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All documents submitted to WHO for emergency use listing of Covaxin, says Bharat Biotech

The Hyderabad-based biotechnology firm said the review process has now commenced and it expects to receive EUL from the WHO at the earliest All documents required for Emergency Use Listing (EUL) of Covaxin have been submitted to the World Health Organisation (WHO) as of 9 July, Hyderabad-based Bharat Biotech said today. The biotechnology company also said that the review process has now commenced and it expects to receive EUL from the WHO at the earliest. Recently, WHO chief scientist Soumya Swaminathan said that the global health body is likely to take a call on whether to include Bharat Biotech's Covid-19 vaccine Covaxin in the EUL in the next four to six weeks. At a webinar held by the Centre for Science and Environment (CSE) on Friday, the WHO chief scientist said that the global health body is reviewing Covaxin while its manufacturer Bharat Biotech uploads all the data on the WHO portal. According to WHO guidelines, EUL is a procedure to streamline the process in which new products can be approved and used during public health emergencies like a pandemic. "There is a process to be followed for EUL and pre-qualification of vaccines under which a company has to complete Phase 3 trials and submit the whole data to the regulatory department of WHO which is examined by an expert advisory group," Swaminathan explained. "The completeness of the data, which includes safety and efficacy and also the manufacturing quality and standard, is provided. So, I expect that Bharat Biotech has already submitted data and in four to six weeks there will be a decision on its inclusion," she said. As of now, the WHO has approved Covid-19 vaccines by Pfizer/BioNTech, Astrazeneca-SK Bio/Serum Institute of India, AstraZeneca EU, Janssen, Moderna and Sinopharm for emergency use. "We currently have six vaccines approved with EUL and have recommendations from our Strategic Advisory Group of Experts (SAGE). We continue to look at Covaxin. Bharat Biotech has now started uploading their data on our portal and that is the next vaccine that will be reviewed by our experts' committee," Swaminathan said. At present, there are 105 vaccine candidates under clinical evaluation of which 27 are in the third or fourth phase. Another 184 candidates are in preclinical evaluation. Most coronavirus vaccines are designed with a two-dose schedule.

Coronavirus: India reports 41K+ new cases nearly 900 more dead

India on Sunday reported over 41,000 new COVID-19 cases along with nearly 900 more deaths. Several states have eased COVID-19 restrictions to stem the viral spread in light of the decline in infections, however, government officials warn against letting the guard down. World Health Organisation (WHO) Chief Scientist Soumya Swaminathan has also noted that the coronavirus pandemic isn't slowing down. Here are more details. In this article India's tally reaches 3.08 crore; 4.08 lakh dead Cases dipped after second wave peaked in May 73% new cases concentrated in 5 states Over 38 crore vaccine doses provided to states/UTs: Centre COVAXIN emergency listing likely in 4-6 weeks: WHO Statistics India's tally reaches 3.08 crore; 4.08 lakh dead According to the Union Health Ministry, till Sunday morning, India reported a total of 3,08,37,222 COVID-19 cases . The death toll has reached 4,08,040. So far, 2,99,75,064 patients have recovered, while 4,54,118 cases involve active infections. In the past 24 hours alone, India recorded 41,506 new infections, 41,526 more discharges, and 895 fresh fatalities. 37,60,32,586 vaccine doses have been administered so far. Trend Cases dipped after second wave peaked in May India's second wave peaked on May 7, when 4.14 lakh single-day cases were reported, over four times the number of cases reported during the first wave in mid-September. Although infections have declined since the second wave peaked, India crossed the three crore-mark on June 23. Notably, India had crossed the one crore-mark on December 19, 2020, and the two crore-mark on May 4, 2021. States 73% new cases concentrated in 5 states Maharashtra reported 8,296 new COVID-19 cases along with 6,026 more recoveries. Kerala, the second worst-hit state after Maharashtra, reported 14,087 new cases and 11,867 discharges. Meanwhile, the third worst-hit Karnataka added 2,162 new cases and 2,879 recoveries. Tamil Nadu, the fourth worst-hit state, reported 2,913 new cases and 3,321 recoveries. Andhra Pradesh reported 2,925 new cases and 3,937 recoveries. Vaccinations Over 38 crore vaccine doses provided to states/UTs: Centre The Health Ministry said Sunday that over 38.6 crore COVID-19 vaccine doses have been provided to states/union territories so far, while 11.25 lakh doses are in the pipeline. Over 1.44 crore doses are still available with states/UTs for use, it said. India has managed to fully vaccinate 5.5% of its total population, while over 22% has received at least one dose. COVAXIN COVAXIN emergency listing likely in 4-6 weeks: WHO WHO's Swaminathan also said that the global health body is likely to take a call on whether Bharat Biotech's COVAXIN will be granted emergency use listing (EUL) in the coming four to six weeks. She was speaking at a webinar held by the Centre for Science and Environment (CSE) on Friday. COVAXIN —over 77% effective—is a two-dose inactivated vaccine indigenously produced in India.

India Today Impact: Delhi Health Minister assures action on illegal sale of Covid trash

Delhi Health Minister Satyendar Jain has taken note and assured action against the illegal sale of Covid-19 biomedical waste in the national capital region. After an India Today investigation revealed the illegal sale and re-use of Covid-19 biomedical waste in the national capital region, Delhi Health Minister Satyendar Jain took note and assured action. He said, "If this is happening, then it is absolutely wrong. The responsibility of proper disposal of biomedical waste is that of the Municipal Corporation of Delhi. Keep me informed, I will definitely take action against it." "We will also talk to the Municipal Corporation of Delhi and take action against it," he said. An India Today investigation found large junkyards in the national capital region procuring the pandemic trash for re-sale. Along the Delhi-Ghaziabad border at Bhopura, discarded protective gear was being dried under the summer sun on an open compound. When probed, workers and their operators explained that the waste is prepared for local retailers, wholesalers and for recycling units. India has generated 203 tons of Covid medical waste per day during the pandemic, according to the data issued by the Central Pollution Control Board (CPCB) till May 10, 2021. The quantity makes up almost 20 per cent of the total biomedical trash generated since the outbreak began. But even this hefty percentage might be an under-representation, warns a recent study by the Centre for Science and Environment (CSE). "While the Covid-19 caseload has increased by a massive 234 per cent between the first and second waves of the pandemic, Covid-19 biomedical waste generation went up by only eleven per cent. The CPCB attributes this mismatch to better segregation of the waste, but our research points clearly to under-representation," said Atin Biswas, a programme director at the CSE. On its part, the CPCB has already recommended separate arrangements for handling, segregating and disposing of Covid bio-medical waste at designated disposal facilities equipped with incinerators.

ऑपरेशन कोविड वेस्ट से हरकत में आई दिल्ली सरकार, स्वास्थ्य मंत्री बोले- दोषी बख्शे नहीं जाएंगे

इंडिया टुडे के 'ऑपरेशन कोविड वेस्ट बाज़ार' पर दिल्ली के स्वास्थ्य मंत्री सत्येंद्र जैन ने कार्रवाई का आश्वासन दिया है. आजतक से बात करते हुए स्वास्थ्य मंत्री सत्येंद्र जैन ने कहा कि दोषियों के खिलाफ कार्रवाई करेंगे. इंडिया टुडे के 'ऑपरेशन कोविड वेस्ट बाज़ार' पर दिल्ली के स्वास्थ्य मंत्री सत्येंद्र जैन ने कार्रवाई का आश्वासन दिया है. आजतक से बात करते हुए स्वास्थ्य मंत्री सत्येंद्र जैन ने कहा कि दोषियों के खिलाफ कार्रवाई करेंगे. इंडिया टुडे ने कोविड -19 बायोमेडिकल कचरे की अवैध बिक्री और फिर से इस्तेमाल करने का खुलासा किया था. इस पर दिल्ली के स्वास्थ्य मंत्री सत्येंद्र जैन ने इंडिया टुडे से कहा, 'अगर ऐसा हो रहा है तो बिल्कुल गलत है, बायोमेडिकल वेस्ट को ठीक से निपटारा करने की ज़िम्मेदारी दिल्ली नगर निगम (MCD) की है,  मुझे जानकारी दीजिए, इसके खिलाफ़ ज़रूर कार्रवाई करेंगे, इस मामले में दिल्ली नगर निगम (MCD) से भी बात करेंगे और इसके खिलाफ़ कार्रवाई करेंगे.' इंडिया टुडे के स्टिंग में खुलासा हुआ था कि दिल्ली के बड़े कबाड़खाने फिर से बिक्री के लिए कोविड कचरा खरीद रहे हैं. भोपुरा में दिल्ली-गाजियाबाद बॉर्डर पर सुरक्षात्मक गियर को सुखाया जा रहा था. स्थानीय लोगों ने बताया था कि कचरा स्थानीय खुदरा विक्रेताओं, थोक विक्रेताओं और रीसाइक्लिंग इकाइयों को भेजा जाता है. केंद्रीय प्रदूषण नियंत्रण बोर्ड (सीपीसीबी) द्वारा 10 मई, 2021 तक जारी किए गए आंकड़ों के अनुसार, भारत में महामारी के दौरान प्रतिदिन 203 टन कोविड कचरा निकला है.  सीपीसीबी के आंकड़े बताते हैं कि दिल्ली में प्रति दिन 18.79 टन और उत्तर प्रदेश में प्रति दिन 15.91 टन कचरा निकल रहा था. सेंटर फॉर साइंस एंड एनवायरनमेंट (सीएसई) के मुताबिक, जब महामारी की पहली और दूसरी लहरों के बीच कोरोना केसलोएड में 234 प्रतिशत की भारी वृद्धि हुई है, बावजूद इसके कोरोना बायोमेडिकल अपशिष्ट केवल 11 फीसदी बढ़ा है, इससे कचरे के फिर से इस्तेमाल का शक शुरू हुआ.

Not a weather blip!

Recent heatwaves in Canada and the United States were 'virtually impossible' without human-caused climate change Searing heat, touching 50 degrees Celsius in the otherwise cold regions of Canada and the western regions of the United States, has brought home the message — once again and loudly — that climate change is here and is about to get worse. The heat was so unbearable and off the charts that it killed an estimated 500 people in Canada's British Columbia province. Then there are reports of the savage damage it has done to animals and other creatures. The inferno is now adding to the challenge of wildfires, threatening lives and properties. Europe is seeing a similar heatwave; it is predicted that this year's temperatures will be the highest since records have been kept. Yet another year when we have broken the previous year's heat record! Also Read - A usurpation? The fact is this heatwave is not incidental or accidental — a mere weather blip. Scientists working with the World Weather Attribution initiative conclude that this heatwave "was virtually impossible" without human-caused climate change. They find that the temperatures were so extreme that they lie outside the range of historically observed heat records. They conclude that the frequency of this once-in-a-thousand-year event would increase with temperature rise, and when the world touches 2°C increase over pre-industrial ages, it would become a five- to 10-year event. What then is clear is this: One, climate change is happening faster than expected and we are certainly unprepared. Two, climate change is a great leveller — extreme and variable rain, increased frequency of tropical cyclones and heat and cold are hitting the world's poorest. Each event cripples them and makes them even more vulnerable and marginalised. But the rich are also not excluded from this revenge of nature. The death of people from heatwaves in Canada must keep reminding us of the tragedy that awaits everyone. Also Read - A fillip to growth Even as I write this, perhaps for the umpteenth time (my readers must forgive me), we have still not seen the writing on the wall. Our actions still do not match our words. The technologies to combat climate change are available — but they require application at a disruptive and transformative scale. This is what we are missing. I say this because every extra day of procrastination will make the task even more difficult. Take the case of rising heat. To adapt and survive, the rich in otherwise temperate regions will now invest more in devices like air conditioners to cool their homes. This will, in turn, add to the energy demand and, given that countries are still fiddling around with fossil fuel-based electricity, it will add to greenhouse gas emissions. Also Read - Latent threat We know that heating and cooling devices take up the bulk of the power demand in our cities today. In Delhi, research by my colleagues at the Centre for Science and Environment (CSE) shows as soon as the temperature crosses 27-28°C, the cooling demand increases exponentially — electricity demand rises by 190 MW for every degree rise in mercury. With more electricity generation, there will be more emissions, increasing the temperatures even more. The vicious cycle will spiral out of control. This direct relationship between heat and energy has another dimension to it — thermal comfort or discomfort. This is not just about temperatures but also about how well-designed and ventilated our living spaces are. This is why even when temperatures are not so high, but there is humidity or lack of air, we feel uncomfortable and "hot". The fan makes the air conditioner more efficient as it evaporates moisture from our bodies. It is about cooling but also about design. Just consider how traditional buildings were designed to keep out the heat; by designing for the sun and wind, and not against nature. They used orientation and shades on a window — what we now call passive architecture — to ensure that buildings were protected from glare; they used courtyards and open windows for ventilation. Trees provided shade, as much as other environmental benefits. Sadly, modern architecture built on glass facades and closed spaces for air cooling has shunned and dismissed this knowledge as unnecessary and backward. Then there is also the fact that more heat will add to water stress — for irrigation, for drinking and for fighting forest fires. As we pump more water from the ground or use electricity for transporting water, we will need more energy — further reinforcing the vicious cycle. This is why we must go back to finding ways of optimising local water resources; harvesting the rain where and when it falls so that we can reduce dependence on pumped- and energy-dense water. In the heating planet, this knowledge of living with extreme heat and cold without increasing the energy footprint of our living spaces and cities will be crucial. So, as much as we need to move away from fossil fuels, we need to make sure we can do much more with much less energy — this is the climate change challenge. The scorched world should teach us this. DTE Views expressed are personal

Virus, variant and vaccines

The main worry is the price of vaccines, not production, says Sunita Narain It’s a make-or-break moment for our world. A race is on between the virus and its variants and vaccination. The speed at which the novel coronavirus is mutating means that nobody is safe until everyone is safe. According to the WHO, the world needs some 11 billion doses of vaccines and these need to reach the poorest and the remotest places as quickly as possible. Otherwise, there is a fear that the virus will spread and it will return in a mutated form and make even the protected vulnerable to the new variant. The issue is not the vaccine, or even the ability of the world to manufacture it. As of June 2021, there are over 200 vaccine candidates in the offing — with 102 reaching the stage of clinical trial. The WHO estimates that the world will be able to manufacture some 14 billion doses by the end of 2021. China’s two vaccine makers — Sinopharm and Sinovac — plan to produce around 3 billion doses. US-headquartered Pfizer-BioNTech have ramped up capacity to 3 billion doses as have Oxford-AstraZeneca. And then there are others. So, there is no shortage per se. The problem is related to the cost of the vaccine; it needs to be affordable for a vast number of people in the world. The going price of the vaccine is extremely opaque as companies are seeking profits wherever they can take them. The WHO does not track the price and the only sources are media reports. A review shows the price in general ranges from $2.50 to $20 per dose, with Oxford-AstraZeneca being the cheapest. Interestingly, while the EU paid $2.50 per dose, South Africa was charged $5.25. The vaccine by Sinopharm costs $15 per dose in Sri Lanka and $10 per dose in Bangladesh — in both cases the governments have placed the orders. But there are also reports that Sinopharm is selling its vaccine at $40 per dose in Argentina and that the US price for Moderna is $37. Vaccine companies want to keep the windfall coming. The strategy for ramping up capacity is to either do so themselves — like Pfizer, which has reportedly outsourced its legacy vaccines to other companies and will manufacture the 3 billion doses in-house — or sign contracts with other facilities so that the Covid-19 vaccine supply is ramped up but prices and profits remain intact. In all cases, the companies will control the price. Wherever they have offered discounts, as in the case of Astra-Zeneca in the EU, they say they have done so because the governments have invested in the research and development of the vaccine. But company executives have been quick to say these are “pandemic prices” and they expect the cost to increase manifold next year or the year after. In this situation vaccine inequity is inherent and inevitable. Poor countries cannot afford the vaccine. The Indian government, which has agreed to vaccinate its 1 billion people free of cost, has placed orders for some 440 million doses (of the 2 billion it needs) at Rs 150 per dose ($2) from Serum Institute of India (Covishield) and Bharat Biotech (Covaxin). This will put a burden on India’s economy, already reeling from the pandemic losses. Yet, the country’s universal vaccine programme is within its reach because of the low cost of each dose. There is no way other countries — from Bangladesh to Cameroon — can afford to pay $10-15 per dose to vaccinate their people free of cost. So, the way ahead has two options. One, which Germany and the UK favour, is to buy the vaccine from their companies and supply it to the WHO’s COVAX facility — set up to distribute Covid-19 vaccines worldwide. Boris Johnson, host of the recently concluded G7 Summit, has with much fanfare said his country will donate 100 million surplus vaccines — they bought in excess of their needs — of which it will dispatch 5 million by September 2021. All together with the US contributing another 500 million, the G7 has said it will provide 1 billion doses by mid-2022. This is too little, too late — cases in Africa are already on the rise. There is also no plan on how the world will, in this strategy of buying and donating, be able to afford the cost of universal vaccination. COVAX is already facing shortages and broken promises of supply. This is where the second option of providing a temporary waiver on intellectual property rights (TRIPS) comes in. It will allow other companies to mass produce the vaccine. And, as it happened in case of HIV/AIDS drugs, the price would go down when this waiver is given. The reduced price will allow for increased availability and access. This makes the pandemic response truly global — and the vaccines a global good. But this does mean that the “free world” has to deepen its tryst with democracy. To fight what the US president called “autocracy” in the world, it will need to show how it will reestablish the “public” in the public — currently we have dismembered the state and allowed the market to grow and believed that this will empower societies. This has not. The state-market-consuming society combine has brought things to such a pass. This is what needs to be reinvented. For Covid-19 and beyond.

WHO to take call on emergency use listing of Covaxin in 4 to 6 weeks, says chief scientist

The WHO is likely to take a decision on the inclusion of Bharat Biotech’s Covid-19 vaccine Covaxin in the emergency use list in the next four to six weeks, chief scientist Soumya Swaminathan said on Friday. The World Health Organisation (WHO) is likely to take a call on whether to include Bharat Biotech’s Covid-19 vaccine Covaxin in the emergency use list (EUL) in the next four to six weeks, WHO chief scientist Soumya Swaminathan said. VDO.AI At a webinar held by the Centre for Science and Environment (CSE) on Friday, she said that the global health body is reviewing Covaxin while its manufacturer Bharat Biotech uploads all the data on the WHO portal. As per WHO guidelines, emergency use listing (EUL) is a procedure to streamline the process in which new products can be approved and used during public health emergencies like a pandemic. “There is a process to be followed for EUL and pre-qualification of vaccines under which a company has to complete Phase 3 trials and submit the whole data to the regulatory department of WHO which is examined by an expert advisory group,” Swaminathan explained. “The completeness of the data, which includes safety and efficacy and also the manufacturing quality and standard, is provided. So, I expect that Bharat Biotech has already submitted data and in four to six weeks there will be a decision on its inclusion,” she said. advertisement VACCINES UNDER EVALUATION As of now, the WHO has approved Covid vaccines by Pfizer/BioNTech, Astrazeneca-SK Bio/Serum Institute of India, AstraZeneca EU, Janssen, Moderna and Sinopharm for emergency use. “We currently have six vaccines approved with EUL and have recommendations from our Strategic Advisory Group of Experts (SAGE). We continue to look at Covaxin. Bharat Biotech has now started uploading their data on our portal and that is the next vaccine that will be reviewed by our experts committee,” Soumya Swaminathan said. Currently, there are 105 vaccine candidates under clinical evaluation of which 27 are in the third or fourth phase, she said. Another 184 candidates are in preclinical evaluation. Most vaccines are designed with a two-dose schedule. WHO RESEARCH AND DEVELOPMENT BLUEPRINT She went on to speak of the WHO Research and Development Blueprint created in 2016 after the Ebola outbreak. In the blueprint, a research roadmap for diseases with the potential to become pandemics was laid out. “I want to mention the Research and Development (R&D) Blueprint. I think we need to think about how we can do better in the future in terms of development of not just vaccines but drugs, diagnostics and ensuring equitable access. This blueprint was developed after the Ebola outbreak and essentially it laid out a research roadmap for diseases which have pandemic potential,” she said. advertisement “So, when the roadmap was developed in 2016, it mentioned 'Pathogen X' in it which showed that we were anticipating a pandemic, which is now Covid-19,” she added. Swaminathan explained that the roadmap laid out steps to develop target product profiles. This includes standards for vaccines, diagnostics regulatory standards, trial designs and trial simulators. “This pre-thinking helped because WHO was able to bring together scientists, researchers, academics and companies at the beginning of last year to develop a research roadmap for Covid,” she said. DELTA VARIANT Apart from that, Soumya Swaminathan said that the Delta variant of Covid-19 is very transmissible. “Two complete doses are required for protection against the Delta variant but you can still get the infection and can transmit it. This is why masking and other precautions are important to continue,” she said. BOOSTER DOSE On booster doses, Swaminathan said that right now there is no data to confirm whether a booster dose is required after two doses to protect people. “Science is evolving. At this point we don't have data to indicate that everyone will need a booster. If required, we do not know if it will be needed after one year or two years. But data from follow-up studies of vaccinated people are very encouraging and show that immune responses are lasting up to 8, 10 or even 12 months,” she said. “A few studies that have looked at giving booster dose after six months have shown that it can increase the antibody levels so that they can protect against all variants. What we know is you need a high level of antibodies, whether it's through a booster or the first course. We need more studies to see which vaccines will require a booster and when. It could be possible that a combination of two different vaccines is administered in future but these are all being looked into through research and we have to wait,” she concluded.

Coronavirus: India reports 41K+ new cases; nearly 900 more dead

India on Sunday reported over 41,000 new COVID-19 cases along with nearly 900 more deaths. Several states have eased COVID-19 restrictions to stem the viral spread in light of the decline in infections, however, government officials warn against letting the guard down. World Health Organisation (WHO) Chief Scientist Soumya Swaminathan has also noted that the coronavirus pandemic isn't slowing down. Here are more details. n this article India's tally reaches 3.08 crore; 4.08 lakh dead Cases dipped after second wave peaked in May 73% new cases concentrated in 5 states Over 38 crore vaccine doses provided to states/UTs: Centre COVAXIN emergency listing likely in 4-6 weeks: WHO According to the Union Health Ministry, till Sunday morning, India reported a total of 3,08,37,222 COVID-19 cases. The death toll has reached 4,08,040. So far, 2,99,75,064 patients have recovered, while 4,54,118 cases involve active infections. In the past 24 hours alone, India recorded 41,506 new infections, 41,526 more discharges, and 895 fresh fatalities. 37,60,32,586 vaccine doses have been administered so far. Cases dipped after second wave peaked in May India's second wave peaked on May 7, when 4.14 single-day cases were reported, over four times the number of cases reported during the first wave in mid-September 2020. Although infections have declined since the second wave peaked, India crossed the 3 crore-mark on June 23. Notably, India had crossed the 1 crore-mark on December 19, 2020, and the 2 crore-mark on May 4, 2021. 73% new cases concentrated in 5 states Maharashtra reported 8,296 new COVID-19 cases along with 6,026 more recoveries. Kerala, the second worst-hit state after Maharashtra, reported 14,087 new cases and 11,867 discharges. Meanwhile, the third worst-hit Karnataka added 2,162 new cases and 2,879 recoveries. Tamil Nadu, the fourth worst-hit state, reported 2,913 new cases and 3,321 recoveries. Andhra Pradesh reported 2,925 new cases and 3,937 recoveries. Vaccinations Over 38 crore vaccine doses provided to states/UTs: Centre The Health Ministry said Sunday that over 38.6 crore COVID-19 vaccine doses have been provided to states/union territories so far, while 11.25 lakh doses are in the pipeline. Over 1.44 crore doses are still available with states/UTs for use, it said. India has managed to fully vaccinate 5.5% of its total population, while over 22% has received at least one dose. COVAXIN COVAXIN emergency listing likely in 4-6 weeks: WHO WHO's Swaminathan also said that the global health body is likely to take a call on whether Bharat Biotech's COVAXIN will be granted emergency use listing (EUL) in the coming four to six weeks. She was speaking at a webinar held by the Centre for Science and Environment (CSE) on Friday. COVAXIN—over 77% effective—is a two-dose inactivated vaccine indigenously produced in India.

WHO से 4-6 हफ्तों में Covaxin को मिल सकती है इमरजेंसी इस्तेमाल की मंजूरी, चीफ साइंटिस्ट ने दी अहम जानकारी

Covaxin in WHO: विश्व स्वास्थ्य संगठन ने अभी तक भारत बायोटेक की कोविड-19 वैक्सीन कोवैक्सीन को अपनी आपातकालीन उपयोग सूची में शामिल नहीं किया है. इसपर अब जल्द की फैसला हो सकता है. Covaxin WHO Approval Status: विश्व स्वास्थ्य संगठन (World Health Organisation) आने वाले चार से छह हफ्तों में ये फैसला लेगा कि भारत बायोटेक की कोविड-19 वैक्सीन कोवैक्सीन को इमरजेंसी यूज लिस्ट (ईयूएल) में शामिल किया जाएगा या फिर नहीं. इस बात की जानकारी संगठन की चीफ साइंटिस्ट सौम्या स्वामीनाथन (Soumya Swaminathan) ने दी है. शुक्रवार को सेंटर फॉर साइंस एंड एनवायरनमेंट (सीएसई) ने एक वेबीनार कराया था, जिसमें स्वामीनाथन ने ये जानकारी दी. उन्होंने कहा कि विश्व स्वास्थ्य संगठन कोवैक्सीन की समीक्षा कर रहा है (Covaxin WHO Approval Update). वहीं भारत बायोटेक ने भी डब्ल्यूएचओ के पोर्टल पर सारा डाटा अपलोड कर दिया है. संगठन के दिशा-निर्देशों के अनुसार, आपातकालीन उपयोग सूची यानी ईयूएल उस प्रक्रिया को कारगर बनाने की एक प्रक्रिया है, जिसके तहत नए उत्पादों को महामारी जैसी सार्वजनिक स्वास्थ्य आपात स्थिति के दौरान मंजूरी दी जा सकती है और उसका इस्तेमाल हो सकता है. कैसे मिलती है वैक्सीन को मंजूरी? स्वामीनाथन ने कहा, ‘ईयूएल के लिए एक प्रक्रिया का पालन होता है. जिसके तहत कंपनी को तीन चरण पूरे करने होते हैं और फिर सारा डाटा डब्ल्यूएचओ के रेगुलेटरी डिपार्टमेंट को सौंपना होता है (Covaxin WHO Approval Latest). बाद में फिर विशेषज्ञ सलाहकार समूह इस डाटा का विश्लेषण करता है. डाटा में सुरक्षा, प्रभाविकता, विनिर्माण गुणवत्ता और मानक भी शामिल हैं. इसलिए मुझे उम्मीद है कि भारत बायोटेक ने पहले ही डाटा जमा कर दिया है और चार से छह हफ्ते में इसे शामिल करने पर निर्णय हो जाएगा.’ इन वैक्सीन को मिली है मंजूरी अभी तक डब्ल्यूएचओ ने इमरजेंसी इस्तेमाल के लिए फाइजर-बायोएनटेक, एस्ट्राजेनेका-एसके बायो/सीरम इंस्टीट्यूट ऑफ इंडिया, एस्ट्राजेनेका ईयू, जेनसीन, मॉडर्ना और सिनोफार्म की वैक्सीन को मंजूरी दी है (Covid Vaccines Approved by WHO). सौम्या स्वामीनाथन ने कहा, ‘हम कोवैक्सिन को देख रहे हैं. भारत बायोटेक ने अब अपना डाटा हमारे पोर्टल पर अपलोड करना शुरू कर दिया है और यह अगली वैक्सीन है, जिसकी समीक्षा हमारी विशेषज्ञ समिति करेगी.’ उन्होंने कहा कि वर्तमान में क्लिनिकल इवैलुएशन में 105 वैक्सीन कैंडिडेट हैं, जिनमें से 27 तीसरे या चौथे चरण में हैं.

WHO to take decision on Covaxin's EUL listing in August first week

WHO has so far approved COVID-19 vaccines belonging to Pfizer-BioNTech, AstraZeneca- SK Bio/SII, Johnson & Johnson Janssen, Moderna and Sinopharm for The World Health Organisation (WHO) is likely to take a decision on the Emergency Use Listing (EUL) of Bharat Biotech's Covaxin in the first week of August. WHO's Emergency Use Listing is important for the vaccine company to supply vaccines for global facilities such as Covax or international procurement. WHO's Chief Scientist Soumya Swaminathan, while speaking at a webinar organised by the Centre for Science and Environment (CSE) on July 9, 2021 said that WHO is reviewing Covaxin as its manufacturer Bharat Biotech is now uploading its entire data on the health body's portal. What all is required for WHO's EUL Listing? • A vaccine company has to follow a certain process to get WHO's EUL listing such as completing phase 3 trials and submitting the whole data to WHO's regulatory department, which will then be examined by an expert advisory group. • The data includes safety and efficacy for the vaccine and also the manufacturing quality and standard. • As per WHO guidelines, Emergency Use Listing is a procedure to streamline the process by which new or unlicensed products can be used during public health emergencies. • Bharat Biotech has already submitted the required data and WHO is expected to announce the decision on its inclusion in 4-6 weeks. Covaxin • India's indigenous COVID-19 vaccine, Covaxin has showed 63.6 percent efficacy against the Delta variant of Covid-19, which is currently spreading cross the world. • It has demonstrated 93.4 percent efficacy against severe symptomatic Covid-19 and 63.6 percent against asymptomatic Covid-19. • The trial was conducted on 25,800 participants and the data submitted to the Subject Expert Committee (SEC) showed the vaccine was "well-tolerated."

Decision on emergency use listing of Covaxin likely in 4-6 weeks: WHO

The World Health Organization (WHO) is likely to take a decision on including Bharat Biotech's COVID-19 vaccine Covaxin in the emergency use list (EUL) within four to six weeks, Soumya Swaminathan, the global health body's chief scientist has said. Speaking at a webinar organised by the Centre for Science and Environment (CSE) on Friday, Swaminathan said the WHO is reviewing Covaxin as its manufacturer Bharat Biotech is now uploading its entire data on the health body's portal. According to WHO guidelines, EUL is a procedure to streamline the process by which new or unlicensed products can be used during public health emergencies. There is a process to be followed for EUL and pre-qualification of vaccines under which a company has to complete phase 3 trials and submit the whole data to the regulatory department of WHO which is examined by an expert advisory group, Swaminathan said.

Alert: Chemical in cosmetics

There was excessive use of hazardous heavy metals, including mercury, in many of the products. This accumulates over time causing skin issues. A study by the American Environment Working Group shows that a person can apply up to 168 different chemicals on their skin. In another study done by the Pollution Monitoring Lab at Centre for Science and Environment (CSE) in 2014, it was seen that leading cosmetics brands both Indian and abroad used toxic chemicals in some of their products. There was excessive use of hazardous heavy metals, including mercury, in many of the products. This accumulates over time causing skin issues. The most prominent preservatives are parabens and sulfates. Since the 1920s, parabens have been added to beauty care products to slow down the rate of biodegradation of the ingredients used in them. They help increase the product’s shelf life. However, parabens can cause hormonal imbalance, fertility issues, and increase the chances of getting breast cancer. Sulfates, SLS or SLES found in shampoos and body washes are skin irritants that can lead to excessive dryness, dermatitis, itchy skin, and eczema. For those prone to acne, sulfates can clog pores. Also, mineral oil is your worst enemy as it forms a barrier over the skin and clogs the pores. Phthalate, often shown as a synthetic fragrance, is harmful for young children. In India, a chemical preservative called hexachlorophene is banned for use in beauty products but is still found in some products. Similarly, manufacturers have been asked to control the use of fluoride in toothpaste. If included, it has to be mentioned on the packaging. To control the use of such toxins in beauty products, the government is working on setting up a Central Cosmetics Laboratory that will keep track of the actives being put into creams and lotions. Now it has become compulsory for beauty care product manufacturers to declare all the ingredients that they are including, so it is your job as a consumer to read the fine print carefully. The author is Co-founder, WOW Skin Science, a #MakeInIndia skincare and wellness brand

Only 1 per cent of population in low-income countries vaccinated; in high-income nations, the figure is 48.3 per cent – say experts at CSE-Down To Earth global webinar

The vaccination drive to combat Covid-19 is one of the most anticipated events of our times, but severe vaccine “apartheid” and inequity across the world is threatening to derail the fight against the virus – said experts speaking at a global webinar here today. Covid-19 has already infected 184,572,371 people globally and claimed 3,997,640 lives. A mere 24.7 per cent of the world population has received at least one dose till date. However, most of these doses have been hogged by the rich countries. At the webinar on ‘Vaccines for all’, some of the world’s top experts came together to examine the race between the virus, its variants and vaccines, and the question of inequity. The webinar was addressed by Soumya Swaminathan, chief scientist, World Health Organization; Shabir A Madhi, professor of vaccinology and dean, Faculty of Health Sciences, University of Witwatersrand, South Africa; Leena Menghaney, regional head (South Asia), Access Campaign for Medicines Sans Frontiers; and Vibha Varshney, associate editor, Down To Earth. CSE director general Dr. Sunita Narain anchored the discussions. Speaking at the webinar, Sunita Narain pointed out: “As early as April 2020, COVID-19 Vaccines Global Access or COVAX, an alliance between WHO, GAVI, the Vaccine Alliance and Coalition for Epidemic Preparedness Innovations, was set up to accelerate the development and production of and equitable access to vaccines. Yet, a year later, shortages and inequitable distribution of doses threatens to derail this largest vaccination campaign the world has ever seen.” Gross inequity For an estimated global adult population of 5.5 billion, 11 billion vaccine doses are needed. Of this, 3.32 billion doses have already been administered. “The industry seems to have promised overambitious production numbers without actually setting its house in order. The unavailability of enough raw materials is likely to make matters worse,” says Vibha Varshney. About 48.3 per cent of people in high-income countries have been vaccinated. The percentage drops to 33.8, 13.2 and a mere 1 per cent in middle-income, lower-middle income and low-income countries, respectively. Under COVAX (with 180 participating countries) rich countries pay for vaccines, and 92 low- and middle-income countries are subsidised. Serum Institute of India (SII) has to provide one billion of the doses under COVAX. The initiative has been facing acute shortfall after SII slipped on the delivery timeline because of a surge in cases in India. COVAX has also been criticised for allocating vaccines in proportion to population sizes, which is not the best public health metric. As a result, it has short-changed nations in desperate need of vaccines, while providing it to others that have comparatively fewer cases. The alliance also does not consider countries’ capacities to roll out massive immunisation campaigns,” says Down To Earth in a report it has published earlier. What the WHO is saying – Soumya Swaminathan Speaking at the webinar, Swaminathan pointed out that the ongoing spike in many countries is worrying mainly because the cases of Delta variant are rising sharply. “There had been a hope that the number of daily deaths will decrease, but they have been increasing as well,” she said. Swaminathan said COVAX has mobilized significant amount of resources and access to the vaccines, but due to supply considerations, most of the roll-out is now going to happen in the last quarter of 2021. She also listed some of the reasons for the relatively slow uptake of the vaccines — lack of knowledge and information, operational issues, and apprehensions about vaccination, among others. “WHO’s initial 20 per cent goal of vaccine coverage was aimed at covering the vulnerable in each country, the idea being that healthcare and frontline workers and the elderly should be covered so that the mortality rate is brought down. The goal has now been revised to 40 per cent coverage in each country by the end of this year, and 70 per cent by the middle of the next year,” she said. Swaminathan thinks the big challenge in vaccine research is “the need for well-designed effectiveness trials in multiple countries”. The only way to increase supplies right now, according to her, is dose-sharing by countries that have already vaccinated more than 40 per cent of their population. The question of TRIPS and Big Pharma Perhaps the biggest spanner in the works of the vaccination drive are powerful multinational pharmaceutical companies encouraged by prevaricating governments of high-income countries. Big Pharma is not willing to part with scientific know-how on the vaccines. They are protected by World Trade Organisation (WTO)’s strict trade-related intellectual property rights (TRIPS). While it is true that many developing nations do not have the capacity to manufacture vaccines, even those that do are seriously hampered by TRIPS. “When COVAX was set up, the world’s richest countries went ahead and donated to COVAX but then tied up supplies to themselves first. The disparity in access that we see today is the direct result of this strategy,” said Leena Menghaney, speaking at the webinar. Developed countries could do this because of concentration of manufacturing in these geographical location and control of manufacturing through a variety of business strategies including IPR, says Menghaney. COVAX can procure only WHO-approved vaccines, explained Varshney. The UN agency has given a nod to just six of the 17 vaccines that are being administered in different countries across the world. Of these, Covishield, manufactured by SII, is the cheapest at around US $3 a dose. The other vaccines cost anywhere between $1 and $40, as manufacturers are selling them at different prices to different countries to maximise profits. How is Africa faring – the Valleys of Death In his presentation, Shabir Madhi said that cases in Africa have been grossly underreported. The continent is struggling with what has been called the two ‘Valleys of Death’. The first of these is the disease itself and its rapid spread, and the second is the unavailability of a cure or vaccine. According to Madhi: “Only 64 per cent of the vaccines available in Africa are actually being administered. Less than 3 per cent of Africans have been vaccinated.” He pointed out that Africa does not have much vaccine manufacturing capacity, and will have to depend on countries that have the capacity to share vaccines with it. “The virus is going to be with us for some time,” said Madhi. “Herd immunity is not going to be achieved soon. The focus should be to accelerate innovation so that high-risk individuals have access to the best treatment and care to protect them against severe disease and death.” Vaccines for all Says Richard Mahapatra, managing editor of Down To Earth: “The virus is rapidly mutating, multiplying variants and policy and logistic headaches. Four variants, named after the first four letters of the Greek alphabet, are already of serious concern. Many more are being observed closely. In the mad race between the virus and the vaccine, cooperation between nations and agencies will be crucial.” “We must free technology through TRIPS waiver and COVID-19 Technology Access Pool (C-TAP), augment production facilities and promote collaborations for raw materials. We must set a system for equitable distribution via COVAX by restricting hoarding, ensuring funding and increasing transparency. Vaccines must be provided free of cost and their access and delivery rate should be increased. Promotion of pandemic-appropriate behaviour to control spread needs to be continued. Only then can we hope to beat the pandemic,” says Varshney. Said webinar anchor Dr. Sunita Narain: “The virus has been a great equalizer and we must learn our lessons from it. It is impossible to try to compartmentalise our responses to a pandemic of this magnitude and scale. It will continue to be a threat as long as we don’t truly unite against it, rising over national and corporate interests. No one is safe until everyone is safe.”

Decision on emergency use listing of Covaxin likely in 4-6 weeks: WHO

Soumya Swaminathan said the WHO is reviewing Covaxin as its manufacturer Bharat Biotech is now uploading its entire data on the health body's portal The World Health Organization (WHO) is likely to take a decision on including Bharat Biotech's COVID-19 vaccine Covaxin in the emergency use list (EUL) within four to six weeks, Soumya Swaminathan, the global health body's chief scientist has said. Speaking at a webinar organised by the Centre for Science and Environment (CSE) on Friday, Swaminathan said the WHO is reviewing Covaxin as its manufacturer Bharat Biotech is now uploading its entire data on the health body's portal. According to WHO guidelines, EUL is a procedure to streamline the process by which new or unlicensed products can be used during public health emergencies. There is a process to be followed for EUL and pre-qualification of vaccines under which a company has to complete phase 3 trials and submit the whole data to the regulatory department of WHO which is examined by an expert advisory group, Swaminathan said. The completeness of the data, which includes safety and efficacy and also the manufacturing quality, standard is provided. So, I expect that Bharat Biotech has already submitted data and in four to six weeks there will be a decision on its inclusion, Swaminathan added. At present, the WHO has approved vaccines by Pfizer/BioNTech, Astrazeneca-SK Bio/Serum Institute of India, AstraZeneca EU, Janssen, Moderna and Sinopharm for emergency use. We currently have six vaccines approved with EUL and have recommendations from our Strategic Advisory Group of Experts (SAGE). We continue to look at Covaxin. Bharat Biotech has now started uploading their data on our portal and that is the next vaccine that will be reviewed by our experts committee, the chief scientist said. She also mentioned the WHO Research and Development Blueprint prepared in 2016, shortly after the Ebola outbreak, in which a research roadmap for diseases with pandemic potential was laid out. I want to mention the Research and Development (R&D) Blueprint. I think we need to think about how we can do better in the future in terms of development of not just vaccines but drugs, diagnostics and ensuring equitable access. This blueprint was developed after the Ebola outbreak and essentially it laid out a research roadmap for diseases which have pandemic potential, she said. So, when the roadmap was developed in 2016, it mentioned 'Pathogen X' in it which showed that we were anticipating a pandemic, which is now COVID-19, she added. Swaminathan also said the roadmap essentially laid out the steps in terms of developing target product profiles like standards for vaccines, diagnostics regulatory standards, trial designs, and trial simulators. This pre-thinking helped because WHO was able to bring together scientists, researchers, academics and companies at the beginning of last year to develop a research roadmap for COVID, she said. At present, there are 105 candidate vaccines in clinical evaluation out of which 27 are in phase three or four, she said. There are another 184 candidate vaccines in preclinical evaluation. Most of the vaccines are designed for a two-dose schedule, she added. The WHO chief scientist also said the Delta variant of the coronavirus is very transmissible. Two complete doses are required for protection against the Delta variant but you can still get the infection and can transmit it. This is why masking and other precautions are important to continue, she said. Talking about some companies stressing on the need to develop a booster dose after two vaccine shots doses to protect people, Swaminathan said, at this point there is no data to indicate if a booster dose is required. Science is evolving. At this point we don't have data to indicate that everyone will need a booster and is it going to be after one year or two years. But data from follow up studies of vaccinated people are very encouraging and is showing that immune responses are lasting up to 8, 10 or even 12 months, she said. A few studies that have looked at giving booster dose after six months have shown that it can increase the antibody levels so high that they can protect against all variants. What we know is you need a high level of antibodies, whether it's through a booster or the first course. We need more studies and see which vaccines will require a booster and when. It could be possible that a combination of two different vaccines is administered in future but these are all being looked into through research and so we have to wait, she said.