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 Money Control 30.11.2020 Moderna Inc on November 30 said that it will be seeking emergency use authorisation of its COVID-19 vaccine from the United States Food and Drug Administration (USFDA) and European regulators after results from a late-stage study showed its vaccine was 94.1 percent effective. It also reported a 100 percent success rate in preventing severe cases, news agency Reuters reported. "We believe that we have a vaccine that is very highly efficacious. We now have the data to prove it," Moderna Chief Medical Officer Dr. Tal Zaks said in a interview, adding that Moderna expects to play a "major part in turning around this pandemic". It was the first time I allowed myself to cry. At this level of effectiveness, when you just do the math of what it means for the pandemic that's raging around us, it's just overwhelming," Zaks said, according to Reuters. Earlier on November 16, reports had suggested that  Moderna Inc's experimental COVID-...

  A vaccine for Covid-19 is not yet available but many rich countries and some middle-income ones have entered partnerships to reserve vaccine doses. This shopping spree means that there will be fewer doses for billions in low-income countries, according to an  analysis  by the Duke Global Health Innovation Center.   Currently there are nearly 200 Covid-19 candidates that are moving forward through the development and clinical trials processes, and over ten candidates are already in Phase-3 large-scale trials, the analysis found. The confirmed purchases from countries cover nearly four billion doses of vaccines, with another five billion doses under negotiation.  There will not be enough vaccine to cover the world’s population until 2024, according to current models taking into account the manufacturing capacity.  “An ambitious effort to create a global system of vaccine equity is being undermined as a handful of countries—including those who made a co...

 The Telegraph online, G.S. Mudur, October 31, 2020 A top medical virologist has proposed that vaccine candidates against the coronavirus disease shown to be safe and generating a good immune response in humans should be offered to high-risk individuals in parallel with phase 3 efficacy trials. The proposal by T. Jacob John, former head of clinical virology at the Christian Medical College, Vellore, represents a dramatic departure from standard practice that allows vaccine roll-outs only after efficacy has been established through large-scale phase 3 trials. “There is a strong case for allowing emergency use of any Covid-19 vaccine already in phase 3 or ready for phase 3,” John said in a peer-reviewed paper co-authored with Mumbai-based paediatrician Dhanya Dharmapalan and set to appear in the Indian Journal of Medical Ethics. A phase 1 trial on a small number of healthy volunteers evaluates a vaccine for safety, while a phase 2 trial on a few hundred volunteers examines whether th...

 The Livemint October 19, 2020 Russian Direct Investment Fund (RDIF) has signed a pact with Delhi-based pharmaceutical company Mankind Pharma for marketing and distribution of its Sputnik V vaccine, two sources in the know of the matter said.  “It depends on how many doses they will give Mankind. RDIF has pacts with Russian and Korean manufacturers for around 50 million doses so far. Talks with Indian manufacturers are also ongoing. Mankind will get the doses once the approvals are in place and the doses are supplied," one of the sources said, adding that a formal announcement is likely to be made later this week. Queries sent to Mankind Pharma were unanswered at the time of publishing. A spokesperson for RDIF decline to comment on the development.  The pact with Mankind Pharma is expected to supplement the one with Dr Reddy’s Laboratories, but unlike Dr Reddy’s, Mankind will not be conducting the clinical trials. Last month, Dr Reddy’s and RDIF, Russia’s sovereign wealth...

  CNBC October 19,2020 Healthy young people might not get the coronavirus vaccine until 2022 as public health officials focus on immunizing the elderly and other vulnerable groups first, top officials from the World Health Organization said Wednesday. Dr. Soumya Swaminathan, WHO’s chief scientist, said health workers, frontline workers and the elderly will likely be offered a vaccine first, though prioritization details are still being worked out by the WHO and its advisory groups. And, of course, a vaccine for the virus has yet to be deemed safe and effective by the WHO, the European Union or the United States.“People tend to think that on the first of January or the first of April, I’m going to get the vaccine, and then things will be back to normal,” Swaminathan said. “It’s not going to work like that.” She added that the world will hopefully have at least one safe and effective vaccine by 2021, but it will be available in “limited quantities.” The WHO’s strategic advisory group...

Tech Crunch,  October 08, 2020 Dr Lal PathLabs, one of the largest lab testing companies in India, left a huge cache of patient data on a public server for months, TechCrunch has learned. The lab testing giant, headquartered in New Delhi, serves some 70,000 patients a day, and quickly became a major player in testing patients for COVID-19 after winning approval from the Indian government. But the company was storing hundreds of large spreadsheets packed with sensitive patient data in a storage bucket, hosted on Amazon Web Services (AWS), without a password, allowing anyone to access the data inside. Australia-based security expert Sami Toivonen found the exposed data and reported it to Dr Lal PathLabs in September. The company quickly shut down access to the bucket but the company did not reply, Toivonen told TechCrunch. It’s not known how long the bucket was exposed. Toivonen said the exposed data amounted to millions of individual patient bookings. A redacted section of the sprea...

The Economic Times,  October 09, 2020 New Delhi: Vaccine maker Bharat Biotech has approached the drug regulatory authority and sought permission to conduct phase III clinical trials of its indigenous Covid-19 vaccine Covaxin. The subject expert committee, which discussed the matter in a meeting held on October 5, has asked the Hyderabad-based company to resubmit the protocol. “After detailed deliberation the committee opined that the design of the phase III study is in principle satisfactory except for clarification on definition of asymptomatic, etc,” said the minutes of the meeting. “However, the study should be initiated with appropriate dose identified from the phase II safety & immunogenicity data. Accordingly, the firm should submit safety & immunogenicity data from phase II trial for consideration.” The company had approached the drug controller’s office and presented its phase III clinical trial protocol along with interim data of phase I and II clinical trials. “Th...

Vision Times, October 07, 2020 A defector from China’s People’s Liberation Army (PLA) recently provided American intelligence agencies with information regarding the CCP’s bioweapons programs. The Asian nation is believed to be actively developing biological weapons, thereby posing a threat to global security.   China and bioweapons “The defector escaped from China and traveled to Europe, where he is under the protection of a European government security service… The PLA defector believes that Chinese intelligence has penetrated the U.S. government and is therefore wary of cooperating with the CIA and other Western spy agencies,” according to the  Washington Times. However, the person has provided some information about Chinese bioweapons to the U.S. Recently, a researcher from China, Dr. Yusen Zhou, was found dead under mysterious circumstances. Zhou was the team leader at the State Key Laboratory of Pathogen and Biosecurity, Beijing Institute of Microbiology and Epidemi...

The Indian Express,  October 08, 2020 At the centre of the storm around the Narcotics Control Bureau’s investigation into the alleged drug trafficking in connection with actor Rhea Chakraborty — given bail by Bombay High Court on October 7 — following the death of actor Sushant Singh Rajput and what has now become an ‘inquiry’ aimed at “uprooting the drug citadel in Bollywood”, is a plant that goes by many names: cannabis, hemp, marijuana or pot. As potent as various parts of its anatomy may be, not all of them amount to criminality under the Narcotic Drugs and Psychotropic Substances (NDPS) Act, 1985. What is the cannabis plant? According to the World Health Organisation (WHO), cannabis is a generic term used to denote the several psychoactive preparations of the plant Cannabis sativa. The major psychoactive constituent in cannabis is Delta-9 tetrahydrocannabinol (THC). The Mexican name ‘marijuana‘ is frequently used in referring to cannabis leaves or other crude plant material in...

Dailyhunt October 08, 2020 New Delhi | Jagran News Desk: India's drug regulatory authority Central Drugs Standard Control Organisation (CDSCO) has rejected a proposal from Dr Reddy's Laboratories Ltd to conduct a large study in the country to evaluate Russia's Sputnik-V COVID-19 vaccine and has asked it to first test the vaccine in a smaller trial. The recommendations by an expert panel of the CDSCO noted that safety and immunogenicity data from early-stage studies being conducted overseas is small, with no inputs available on Indian participants. India's move comes as a setback for Russia's plan to roll-out the vaccine even before full trials show how well it works, while pushing back its efforts to win approval for the vaccine in the country that leads the world on average number of new infections. The past few days have seen a flattening curve of cases in India with the country recording continuous dip in number of active cases and deaths. The number of infection...

The Indian Express,  October 08, 2020 At 1.55 per cent, India’s COVID-19 mortality (case fatality rate) is an important talking point. It’s been hailed as among the lowest in the world, “less than many nations in Europe”, and the government is targeting to bring it down to less than 1 per cent. However, The Lancet cautioned about “the dangers of false optimism” in its September 26 editorial on the Indian situation. Overall, Asian countries have experienced much lower COVID-19 mortality as compared to those in Europe. The initial high mortality in Spain and France has been attributed to several reasons: More than 75 per cent of the deaths were among those aged more than 75 years and living in care homes; high prevalence of co-morbidities, obesity and smoking among those infected; disproportionate number of health care providers infected early on (15 per cent of total cases) rendering the health services weak; and, shortage of diagnostic tests and personal protective equipment. Three...

  Sep 11, 2020 15:37 IST Associated Press Geneva Posted by: Harshit Sabarwal “The social safety nets put into place are full of holes,” said Olivier De Schutter, a Belgian legal scholar appointed by the UN Human Rights Council as special rapporteur on extreme poverty and human rights. “These current measures are generally short-term, the funding is insufficient and many people will inevitably fall between the cracks,” De Schutter said. “These current measures are generally short-term, the funding is insufficient and many people will inevitably fall between the cracks,” De Schutter said.(Reuters file photo)  The United Nations independent expert on poverty has warned that the worst impacts from the coronavirus pandemic on poverty are yet to come, and that measures taken by governments to protect people so far have been insufficient. “The social safety nets put into place are full of holes,” said Olivier De Schutter, a Belgian legal scholar appointed by the UN Human Rights Counc...

The Indian Express August 25, 2020 Responding to an outcry from medical experts, Food and Drug Administration Commissioner Stephen Hahn on Tuesday apologised for overstating the life-saving benefits of treating COVID-19 patients with convalescent plasma. Scientists and medical experts have been pushing back against the claims about the treatment since President Donald Trump’s announcement on Sunday that the FDA had decided to issue emergency authorisation for convalescent plasma, taken from patients who have recovered from the coronavirus and rich in antibodies. Trump hailed the decision as a historic breakthrough even though the treatment’s value has not been established. The announcement on the eve of Trump’s Republican National Convention raised suspicions that it was politically motivated to offset critics of the president’s handling of the pandemic. Hahn had echoed Trump in saying that 35 more people out of 100 would survive the cor...

Financial  Express August 24, 2020 The proposed mission that will focus on end-to-end vaccine development from clinical trial stage to regulatory facilitation to manufacturing, will be piloted by the Department of Biotechnology, the PTI report stated. There is no official word on it as yet, but senior officials told PTI that it is in “a proposal stage”. As per the draft proposal, the Mission COVID Suraksha is proposed to have a timeline of 12-18 months and a budget of approximately Rs 3,000 crore. It will also look at ensuring that sufficient volumes of the vaccine are manufactured to meet India’s COVID-19 vaccine requirement. Also, as per the approval of the National Technical Advisory Group on Immunisation (NTAGI), the mission will focus on efficient ways to introduce the vaccine in public health systems of the Ministry of Health post to combat further spread of COVID-19 infection. The draft proposal says that it is imperative that the vaccine development an...

The Indian Express August 21, 2020  Recently, Australian Prime Minister Scott Morison said the government would offer free doses of Covid-19 vaccine to the entire 25 million population, putting into focus a rather tricky issue nations are grappling with across the world: who should get the vaccine first — and why. Most nations, including India, are unanimous on the first recipients — frontline health workers directly interacting with Covid-19 patients. However, there is no straight answer to which population group comes next. For this purpose, several countries have set up expert committees to decide on the next tier of distribution as initially only a limited amount of vaccines will be available before mass production. In June, the World Health Organisation (WHO) had come out with a tentative plan of “strategic allocation” of the coronavirus vaccine. It said healthcare workers should be given priority first followed by adults older than 65 and those having comorbid...

The Indian Express August 21, 2020 Six months after the outbreak of the novel coronavirus epidemic — and over 27 lakh cases and 52,000 deaths later — several indicators have begun to suggest that an improvement in the situation might just be round the corner in India. Consider: For the first time since May, the overall positivity rate in the country has begun to decline. Which means, for the same number of tests, fewer people are now being found infected with the virus. The positivity rate touched a high of 9 per cent on August 9, and has been declining steadily since. As of Tuesday (August 18), positivity had fallen to 8.72 per cent. Simultaneously — and not unrelatedly — there is a relative stagnation in the numbers of new positive cases being detected every day. This number has been locked in the mid-60,000s for almost two weeks – much longer than it has remained in any other range of quite some time now.  Overall positivity rate has come down to 8.72 p...