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Tag: Serum Institute of India

Covid-19: Panel for nod to P-2/3 vaccine trials for 2-17-year-olds | India News – Times of India
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Covid-19: Panel for nod to P-2/3 vaccine trials for 2-17-year-olds | India News – Times of India

NEW DELHI: An expert panel of India’s Central Drug Authority on Tuesday recommended granting permission to Serum Institute of India for conducting phase 2/3 trials of Covid vaccine Covovax on kids aged 2 to 17 years with certain conditions, official sources said. The trials would cover 920 children, 460 each in the age-group of 12-17 and 2-11 across 10 sites. “The Subject Expert Committee on Covid-19 deliberated on the revised study protocol application given by SII on Tuesday and recommended granting permission to the firm for conducting phase 2/3 trial of Covovax on kids aged 2 to 17 years,” a source said. Source link
No application received for EU authorisation of Covishield, says European Medicines Agency | India News – Times of India
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No application received for EU authorisation of Covishield, says European Medicines Agency | India News – Times of India

NEW DELHI: The European Medicines Agency (EMA) said it has not received any application from the Covid-19 vaccine Covishield maker Serum Institute of India (SII) for authorisation. "For the Covid-19 vaccine Covishield to be evaluated for use in the EU, the developer needs to submit a formal marketing authorisation application to EMA, which to date has not been received," the EMA said at a press briefing. The EMA has approved Pfizer BioNTech's Comirnaty, Moderna's Spikevax, AstraZeneca's Vaxzevria and Johnson and Johnson's Janssen as vaccines for Covid-19. SII was confident of receiving approval from the European Medicines Agency (EMA) for its Covid-19 vaccine Covishield in a month, the company's CEO Adar Poonawalla had earlier said. Speaking at India Global Forum 2021, Poonawalla said, ...
Immunized but banned: EU says not all Covid vaccines equal – Times of India
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Immunized but banned: EU says not all Covid vaccines equal – Times of India

LONDON: After Dr. Ifeanyi Nsofor and his wife received two doses of AstraZeneca's coronavirus vaccine in Nigeria, they assumed they would be free to travel this summer to a European destination of their choice. They were wrong. The couple and millions of other people who have been vaccinated through a UN -backed effort - could find themselves barred from entering many European and other countries because those nations don't recognize the Indian-made version of the vaccine for travel. Although AstraZeneca vaccine produced in Europe has been authorized by the continent's drug regulatory agency, the same shot manufactured in India hasn't been given the green light. EU regulators said AstraZeneca hasn't completed the necessary paperwork on the Indian factory, including details on its produc...
Mumbai: City hospitals to soon start trials of new Serum vaccine and ZyCoV-D for children
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Mumbai: City hospitals to soon start trials of new Serum vaccine and ZyCoV-D for children

HOSPITALS IN Mumbai are in the process to conduct trials for new vaccines against Covid-19. KEM hospital is slated to begin trial for Phases II and III of Covovax for adults while Nair hospital will soon start with Phase-III trial of ZyCoV-D vaccine for children. Mumbai’s JJ hospital has finished enrolment of adult participants for ZyCoV-D vaccine candidate and is now studying efficacy data. Both KEM and Nair hospitals are in the final phase of receiving approval from their ethics committee. Covovax, manufactured by Serum Institute of India (SII), will undergo a Phase II/III trial to measure safety and immune response across 20 hospital sites. Of those, eight sites are in Maharashtra. The trial was registered in February. Dr Hemant Deshmukh, dean of KEM hospital, said they ...
Bharat Biotech: Covaxin is 77.8% effective, provides 65.2% protection against Delta variant | India News – Times of India
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Bharat Biotech: Covaxin is 77.8% effective, provides 65.2% protection against Delta variant | India News – Times of India

NEW DELHI: Phase-III trials of Covaxin, made by Hyderabad's Bharat Biotech, showed it was 93.4% effective against severe symptomatic Covid-19, the firm claimed on Saturday. The data demonstrated 65.2% protection against the Delta variant, first identified in India. The Delta variant had led to a surge in infections in April and May, and the world's highest daily death tolls. It further showed effectiveness of 77.8% against symptomatic Covid-19 in the trial. On Saturday, India reported 44, 111 new Covid cases and 738 deaths. The recovery rate further jumped to 97.06% with 2,96,05,779 recoveries. Last month, vaccine maker AstraZeneca also said its vaccine was effective against the Delta and Kappa variants, citing a study. India has been administering the AstraZeneca vaccine, made domestic...
Approval to Covishield would be considered should we receive marketing authorisation application: EU agency | India News – Times of India
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Approval to Covishield would be considered should we receive marketing authorisation application: EU agency | India News – Times of India

NEW DELHI: The Covishield vaccine "does not currently have a marketing authorisation" in Europe and the matter would be considered when an application is received for it, the European Medicines Agency (EMA) said on Monday. People vaccinated with Covishield, manufactured by Pune-based Serum Institute of India (SII), are unlikely to be eligible to travel to the European Union member states under the 'Green Pass' scheme as the vaccine is yet to be cleared by the EMA. The EU Digital Covid certificate or 'Green Pass' will be mandatory to travel to European countries and the document is likely to serve as proof that a person is vaccinated against Covid-19. Travel under 'Green Pass' to non-EU citizens may be rolled out in a phased manner from July 1. However, individual European Union member c...
On visit to Novavax facility, Indian ambassador lauds ‘robust’ Indo-US healthcare cooperation | India News – Times of India
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On visit to Novavax facility, Indian ambassador lauds ‘robust’ Indo-US healthcare cooperation | India News – Times of India

WASHINGTON: India's Ambassador to the United States Taranjit Singh Sandhu on Friday visited the facilities of pharma major Novavax saying its partnership with Serum Institute of India (SII) is an example of the “robust” India-US healthcare cooperation. Headquartered in Gaithersburg, Maryland, Novavax is a biotechnology company that focuses on the discovery, development and commercialisation of vaccines to prevent infectious diseases. During his discussions with Stanley C Erck, President, Chief Executive Officer & Director at Novavax, Sandhu said the partnership between Novavax and SII is another example of the “robust India-US healthcare cooperation”, especially in the manufacturing of affordable and accessible vaccines and medicines. Erck briefed the ambassador on the high efficacy...
Just give us the vaccines, WHO pleads, as poor countries go wanting | India News – Times of India
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Just give us the vaccines, WHO pleads, as poor countries go wanting | India News – Times of India

GENEVA: Rich countries are opening up societies and vaccinating young people who are not at great risk from Covid-19, while the poorest countries cruelly lack doses, the World Health Organization said on Friday, condemning a global failure. The situation in Africa, where new infections and deaths jumped by nearly 40% last week compared to the previous week, is "so dangerous" as the Delta variant spreads globally, WHO director-general Tedros Adhanom Ghebreyesus said. "Our world is failing, as the global community we are failing," he told a news conference. Tedros, who is Ethiopian, chastised unnamed countries for reluctance to share doses with low-income countries. He compared it to the HIV/AIDS crisis, when some argued that African nations were unable to use complicated treatments. "I m...
Covaxin phase 3 trail: Bharat Biotech’s Covaxin shows 77.8% efficacy in phase 3 trials’ | India News – Times of India
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Covaxin phase 3 trail: Bharat Biotech’s Covaxin shows 77.8% efficacy in phase 3 trials’ | India News – Times of India

NEW DELHI: Bharat Biotech's Covaxin has demonstrated 77.8% efficacy in phase 3 trials, reported ANI quoting sources. The Hyderabad-based firm had earlier submitted the trial data to the Subject Expert Committee (SEC) of the Indian drug regulator. The expert panel has approved the trial data. The trials were conducted on 25,800 subjects, as per reports. Bharat Biotech's indigenously developed Covaxin is one of the three vaccines currently in use in India. Covishield, developed by AstraZeneca and manufactured locally by Serum Institute of India and Russia's Sputnik V are the other two vaccines being administered The company has developed the vaccine in association with the Indian Council of Medical Research (ICMR). Watch Covaxin phase III trial is approved by Subject Expert Committee with...
Explained: What is recombinant protein vaccine | India News – Times of India
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Explained: What is recombinant protein vaccine | India News – Times of India

NEW DELHI: Different pharmaceutical companies have taken different approaches to developing Covid-19 vaccines to stimulate longer-lasting immune system response. Recombinant protein vaccine is another proven approach against the deadly Covid-19 virus. This technology teaches the body how to develop immunity against the novel coronavirus by using virus' spike proteins. Used by Novavax in developing Covovax vaccine, these vaccines often require the incorporation of adjuvants to generate a stronger response against the virus. According to sources, the Serum Institute of India (SII) is likely to launch clinical trials of the Novavax vaccine for children in July. "Novavax results are promising. This vaccine is very safe and highly effective. Clinical trials are being conducted and are in an...
Nepal to buy 4 million Chinese Covid-19 vaccine, non-disclosure deal raises concerns – Times of India
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Nepal to buy 4 million Chinese Covid-19 vaccine, non-disclosure deal raises concerns – Times of India

KATHMANDU: Nepal is set to buy four million doses of the Chinese Sinopharm vaccine amid its fight the second wave of the Covid-19 pandemic, local media reported. However, details like the price and delivery date have been kept under wraps. The Kathmandu Post reported that the vaccines would be bought under a non-disclosure agreement, as proposed by Sinopharm, raising concerns among many people in the Himalayan nation. "The Cabinet has authorised the vaccine procurement unit of the Ministry of Health to buy four million doses of the vaccine from China," Minister for Industry, Supplies and Commerce Rajkishwor Yadhav told the Post. "Other issues including price, logistics, transportation will be looked into by the government agencies concerned." The Nepali daily newspaper reported a minist...
BREAKING: Serum Institute To Start Clinical Trials Of Novavax Shot For Children In July
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BREAKING: Serum Institute To Start Clinical Trials Of Novavax Shot For Children In July

Pune: Pune-based vaccine manufacturer Serum Institute of India plans to start clinical trials of the Novavax shot for children against Covid-19 in July. News agency ANI quoted its sources saying, "Serum Institute of India plans to start clinical trials of the Novavax shot for children in July."  ALSO READ | Novavax- Serum Institute Come Together To Manufacture 'NVX‑CoV2373' COVID Vaccine; Aim To Increase Production To Over 2 Billion DosesIn addition to this, SII also hopes to introduce Covavax in the country by September which is a version of US firm Novavax's COVID19 vaccine candidate. Developed by the Maryland-based biotechnology company Novavax, vaccine candidate called NVX-CoV2373 is a protein-based vaccine  engineered from the genetic sequence of the first strai...
Video | Novavax Announces 90% Efficacy In US Trials
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Video | Novavax Announces 90% Efficacy In US Trials

Novavax has announced that its vaccine is more than 90 per cent effective, even against coronavirus variants. The announcement was made after a large-scale U.S. study, does this give India hope for another vaccine soon? Source link
‘Mass gatherings, virulent variants create perfect storm for virus to spread’ | India News – Times of India
Politics

‘Mass gatherings, virulent variants create perfect storm for virus to spread’ | India News – Times of India

Head of the UN office for disaster risk reduction Mami Mizutori tells Pradeep Thakur Covax is making progress towards having 2 billion doses available by the end of 2021, which should be enough to protect high-risk and vulnerable people. Excerpts from the interview:The World Bank estimates 150 million people will be pushed into extreme poverty in 2021 due to Covid-19. How can India minimise the impact?Firstly, I would like to express my sincere condolences to the people and government of India on the tragic loss of life that is taking place across the country. All major disasters which affect low- and middle-income countries result in economic losses on a scale which has a damaging effect on their ability to eradicate poverty and meet other basic needs, including health services and acc...
No Immediate Changes In Covishield Vaccine Dose Gap; Respect NTAGI Decision: Centre
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No Immediate Changes In Covishield Vaccine Dose Gap; Respect NTAGI Decision: Centre

New Delhi: The government on Friday informed that there are going to be no changes in the interval between Covishield doses immediately adding that scientific evidence has been collected to review the decision in the coming meeting of NEGVAC.A recent Lancet study suggested that it would be better to reduce that gap between doses, in light of the variants in circulation, Dr. V K Paul, Member (Health) at NITI Aayog, said there is a need to balance such concerns.ALSO READ: Nirmala Sitharaman To Chair GST Council Meet, Decision On Tax Exemption Of Covid Related GoodsWhile addressing a media briefing, Dr. Paul was quoted by PTI as saying, "There is no need for any panic, suggesting a need for immediate switchover or change in the gap between the doses. All these decisions...
Vaccines are working against infection, severe disease of Covid-19, reveals study | India News – Times of India
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Vaccines are working against infection, severe disease of Covid-19, reveals study | India News – Times of India

NEW DELHI: Christian Medical College, Vellore, a 2,600 bed tertiary care hospital in India with 10,600 employees has vaccinated 84.8 per cent staff with majority of them getting Covishield and rest received Covaxin by Bharat Biotech, a latest research done on healthcare workers revealed. "Christian Medical College, Vellore, a 2,600-bed tertiary care hospital in India with 10,600 employees, vaccinated 8,991 staff (84.8 per cent) between January 21 and April 30. A majority (93.4 per cent) received Covishield, the Oxford-AstraZeneca vaccine manufactured by Serum Institute of India, and the remainder, Covaxin, a killed virus vaccine, produced by Bharat Biotech, India," said the study, "Vaccines are working against infection and severe disease of Covid-19", by CMC Vellore. Dr. Joy J Mammen, ...
Flying abroad for job, education? Centre announces SOPs | India News – Times of India
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Flying abroad for job, education? Centre announces SOPs | India News – Times of India

NEW DELHI: The government on Monday issued guidelines for people who are planning to travel internationally for education, work opportunities or as part of the Indian contingent for the Tokyo Olympics. In a statement, the Union health ministry said that CoWin certificates of all such people will be linked to the passport. It said that in the vaccination certificate, the mention of Covishield vaccine is sufficient enough and no other qualifying entry would be required. The government has also provisioned for early administration of the second dose of Covishield in specific cases if the travel dates fall before the period of the 84-day gap. Currently, the government has recommended a gap of at least 12 weeks between the two doses of Covishield. Covishield, produced by the Serum Institute ...
Covishield produces more antibodies than Covaxin, finds study | India News – Times of India
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Covishield produces more antibodies than Covaxin, finds study | India News – Times of India

NEW DELHI: The Covishield vaccine produces more antibodies than Covaxin though both generate a "good immune response", says a pan-India study of healthcare workers who had received both doses of the preventives. The yet-to-be-published study, posted on the preprint repository MedRxiv on June 4, covered 515 healthcare workers (HCW) - 305 men and 210 women - from 22 cities in 13 states. Covishield, from the Oxford-AstraZeneca stable, is manufactured by the Serum Institute of India in Pune. Covaxin is the indigenously manufactured vaccine by Hyderabad-based Bharat Biotech in collaboration with ICMR and National Institute of Virology (NIV). The blood samples of those participating in the study were tested for the quantity of antibodies produced and levels of specific antibodies that are dir...
Government still seeking middle path on vaccine indemnity demand | India News – Times of India
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Government still seeking middle path on vaccine indemnity demand | India News – Times of India

NEW DELHI: The indemnity demand put forward by multinational vaccine makers has seen them call for disputes being resolved overseas, prompting the government to tread cautiously on the issue as the two sides try and reach a middle ground. The Centre is engaging with multinational pharma majors such as Pfizer and Moderna for sourcing Covid-19 vaccines but is also weighing the commitments it undertakes as part of the deal since it may have longer-term implications. The view in government is that while vaccines are needed in the near term, India's domestic supplies will be comfortable from August. The indemnity will not just impact domestic rules but also set a precedent for the future with other drug-makers also expected to seek similar facility for life-saving medicines. In addition, thi...
Poonawalla thanks Biden, Jaishankar for policy change to boost vaccine production | India News – Times of India
Politics

Poonawalla thanks Biden, Jaishankar for policy change to boost vaccine production | India News – Times of India

NEW DELHI: Serum Institute of India CEO Adar Poonawalla on Friday thanked US President Joe Biden and External Affairs Minister S Jaishankar for a policy change that will boost the production of Covid-19 vaccines in India and globally. Confident of the availability of Covid-19 vaccines in the US, the Biden administration has removed Defense Production Act priority ratings on AstraZeneca, Novavax and Sanofi vaccines. While the firms will continue to make these three vaccines, this action will allow US-based companies that supply these vaccine manufacturers to make their own decisions on which orders to fulfil first. Sharing the link of a press briefing by White House Covid-19 response team and public health officials, Poonawalla said, "Thanks to the efforts of @POTUS, @WhiteHouse, & @...