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    • A New, Large Study Finds Plasma Does Not Lower Risk of Dying from COVID-19

    Researchers in India report that COVID-19 patients who received convalescent plasma from recovered patients did not see a lower risk of dying from the disease.

    The study, published in BMJ, included 464 people with moderate COVID-19 disease, meaning they had oxygen saturation levels of 93% or less when breathing room air, the criterion that most doctors use to determine if they should hospitalize people who are infected with SARS-CoV-2, the virus that causes the illness. Study co-author Aparna Mukherjee, a scientist in epidemiology and communicable diseases at the Indian Council of Medical Research, notes that patients in her study would likely be considered severely ill in other countries, since definitions of illness vary considerably around the world. Once in the hospital, some patients in the study received two doses of convalescent plasma from those who had recovered from the disease and donated their immune cell-rich blood. These patients were compared to those treated with standard of care, who acted as a control group (but did not receive a placebo infusion). Both groups had similar mortality rates after 28 days.

    “This study had a large sample size and it showed that when plasma is infused in patients who have moderate COVID-19 (similar to severe in other countries), it did not reduce mortality or progression to more critical COVID-19,” Aparna Mukherjee, a scientist in epidemiology and communicable diseases at the Indian Council of Medical Research and one of the co-authors of the study, said in an email response to questions.

    The results add to the continued debate over how useful convalescent plasma might be as a treatment for COVID-19. Convalescent plasma is one of the oldest therapies that doctors have used in treating infectious diseases, based on the idea that people who are naturally infected and recover will have a ready supply of the proper immune cells needed to fight off the virus or bacteria in question. But because people’s immune systems vary widely, their volume of disease-fighting cells is also unpredictable, and may range from barely adequate levels to extremely rich sources of immune cells. That variability has led to conflicting results on the effectiveness of the therapy, including in this study, which used donated plasma from people who were sick for an average of six days with what the authors describe as mild disease.

    Two other international studies also failed to find a benefit of convalescent plasma, but those were stopped early because too few eligible patients were enrolled. Other, smaller studies were more encouraging, so in the U.S. the Food and Drug Administration issued an emergency use authorization for the therapy in August that allows doctors to treat patients with plasma. Key public health leaders including Dr. Francis Collins, director of the National Institutes of Health, and Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, however, have noted that researchers are still studying convalescent plasma’s role in COVID-19. Those ongoing studies are comparing people who receive the plasma to those receiving a placebo, and may provide more convincing data on whether plasma can help COVID-19 patients or not.

    It’s also possible that because convalescent plasma serves as a stand-in for immune cells that an infected person might not have generated yet (or won’t generate at robust levels), it’s best used not in hospitalized patients who are already sick but in those who are more recently infected. The ongoing studies are looking at this possibility as well, and Mukherjee agrees that it’s worth investigating. Her study’s findings might even suggest that the plasma was used in patients who were too sick to benefit. “The main cause of mortality in COVID-19 is inflammation in the body that causes pneumonia and other organ failures,” she says. “While the body’s response to virus infection initiates the inflammation, it is not regulated by the virus. So even when the virus is neutralized, the inflammation continues. That is why it is being hypothesized in the upcoming studies on convalescent plasma that it may work in the very early phases of the disease … and may prevent the initiation of the inflammation cascade.”: https://time.com/5903423/plasma-coro...risk-of-dying/
    • Coronavirus Cases: 43,259,107

    Deaths: 1,157,700

    Underreported US death count: 230,279

    American Civil War Casualties (North and South) - 214,938

    Originally posted by Boon Mee View Post
    it's been blown way out of proportion.
    Keep your friends close and your enemies closer

    Comment


      • Spain imposing curfew amid surge in coronavirus cases

      An overnight curfew will be imposed in Spain in light of rising coronavirus cases beginning on Sunday.

      The Associated Press reports that the order restricts free movement on the streets from 11 p.m. to 6 a.m., with exceptions made for commuters and those buying medicine or caring for family members. The restrictions are expected to last for the next six months.

      Regional Spanish leaders will be able to choose when curfews begin and end, however, with the flexibility to begin it between 10 p.m. to 12 a.m. and end it from 5 a.m. to 7 a.m.

      Authorities are hoping to avoid another complete shutdown like the one ordered in March. Health officials have also begun targeting night clubs and parties believed to be the primary source of new infections.

      “There is no home confinement in this state of emergency, but the more we stay at home, the safer we will be. Everyone knows what they have to do,” Prime Minister Pedro Sánchez said.

      The Canary Islands will not be affected by the new curfew, however, as data indicates the small group of islands is making positive progress in their number coronavirus cases. They were recently taken off Britain and Germany's list of unsafe travel destinations.

      The Spanish curfew reflects similar actions taken by other European countries as they try to stymie an impending second wave of COVID-19 cases. A few weeks ago, France instated curfews on nine major cities, affecting up to a third of the French population. Italy announced new measures last week that allow Italian mayors to enforce 9 p.m. curfews on public squares and penalties for facilities that fail to follow guidelines.: https://thehill.com/homenews/coronav...onavirus-cases
      • Coronavirus Cases: 43,319,530

      Deaths: 1,158,760

      Underreported US death count: 230,497

      American Civil War Casualties (North and South) - 214,938

      Originally posted by Boon Mee View Post
      it's been blown way out of proportion.

      Keep your friends close and your enemies closer

      Comment


      • Thailand - Cops miss out on Covid payments

        Police around the country claim they have been cheated of extra payments due to them for special work carried out during the Covid-19 pandemic.

        Initial inquiries have found these officers have not been fully paid the extra money they were promised, says Pol Gen Wissanu Prasarttong-Osoth, Inspector General of the Royal Thai Police.

        "There have been irregularities in the disbursement of extra Covid-19 prevention payments to police," said Pol Gen Wissanu, head of a committee looking into the matter. "Some police did not receive any extra at all and others have been asked to return part of their payments."

        Pol Gen Wissanu was referring to the special overtime rates offered to policemen who were sent to staff Covid-19 checkpoints or work extra hours during the prevention of the coronavirus.

        Each officer was entitled to overtime at the rate of 60 baht per hour, up to a maximum of seven hours/420 baht per day. However, some police have complained they either received less than what they were they due or less than what they were entitled to.

        Pol Gen Wissanu said the RTP found there was some truth in the allegations and the blame lay with administration officials in its Bursar Office, who make the extra payments.

        "We need to find out whether the problem was due to cheating or just a mistake," he said, pointing out the irregularities appeared to have only been for some individuals, not on a systemic basis.

        He said the shortfalls affected police in Saraburi, Nonthaburi in the Central region, Surin, Loei, Khon Kaen and Maha Sarakham in the Northeastern region, Chiang Rai in the North as well as Phuket and Phatthalung in the South.

        Pol Gen Wissanu said the inquiry team would need another 60 days to complete its job. If anyone is found guilty of cheating, the RTP would send their files to the National Anti-Corruption Commission, he said.

        Meanwhile, Thailand recorded seven new imported Covid-19 cases on Monday, taking total infections to 3,743. No new deaths were reported.

        The Centre for Covid-19 Situation Administration (CCSA) said all new cases were Thai nationals returning from overseas and all were asymptomatic.

        The seven returnees had flown back separately from Bahrain, Austria, Jordan, Iraq, Qatar, Turkey and Kuwait.: https://www.bangkokpost.com/thailand...covid-payments

        Originally posted by Somchai Boonporn View Post
        Perhaps a blessing in disguise for the Golden Land.

        Keep your friends close and your enemies closer

        Comment


          • Asia becomes second region to exceed 10 million coronavirus cases

          Asia surpassed 10 million infections of the new coronavirus on Saturday, the second-heaviest regional toll in the world, according to a Reuters tally, as cases continue to mount in India despite a slowdown and sharp declines elsewhere.

          Behind only Latin America, Asia accounts for about one-fourth of the global caseload of 42.1 million of the virus. With over 163,000 deaths, the region accounts for some 14% of the global COVID-19 toll.

          The Reuters tally is based on official reporting by countries. The true numbers of cases and deaths are likely much higher, experts say, given deficiencies in testing and potential underreporting in many countries.

          Despite the Asian spikes, the region overall has reported improvement in handling the pandemic in recent weeks, with daily caseloads slowing in places like India - a sharp contrast to the COVID-19 resurgence seen in Europe and North America.

          Within the region, South Asia led by India is the worst affected, with nearly 21% of the reported global coronavirus cases and 12% of deaths. This contrasts with countries like China and New Zealand that have crushed infections and Japan, where COVID-19 had been stubbornly entrenched but not accelerating.

          India is the worst-hit country in the world after the United States, although infections are slowing in the world’s second-most populous country. India is reporting more than 57,000 cases of the virus a day, viewed on a weekly average, with 58 new cases per 10,000 people in Asia’s third-largest economy, according to a Reuters analysis.

          India is averaging 764 COVID-19 deaths a day, the worst in the world and accounting for one in every 13 global pandemic deaths.

          The country has reported nearly 7.8 million infections, behind the U.S. tally of 8.5 million, and nearly 118,000 deaths, versus 224,128 in the United States. Unlike the recent U.S. surge, however, India’s slowdown saw the lowest daily caseload in nearly three months on Wednesday.

          But India’s infections may surge again, doctors fear, with a holiday approaching and winter bringing more severe pollution from farmers burning stubble, worsening the breathing difficulties that many COVID-19 patients suffer.

          India’s eastern neighbour Bangladesh is Asia’s second-worst hit country, with nearly 400,000 cases. But daily infections have slowed to 1,453, less than 40% of the July peak.

          Although the pandemic is slowing in Bangladesh, the world’s biggest apparel producer after China faces harsh recession as a second wave of COVID-19 hits key markets in Europe and the United States.

          Even if the country is making progress on controlling the disease, leaders of the key garment sector say international retailers are delaying orders or demanding steep price cuts, forcing them to lay off their workers. Some 1 million workers were furloughed or laid off. About one-third of those have been rehired since July, according to union leaders.

          In Southeast Asia, Indonesia surpassed the Philippines last week as the worst-hit nation with more than 370,000 infections.

          The world’s largest Muslim-majority nation, Indonesia has struggled to get its outbreak under control. With the country due to host soccer’s under-20 World Cup next year, the government is racing to secure a supply of vaccines still under development, which some epidemiologists say means seeking a “silver bullet” solution before full vaccine efficacy and safety is known.

          The Philippines, which last week reported its biggest daily tally in a month, has put partial coronavirus restrictions around the capital Manila until Oct. 31 to check COVID-19..

          Despite Asia’s patchy record, a World Health Organization expert said on Monday that Europe and North America should follow the example of Asian states in persevering with anti-COVID measures and quarantine restrictions for infected people.

          Mike Ryan, head of the UN agency’s emergencies programme, said the global death toll from COVID-19 could double to 2 million before a successful vaccine is widely used and could be even higher without concerted action to curb the pandemic.: https://uk.reuters.com/article/healt...-idUSKBN27909I
          • Coronavirus Cases: 43,432,377

          Deaths: 1,160,381

          Underreported US death count: 230,510

          American Civil War Casualties (North and South) - 214,938

          Originally posted by Boon Mee View Post
          it's been blown way out of proportion.
          Keep your friends close and your enemies closer

          Comment


            • AstraZeneca says its vaccine produces immune response in older adults

            AstraZeneca said Monday that its potential coronavirus vaccine provokes an immune response in older adults, which it touted as a positive development as clinical trials proceed.

            The immune response in older adults was similar to that in younger people, the company said, and adverse responses to the vaccine, known as reactogenicity, was lower in older people.

            “It is encouraging to see immunogenicity responses were similar between older and younger adults and that reactogenicity was lower in older adults, where the COVID-19 disease severity is higher,” an AstraZeneca spokesperson said. “The results further build the body of evidence for the safety and immunogenicity of [the vaccine].”

            AstraZeneca, partnered with Oxford University, is developing one of the leading potential coronavirus vaccines, which is now in the third phase of clinical trials, along with other potential vaccines from Pfizer and Moderna.

            AstraZeneca faced a setback in early September when its vaccine trial was halted to review potential safety concerns from a participant developing neurological symptoms. The Food and Drug Administration allowed the trial to resume on Friday.

            “The restart of clinical trials across the world is great news as it allows us to continue our efforts to develop this vaccine to help defeat this terrible pandemic,” AstraZeneca CEO Pascal Soriot said in a statement Friday. “We should be reassured by the care taken by independent regulators to protect the public and ensure the vaccine is safe before it is approved for use.”

            The complete picture of the potential vaccine’s safety and efficacy will not be known until the full data from the phase three trial is published.

            Reacting to Monday’s announcement about the immune response, Florian Krammer, a professor of vaccinology at Icahn School of Medicine at Mount Sinai in New York, tweeted: “AZ says the vaccine is immunogenic in older individuals. This has been shown for other COVID-19 vaccines too. Good, but no breakthrough.”: https://thehill.com/policy/healthcar...n-older-adults
            • Coronavirus Cases: 43,627,528

            Deaths: 1,162,520

            Underreported US death count: 230,747

            American Civil War Casualties (North and South) - 214,938

            Originally posted by Boon Mee View Post
            it's been blown way out of proportion.
            Keep your friends close and your enemies closer

            Comment


              • Study finds sharp fall in immunity after coronavirus infection

              British scientists have found that the number of people testing positive for antibodies has fallen by 26 percent over three months, raising questions about long-term protection from the virus.

              Latest data from the REACT2 study, published Tuesday, showed that in a random sample of more than 365,000 adults in the U.K. from June to September, the presence of antibodies fell for all age groups. It fell from 6 percent to 4.4 percent over that time.

              “We know seasonal colds can reinfect people every six months,” said Wendy Barclay, head of infectious disease department at Imperial College London, in a video call with journalists Monday. She added that COVID-19 shows a similar profile.

              Asymptomatic cases had a more rapid decline in antibodies, according to Helen Ward, professor of public health at Imperial College London. Younger people had a higher level of antibodies and a slower decline, while older people had a lower level of antibodies to begin with.

              “We don’t yet know what level of antibody is needed in a person’s blood to prevent reinfection,” said Barclay. This was “critical to understand,” since vaccines were being developed to generate an immune response, she added.

              In Germany, the country’s top virologist is looking into whether antigen tests could form the next part of the solution in its public health strategy to manage the virus.

              Christian Drosten told a World Health Summit online discussion Monday that antigen testing could be the next tool in combating rising rates of COVID-19.

              He said that Germany’s introduction of mass PCR testing — which indicates whether someone currently has coronavirus but is slower than antigen tests — very early in the pandemic had a significant and lasting effect at dampening infection rates. As rates rise again, antigen testing could be used in those who had previously had positive PCR tests for coronavirus to predict when populations are again at risk.

              “So we could develop a working hypothesis in public health,” he said. “A negative result of [an] antigen test predicts a waning of infectability in a patient.” This “absence of infectivity” is a crucial diagnostic tool in public health, he added.: https://www.politico.eu/article/stud...rus-infection/
              • Coronavirus Cases: 44,151,400

              Deaths: 1,169,724

              Underreported US death count: 231,847

              American Civil War Casualties (North and South) - 214,938

              Originally posted by Boon Mee View Post
              it's been blown way out of proportion.
              Keep your friends close and your enemies closer

              Comment


                • Nurses are at high risk for COVID among health workers, CDC says

                Among health care workers, nurses in particular have been at significant risk of contracting COVID-19, according to a new analysis of hospitalized patients by the Centers for Disease Control and Prevention.

                The findings were released Monday as a surge of new hospitalizations swept the country, with several states hitting record levels of cases.

                About 6% of adults hospitalized from March through May were health care workers, according to the researchers, with more than a third either nurses or nursing assistants. Roughly a quarter, or 27%, of those hospitalized workers were admitted to the intensive care unit, and 4% died during their hospital stay.

                The study looked at 6,760 hospitalizations across 13 states, including California, New York, Ohio and Tennessee.

                Health care workers “can have severe COVID-19-associated illness, highlighting the need for continued infection prevention and control in health care settings as well community mitigation efforts to reduce transmission,” the researchers said.

                From the beginning of the pandemic in the United States, front-line medical personnel have complained of shortages of personal protective equipment. Some of the shortages abated for a while, but supplies have become strained in certain areas of the country as a surge of coronavirus outbreaks has reached daily records.

                “We need more testing,” said Michelle Mahon, assistant director of nursing practice at National Nurses United, a union whose members have been vocal from the beginning of the pandemic about the dangers they faced without adequate supplies and protection.

                Calling the findings no surprise, Mahon criticized federal officials for not having more robust guidelines in place. Her organization, which issued a report on workers' deaths last month, says about 2,000 health care workers have so far died from the virus.

                She says that workers should be tested more frequently so they can be identified and isolated so the infection does not spread, and that supplies of protective gear remain uneven, with some facilities unprepared for an increase in cases.

                Even though workers may be taking more precautions and treatments have improved in recent months, the analysis underscored how vulnerable many individuals are because of underlying health conditions, which include diabetes and high blood pressure. Almost three-quarters of those hospitalized were obese, a high-risk category for death, the study showed.

                The majority had cared directly for patients, whether in a hospital, home or school setting. It could not be determined whether the individuals contracted the virus at work or in the community, but the study highlighted the potential risk faced by nurses who serve as front-line workers “because of their frequent and close patient contact, leading to extended cumulative exposure time.”

                Most of the hospitalized workers in the analysis were female. They also tended to be older, and more were Black employees than the overall group of health care workers who contracted the virus.: https://www.chicagotribune.com/coron...gj4-story.html
                • Coronavirus Cases: 44,325,170

                Deaths: 1,173,200

                Underreported US death count: 232,101

                American Civil War Casualties (North and South) - 214,938

                Originally posted by Boon Mee View Post
                it's been blown way out of proportion.
                Keep your friends close and your enemies closer

                Comment


                  • Lilly antibody drug fails in study of hospitalized Covid patients, other trials go on

                  U.S. government officials are putting an early end to a study testing an Eli Lilly antibody drug for people hospitalized with Covid-19 because it doesn’t seem to be helping them.

                  Independent monitors had paused enrollment in the study two weeks ago because of a possible safety issue. But on Monday, the National Institute of Allergy and Infectious Diseases, which sponsors the study, said a closer look did not verify a safety problem but found a low chance that the drug would prove helpful for hospitalized patients.

                  It is a setback for one of the most promising treatment approaches for Covid-19. President Donald Trump received a similar experimental, two-antibody drug from Regeneron Pharmaceuticals Inc. on an emergency basis when he was sickened with the coronavirus earlier this month.

                  In a statement Lilly notes that the government is continuing a separate study testing the antibody drug in mild to moderately ill patients, to try to prevent hospitalization and severe illness. The company also is continuing its own studies testing the drug, which is being developed with the Canadian company AbCellera.: https://www.nbcnews.com/health/healt...rials-n1244900
                  • Coronavirus Cases: 44,641,774

                  Deaths: 1,176,962

                  Underreported US death count: 232,735

                  American Civil War Casualties (North and South) - 214,938

                  Originally posted by Boon Mee View Post
                  it's been blown way out of proportion.

                  Keep your friends close and your enemies closer

                  Comment


                    • Global coronavirus report: US adds nearly 500,000 cases in a week; Europe faces more lockdowns

                    The United States has added nearly half a million people to its tally of coronavirus infections in the last seven days, as Donald Trump continues to insist the country is “rounding the turn” of the pandemic.

                    Nearly 500,000 people have contracted Covid-19 in the United States over the last seven days, as new cases and hospitalizations set records in the Midwest. The seven-day total is 491,000, according to Johns Hopkins University.

                    The US has the highest number of infections worldwide, with more than 8.7 million people who have contracted the virus. Its death toll, also the world’s largest, stands at more than 226,000.

                    But on Tuesday the White House included among a lists of accomplishments this year “Ending the Covid-19 pandemic”. A news release accompanying a 62-page report from the White House office of science and technology policy includes, among the “highlights” to be found in the report, the phrase “Ending the pandemic”.

                    The release, quoted in the Huffington Post, states: “From the outset of the Covid-19 pandemic, the administration has taken decisive actions to engage scientists and health professionals in academia, industry, and government to understand, treat, and defeat the disease.”

                    Trump, facing a tough re-election battle on 3 November, reiterated his claim on Tuesday that the country is “rounding the turn” in the pandemic that has killed more than 226,000 people since erupting in March.

                    “We did the ventilators and now we’re doing all of the equipment and now we’re doing vaccines, we’re doing therapeutics. We’ve done a great job, and people are starting to see,” Trump told reporters at the White House.

                    Infections are also rising rapidly in several other countries, notably Europe and India.

                    France’s prime minister, Jean Castex, told MPs on Tuesday that hospital intensive care units will be saturated with Covid-19 patients by 11 November if nothing is done to stop the epidemic in the country.

                    President Emmanuel Macron announced that he would be giving a televised address on Wednesday evening amid reports that his government was considering placing the country under a month-long lockdown to stop the surge in cases. France recorded 33,417 new cases on Tuesday and 523 deaths – the most daily fatalities since April. The UK had its highest total since May.

                    Cases and deaths are also spiking in Italy where there were more protests on Tuesday at the government’s latest lockdown measures.

                    In Germany, chancellor Angela Merkel is expected to push for a “lockdown light” in crisis talks with regional leaders on Wednesday.

                    The proposed new restrictions would include closing restaurants and bars and putting strict limits on private and public gatherings while keeping schools, daycares and shops open, according to the best-selling Bild daily.

                    India’s tally of coronavirus cases stood less than 10,000 away from the grim milestone of 8 million, as 43,893 new cases were reported in the last 24 hours, data from the federal health ministry showed.: https://www.theguardian.com/world/20...more-lockdowns
                    • Coronavirus Cases: 44,680,656

                    Deaths: 1,177,471

                    Underreported US death count: 232,834

                    American Civil War Casualties (North and South) - 214,938

                    Originally posted by Boon Mee View Post
                    it's been blown way out of proportion.
                    Keep your friends close and your enemies closer

                    Comment


                      • Italy posts record infection numbers as Europe locks down

                      Italy has posted its highest number of daily infections as its citizens rebel against restrictions. Now, a second wave of lockdowns is being implemented across Europe, with Germany being the latest to announce measures.

                      Italy reported a record 24,911 new coronavirus infections on Wednesday. It was the second day in a row the country has registered more than 20,000 new cases. The 205 deaths logged Wednesday brought Italy's total number of COVID-19 fatalities to 37,905, second only to the UK in Europe.

                      Despite the surging infection rates, government-imposed safety measures have enraged citizens. On Tuesday evening, police fired teargas after demonstrators rallied across the country against nationwide coronavirus restrictions.

                      Members of the neo-fascist political party Forza Nuova (New Force) clashed with police in the Rome's central Piazza del Popolo.

                      The northern cities of Milan and Turin saw scenes of unrest from Monday into Tuesday, after the Italian government imposed the most severe restrictions since the end of the main lockdown in June. Hundreds gathered outside the offices of the regional government in Milan, with some throwing stones, petrol bombs and fireworks. In Turin, shop windows were smashed and stock looted.

                      The country's prosecutor for terrorism and organized crime, Federico Cafiero de Raho, said subversives — including those from the extreme right and anarchists on the extreme left — had infiltrated peaceful protests nationwide.

                      Under the latest rules, all bars and restaurants must close by 6 p.m. local time. Cinemas, theaters, gyms, pools and concert halls will also have to shut. Prime Minister Giuseppe Conte said the pandemic had reached "worrying levels" and that tough measures were needed to "manage it without being overwhelmed.": https://www.dw.com/en/coronavirus-it...sts/a-55417951
                      • Coronavirus Cases: 44,848,431

                      Deaths: 1,180,379

                      Underreported US death count: 233,137

                      American Civil War Casualties (North and South) - 214,938

                      Originally posted by Boon Mee View Post
                      it's been blown way out of proportion.
                      Keep your friends close and your enemies closer

                      Comment


                        • Historic vaccine race meets harsh reality

                        Pfizer’s admission that it still doesn’t know whether its coronavirus vaccine works is a dose of reality for the historic global vaccine race.

                        Pfizer’s admission Tuesday that it still doesn’t know whether its coronavirus vaccine works is a dose of reality for the historic global vaccine race.

                        The company’s failure to meet its self-imposed goal — having proof of efficacy in October — is the latest reminder that vaccine development is a long, complicated process that doesn’t stick to political deadlines. Despite the government and drug companies pumping billions of dollars into the vaccine race, getting shots into trials faster than ever before, and enrolling tens of thousands of volunteers in studies, a Covid-19 vaccine could still be months away.

                        “All [government and drugmaker] timelines assume that we have a vaccine that is actually shown to work and is safe before the end of the year,” says Peter Hotez, a virologist and dean of the National School of Tropical Medicine at the Baylor College of Medicine. “But we still have no guarantee.” Vaccines normally take years to produce, he adds.

                        Four shots are now in late-stage U.S. trials — and while they have faced bumps along the way that derailed President Donald Trump’s promises to have a vaccine before Election Day, all are still on track. Johnson & Johnson and AstraZeneca were forced to pause their trials over safety concerns, but got the all-clear last week from the FDA to resume the studies.

                        Pfizer, a Trump favorite, held out hope that it would know this month whether its shot worked. That is now all but impossible. Though 36,000 people have received both doses of the vaccine or a placebo, the company has not yet recorded 32 cases of coronaviruses among participants. That is the standard the Pfizer set for its first hotly anticipated look at the trial data, known as an interim analysis.

                        That could mean that many volunteers in Pfizer’s trial simply have not been exposed to the virus. It could also mean that the vaccine is effective, but there have not been enough infections in the placebo group to prove it. Twenty-six infections among the placebo group and six among the vaccine group would signal that the shot is 77 percent effective, according to the company’s blueprint for its Phase III — or final stage — trial.

                        Umer Raffat, an analyst at Evercore ISI, says that other vaccine trials could see similarly slower-than-expected rates of infection among participants.

                        “If people enroll in this vaccine trial and don’t feel fever or major sore arm after the shot, they kinda know they got placebo, so they remain cautious and keep masks on,” he said. That extra caution could depress infection rates, delaying data that reveal whether a vaccine works or not.

                        The fourth company with a vaccine in a late-stage U.S. trial, Moderna, has been chugging along quietly towards its goal of filing for FDA review in late November. But the company’s vaccine relies on new technology that has never been used in a shot that has reached the market.

                        Many of the vaccine makers are walking a tightrope between optimism, given the so-far unprecedented pace of their coronavirus work, and caution driven by the knowledge that reaching the final stage of clinical testing doesn’t guarantee success.

                        J&J’s coronavirus shot relies on a tried-and-true technology that the company used in its recent Ebola vaccine. J&J’s candidate is the only one of the four front-runners that is given as one dose and it does not need as much cold storage as others.

                        The J&J shot “has some real advantages,” National Institutes of Health Director Francis Collins said during a National Press Club event on Friday.

                        Still, CEO Alex Gorsky has shied away from hard deadlines — saying only that J&J could begin regulatory review for its shot late this year or early next year.

                        He has also tried to manage expectations that the first vaccine to win emergency authorization would end the pandemic, noting this summer that mass-inoculation efforts would be unprecedented. “The world has never attempted something quite that large or quite that complex,” he said during Fortune’s Brainstorm Health conference. “That’s why I think a vaccine, while a very critical element to bringing an end to this pandemic, is part of the puzzle.”

                        An integral part of the challenge is distributing vaccines, and assuring that people take them. Nine drugmakers including Pfizer, J&J, Moderna and AstraZeneca co-signed an open letter recently pledging to stick to science and put safety first. But public confidence is still sliding.

                        Nearly half of voters across party lines believe that Trump is pressuring the FDA to deliver a vaccine prematurely, according to a recent POLITICO and Morning Consult poll.

                        The looming election has only sharpened political rhetoric around vaccines. "I trust vaccines. I trust scientists. But I don't trust Donald Trump,” Democratic presidential candidate Joe Biden said during a debate last month. “And at this point, the American people can't, either.”

                        Those concerns won't evaporate if Biden wins the presidency. While voters in the POLITICO/Morning Consult poll would rather have him oversee vaccine development instead of Trump, only 47 percent say they trust Biden more. The most trusted official is Anthony Fauci, the top government infectious disease expert that Trump has derided for months. “People are tired of hearing Fauci and all these idiots,” the president said weeks ago.

                        FDA sought to quell public fears with guidance this month that bolsters standards for any vaccine authorized for emergency use. But in a meeting of expert advisors for the agency last week, the question of consumer confidence hung heavy over the panel. Government officials and infectious disease scientists raised the possibility that average Americans would not want to take the first coronavirus vaccine, and that certain communities in particular — including Black Americans historically abused by medical research — would reject an eventual shot.

                        Then there is the question about when the U.S. might have enough doses of any vaccine to immunize most Americans. The Trump administration has pre-ordered millions of doses of several shots, betting that at least one will prove effective, but those early buys would treat only a fraction of the population.

                        Coronavirus vaccines will be distributed based on priority groups established, at first, on the federal level to put health care workers, vulnerable people and those likely to spread the virus first. But state and local authorities will ultimately make the call in their areas, especially if there are limited supplies.

                        “It’s a bit frustrating, but I think it would be unrealistic to expect that this is going to be widely available to older adults and people with high-risk conditions in early ‘21. That’s clearly not going to be the case,” said Edward Belongia, a director at the Marshfield Clinic Research Institute who has advised CDC on its vaccine committee.

                        That is expected. While the first shots could be authorized in the final weeks of 2021, federal health officials, drugmakers and Trump himself have said a stockpile to vaccinate all Americans will not be feasible before April 2021. From there, the arduous task of reaching vulnerable, isolated and skeptical people continues.

                        “People are watching this process very closely. We have to get it right the first time," Belongia said. "We have already lost a lot of public trust and the process needs to go well, with no hiccups.": https://www.politico.com/news/2020/1...reality-432964
                        • Coronavirus Cases: 44,876,236

                        Deaths: 1,180,901

                        Underreported US death count: 233,137

                        American Civil War Casualties (North and South) - 214,938

                        Originally posted by Boon Mee View Post
                        it's been blown way out of proportion.
                        Keep your friends close and your enemies closer

                        Comment


                          • France Follows Germany In Second Wave Of Lockdowns

                          French President Emmanuel Macron announced Wednesday that the country will revert to a strict coronavirus lockdown Friday—soon after Germany announced new measures—as the country has seen an increasing number of cases.

                          KEY FACTS
                          In a televised address, Macron said the lockdown will last at least through December 1.

                          Macaron said under the new lockdown order, non-essential workers will only be able to leave for doctors appointments, to buy essential goods or for one-hour of daily exercise and will need to fill out paperwork stipulating why they are leaving, according to Reuters.

                          Macaron said people will be able to go to work if they are unable to work from home and schools will stay open, according to Reuters.

                          France 24 reported that doctors urged the government to go into lockdown because 58% of the intensive care units are taken up by Covid-19 patients and the influx of patients is taking a toll on doctors and nurses.

                          Frederic Valletoux, president of the French Hospital Federation, on Wednesday told France Inter radio “this wave will be much more devastating for the hospital system” and “hospitals won’t manage if we don’t take drastic measures.”

                          Earlier on Wednesday German Chancellor Angela Merkel announced that German officials agreed to implement a four-week shutdown starting Monday with people being advised to stay home although schools and daycares will be open as long as hygiene protocols are met, according to CNN.

                          CRUCIAL QUOTE
                          “The virus is circulating in France at a speed that even the most pessimistic forecasts had not anticipated. Unlike the first wave, all the regions are now at the alert threshold,” Macron tweeted Wednesday. He noted that there have been more than 36,000 cases within 24 hours.

                          BIG NUMBER
                          1,279,384. France has had that many confirmed coronavirus cases and 35,820 deaths, according to Johns Hopkins University data.

                          KEY BACKGROUND
                          Last Thursday, Ireland became the first European country to go back into lockdown, according to a CNN report which noted that Italy, Spain, France and Germany implemented curfews. The World Health Organization says nearly 50% of the 2.8 million new coronavirus cases reported globally last week were from European countries, Associated Press reported.: https://www.forbes.com/sites/elanagr.../#487a81055f6e
                          • Coronavirus Cases: 44,967,587

                          Deaths: 1,181,726

                          Underreported US death count: 233,340

                          American Civil War Casualties (North and South) - 214,938

                          Originally posted by Boon Mee View Post
                          it's been blown way out of proportion.
                          Keep your friends close and your enemies closer

                          Comment


                            • Moderna already has $1.1 billion in deposits for COVID-19 vaccine

                            Moderna said Thursday it took in $1.1 billion in deposits in the third quarter for a coronavirus vaccine that it is “actively preparing” to launch.

                            The biotech company, releasing quarterly results, completed its enrollment earlier this month for the phase-3 trial of “mRNA-1273,” a vaccine candidate for Covid-19.

                            “We are actively preparing for the launch of mRNA-1273 and we have signed a number of supply agreements with governments around the world,” said Moderna chief executive Stephane Bancel.

                            “I believe that if we launch our Covid-19 vaccine, 2021 could be the most important inflection year in Moderna’s history. We will have the resources to scale Moderna to maximize the impact we can have on patients in the next 10 years through numerous new medicines.”

                            Moderna, among the furthest along in developing a vaccine for Covid-19, has signed supply contracts with the US, Canada, Switzerland, Japan, Israel and Qatar and is in talks with other parties, including the European Union.

                            Moderna said there would be two interim analyses of the Covid-19 vaccine candidate and that the company is committed to “full transparency” in the development of the vaccine.

                            The company, founded in 2010, reported a loss of $233.6 million in the third quarter on revenues of $157.9 million.

                            The company had nearly $4.0 billion in cash at the end of the quarter, including more than $1 billion in deferred revenues connected to supply agreements with government agencies for future Covid-19 vaccine supply.: https://www.rawstory.com/2020/10/mod...9-vaccine/amp/
                            • Coronavirus Cases: 45,169,371

                            Deaths: 1,183,634

                            Underreported US death count: 233,565

                            American Civil War Casualties (North and South) - 214,938

                            Originally posted by Boon Mee View Post
                            it's been blown way out of proportion.
                            Keep your friends close and your enemies closer

                            Comment


                              • Taiwan reaches a record 200 days with no local coronavirus cases

                              Taiwan on Thursday marked no locally transmitted coronavirus cases for 200 days, as the island of 23 million people's total number of infections reported stands at 550 and the COVID-19 death toll at seven.

                              Why it matters: Nowhere else has reached such a milestone. While COVID-19 cases surge across the U.S. and Europe, Taiwan's last locally transmitted case was on April 12. Experts credit tightly regulated travel, early border closure, "rigorous contact tracing, technology-enforced quarantine and universal mask wearing" and the island state's previous experience with the SARS virus for the achievement, per Bloomberg.: https://www.axios.com/taiwan-record-...eeb9b3f13.html
                              • Coronavirus Cases: 45,218,467

                              Deaths: 1,184,214

                              Underreported US death count: 233,809

                              American Civil War Casualties (North and South) - 214,938

                              Originally posted by Boon Mee View Post
                              it's been blown way out of proportion.

                              Keep your friends close and your enemies closer

                              Comment


                                • 2nd study testing a COVID-19 antibody drug has a setback

                                For the second time, a study testing an experimental antibody drug for COVID-19 has been paused to investigate a possible safety issue in hospitalized patients.

                                Regeneron Pharmaceuticals Inc. said Friday that independent monitors had recommended placing on hold enrollment of the most severely ill patients -- those who need intense oxygen treatment or breathing machines -- because of a potential safety problem and unfavorable balance of risks and benefits.

                                The study can continue to test the two-antibody drug combo in hospitalized patients who need little or no extra oxygen, the monitors said. Other studies in mild or moderately ill people also are continuing.

                                Antibodies are proteins the body makes when an infection occurs; they attach to a virus and help it be eliminated. But it can take several weeks for the most effective ones to form. The experimental drugs aim to help immediately, by supplying concentrated versions of one or two antibodies that worked best against the coronavirus in lab and animal tests.

                                Earlier this month, a different group of monitors recommended pausing enrollment in a U.S. National Institutes of Health study testing an Eli Lilly antibody drug to investigate a possible safety issue in hospitalized patients. On Monday, the NIH said no safety problem had been verified, but they stopped the study because the drug didn’t seem to work in that situation.

                                “These kinds of results are informing us about the timing of the benefit,” said Dr. Myron Cohen, a University of North Carolina virologist who advises the government on COVID-19 treatments.

                                Tests in animals suggest that antibody drugs work best when given early in infection to lower the amount of virus, he said. Once someone is very sick, the drugs may not help, but it’s too soon to know if that's the case, he said.

                                Doctors already know that timing can matter when it comes to COVID-19 treatments. Studies suggest that dexamethasone and other steroids can lower the risk of death when given to very sick patients to tamp down an over-active immune system, but they may be harmful for those who are only mildly ill.

                                Lilly and Regeneron have asked the Food and Drug Administration to allow emergency use of their experimental antibody drugs for mild and moderately ill patients who don’t need hospitalization. President Donald Trump got the Regeneron drug when he was sickened earlier this month.

                                Regeneron said it would share Friday's advice from independent monitors with the FDA and leaders of a separate study in the United Kingdom testing its drug in hospitalized patients.: https://abcnews.go.com/Health/wireSt...tback-73925890
                                • Coronavirus Cases: 45,795,473

                                Deaths: 1,191,363

                                Underreported US death count: 234,842

                                American Civil War Casualties (North and South) - 214,938

                                Originally posted by Boon Mee View Post
                                it's been blown way out of proportion.
                                Keep your friends close and your enemies closer

                                Comment

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