Novavax\, Serum Institute to produce 2 bn Covid vaccine doses under new deal

Novavax, Serum Institute to produce 2 bn Covid vaccine doses under new deal

The U.S. company's vaccine is in mid-stage trials after an early-stage trial showed it produced high levels of antibodies against the novel coronavirus

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Serum Institute of India | Coronavirus | Coronavirus Vaccine

Reuters 

r&d, coronavirus, vaccine, research & development
As part of the expanded agreement, Serum Institute will also manufacture the antigen component of the vaccine, which is dubbed NVX-CoV2373.

US drug developer Novavax Inc said on Tuesday it was doubling its potential Covid-19 vaccine manufacturing capacity to two billion doses annually under an agreement with Serum Institute of India, sending its shares up about 7 per cent.

In August, Novavax signed a deal with Serum Institute, the world's largest producer of vaccines, to produce a minimum of one billion doses of its vaccine candidate, when approved, for low- and middle-income countries and India.

As part of the expanded agreement, Serum Institute will also manufacture the antigen component of the vaccine, dubbed NVX-CoV2373, which Novavax said will bring its manufacturing capacity to over two billion doses by mid-2021.

Novavax's vaccine is currently in mid-stage trials after an early-stage study showed it produced high levels of antibodies against the novel The company plans to begin late-stage trials in the third quarter.

Last month, Novavax said it will supply 60 million doses of its vaccine candidate to the UK beginning as early as the first quarter of 2021.

The company is also preparing to deliver 100 million doses to the United States by January after it was awarded $1.6 billion for its potential vaccine, and has also signed supply agreements with Canada and Japan.

Other drugmakers such as Pfizer Inc and Moderna Inc have already begun large late-stage studies of their experimental vaccines.

Read our full coverage on Serum Institute of India
First Published: Tue, September 15 2020. 23:35 IST
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Novavax\, Serum Institute to produce 2 bn Covid vaccine doses under new deal

Karnataka Govt Requests Striking Doctors to Withdraw Stir as it Agrees to Fulfill Demands
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Karnataka Govt Requests Striking Doctors to Withdraw Stir as it Agrees to Fulfill Demands

For Representation. Police and health officials arrive for inspection at Tipu Nagar in Bengaluru. (PTI)

For Representation. Police and health officials arrive for inspection at Tipu Nagar in Bengaluru. (PTI)

With medical officers refusing to share COVID-19 reports with the government, there was under-reporting of cases in some districts on Tuesday, like- Bagalkote reporting zero cases, Udupi 1 and lesser than usual in others, official sources said.

  • Last Updated: September 16, 2020, 12:23 AM IST

The Karnataka government on Tuesday requested the government doctors to withdraw their agitation over salary hike as it has conceded to their demand,"despite the grim economic conditions." However, the Karnataka Government Medical Officers Association (KGMOA) said they would take a call on withdrawing their agitation after consulting their district units and holding a meeting with the government once again on Friday. Until then, as per their plan, they will boycott meetings and not share COVID-19 data, KGMOA said.

With medical officers refusing to share COVID-19 reports with the government, there was under-reporting of cases in some districts on Tuesday, like- Bagalkote reporting zero cases, Udupi 1 and lesser than usual in others, official sources said. Though the tests and treatment to that infected are going on, the data was not being shared, they said, adding that "we need to see what happens tomorrow." Medical Education Minister K Sudhakar, terming the talks with KGMOA office-bearers as "fruitful", said the government has decided to give in to the demand "to uplift the hardworking doctors." "The doctors have been working hard day in and out.. in the light of this, the Chief Minister has given the nod to all the proposals by the Health Department in the past six months and this too will be fulfilled," he said.

The demand will be addressed and the Finance department has been briefed in this regard, Sudhakar was quoted as saying by his office in a release. "The revision in salaries will be made based on six-year,13-year, and 20-year promotions for the doctors and details on the same will be obtained from the medical officers," he said, adding that even though this was a burden on the government, it would be addressed on a priority basis.

Along with Sudhakar, Deputy Chief Minister C N Ashwath Narayan and Health Minister B Sriramulu was part of the meeting that was attended by senior health department officials. Over 4,900 government doctors working in various health facilities run by the Health and Family Welfare Department are on strike, demanding pay parity with their counterparts in the medical Education Department or pay revision as per theCentral Government Health Scheme (CGHS) scale.

They had decided not to share COVID data online or offline, and to boycott the meetings. KGMOA President Dr Srinivas G A Tuesday said the government had stated it would fulfill their demands.

"We will discuss with office bearers of all our district units tomorrow, and on Friday will hold a meeting with ministers once again and announce our decision." He said their agitation would continue till Friday.

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Novavax\, Serum Institute to produce 2 bn Covid vaccine doses under new deal

No insolvency proceeding for Covid-related default, Sitharaman places Bill in Rajya Sabha - The Financial Express
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No insolvency proceeding for Covid-related default, Sitharaman places Bill in Rajya Sabha

By: |
September 16, 2020 3:30 AM

The Insolvency and Bankruptcy Code (Second Amendment) Bill, 2020, will be made into law once Parliament clears it and replace the Ordinance the validity of which expires in six months.

The government had sought to suspend invocation of three sections – 7, 8 and 10 — of the IBC for fresh default from March 25.The government had sought to suspend invocation of three sections – 7, 8 and 10 — of the IBC for fresh default from March 25.

Finance minister Nirmala Sitharaman on Tuesday introduced in the Rajya Sabha a Bill to replace an ordinance that was promulgated in June to suspend insolvency proceedings for up to one year against fresh Covid-related default from March 25. The move was aimed at providing breather to thousands of firms battered by the pandemic.

The Insolvency and Bankruptcy Code (Second Amendment) Bill, 2020, will be made into law once Parliament clears it and replace the Ordinance the validity of which expires in six months.

The government had sought to suspend invocation of three sections – 7, 8 and 10 — of the IBC for fresh default from March 25. These sections deal with the initiation of the insolvency proceedings by financial and operational creditors and corporate debtors. However, insolvency applications filed for default before March 25 are being entertained.

The cut-off date of March 25 (for filing insolvency application) also came as a relief for the lenders who had filed applications or intended to do so against stressed firms that had defaulted before the pandemic started to spread, in sync with the central bank’s June 7, 2019, circular. According to this circular, a default case will have to be referred to the NCLT under the IBC if no other resolution plan is firmed up within six months.

However, as some analysts have pointed out, the breather will potentially hit financial and operational creditors hard and bleed their balance sheet, apart from temporarily depriving them of a credible mode of bad debt resolution.

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Novavax\, Serum Institute to produce 2 bn Covid vaccine doses under new deal

CSIR Collaborates With Aurobindo Pharma To Develop COVID-19 Vaccines

CSIR Collaborates With Aurobindo Pharma To Develop COVID-19 Vaccines

As per the release issued by the Centre for Cellular & Molecular Biology (CCMB), Aurobindo will partner with CSIR for the development of several novel COVID-19 vaccines.

CSIR Collaborates With Aurobindo Pharma To Develop COVID-19 Vaccines

Aurobindo is already developing a vaccine through its wholly-owned US subsidiary Auro Vaccines

Hyderabad:

The Council of Scientific and Industrial Research (CSIR) and Aurobindo Pharma Limited on Tuesday announced a collaboration to develop vaccines for COVID-19.

As per the release issued by the Centre for Cellular & Molecular Biology (CCMB), under the signed agreement between CSIR- CCMB and Aurobindo Pharma, Aurobindo will partner with CSIR for the development of several novel COVID-19 vaccines.

"Three CSIR labs namely CCMB Hyderabad, Institute of Medical Technology (IMTECH), Chandigarh and Indian Institute of Chemical Biology (IICB), Kolkata are developing vaccine candidates using different technology platforms. Aurobindo will undertake clinical development and commercialization of the vaccines," it said.

Commenting on this partnership, Dr Shekhar C Mande, Director General, CSIR, said that "Joining of hands of premier CSIR labs with industry for the development of vaccines will amplify India's efforts in indigenous vaccine development and also help in preparedness for future pandemics".

Dr. Rakesh Mishra, Director, CSIR-CCMB, while talking about the development strategies for the vaccines said, "Our labs are working on novel proteins for vaccine development that has the potential to address the need for a second-generation vaccine. We are happy to partner with Aurobindo who have proven manufacturing and commercialization capabilities."

Aurobindo Pharma Limited also expresses pride over the collaboration with CSIR for developing vaccines to combat the COVID-19 pandemic and said that is already setting up a large-scale facility in Hyderabad for manufacturing the vaccine.

"We are proud to join hands with CSIR for developing vaccines to combat the COVID-19 pandemic. This collaboration further strengthens our COVID-19 vaccine development efforts. We are already setting up a large-scale facility in Hyderabad for manufacturing COVID-19 vaccine and other viral vaccines," said N. Govindarajan, Managing Director, Aurobindo Pharma Limited.

The release said that apart from this collaboration, Aurobindo is already developing a vaccine for COVID-19 (SARS COV-2) through its wholly-owned US subsidiary Auro Vaccines.

"The SARS COV-2 vaccine candidate is based on the company's proprietary replication-competent, attenuated, recombinant vesicular stomatitis (VSV, VesiculoVax(tm)) vaccine delivery platform," it added.

(This story has not been edited by NDTV staff and is auto-generated from a syndicated feed.)

Novavax\, Serum Institute to produce 2 bn Covid vaccine doses under new deal

Migrants returning to Surat greeted with masks, sanitizers | Surat News - Times of India

Migrants returning to Surat greeted with masks, sanitizers

SGCCI started the ‘shramik aavkar suraksha parva’ from Tuesday
Surat: The Southern Gujarat Chamber of Commerce and Industry (SGCCI) on Tuesday kick-started the four-day long event to welcome the migrant workers arriving in special trains to Surat. It began with the free distribution of sanitizer bottles and face masks under the ‘shramik aavkar suraksha parva’ starting from Tuesday.
The first batch of passengers from Muzzafarpur-Ahmedabad Express train were distributed masks and sanitisers in the presence of municipal commissioner Banchhanidhi Pani and SGCCI president Dinesh Navadiya at the Surat Railway Station on Tuesday.
“Following the strong representation of the SGCCI to the government, special trains carrying migrants from Uttar Pradesh and Odisha have been made operational. About 1,800 workers are coming in a single train due to the social distancing norms. To welcome our workers, we are distributing masks and sanitisers with the message of their safety and protection,” said SGCCI president, Dinesh Navadiya.
“About 10 lakh migrant workforce moved out of the city during lockdown. At present, the textile industry is facing an acute shortage of migrant workers. We need more than 300 trains between Surat and Odisha to bring back the migrant workers. We have urged the central government to start Shramik special trains to bring back the workers,” added Navadiya.
Sources said that the distribution of sanitisers and face masks will continue till September 18.
Many organisations including Mangrol Taluka Industries Association, Sachin Industrial Co-operative Society, Pandesara Weavers Association, Surat Jewellery Manufacturers Association, True Drug Charitable Trust etc. have given their support.

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    Pandemic encouraging small towns to develop co-working office spaces | Mangaluru News - Times of India

    Pandemic encouraging small towns to develop co-working office spaces

    Mangaluru: The pandemic has definitely brought in a change in the way people work. It caused a shift to remote working and has altered the idea of workspace.
    Puttur MLA Sanjeeva Matandoor, on seeing the professionals attached to IT sector working from petty shops or bus shelters due to non-availability of internet signals inside their homes, is encouraging businessmen to launch co-working office spaces.
    IT professionals returned home due to lockdown
    Sanjeeva Matandoor told TOI, “We are encouraging setting up of co-working office spaces in my constituency. Professionals, particularly those in the IT sector, have returned home during the lockdown and are likely to continue working from home at least until the year-end. Though many have opted for Wi-Fi connections, some employees continue to struggle due to lack of proper internet signals at home and come to the town every day to work from shops etc. As I was thinking of setting up co-working office spaces, I met businessmen Keshava Prasad Muliya and Krishna Narayana Muliya who were also thinking on the same lines. They have launched a co-working office space about 15 days ago with eight cabins and 27 cubicles and the demand has been good,” he said.
    Further, the MLA said, the development is also an attempt to project that smaller towns have the capacity to accommodate IT industries.
    This is a win-win situation for both the user and the service provider, and in case this turns out to be a success, we will consider setting up more co-working zones, he said.
    A pilot initiative
    Keshava Prasad Muliya, partner, Muliya Cubic Spaces said: “When we were planning to expand our business in Bengaluru about a decade ago, I worked from a co-working office space in the city and since then having a co-working office space in Puttur has always been in my mind. We have taken this up on a pilot basis.
    “If smaller cities upgrade themselves with IT support system, it is definitely the best place to work — all sans traffic congestion. Government should encourage such projects in smaller towns across Karnataka,” Muliya said.
    100 acres requested for industrial park
    According to an estimate, more than 2,500 people from the taluk are working in the IT and related sectors, mostly in Bengaluru. Meanwhile, under Prime Minister’s Atmanirbhar Bharat Abhiyan, the MLA has requested the government for a 100-acre industrial park in Puttur.

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      Three hit by lightening in Kaushambi, die of burns | Allahabad News - Times of India

      Three hit by lightening in Kaushambi, die of burns

      Prayagraj: Three people, including two sisters and one teenager, died due to lightning in Gauspur and Kazipur village of Puramufti police station area of the neighbouring Kaushambi district, on Tuesday.
      According to reports, four goats and a buffalo too died while around half a dozen people are being treated in hospitals after being injured by the lightening.
      As per reports, Sarla, wife of Shankarlal, a resident of Gauspur in Chail tehsil area had gone to graze the cattle with her daughter Archana (17), Sanjana (10) and Aanchal (06). She was coming back in the evening when sudden lightning struck them. Sarala, Sanjana, Aanchal and Archana came in its grip and Aanchal and Sanjana died due to severe burns.
      Sarla and Archana were admitted to the hospital and are undergoing treatment. Similarly, Rajkaran (15), a resident of Hiralal, Kazipur and who was grazing the goats in the fields also died after being struck by lightning.
      Four goats of Rajakaran have also died. Hussainmai resident Ram Manohar (45) is severely burnt and is hospitalized. As soon as the incident was known, SDM Jyoti Maurya visited Gauspur, Junaidpur and Hussainmai villages.
      Meanwhile, rain was reported in the city also. Several roads, which have poor drainage, were water-logged for hours together while several rural areas witnessed lightening too.
      According to the met department of the Indian Air Force, Bamrauli, the maximum temperature of the city was recorded as 35.6 degree Celsius while the minimum was recorded as 27.5 degrees. The city received 4mm of rainfall.

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        Uproar in Chanda over lack of beds for Covid patients | Nagpur News - Times of India

        Uproar in Chanda over lack of beds for Covid patients

        Chandrapur: There was uproar in the city on Tuesday over lack of beds for Covid patients and private hospitals asking for advance deposits up to Rs1.50 lakh. The Covid total surged to 6,309 with 251 new cases.
        Aam Aadmi Party (AAP) slammed guardian minister Vijay Wadettiwar for the situation and demanded that he stays at the headquarters to tackle the pandemic. AAP delegation met Wadettiwar and told him that the health mechanism in the city has completely collapsed, while private hospitals are seeking exorbitant deposits in advance.
        Party officials demanded immediate arrangement of additional beds and necessary manpower for patients as well as action against private hospitals.
        Wadettiwar agreed that the health department lacks manpower to deal with situation, but said that they will recruit manpower through outsourcing. In a media statement, president of Chandrapur IMA Dr Anil Madurwar clarified that private hospitals are charging as per the directives of the government.
        State health minister Rajesh Tope held a video conference with people’s representatives and officials on Monday evening and directed them ti recruit 50 doctors immediately to deal with the situation. He directed to set up a taskforce for Covid- and take over private ambulances.
        Following instances of unrest among the relatives of critical patients, the guardian minister on directed the officials to install CCTVs in Covid wards and build information centers to brief the relatives.

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          Novavax\, Serum Institute to produce 2 bn Covid vaccine doses under new deal

          Serum Institute Gets Nod To Resume Oxford COVID-19 Vaccine Trial In India

          Serum Institute Gets Nod To Resume Oxford COVID-19 Vaccine Trial In India

          Serum Institute of India has also been asked to submit to the DCGI's office details of medication used in accordance with the protocol for management of adverse events.

          Serum Institute Gets Nod To Resume Oxford COVID-19 Vaccine Trial In India

          SII has partnered with AstraZeneca for manufacturing vaccine candidate for COVID-19 (Representational)

          New Delhi:

          Drugs Controller General of India (DCGI) Dr VG Somani on Tuesday gave permission to Serum Institute of India to resume clinical trial of the Oxford COVID-19 vaccine candidate in the country while revoking its earlier order of suspending any new recruitment for phase two and three trial.

          The DCGI, however, put certain conditions like taking extra care during screening, providing additional information in informed consent and close monitoring for adverse events during follow-up of the study which have to be "scrupulously" followed by Serum Institute of India (SII).

          SII has also been asked to submit to the DCGI's office details of medication used in accordance with the protocol for management of adverse events.

          The DCGI had on September 11 directed Serum Institute of India to suspend any new recruitment in the phase two and three clinical trial of the Oxford COVID-19 vaccine candidate till further orders in the backdrop of pharma giant AstraZeneca pausing the clinical trials in other countries because of "an unexplained illness" in a participant in the study.

          On Saturday, British-Swedish biopharmaceutical giant AstraZeneca and the University of Oxford said clinical trials for their coronavirus vaccine have resumed in the UK after the Medicines Health Regulatory Authority's (MHRA) confirmed that the trials were safe.

          SII, which has partnered with AstraZeneca for manufacturing the vaccine candidate for COVID-19, on Tuesday submitted the recommendations of the Data and Safety Monitoring Board (DSMB), UK and DSMB, India, and requested for permission to restart enrolment in the clinical trial.

          According to Tuesday's order issued by DCGI, the DSMB, UK, recommended that the investigators recommence all immunization in their clinical trials subject to certain conditions.

          DSMB, India, also has recommended to continue the study and enroll the remaining participants in the clinical trial as per protocol subject to certain conditions.

          According to the order, SII has submitted revised participant information sheet, revised informed consent form and additional safety monitoring plan for the evolved participants.

          The Pune-based firm has also submitted a summary of safety follow up of seven days post first vaccination, stating that no serious adverse events were experienced by any of the subjects till the date of the reporting, and the reported adverse events were stated to be mild, resolved on their own and did not have any sequale.

          "In view of the above, I Dr V G Somani, Drugs Controller General of India, Central Licensing Authority, after careful examination of your reply and the recommendations of the DSMB in India and in UK revoke herewith the order dated September 11 issued under Rule 30 of the New Drugs and Clinical Trials Rules, 2019.

          "You may recommence the clinical trial as recommended by DSMB, India, as per already approved protocol and the provisions laid down under the New Drugs and Clinical Trial Rules, 2019, subject to the conditions mentioned," the order said.

          (Except for the headline, this story has not been edited by NDTV staff and is published from a syndicated feed.)

          Novavax\, Serum Institute to produce 2 bn Covid vaccine doses under new deal

          Consumer forum hears over 300 cases virtually | Thiruvananthapuram News - Times of India

          Consumer forum hears over 300 cases virtually

          Thiruvananthapuram: Kerala state consumer disputes redressal commission has held online hearing of more than 300 cases since the imposition of the lockdown. The state commission was the first to switch to online hearing in the country, though the national commission has recently mooted the virtual option to circumvent the hurdles posed by Covid-19 related restrictions.
          According to the commission authorities, it had started hearing cases through videoconferencing on April 14. “The commission hears 10 to 12 cases per day on an average. On certain days the number goes up to 15. The cases taken up for virtual hearing are those which require high priority,” commission authorities said. The commission chaired by Justice K Surendra Mohan has jurisdiction in Kerala as well as Lakshadweep. The commission directly accepts complaints amounting to consumer loss claimed between Rs 1 crore and Rs 10 crore. It also adjudicates appeals filed on orders passed by district commissions all over the state.
          The virtual hearing schedule is same as the physical schedule as per which the commission works from 11.30 am to 3.30 pm. “During pre-Covid days, the commission used to organize physical hearing of up to 20 cases a day. The number of cases being filed in the commission too has come down following the Covid restrictions, prompting the commission to receive complaints online.
          “If 100 to 150 complaints, including appeal petitions, used to come up every day during the pre-Covid period, it has now come down to 50-60 per day. That’s why the commission has now started accepting complaints online,” said commission court officer H Sajeer.
          Complaints can be filed online by sending a scanned copy of the petition to the commission email address cdrckerala@gmail.com. The hard copy of the complaint with mandatory documents have to be sent to the commission.
          For details about the procedures for submitting complaints online, contact: 7012156758, 9557584730.

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            India wants Queen's Counsel for Jadhav; Harish Salve fits the bill | India News - Times of India

            India wants Queen's Counsel for Jadhav; Harish Salve fits the bill

            India has asked Pakistan for appointment of a Queen's Counsel (QC) as lawyer for Kulbhushan Jadhav in the ICJ-mandated, ongoing review of his death sentence in Islamabad High Court.
            Senior advocate and former Solicitor General Harish Salve is the natural choice for India as he's the only Indian lawyer to be appointed Queen's Counsel in recent times.
            As per its legal definition, Queen's Counsel is a barrister, or advocate, appointed Counsel to the Crown on the recommendation of the Lord Chancellor and is entitled to sit within the Bar of the court and wear a silk gown.
            Salve, who represented Jadhav at ICJ too, was appointed Queen's Counsel for the courts of England and Wales in January this year. While he still practises in India, he's based out of London mostly now.
            While Islamabad has rejected the demand for an Indian lawyer, saying that only a lawyer with licence to practice in Pakistan can represent Jadhav, India believes that a Queen's Counsel may be a way out of this impasse if Pakistan is serious about the Jadhav review.
            Salve's defence of Jadhav saw the ICJ asking Pakistan for an effective review and reconsideration of the death sentence awarded to him by a military court and also upholding India's demand for consular access to Jadhav.
            As Salve himself explained in an interview to ToI earlier this year, the title of QC is recognised all over the world.
            "People know you have to be of a particular class to be recognised by the English system as a QC, so it gives you that kind of stature. Otherwise, how does a client in the Middle East or Malaysia know you are a good lawyer? I am given to understand there is no other Indian citizen practising in both countries who is a QC, but I am not sure, as that would require a lot of research," he had said.
            As a directive by the Islamabad High Court, Pakistan had asked India to appoint a lawyer and join the court proceedings. India has laid down 3 conditions though for doing so. First, Pakistan must allow an Indian lawyer to represent Jadhav. Second, India must be allowed access to all relevant case documents and, third, unconditional or private access to Jadhav.
            Meanwhile, reports from Islamabad said Tuesday, that Pakistan's Parliament had extended for 4 months an ordinance that allowed Jadhav to file an appeal against his conviction in the high court.
            Dawn News reported that The International Court of Justice (Review and Reconsideration) Ordinance promulgated in May was set to expire on September 17 but the National Assembly on Monday through a voice vote extended it for four months.

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