the order is expected to be delivered in the case.