Covovax Approve From Who

विश्व स्वास्थ्य संगठन ने शुक्रवार को नोवावैक्स से लाइसेंस के तहत सीरम इंस्टीट्यूट ऑफ इंडिया द्वारा निर्मित और कोवोवैक्स सुविधा पोर्टफोलियो के हिस्से के तहत कोविड वैक्सीन कोवोवैक्स की आपातकालीन उपयोग सूची को मंजूरी दे दी है। सीरम इंस्टीट्यूट ऑफ इंडिया के सीईओ अदार पूनावाला ने कहा, "कोविड-19 के खिलाफ हमारी लड़ाई में यह एक और मील का पत्थर है। कोवोवैक्स को अब आपातकालीन उपयोग के लिए मंजूरी दे दी गई है, जो उत्कृष्ट सुरक्षा और प्रभावकारिता दिखा रहा है। एक महान सहयोग के लिए आप सभी का धन्यवाद।" कोवोवैक्स में दो-खुराक वाली वैक्सीन है और यह डब्ल्यूएचओ से आपातकालीन उपयोग की स्वीकृति प्राप्त करने वाला नौवां वैक्सीन है। हालांकि, इसे भारत में शीर्ष दवा नियामक, डीसीजीआई द्वारा आपातकालीन उपयोग प्राधिकरण (ईयूए) प्रदान किया जाना बाकी है। वैश्विक स्वास्थ्य निकाय ने कहा कि लिस्टिंग का उद्देश्य विशेष रूप से कम आय वाले देशों में पहुंच बढ़ाना है, जिनमें से 41 अभी भी अपनी 10 प्रतिशत आबादी का टीकाकरण नहीं कर पाए हैं, जबकि 98 देश 40 प्रतिशत तक नहीं पहुंचे हैं। कोवोवैक्स का मूल्यांकन डब्ल्यूएचओ ईयूएल प्रक्रिया के तहत गुणवत्ता, सुरक्षा और प्रभावकारिता पर डेटा की समीक्षा, एक जोखिम प्रबंधन योजना, प्रोग्रामेटिक उपयुक्तता और भारत के औषधि महानियंत्रक द्वारा किए गए निर्माण स्थल निरीक्षण के आधार पर किया गया था। डब्ल्यूएचओ द्वारा बुलाई गई और दुनिया भर के विशेषज्ञों से बने तकनीकी सलाहकार समूह फॉर इमरजेंसी यूज लिस्टिंग (टीएजी-ईयूएल) ने यह निर्धारित किया है कि वैक्सीन कोविड -19 के खिलाफ सुरक्षा के लिए डब्ल्यूएचओ के मानकों को पूरा कर लिया है। डब्ल्यूएचओ ने एक बयान में कहा, किसी भी जोखिम से अधिक है और यह कि वैक्सीन का उपयोग विश्व स्तर पर किया जा सकता है। अमेरिका स्थित नोवावैक्स के साथ साझेदारी में एसआईआई द्वारा विकसित कोवोवैक्स वैक्सीन, डब्ल्यूएचओ द्वारा अनुमोदित भारत से संबंधित तीसरा टीका है। अन्य दो टीके कोविशील्ड और कोवैक्सिन हैं। कोवैक्सीन भारत का पहला स्वदेशी कोविड वैक्सीन है, जबकि कोवीशील्ड ब्रिटेन के एस्ट्राजेनेका का भारतीय संस्करण है। यह भी पढ़े► फाइजर की एंटी वायरल टेबलेट कोविड मरीजों पर 89 प्रतिशत प्रभावी: शोध

"This is yet another milestone in our fight against Covid-19. Covovax is now WHO approved for emergency use, showing excellent safety and efficacy. Thank you all for a great collaboration," Serum Institute of India CEO Adar Poonawala said. Covovax has a two-dose regimen and is the ninth to receive emergency use approval from the WHO. However, it is yet to be granted emergency use authorisation (EUA) by the top drug regulator, the DCGI, in India. The listing aims to increase access particularly in lower-income countries, 41 of which have still not been able to vaccinate 10 per cent of their populations, while 98 countries have not reached 40 per cent, said the global health body. Covovax was assessed under the WHO EUL procedure based on the review of data on quality, safety and efficacy, a risk management plan, programmatic suitability, and manufacturing site inspections carried out by the Drugs Controller General of India. The Technical Advisory Group for Emergency Use Listing (TAG-EUL), convened by the WHO and made up of experts from around the world, has determined that the vaccine meets WHO standards for protection against Covid-19, that the benefit of the vaccine far outweighs any risks, and that the vaccine can be used globally, the WHO said in a statement. The Covovax vaccine, developed by the SII in partnership with the US-based Novavax, is the third India-related vaccines to be approved by the WHO. The other two vaccines are Covishield and Covaxin. Covaxin is India's first indigenous Covid vaccines, while Covishield is Indian version of Britain's AstraZeneca jab. Read More► Omicron Likely to Affect Fully Vaccinated, Shows Oxford Study

New Delhi, June 26 (IANS) The Pune-based Serum Institute of India (SII) has begun manufacturing Novavax's protein-based vaccine Covovax, CEO Adar Poonawalla has said.The company will also begin clinical trials of Novavax for children starting July."Excited to witness the first batch of Covovax (developed by @Novavax) being manufactured this week at our facility in Pune," he shared in a tweet on Friday.In the recently released Phase -3 trials, Covovax has shown overall 90 per cent efficacy against Covid-19. The US-based trials also demonstrated the two-shot vaccine 100 per cent protection against moderate and severe disease."The vaccine has great potential to protect our future generations below the age of 18. Trials are ongoing. Well done team," he said.SII's Phase-2 and 3 clinical trials of Covovax will reportedly be conducted in 920 children -- 460 each in 12-17 years and 2-11 years groups, media reports said.In August 2020, Novavax and SII had 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 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 had said.Recently, the Centre stated that Novavax Covid vaccine efficacy data in a large trial are promising and that clinical trials are being conducted and are in an advanced stage of completion in India."What we're learning from data available in the public domain is that this vaccine is very safe and highly effective," Dr V.K. Paul, NITI Aayog Member (Health) said earlier this month.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.Hyderabad-based Bharat Biotech has also two vaccines that are being tried on children, Covaxin and BBV154, a one-shot nasal vaccine. ZyCov-D, the Zydus' Covid-19 vaccine has also started trials on children in the age group 12-18 years.The government is also considering providing legal indemnity to Pfizer and Moderna to roll out their vaccines in India. Pfizer has announced that its vaccine is safe for children above 12 years of age.--IANSrvt/sdr/

Pune, Jan 30 (IANS) In what could be a mega boost to the ongoing Covid-19 vaccination drive in India, the Serum Institute of India (SII) has announced its plan to launch its new vaccine, Covovax, by June this year.SII CEO Adar Poonawalla said on Saturday that its partnership for a Covid-19 vaccine with Novavax has shown excellent efficacy results."We have applied for starting trials in India. Hope to launch Covocax by June 2021," Poonawalla said in a tweet.The new vaccine shall be launched under the brand name of Covovax, which SII is manufacturing in partnership with Novovax. The Pune-based global vaccine giant has sought permission from the DCGI to start domestic trials of the new product.The development comes close on the heels of US-based biotechnology company Novavax announcing that its vaccine is 89.3 per cent effective in preventing Covid-19 in a trial conducted in the UK.The study assessed the efficacy of the vaccine -- NVX-CoV2373 -- during a period with high transmission and with a new UK variant strain of the virus emerging and circulating widely."NVX-CoV2373 has the potential to play an important role in solving this global public health crisis. We look forward to continuing to work with our partners, collaborators, investigators and regulators around the world to make the vaccine available as quickly as possible," Stanley C. Erck, President and Chief Executive Officer, Novavax, said in a statement on Friday.Last year, Novavax had announced its tie up with SII to produce 2 billion doses of Covid-19 vaccine.--IANSqn/arm