Asia Times Canada
Moderna vaccine in final stage trial this month - Asia Times
US biotech firm Moderna said Tuesday it would enter the final stage of human trials for its Covid-19 vaccine on July 27, to test how well it protects people in the real world. The announcement came…
US biotech firm Moderna said Tuesday it would enter the final stage of human trials for its Covid-19 vaccine on July 27, to test how well it protects people in the real world. The announcement came as the results from an earlier trial intended to prove the vaccine was safe and triggered antibody production were published. The upcoming Phase 3 trial will recruit 30,000 participants in the US, with half to receive the vaccine at 100 microgram dose levels, and the other half to receive a placebo. Researchers will then track them over two years to determine whether they are protected against infection by the virus. Or, if they do get infected, whether the vaccine prevents symptoms from developing. If they do get symptoms, the vaccine can still be considered a success if it stops severe cases of Covid-19. The study should run until October 27, 2022, but preliminary results should be available long before. The announcement came shortly after the New England Journal of Medicine published results from the first stage of Modernas vaccine trial, which showed the first 45 participants all developed antibodies to the virus. Moderna is considered to be in a leading position in the global race to find a vaccine against the coronavirus, which has infected more than 13.2 million people and killed 570,000. But scientists caution that the first vaccines to come to market may not be the most effective or safest. Encouraging results Moderna had previously published interim results from the first stages of its trial, called Phase 1 in May. The early results were called encouraging by Anthony Fauci, director of the US National Institute of Allergy and Infectious Diseases, which is co-developing the vaccine. But some in the scientific community said they would reserve judgment until they saw the full results in peer-reviewed form. According to the paper, 45 participants were split into three groups to test doses of 25 micrograms, 100 micrograms and 250 micrograms. They were given a second dose of the same amount 28 days later. After the first round, antibody levels were found to be higher with higher doses. Following the second round, participants had higher levels of antibodies than most patients who have had Covid-19 and gone on to generate their own antibodies. More than half the participants experienced mild or moderate side effects, which is considered normal. The side effects included fatigue, chills, headache, body ache and pain at the injection site. Three participants did not receive their second dose. They included one who developed a skin rash on both legs, and two who missed their window because they had Covid-19 symptoms, but their tests later returned negative. Amesh Adalja, an infectious diseases specialist at Johns Hopkins University, said it was encouraging that the participants developed high levels of an advanced class of antibodies. He added, however: You have to be very limited in how much you can extrapolate from a phase one clinical trial, because you want to see how this works when a person is exposed to the actual virus. The Moderna vaccine belongs to a new class of vaccine that uses genetic material in the form of RNA to encode the information needed to grow the viruss spike protein inside the human body, in order to trigger an immune response. The spike protein is a part of the virus that it uses to invade human cells, but by itself the protein is relatively harmless. The advantage of this technology is that it bypasses the need to manufacture viral proteins in the lab, helping to ramp up mass production. No vaccines based on this platform have previously received regulatory approval. Early work using this technology backfired by making hosts more, not less, susceptible to infection, said David Lo, a professor of biomedical sciences at University of California Riverside. One of the things we certainly want to look out for is whether there is a long term effect where the immune response potentially develops an immunologic tolerance which would actually be detrimental to protection, he said. AFP Asia Times Financial is now live. Linking accurate news, insightful analysis and local knowledge with the ATF China Bond 50 Index, the world's first benchmark cross sector Chinese Bond Indices. Read ATF now.
New swine flu in China has pandemic potential - Asia Times
Researchers in China have discovered a new type of swine flu that is capable of triggering a pandemic, according to a study published Monday in the US science journal PNAS. Named G4, it is genetica…
Researchers in China have discovered a new type of swine flu that is capable of triggering a pandemic, according to a study published Monday in the US science journal PNAS. Named G4, it is genetically descended from the H1N1 strain that caused a pandemic in 2009. It possesses all the essential hallmarks of being highly adapted to infect humans, say the authors, scientists at Chinese universities and Chinas Center for Disease Control and Prevention. From 2011 to 2018, researchers took 30,000 nasal swabs from pigs in slaughterhouses in 10 Chinese provinces and in a veterinary hospital, allowing them to isolate 179 swine flu viruses. The majority were of a new kind which has been dominant among pigs since 2016. The researchers then carried out various experiments including on ferrets, which are widely used in flu studies because they experience similar symptoms to humans principally fever, coughing and sneezing. G4 was observed to be highly infectious, replicating in human cells and causing more serious symptoms in ferrets than other viruses. Tests also showed that any immunity humans gain from exposure to seasonal flu does not provide protection from G4. According to blood tests that showed up antibodies created by exposure to the virus, 10.4% of swine workers had already been infected. The tests showed that as many as 4.4% of the general population also appeared to have been exposed. The virus has therefore already passed from animals to humans, but there is no evidence yet that it can be passed from human to human the scientists main worry. It is of concern that human infection of G4 virus will further human adaptation and increase the risk of a human pandemic, the researchers wrote. Asked about the virus on Tuesday, Chinese foreign ministry spokesman Zhao Lijian told a regular press briefing that China has been paying close attention to its development and will take all needed action to prevent its spread and any outbreaks. The studys authors called for urgent measures to monitor people working with pigs. The work comes as a salutary reminder that we are constantly at risk of new emergence of zoonotic pathogens and that farmed animals, with which humans have greater contact than with wildlife, may act as the source for important pandemic viruses, said James Wood, head of the department of veterinary medicine at Cambridge University. A zoonotic infection is caused by a pathogen that has jumped from a non-human animal into a human. AFP Asia Times Financial is now live. Linking accurate news, insightful analysis and local knowledge with the ATF China Bond 50 Index, the world's first benchmark cross sector Chinese Bond Indices. Read ATF now.
Unveiling Covid-19 research scandal - Asia Times
The first research scandal of the coronavirus pandemic has created unnecessary distraction around the politically divisive drug hydroxychloroquine, scientists say, as questions swirl around the tin…
The first research scandal of the coronavirus pandemic has created unnecessary distraction around the politically divisive drug hydroxychloroquine, scientists say, as questions swirl around the tiny health care company at the center of the affair. On Thursday, most of the authors of major studies that appeared in The Lancet and the New England Journal of Medicine (NEJM) retracted their work and issued apologies, saying they could no longer vouch for their data after the firm that supplied it Chicago-based Surgisphere refused to be audited. At any other time the matter might have led to hang-wringing within academia, but it has taken on a new dimension as the world grapples with a virus that has claimed some 400,000 lives. Of particular interest was the paper in The Lancet that claimed to have analyzed the records of 96,032 patients admitted to 671 hospitals across six continents, finding that hydroxychloroquine showed no benefit and even increased the risk of death. Its withdrawal is seen as a boost to backers of the decades-old anti-malarial drug, who include US President Donald Trump and his Brazilian counterpart Jair Bolsonaro. Its very politicized there is a group, probably not particularly small, who have learned to mistrust science and scientists, and this just feeds into that narrative, Gabe Kelen, a professor of emergency medicine at Johns Hopkins University, told AFP. This is despite the fact that even without The Lancet paper, evidence has been building against hydroxychloroquines use against Covid-19. On Friday, results from a fourth randomized controlled trial carefully designed human experiments considered the most robust form of clinical investigation showed it had no impact against the virus. Mystery company The Lancet, which first published in 1823, is one of the worlds most trusted medical journals. As a result, the hydroxychloroquine paper had an outsized impact: the World Health Organization, Britain and France all suspended ongoing clinical trials. But things soon began unravelling after researchers noticed numerous red flags, from the huge number of patients involved to the unusual level of detail about the doses they had received. Both The Lancet and the equally prestigious NEJM, which had published a paper on whether blood thinners elevated the risk of Covid-19 that relied on the same company, issued expressions of concern before the authors themselves pulled both papers. Surgisphere, founded in 2007 by vascular surgeon Sapan Desai, had refused to share data with third-party reviewers, saying it would violate privacy agreements with hospitals. However, when science news site The Scientist began reaching out to hospitals throughout the US to ask whether they had participated, it found none. Surgispheres internet profile has also raised numerous questions. Only a handful of employees could be found on LinkedIn, and most have now deactivated their accounts. According to the Guardian newspaper, its employees included an adult model and until last week the contact page on its website redirected to a WordPress template for a cryptocurrency website, leaving it unclear how hospitals could have reached out to them. Meanwhile Desai, who according to court records has three outstanding medical malpractice suits against him, has written extensively in the past on research misconduct. The most serious cause of fraud in medical publishing is manufactured data that authors use to support high impact conclusions, he said in a 2013 paper. Systemic issues For Ivan Oransky, who founded Retraction Watch in 2010, the affair is far from surprising, serving instead to highlight systemic issues in science publishing and the way science is reported to the public. No one took a hard look at the data, said Oransky. But weve known about these issues for literally decades. Policymakers should get away from the idea of using the results of a single study to inform their decisions, he added, as was the case for the WHO and the media has a responsibility to place papers in context instead of hyping them up. The problem also stems from the fact that even leading journals rely too heavily on an honor system, but you never know when a catastrophe is going to happen, if youre not willing to put into place some reasonable safeguards, added Oransky. As to the future, the current episode is unlikely to serve as a wake-up call, he said. If one journal increases its diligence, more blockbuster papers will start appearing in its competitors. AFP Asia Times Financial is now live. Linking accurate news, insightful analysis and local knowledge with the ATF China Bond 50 Index, the world's first benchmark cross sector Chinese Bond Indices. Read ATF now.