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FDA, Under Pressure, Plans ‘Sprint’ to Accelerate Review of Pfizer’s Covid-19 Vaccine for Full Approval

July 30, 2021

(STAT News) – Under heavy pressure, the Food and Drug Administration center that reviews vaccines is planning to deprioritize some of its existing work, like meetings with drug sponsors and plant inspections, in an effort to accelerate its review of Pfizer’s application for the formal approval of its Covid-19 vaccine, a senior agency official told STAT. Pfizer’s vaccine is currently cleared under a so-called emergency use authorization, which allows the company to sell the vaccine for as long as Covid-19 is considered a public health emergency. (Read Full Article)

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CDC Releases Data Behind Latest Mask Guidelines

July 30, 2021

(Politico) – The Centers for Disease Control and Prevention has collected data that suggest fully vaccinated Americans who contract the Delta variant can spread Covid-19 as easily as unvaccinated people infected with the variant. The hotly anticipated study helped convince the agency to revise its guidance on mask-wearing earlier this week, when it said vaccinated people should wear masks indoors in areas with high levels of Covid-19 transmission. But CDC had not made the data underlying its decision public until now.  (Read Full Article)

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CDC: Delta Variant May Cause Mild COVID Among Fully Vaccinated People

July 30, 2021

(Axios) – About 74% of 469 COVID-19 cases associated with large gatherings held in Barnstable County, Mass., from July 3 to 17 were among fully vaccinated people, according to data released Friday from the Centers for Disease Control and Prevention. Why it matters: The data bolsters emerging evidence that vaccinated people have high viral loads and may transmit the Delta variant as easily as those who are unvaccinated. (Read Full Article)

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States Could Get Billions from Opioid Lawsuits. They Have to Decide How to Spend It

July 30, 2021

(STAT News) – The endgame of the sprawling mass of opioid lawsuits is starting to come into focus: Already, a settlement with Johnson & Johnson and three major drug distributors will pour billions of dollars into communities to combat the addiction crisis, with more to come. But what that looks like, exactly, will vary from place to place. States are likely to see lump sums of money doled out for years, and they will be left to decide how to spend it under the guideposts set up in the settlements. It could easily become subject to competing interests: Legislatures could squabble with governors over priorities, while in some places, counties could demand more autonomy. Some public health experts are also raising questions about the quality of addiction programs to which states could allocate funding. (Read Full Article)

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Covid-19 Outbreak During Olympics Leads Japan to Widen State of Emergency

July 30, 2021

(Wall Street Journal) – Japan widened its state of emergency to the entire Tokyo region and extended it until the end of August in response to a record-setting Covid-19 wave during the Tokyo Summer Olympics. Prime Minister Yoshihide Suga said there would be no changes to the Olympics, which run through Aug. 8, and officials said there wasn’t a connection between the start of the Games on July 23 and the rapid rise in new cases. Nonetheless, the outbreak put a damper on the nation’s mood despite a string of gold medals won by Japanese athletes. (Read Full Article)

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CDC Says Nearly 67% of US Counties Have Substantial, High COVID-19 Transmission

July 30, 2021

(Medscape) – The Centers for Disease Control and Prevention (CDC) said on Wednesday that 66.6% of U.S. counties had transmission rates of COVID-19 high enough to warrant indoor masking and should immediately resume the policy. The transmission rate was up from 63.4% as of Tuesday. In total, 49.9% of U.S. counties have high COVID-19 community transmission rates and 16.7% have substantial rates, the CDC said. The CDC reversed its mask guidance policy for vaccinated Americans on Tuesday. (Read Full Article)

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Deal Agreed for Patients and Children of Fertility Doctor Who Used Own Sperm

July 29, 2021

(BBC) – Former patients and children of a Canadian fertility doctor who used his own or unknown sperm to impregnate patients have been offered a C$13m ($10m, £7m) settlement agreement. It is thought to be the first-ever legal settlement of its kind. Under the terms of the deal, claimants will be given compensation based on court-determined level of harm. Money will also be set aside for a DNA database to allow dozens of children to identify their biological fathers. (Read Full Article)

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Brazil Begins Mass Vaccine Study in Poor Rio Neighborhood

July 29, 2021

(Medical Xpress) – Brazilian health authorities on Thursday began the mass immunization of Rio de Janeiro’s Mare neighborhood in a novel bid to control COVID-19 in a poor community while studying vaccine effectiveness and the prevalence of worrisome variants.  The bayside Mare complex is comprised of more than a dozen so-called favelas and home to some 130,000 people, and the study is Brazil’s first to target a low-income area. The Brazilian researchers leading the effort aren’t aware of another elsewhere in the world that has specifically focused on slums. (Read Full Article)

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More Than 1 in 10 COVID-19 Patients Report Memory Loss 8 Months Later

July 29, 2021

(UPI) – More than one in 10 people with COVID-19 report memory and concentration problems up to eight months after infection, a study published Thursday by JAMA Network Open found. Also, more than half of these patients also suffer from persistent fatigue, and about 20% indicate that these persistent symptoms continue to limit their work and other life activities, the data showed. (Read Full Article)

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Israel Is Offering Its Older Citizens a 3rd COVID-19 Shot as Infections Rise

July 29, 2021

(NPR) – Israel’s prime minister on Thursday announced that the country would offer a coronavirus booster to people over 60 who have already been vaccinated. The announcement by Naftali Bennett makes Israel, which launched one of the world’s most successful vaccination drives early this year, the first country to offer a third dose of a Western vaccine to its citizens on a wide scale. (Read Full Article)

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Children and COVID: Vaccinations, New Cases Both Rising

July 29, 2021

(Medscape) – COVID-19 vaccine initiations rose in US children for the second consecutive week, but new pediatric cases jumped by 64% in just 1 week, according to new data. The new-case count was 38,654 for the week of July 16-22, an increase of 64% over the 23,551 child cases reported during the week of July 9-15, the American Academy of Pediatrics (AAP) and the Children’s Hospital Association (CHA) said in their weekly COVID-19 report. (Read Full Article)

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Atypical COVID Symptoms Common in Older Adults

July 29, 2021

(Medscape) – New research provides more evidence that older adults with COVID-19 often present with atypical symptoms, including functional decline and altered mental status, and pinpoints demographic and clinical factors associated with atypical presentation. Those most at risk are adults age 75 and older, women, Blacks and non-Hispanics, those with a higher comorbidity index and those who have dementia and/or diabetes, according to the Journal of Gerontology report. (Read Full Article)

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France Issues Moratorium on Prion Research After Fatal Brain Disease Strikes Two Lab Workers

July 28, 2021

(Science) – Five public research institutions in France have imposed a 3-month moratorium on the study of prions—a class of misfolding, infectious proteins that cause fatal brain diseases—after a retired lab worker who handled prions in the past was diagnosed with Creutzfeldt-Jakob disease (CJD), the most common prion disease in humans. An investigation is underway to find out whether the patient, who worked at a lab run by the National Research Institute for Agriculture, Food and Environment (INRAE), contracted the disease on the job. If so, it would be the second such case in France in the past few years. In June 2019, an INRAE lab worker named Émilie Jaumain died at age 33, 10 years after pricking her thumb during an experiment with prion-infected mice. Her family is now suing INRAE for manslaughter and endangering life; her illness had already led to tightened safety measures at French prion labs. (Read Full Article)

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Genetic Engineering Test with Mosquitoes ‘May Be Game Changer’ in Eliminating Malaria

July 28, 2021

(The Guardian) – Scientists have successfully wiped out a population of malaria-transmitting mosquitoes by using a radical form of genetic engineering to render the females infertile – in the most advanced and largest ever test of use of the technology to fight the disease. As well as bringing fresh hope in the fight against one of the world’s biggest killers, the study lays the foundations for further trials of gene-drive technology, which could mean self-destroying mosquitoes being released into the wild within 10 years. (Read Full Article)

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Efficacy of Pfizer/BioNTech Covid Vaccine Slips to 84% After Six Months, Data Show

July 28, 2021

(STAT News) – The efficacy of the Covid-19 vaccine developed by Pfizer and BioNTech fell from 96% to 84% over six months, according to data released Wednesday, a decline that could fuel Pfizer’s case that a third dose will eventually be required. The data, released in a preprint that has not been reviewed by outside scientists, suggest the vaccine was 91% effective overall at preventing Covid-19 over the course of six months. (Read Full Article)

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CDC Calls for Masks in Schools, Hard-Hit Areas Even If Vaccinated

July 28, 2021

(Medscape) – The Centers for Disease Control and Prevention (CDC) once again is recommending that some Americans wear masks indoors. The agency called today for masks in K-12 school settings and in areas of the United States experiencing high or substantial SARS-CoV-2 transmission, even for the fully vaccinated. The move reverses a controversial announcement the agency made in May 2021 that fully vaccinated Americans could skip wearing a mask in most settings. (Read Full Article)

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Biogen Pulled Aduhelm Paper After JAMA Demanded Edits

July 28, 2021

(Axios) – Biogen recently submitted a paper to JAMA, a top medical research journal, that analyzed results from the clinical trials of its new Alzheimer’s drug, Aduhelm. However, Biogen later withdrew the paper because JAMA considered rejecting it unless edits were made, according to two sources familiar with the matter. Why it matters: The FDA’s decision to approve Aduhelm has been mired in controversy; experts say there simply isn’t strong enough data to show the drug works. And it appears medical journal reviewers also weren’t sold on Biogen’s interpretation of the data. (Read Full Article)

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Why Workplace Covid-19 Vaccine Mandates Aren’t Widespread–Yet

July 28, 2021

(Wall Street Journal) – Some companies, including Morgan Stanley, Goldman Sachs and Wells Fargo, have mandated that all workers must get vaccinated or divulge their vaccination status before returning to the office. United Airlines requires Covid-19 vaccines for new employees. Overall, though, Covid-19 vaccine mandates at work remain rare, partly because doing so can be a legal minefield for companies, employment attorneys say. In some cases, mandates have resulted in employee lawsuits and termination of workers. And in a tight labor market, employers also risk losing workers who balk at such requirements. (Read Full Article)

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Saudi Arabia to Impose Covid-19 Vaccine Mandate

July 27, 2021

(Wall Street Journal) – Saudi Arabia is set to impose one of the world’s most sweeping vaccine mandates in an attempt to combat hesitancy toward the Covid-19 shots in the kingdom, as governments globally try to confront a new surge in cases of the Delta variant. People in Saudi Arabia will need to show proof on a mobile app that they have received at least one vaccine dose to enter public and private institutions beginning Sunday, including schools, shops, malls, markets, restaurants, cafes, concert venues and public transportation. From Aug. 9, Saudi citizens will need two doses to travel abroad. (Read Full Article)

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CDC: Vaccinated People in COVID Hotspots Should Resume Wearing Masks

July 27, 2021

(Axios) – The Centers for Disease Control and Prevention issued updated guidance on Tuesday recommending that vaccinated people wear masks in indoor, public settings if they are in parts of the U.S. with substantial to high transmission, among other circumstances. (Read Full Article)

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