न्यूयॉर्क- तीसरे चरण के क्लिनिकल परीक्षण के परिणामों के अनुसार, नोवावैक्स का टीका कोविड-19 बीमारी को रोकने में 90 प्रतिशत प्रभावी है।
न्यू इंग्लैंड जर्नल ऑफ मेडिसिन में प्रकाशित अध्ययन से पता चला है कि किसी भी गंभीरता की कोविड बीमारी को रोकने में अत्यधिक प्रभावी होने के अलावा, वैक्सीन मध्यम और गंभीर बीमारी को रोकने में 100 प्रतिशत प्रभावी है।
परीक्षण के लिए, मैरीलैंड विश्वविद्यालय की टीम ने अमेरिका में 113 नैदानिक स्थलों और मैक्सिको में छह साइटों पर लगभग 30,000 वयस्क स्वयंसेवकों को शामिल किया।
लगभग 20,000 प्रतिभागियों को टीके की दो खुराकें तीन सप्ताह के अंतराल में मिलीं और 10,000 को प्लेसबॉस प्राप्त हुआ। परीक्षण 2021 के पहले कुछ महीनों के दौरान आयोजित किया गया था और केवल अल्फा वेरिएंट के खिलाफ परीक्षण किया गया था।
अधिकांश दुष्प्रभाव हल्के से मध्यम और अस्थायी थे। बुखार बहुत दुर्लभ था। वैक्सीन प्राप्त करने वालों में सबसे आम साइड इफेक्ट्स में इंजेक्शन स्थल पर दर्द, सिरदर्द, मांसपेशियों में दर्द और थकान शामिल है, जो औसतन एक दिन तक चलता है। किसी भी प्राप्तकर्ता ने हृदय की सूजन (मायोकार्डिटिस) या ब्लड क्लॉट्स जैसी गंभीर प्रतिक्रिया दर्ज नहीं की।
विश्वविद्यालय के स्कूल ऑफ मेडिसिन में बाल रोग के प्रोफेसर करेन कोटलॉफ ने कहा, "हमारे अध्ययन के परिणाम बताते हैं कि यह टीका अत्यधिक प्रभावकारी और बहुत सुरक्षित है। इसके अलावा, इस टीके में कई आकर्षक विशेषताएं हैं।"
कोटलॉफ ने कहा, "यह प्रोटीन के एक छोटे टुकड़े से बना है, जैसे कि अमेरिका में वर्तमान में लाइसेंस प्राप्त कई टीके और सुविधाजनक रेफ्रिजरेटर भंडारण आवश्यकताएं हैं, इसलिए यह कोविड -19 वैक्सीन पोर्टफोलियो के लिए महत्वपूर्ण होगा, अमेरिका में और उन देशों में जहां आपूर्ति है कमी है।"
एसआईआई के सीईओ अदार पूनावाला ने कहा है कि नोवावैक्स पुणे स्थित सीरम इंस्टीट्यूट ऑफ इंडिया का भी भागीदार है। वैक्सीन एनवीएक्स-सीओवी2373 पहले से ही कंपनी द्वारा कोवोवैक्स ब्रांड नाम के तहत 3 साल से अधिक उम्र के बच्चों के लिए इसका टीका स्थानीय रूप से निर्मित किया जा रहा है। इसे अगले छह महीनों में लॉन्च किया जाएगा।
पूनावाला ने कहा कि कोवावैक्स का अभी परीक्षण किया जा रहा है।
यह भी पढ़े► फेफड़ों में डेल्टा की तुलना में 70 गुना तेजी से फैलता है ओमिक्रॉन वैरिएंट-रिसर्च
Brussels, Aug 5 (IANS) The European Commission announced it has approved a deal that allows European Union (EU) member states to buy up to 200 million doses of Novavax's Covid-19 jab, once the European Medicines Agency (EMA) deems it safe and effective for use.In a statement on Weednesday, the Commission said that through the agreement with the US pharmaceutical firm, EU countries will be able to purchase 100 million Novavax vaccine doses, with the option to purchase a further 100 million over the course of 2021, 2022, and 2023, reports Xinhua news agency.European Commission President Ursula von der Leyen hailed the deal as further strengthening the bloc's "broad vaccine portfolio".The EU has already signed contracts with AstraZeneca, Sanofi-GSK, Janssen Pharmaceutica NV, BioNTech-Pfizer, CureVac, Moderna and concluded exploratory talks with Valneva. The previously concluded contracts secured a portfolio of up to 4.4 billion doses.Rich western nations have been accused of hoarding far more doses than their citizens need. The Washington Post previously estimated that the US has bought coronavirus vaccines three times the amount needed, while many developing countries are still struggling to get a single dose.The World Health Organization (WHO) on Wednesday called on rich countries to halt the plan to distribute Covid-19 booster shots, citing vaccine inequity around the world."We need an urgent reversal from the majority of vaccines going to high-income countries, to the majority going to low-income countries," WHO Director General Tedros Adhanom Ghebreyesus told a press briefing.--IANSksk/
New Delhi, June 17 (IANS) The Serum Institute of India is likely to launch clinical trials of the Novavax Covid-19 vaccine for children in July, sources said.SII is likely to introduce the Novavax vaccine, to be known as Covavax in the country, by September. This week Novavax Inc announced that its vaccine has turned out to be more than 90 per cent effective in clinical trials conducted in the US. Bharat Biotech has already begun clinical trials of Covaxin for children in the 6-12 age group. Novavax Inc had announced that NVX-CoV2373, its recombinant nanoparticle protein-based Covid-19 vaccine, demonstrated 100 per cent protection against moderate and severe disease, 90.4 per cent efficacy overall, and met the primary endpoint in its PREVENT-19 pivotal Phase 3 trial. The study enrolled 29,960 participants across 119 sites in the US and Mexico to evaluate efficacy, safety and immunogenicity, with an emphasis on recruiting a representative population of communities and demographic groups most impacted by Covid-19. The company intends to file for regulatory authorisations in the third quarter, upon completion of the final phases of process qualification and assay validation needed to meet chemistry, manufacturing and controls (CMC) requirements. Upon regulatory approvals, Novavax remains on track to reach a manufacturing capacity of 100 million doses per month by the end of the third quarter and 150 million doses per month by the end of the fourth quarter of 2021. "PREVENT-19 confirms that NVX-CoV2373 offers a reassuring tolerability and safety profile," said Gregory M. Glenn, President of Research and Development, Novavax. "These data show consistent, high levels of efficacy and reaffirm the ability of the vaccine to prevent Covid-19 amid ongoing genetic evolution of the virus," Glenn added.--IANS san/arm
Washington, June 15 (IANS) US-based biotechnology company Novavax's protein-based vaccine has shown overall 90 per cent efficacy against Covid-19, results of Phase-3 trials have shown.The vaccine NVX-CoV2373 is already being locally manufactured by the company's India partner Pune-based Serum Institute of India (SII) under the brand name Covovax.In the US-based Phase-3 trials, NVX-CoV2373 also demonstrated 100 per cent protection against moderate and severe disease."Today, Novavax is one step closer to addressing the critical and persistent global public health need for additional Covid-19 vaccines. These clinical results reinforce that NVX-CoV2373 is extremely effective and offers complete protection against both moderate and severe Covid-19 infection," said Stanley C Erck, President and Chief Executive Officer, Novavax, in a statement."Novavax continues to work with a sense of urgency to complete our regulatory submissions and deliver this vaccine, built on a well understood and proven platform, to a world that is still in great need of vaccines," Erck added.In August 2020, Novavax and SII announced an agreement under which the US biotechnology company had given SII the licence to manufacture and supply the vaccine in low- and middle-income countries.In March 2021, CEO Adar Poonawalla said Covovax will be launched by September this year."Covovax trials finally begin in India; the vaccine is made through a partnership with Novavax and Serum Institute of India," said Adar Poonawalla."Hope to launch by September 2021!" the CEO of the world's biggest Covid-19 vaccine maker said.The US-based Phase-3 trials began in December 2020 and enrolled 29,960 participants across 119 sites in the US and Mexico to evaluate efficacy, safety and immunogenicity, with an emphasis on recruiting a representative population of communities and demographic groups most impacted by the disease.The study "confirms that NVX-CoV2373 offers a reassuring tolerability and safety profile", said Gregory M Glenn, MD, President of Research and Development, Novavax.The company will file for regulatory authorisations in the third quarter. After receiving the approvals, Novavax will reach a manufacturing capacity of 100 million doses per month by the end of the third quarter and 150 million doses per month by the end of the fourth quarter of 2021, the statement said.NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralising antibodies. It contains purified protein antigen and can neither replicate, nor can it cause Covid-19.The vaccine can be stored at 2 to 8 degrees Celsius, allowing the use of existing vaccine supply chain channels for its distribution. It is packaged in a ready-to-use liquid formulation in 10-dose vials.The two-shot vaccine is also being evaluated in Phase 3 trials in the UK that demonstrated efficacy of 96.4 per cent against the original virus strain, 86.3 per cent against the B117 (Alpha) variant and 89.7 per cent overall.It is also being tested in two ongoing Phase 2 studies that began in August 2020: A Phase 2b trial in South Africa that demonstrated 55 per cent efficacy overall in HIV-negative participants and 48.6 per cent efficacy against the B1351 (Beta) variant, and a Phase 1/2 study in the US and Australia.The company is also conducting trials in adolescents between ages 12 and 18.--IANSrvt/in
Johannesburg, May 7 (IANS) A Covid-19 vaccine developed by the US-based biotechnology company Novavax has been found effective against Coronavirus' B1351 variant, first identified in South Africa, results of a trial have shown.The Phase 2b randomised, observer-blinded, placebo-controlled trial conducted in South Africa evaluated efficacy, safety and immunogenicity in healthy adults, and in a small cohort of medically stable adults living with human immunodeficiency virus (HIV).The Novavax vaccine demonstrated an overall efficacy of 49 per cent in the initial analysis. Among healthy adults without HIV, the Novavax vaccine demonstrated efficacy of 60 per cent in the initial analysis, and 55 per cent in the subsequent complete analysis.AAThe initial analysis, published in New England Journal of Medicine, suggested that prior infection with the original Covid-19 strain did not protect against subsequent infection by the variant predominantly circulating in South Africa through 60 days of follow-up.However, with additional follow-up, the trial indicates that there may be a modest protective effect of prior exposure with the original Covid-19 strain.Among placebo recipients, at 90 days of follow-up, the illness rate was 8.0 per cent in baseline seronegative participants and 5.9 per cent in baseline seropositive participants."The data make a compelling case for use of the Novavax Covid-19 vaccine in settings where the B1351 variant dominates -- which is most of southern Africa -- to reduce the risk of mild disease and also to maximise the opportunity for protection against severe Covid," said Shabir Madhi, Professor and Dean of theFaculty of Health Sciences at the University of the Witwatersrand, Johannesburg (Wits), South Africa."Further work is required for Novavax and all other Covid-19 vaccines, particularly in people living with HIV," Madhi added.NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes Covid-19 disease.The company is also expected to apply for US authorisation in the next few weeks.--IANSrvt/pgh
New York, March 12 (IANS) US-based biotech company Novavax's Covid-19 vaccine was 96.4 per cent effective against original strain of the virus in a phase-3 trial in the UK, the company has said.The vaccine, NVX-CoV2373, was found 86.3 per cent effective against the B.1.1.7/501Y.V1 variant circulating in the UK, Novavax said on Thursday.The study enrolled more than 15,000 participants between 18-84 years of age, including 27 per cent over the age of 65. The results are expected to bring the approval of the vaccine a step closer as Novavax said that it expects the data to serve as the basis for submission for authorisation to various regulatory agencies worldwide.The company also announced the complete analysis of its Phase-2b trial taking place in South Africa, with efficacy of 55.4 per cent among the HIV- negative trial participants in a region where the vast majority of strains are B1.351 escape variants. Across both trials, NVX-CoV2373 demonstrated 100 per cent protection against severe disease, including all hospitalisation and death. Both studies achieved their statistical success criteria, Novavax said."We are very encouraged by the data showing that NVX-CoV2373 not only provided complete protection against the most severe forms of disease, but also dramatically reduced mild and moderate disease across both trials," Stanley Erck, President and Chief Executive Officer, Novavax, said in a statement."Importantly, both studies confirmed efficacy against the variant strains."Giving details of the UK trial, the company said that in volunteers 65 years of age and older, 10 cases of Covid-19 were observed, with 90 per cent of those cases occurring in the placebo group. Older adults are among the groups most impacted by the disease and are at high risk of complications from Covid-19.In the South Africa trial, one cohort evaluated efficacy, safety and immunogenicity in approximately 2,665 healthy adults, the second cohort evaluated safety and immunogenicity in approximately 240 medically stable, HIV-positive adults.A complete analysis of vaccine efficacy among 147 positive cases - 51 cases in the vaccine group and 96 in the placebo group -- demonstrated an overall efficacy of 48.6 per cent against predominantly variant strains. The vast majority of cases circulating during the efficacy analysis were due to the B.1.351/501Y.V2 variant circulating in South Africa, the company said, adding that all five cases of severe disease observed in the trial occurred in the placebo group.--IANSgb/in
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