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A Pivotal Mosquito Experiment Could Not Have Gone Better

June 10, 2021

(The Atlantic) – Dengue fever is caused by a virus that infects an estimated 390 million people every year, and kills about 25,000; the World Health Organization has described it as one of the top 10 threats to global health. It spreads through the bites of mosquitoes, particularly the species Aedes aegypti. Utarini and her colleagues have spent the past decade turning these insects from highways of dengue into cul-de-sacs. They’ve loaded the mosquitoes with a bacterium called Wolbachia, which prevents them from being infected by dengue viruses. Wolbachia spreads very quickly: If a small number of carrier mosquitoes are released into a neighborhood, almost all of the local insects should be dengue-free within a few months. It’s as if Utarini’s team vaccinated a few individuals against a disease, and soon after the whole population had herd immunity. (Read Full Article)

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FDA Accuses Company of Distributing Unapproved Covid Test and Using Falsified Data

June 10, 2021

(STAT News) – The Food and Drug Administration announced a recall Thursday of a coronavirus rapid antigen test, accusing the company that makes the tests of distributing them without regulatory approval and using falsified data that inflates their performance. The agency announced a “Class 1 recall” — its most serious type, indicating that use of the tests may cause serious injuries or death — and fired off a warning letter to Innova Medical Group of Pasadena, Calif., saying an FDA investigation revealed serious problems in the company’s data, but also in its making unapproved rapid tests available to consumers in the United States. (Read Full Article)

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Third Member of FDA Expert Committee Resigns Over Controversial Alzheimer’s Therapy Decision

June 10, 2021

(STAT News) – A third member of a Food and Drug Administration expert panel has resigned over the agency’s contentious approval of an Alzheimer’s therapy this week, a sign of a growing backlash over the decision. In a letter to acting FDA Commissioner Janet Woodcock on Thursday, Aaron Kesselheim, who had served on the FDA’s advisory committee for nervous system therapies since 2015, wrote that the approval of Biogen’s Aduhelm “was probably the worst drug approval decision in recent U.S. history.” (Read Full Article)

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U.S. Health Officials Report Higher-Than-Expected Heart Inflammation Cases Following Covid-19 Vaccination

June 10, 2021

(STAT News) – Federal health officials said Thursday they’re seeing rare but higher-than-expected cases of a heart issue called myocarditis among adolescents and young adults who received their second shot of one of the mRNA Covid-19 vaccines. The data are preliminary and limited, and experts are still trying to determine if there is indeed a link or if there is no connection at all. (Read Full Article)

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The C.D.C. Urges Parents to Get Childhood Vaccinations Up To Date Following a Steep Decline Last Year.

June 10, 2021

(New York Times) – Pediatricians are urging U.S. parents to get their children caught up on routine vaccinations, following a decline in the number of inoculations for diseases like measles as the pandemic forced restrictions, including shelter-at-home orders, last year. New data from 10 jurisdictions that closely monitor immunizations confirm that the number of administered vaccine doses plunged between March and May of last year, especially among older children, the Centers for Disease Control and Prevention reported on Thursday. (Read Full Article)

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Scottish Study Estimates Risk of Bleeding and Clotting Disorders After AstraZeneca Vaccine

June 10, 2021

(Medscape) – A nationwide analysis of over 2.5 million Scottish adults who received a first dose of the Oxford/AstraZeneca or Pfizer/BioNTech vaccine between December 2020 and April 2021 has confirmed a small increased risk of immune thrombocytopenic purpura (ITP) and other bleeding and vascular events associated with the Oxford/AstraZeneca vaccine. However, the research, published in Nature Medicine, suggests the risks are comparable with those seen with other vaccines, including vaccines against hepatitis B, measles, mumps and rubella, and influenza. (Read Full Article)

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Covid-19 Delta Variant First Found in India Is Quickly Spreading Across Globe

June 9, 2021

(Wall Street Journal) – The highly transmissible Covid-19 variant that first emerged in India is rapidly spreading around the world, health authorities say, intensifying the race to increase global vaccinations. The B.1.617.2 variant, now dubbed the Delta variant, is in at least 60 countries, including the U.S. and the U.K., and British scientists recently estimated that it might be 40% to 50% more transmissible than the B.1.1.7 variant, or Alpha, which in turn is more transmissible than the original virus and quickly spread across the globe. (Read Full Article)

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AstraZeneca Vaccine Carries Slightly Higher Risk of Bleeding Disorders, Study Shows

June 9, 2021

(New York Times) – People receiving the Covid vaccine made by Oxford-AstraZeneca had a slightly increased risk of a bleeding disorder, and possibly other rare blood problems, researchers reported on Wednesday. The findings, from a study of 2.53 million adults in Scotland who received their first doses of either the AstraZeneca vaccine or the one made by Pfizer-BioNTech, were published in the journal Nature Medicine. About 1.7 million of the shots were the AstraZeneca vaccine. The study found no increased risk of the blood disorders with the Pfizer-BioNTech vaccine. (Read Full Article)

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US Deaths from Heart Disease and Diabetes Climbed Amid COVID

June 9, 2021

(Associated Press) – The U.S. saw remarkable increases in the death rates for heart disease, diabetes and some other common killers in 2020, and experts believe a big reason may be that many people with dangerous symptoms made the lethal mistake of staying away from the hospital for fear of catching the coronavirus.  (Read Full Article)

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AP Source: US to Buy 500M Pfizer Vaccines to Share Globally

June 9, 2021

(Associated Press) – The U.S. will buy 500 million more doses of the Pfizer COVID-19 vaccine to share through the global COVAX alliance for donation to 92 lower income countries and the African Union over the next year, a person familiar with the matter said Wednesday. (Read Full Article)

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Member of FDA’s Expert Panel Resigns Over Controversial Alzheimer’s Therapy Approval

June 9, 2021

(STAT News) – Following the Food and Drug Administration’s polarizing authorization of the Alzheimer’s therapy Aduhelm on Monday, a member of an agency advisory committee that recommended against the drug’s approval has resigned. Neurologist Joel Perlmutter of Washington University in St. Louis, a member of the FDA’s expert panel for nervous system therapies, told STAT in an email that he had quit the committee on Monday “due to this ruling by the FDA without further discussion with our advisory committee.” (Read Full Article)

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Mixing COVID-19 Vaccines Appears to Boost Immune Responses

June 9, 2021

(Science) – Faced with short supplies of COVID-19 vaccines and unforeseen side effects, some countries have adopted an unproven strategy: switching shots midstream. Most authorized vaccines require two doses administered weeks or months apart, but Canada and several European countries are now recommending a different vaccine for the second dose in some patients. Early data suggest the approach, born of necessity, may actually be beneficial. (Read Full Article)

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Brazil Gives Russian COVID-19 Vaccine a Chance, Approving the Import of Limited Doses

June 9, 2021

(Science) – Despite safety concerns, the Brazilian Health Regulatory Agency (Anvisa) reversed itself last week and voted to allow a trickle of Sputnik V, the Russian-made COVID-19 vaccine, into the country. Only 928,000 doses will be imported—just a fraction of the total requested by a group of state governors—and the agency imposed stringent measures to reduce supposed health risks and monitor the vaccine’s safety and efficacy. (Read Full Article)

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U.S. Report Found It Plausible Covid-19 Leaked from Wuhan Lab

June 8, 2021

(Wall Street Journal) – A report on the origins of Covid-19 by a U.S. government national laboratory concluded that the hypothesis claiming the virus leaked from a Chinese lab in Wuhan is plausible and deserves further investigation, according to people familiar with the classified document. The study was prepared in May 2020 by the Lawrence Livermore National Laboratory in California and was drawn on by the State Department when it conducted an inquiry into the pandemic’s origins during the final months of the Trump administration. (Read Full Article)

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The Complex Ethical Morass of COVID-19 Human Challenge Trials

June 8, 2021

(MedPage Today) – Two institutions in England have launched COVID-19 human challenge trials, which will deliberately infect participants with the SARS-CoV-2 virus. Despite the approval of these trials by European regulators, debates have continued over whether the ethical justification is sufficient. The studies, conducted at Imperial College London and the University of Oxford, are in their initial stages and have recruited participants ages 18 to 30 who have no risk factors for severe COVID-19 illness. (Read Full Article)

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Real-World Study Shows Power of Pfizer, Moderna Vaccines to Prevent COVID

June 8, 2021

(Medical Xpress) – A real-world study shows that even when folks who get the Pfizer and Moderna COVID-19 vaccines do have ‘breakthrough’ infections, those illnesses are mild. The study, from researchers at the U.S. Centers for Disease Control and Prevention, is among the first to show that people who get COVID-19 despite being fully or partially vaccinated are less likely to have serious illness or to infect others. (Read Full Article)

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A ‘Landmark’ Trial to Test mRNA Vaccines Against COVID-19 in Africa Can’t Get the Coveted Shots

June 8, 2021

(Science) – The questions are urgent, and the funding is in place. But a highly anticipated, $130 million clinical trial, meant to test the efficacy of the novel messenger RNA (mRNA) vaccines for COVID-19 against a key variant of the pandemic coronavirus as well as in people living with HIV and pregnant women, is stalled. It is ready to launch in eight countries in sub-Saharan Africa, yet neither maker of the vaccines, Pfizer and Moderna, wants to participate—or even provide their vaccines. (Read Full Article)

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On Top of Everything Else, the Pandemic Messed with Our Morals

June 8, 2021

(The Atlantic) – Health-care workers have had it especially hard during the pandemic, triaging who gets access to life-saving medication and reusing personal-protective equipment with the risk of contaminating patients, colleagues, and themselves. But other people have also been forced into unenviable scenarios. Undertakers have had to empty out old graves to make space for more dead bodies. Many of us have wrestled with whether to visit a parent or grandparent given the possibility of exposing them to the virus. In some cases, these situations have left people with what psychologists call “moral injury”—residual feelings of shame, guilt, and disorientation after having violated their own ethical code. Often, moral injury manifests as feelings of betrayal at the leaders and institutions that forced them into making these decisions in the first place, which may lead to behaviors such as substance abuse and social isolation. (Read Full Article)

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Millions of J&J Covid-19 Vaccines Are at Risk of Expiring in June

June 8, 2021

(Wall Street Journal) – Hospitals, state health departments and the federal government are racing to decide how to use up millions of Johnson & Johnson’s JNJ -0.88% Covid-19 vaccine doses that are set to expire this month. The prospect of so many doses going to waste in the U.S. when developing nations are desperate for shots would add pressure on the Biden administration to share stockpiled vaccines. But there are few practical solutions to administering them quickly in the U.S. or distributing them in time to foreign countries, according to those involved in the vaccination drive. (Read Full Article)

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Fake Covid-19 Vaccines Pose New Threat in Africa

June 7, 2021

(Wall Street Journal) – On a morning last November, officers from customs and an organized crime unit, backed by two K9 units, raided a small warehouse in an industrial park and seized an alarming new contraband: fake Covid-19 vaccines. Inside, authorities found around 2,400 doses of illicit vaccine in 400 ampuls hidden in plastic containers in a refrigerator, according to police officials. Counterfeit 3M-branded N95 masks worth almost $450,000 were discovered in a warehouse next door. Both units were leased by a Zambian national who was arrested on-site, along with a Chinese national. Another two Chinese nationals were arrested following further investigation. (Read Full Article)

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