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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-...

 The Telegraph 26.11.2020 Oxford University and AstraZeneca on Wednesday acknowledged a manufacturing error that is raising questions about  preliminary results of their experimental Covid-19 vaccine . A statement describing the error came days after the company and the university described the shots as "highly effective" and made no mention of why some study participants   did not receive as much vaccine   in the first of two shots as expected. In a surprise finding, the group of volunteers that got a lower dose  seemed to be much better protected  than the volunteers who got two full doses. In the low-dose group, AstraZeneca said, the vaccine appeared to be  90 per cent effective . In the group that got two full doses, the vaccine appeared to be 62 per cent effective. Combined, the drugmakers said the vaccine appeared to be 70 per cent effective, but the way in which the results were arrived at and reported by the compan...

  By Teena Thacker ET Bureau Synopsis A participant in phase 1 clinical trials of the Covid vaccine being developed by Bharat Biotech in collaboration with Indian Council of Medical Research (ICMR) fell ill and had to be hospitalised after taking the shot in July, but the trials were not halted and no public disclosure was made. New Delhi: A participant in the phase 1 clinical trials of the Covid vaccine being developed by Bharat Biotech in collaboration with Indian Council of Medical Research (ICMR) fell ill and had to be hospitalised after taking the shot in July, but the trials were not halted and no public disclosure was made. A senior government official told ET that the matter was examined by the Data and Safety Monitoring Board (DSMB) of the sponsor and the report was shared with the Drug Regulatory Authority.  It was concluded that the ‘serious adverse event’ was unrelated to the vaccine. “The matter was examined and it was not a big thing that required the ongoing tri...

 Although strenuous efforts are on across the globe to develop vaccines and drugs to fight Covid-19, the issue of their equitable access remains a major challenge. A formidable barrier to ensuring timely access to vaccines and drugs could be patents or other intellectual property (IP) rights. Médecins Sans Frontières (MSF), in a 2017 report, documents how patents have hindered the introduction of affordable vaccines in developing countries. The rights of the inventor should be protected through IP laws. Arguably, such protection spurs innovation, overcoming the social costs imposed on the public through limited accessibility of the product. However, in a world living through the worst pandemic in a century, there is a strong case for the collective interests of humanity to trump the individual interests of the inventor. India’s recent proposal at the World Trade Organization (WTO), jointly with South Africa, asking for a temporary waiver of the application of certain provisions of ...

Recently published findings on convalescent plasma therapy on Covid-19 patients have triggered a debate over its efficacy. After the country’s largest such trial, known by the acronym PLACID, found that convalescent plasma was ineffective in arresting Covid-19, the Indian Council of Medical Research (ICMR) has been considering dropping this option from the national guidelines. However, in several states including most-affected Maharashtra and Delhi, health authorities continue to push the option while those running plasma blood banks promote it with anecdotal accounts on social media. What is plasma therapy? Plasma is the liquid part of the blood. Convalescent plasma, extracted from the blood of patients recovering from an infection, is a source of antibodies against the infection. The therapy involves using their plasma to help others recover. For Covid-19, this has been one of the treatment options. The donor would have to be a documented case of Covid-19 and healthy for 28 days sinc...

 The US Food and Drug Administration (FDA) approved remdesivir as the first drug to treat COVID-19, it said on Thursday. The drug is designed to obstruct the replication of the virus in the body and has become the first drug to get official approval from the FDA for the treatment of the disease. Since the pandemic began, there has been debate about the efficacy of this drug, which was originally developed for treating Ebola, which is not caused by a coronavirus. So what does its approval mean and how does the FDA approve drug treatments? So, what has the FDA said? The FDA has approved the use of the antiviral drug remdesivir to treat hospitalised adult and pediatric patients of COVID-19 who weigh at least 40 kg. The agency has clearly stated that the drug should be administered only in hospitals or healthcare settings that are capable of providing acute care. What does FDA’s approval for remdesivir mean? Before Thursday, there were no FDA-approved drugs meant for the treatment of C...

 The World Health Organisation’s chief scientist, Soumya Swaminathan, has said experts and regulators assessing the use of remdesivir against Covid-19 should take into account all evidence, including the WHO’s global trial that found no benefit. “We believe our results are robust and we hope that people doing treatment guidelines and regulators around the world will take note of our study results in addition to other evidence,” Swaminathan said at a WHO briefing, a day after US regulators approved remdesivir for Covid-19. An Indian panel of medical experts is also examining available global evidence on remdesivir and is expected to decide in the coming days if the drug should continue to be offered to Covid-19 patients. The national treatment guidelines pencilled earlier this year recommend remdesivir for Covid-19 as an “investigational drug” under emergency use authorisation. The US Food and Drug Administration on Friday approved remdesivir citing three clinical trials, including ...

Covaxin, the coronavirus vaccine candidate jointly developed by Bharat Biotech and the Indian Council of Media Research (ICMR) in partnership with National Institute of Virology (NIV) has received approval from a panel of the Drugs Controller of India  (DCGI) for Phase 3 trials, as per reports. As per an NDTVreport, the Hyderabad-based company had in an application on 2 October sought permission from the DCGI to conduct Phase 3 trials. According to a LiveMint report, DCGI's Subject Expert Committee recommended giving the go-ahead to the vaccine candidate after examining data from phases 1 and 2 as well as animal challenge study. However, the approval is subject to amendment. As per a CNBC TV18report, the panel has suggested amendments to the criteria on how a suspected case be clinically evaluated and classified as a symptomatic case. Bharat Biotech will now be required to submit a completed protocol to the DCGI for final approval. As per the application made by the firm, the trial...

 The Food and Drug Administration said on Thursday that it had formally approved remdesivir as the first drug to treat Covid-19, a move that indicated the government’s confidence in its safe and effective use for hospitalized patients. The F.D.A. said the drug had been approved for adults and pediatric patients 12 years of age and older and weighing at least 40 kilograms (about 88 pounds) who require hospitalization for Covid-19, the disease caused by the coronavirus, which has killed more than 220,000 people in the United States. The F.D.A. had granted remdesivir emergency authorization in May after a trial by the National Institutes of Health found that it modestly reduced the recovery time in hospitalized patients. President Trump received the antiviral drug after he began showing symptoms earlier this month. The drug does not prevent death from Covid-19. The formal approval by the F.D.A. indicated that the drug had cleared more rigorous regulatory hurdles involving a more thoro...

 The Hindu  Sep 25, 2020 AP A Chinese pharmaceutical company said on Thursday the coronavirus vaccine it is developing should be ready by early 2021 for distribution worldwide, including the United States. Yin Weidong, the CEO of SinoVac, vowed to apply to the U.S. Food and Drug Administration to sell CoronaVac in the United States if it passes its third and final round of testing in humans. Mr. Yin said he personally has been given the experimental vaccine. “At the very beginning, our strategy was designed for China and for Wuhan. Soon after that in June and July we adjusted our strategy, that is to face the world,” Mr. Yin said, referring to the Chinese city were the virus first emerged. “Our goal is to provide the vaccine to the world including the U.S., EU and others,” Mr. Yin said. Stringent regulations in the U.S., European Union, Japan and Australia have historically blocked the sale of Chinese vaccines. But Mr. Yin said that could change. SinoVac is developing one of C...

money control Sep 24, 2020 PTI Scientists in the UK are moving towards what are being referred to as challenge trials, which will involve healthy volunteers being deliberately infected with the novel coronavirus to test whether a vaccine offers any protection, according to a media report. In the first trial of its kind expected to be formally announced next week, participants will be injected with an unnamed experimental vaccine and around a month later exposed to Sars-Cov-2, the virus that causes COVID-19, The Financial Times' reported. The government-funded study is expected to begin in January, with the trials likely to take place in a large secure facility in Whitechapel in east London or nearby. Around 2,000 potential volunteers have signed up for challenge studies in the UK through the US-based group 1Day Sooner, campaigning for COVID-19 trials, and are expected to be paid a few thousand pounds for signing up to the upcoming trials, according to the newspaper. The project...

  Money Control Sep 24,2020 B harat Biotech has planned to start the phase -3 trials of its COVID-19 vaccine Covaxin in October. In this phase, the company plans to test the vaccine on about 25,000 - 30,000 people. The company has also announced that it would be manufacturing up to a billion doses of an intranasal vaccine in collaboration with the Washington University School of Medicine. Reference:  https://www.moneycontrol.com/news/coronavirus/heres-status-update-on-10-covid-19-vaccines-that-are-ahead-of-the-pack-5882971.html

 The Hindu  Sep 23, 2020 PTI The coronavirus pandemic means this year’s General Assembly is a work-from-home production, for the first time in its history. What do you do when Vladimir Putin offers you Russia’s new coronavirus vaccine, for free? United Nations staff in New York and around the world are now facing that choice, after the Russian president offered on Tuesday to provide them the Sputnik-V vaccine in a speech to this year’s General Assembly marking the body’s 75th birthday. Only results from small early studies on Russian vaccine have been published, raising concerns among some scientists that the vaccine isn’t ready yet for widespread use — and prompting worldwide memes about potential bizarre side effects. Also read: The Hindu Explains | What do we know about Russia’s COVID-19 vaccine candidate Sputnik V? “Any one of us could face this dangerous virus. The virus has not spared the staff of the United Nations, its headquarters and regional entities,” Mr. Putin sai...

Scroll.in Date: Aug 07, 2020 letters@scroll.in,  Pharmaceutical company Zydus Cadila on Wednesday said its coronavirus vaccine candidate was found to be safe, immunogenic, and well-tolerated in an early-stage human trial. In a regulatory filing, the firm said it will start Phase II trials in over 1,000 healthy adult volunteers from Thursday to test its effectiveness against the infection. “The Phase I dosing to establish the safety of ZyCoV-D is an important milestone,” Zydus Cadila chairperson Pankaj R Patel said. “All the subjects in Phase I clinical trial were closely monitored in a clinical pharmacological unit for 24 hours post dosing for safety and for 7 days thereafter and vaccine was found to be very safe. We now begin the Phase II clinical trials and look forward to evaluating the safety and immunogenicity of the vaccine in a larger population.” The seven-day safety of the vaccine candidate in volunteers enrolled in the Phase I trial, who were administered doses since July...

The Indian Express June 4, 2020 Balram Bhargava Before the  COVID-19   pandemic  hit the world, we would often refer to science-fiction for cutting edge research such as brain transplants or bioengineering. But in my three decades of work in clinical medicine and medical research, never have I come across something that has transformed the global health landscape as much as the humble vaccine. While the pandemic has highlighted their importance, vaccines have always been the frontrunners in saving lives: With their help, we are able to prevent the death of two to three million children globally every year. It is because of vaccines that we managed to eradicate highly contagious diseases such as smallpox, which used to kill millions only a few decades ago. In India, vaccines have helped us defeat polio — the country was certified polio-free by the World Health Organisation (WHO) in 2014. In 2015, the country also eliminated maternal and neonatal tetanus. While we m...

The Hindu March 25, 2020 PTI Over the last few weeks, India has banned exports of host of medical devices including sanitisers, all types of ventilators and surgical masks. Amid the  coronavirus outbreak , the government on Wednesday banned export of anti-malarial drug hydroxycloroquine, with immediate effect to ensure sufficient availability of the medicine in the domestic market. Indian Council of Medical Research (ICMR) Director General Balram Bhargava had on Monday recommended the use of hydroxychloroquine for treating healthcare workers handling suspected or confirmed coronavirus cases and also the asymptomatic household contacts of the lab-confirmed cases. The treatment protocol recommended by the ICMR-constituted National Task Force for COVID-19 has been approved by the Drug Controller General of India (DGCI) for restricted use in emergency situations. In a notification issued on Wednesday, the Directorate General of Foreign Trade (DGFT), an arm of the co...

Business today March 25, 2020 E Kumar Sharma Private labs are gearing up to carry out coronavirus tests as kit-makers work overtime to ensure timely delivery. Mylab  and Altona Diagnostics India are the two suppliers of the testing kits. Mylab is hoping to ship out its first set of kits today. They are targeting producing 150 kits, which translates to 15,000 tests in batch sizes of 100 tests per day, in the next two days   Mylab's director  Dr Gautam Wankhede  says they are in a position to start supplying because they already have "the raw material and been in the molecular diagnostics manufacturing for the last three to four years." "We have already been approved for other sensitive kits for  HIV , and have been supplying to leading hospitals. We have the manufacturing in place with well set protocols. Having known the  RNA  sequence that needed to be targeted for this virus, we started designing our primers and probes (essential co...

India Today March 24, 2020 Sonali Acharjee hen the Indian Council for Medical Research (ICMR) released a statement on March 23 recommending use of the antimalarial drug hydroxychloroquine as a preventive medicine for those who face a high risk of coronavirus infection, C. Banerjee, a 69-year-old resident of Delhi’s Kalkaji, says the news gave him the shivers. In the 1980s, as cases of malaria began to increase in India, chloroquine (which is closely related to hydroxychloroquine) was widely prescribed. "It is like swallowing death," recounts Banerjee. Reported side effects of chloroquine include nausea, headache, mood swings, skin irritation, swelling, cramps, pale skin, muscle weakness, bleeding from nose and hearing problems. An overdose can result in death. Hydroxychloroquine too can lead to headaches, nausea, lowering of blood glucose, drowsiness, reduced appetite, depression, irreversible blindness, cramps and heart failure (if overdosed). "It leaves a hor...