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FDA Neutral on Moderna Bid for COVID Booster Ahead of Decisive Meeting

October 13, 2021

(Medscape) – The US Food and Drug Administration (FDA) is keeping its cards close to the vest when it comes to the potential approval of a booster dose of Moderna’s COVID-19 vaccine, now called Spikevax. In a briefing document posted ahead of a Thursday meeting of its Vaccines and Related Biological Products Advisory Committee, the agency acknowledged that real-world data present a mixed picture when it comes to the need for boosters. (Read Full Article)

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Havana Syndrome Hits at Least Five U.S. Families Connected to Embassy in Colombia

October 13, 2021

(Wall Street Journal) – At least five American families connected to the bustling U.S. Embassy in Colombia have been afflicted with the mysterious neurological ailment known as Havana Syndrome, in the latest attack against American diplomatic installations, people familiar with the matter said. In emails to embassy personnel, sent by Ambassador Philip Goldberg and others and reviewed by The Wall Street Journal, the State Department vowed to address the issue “seriously, with objectivity and with sensitivity,” as they work to determine the scope of the afflictions in one of the U.S.’s most important diplomatic outposts. (Read Full Article)

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6 Months to Live or Die: How Long Should an Alcoholic Liver Disease Patient Wait for a Transplant?

October 12, 2021

(Kaiser Health News) – In the U.S., a widespread practice requires patients with alcoholic liver disease to complete a period of sobriety before they can get on the waiting list for a liver. This informal policy, often called “the 6-month rule,” can be traced to the 1980s. The thinking then — and among proponents of the practice today — was that six months of abstinence gave a patient’s liver time to heal and, thus, avoid a transplant. If that didn’t work, the patient would have proven they can stay sober and would not return to drinking after a transplant. However, a landmark European study published in 2011 and several American studies in the decade since have exposed flaws in that premise. Six months of abstinence is not a good predictor of long-term sobriety, and for people with conditions like Gorzney’s, more than half die within that time. (Read Full Article)

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New Clues Emerge About Whether Vaccines Can Help Fight Long Covid

October 12, 2021

(Wall Street Journal) – Millions of people suffer from symptoms of long Covid, doctors estimate. Now, early research is offering some clues about whether vaccinations might help. When the vaccines first came out, some people who had suffered from debilitating symptoms for months after their initial Covid-19 infections told their doctors they felt better after getting vaccinated. The response intrigued scientists. Now, emerging research suggests that vaccines may help reduce symptoms in some people. (Read Full Article)

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Children and Teens Face Unequal Mental Health Realities

October 12, 2021

(Axios) – In the weeks after the start of the COVID-19 pandemic, at least 55% of children felt more “sad, depressed, or unhappy,” compared to 25% of adults, according to a new report out Monday from the Child Mind Institute. Why it matters: The data offers a glimpse at the differences in children’s early psych0logical responses as researchers work to tease out the pandemic’s potential long-term effects on the incoming generation’s mental health and developmental skills. (Read Full Article)

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The Health Care Worker Revolt

October 12, 2021

(Axios) – The toll of the coronavirus pandemic has spurred nurses, front-line technicians and other hospital employees to walk out or authorize strikes.  Why it matters: The pandemic has buckled a system that already faced worker shortages and burnout. Patients ultimately can’t receive adequate care if workers leave from the stress and violence. Driving the news: Unions representing more than 24,000 nurses and other hospital workers yesterday authorized strikes at Kaiser Permanente facilities in California and Oregon.  (Read Full Article)

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COVID Immunity Through Infection or Vaccination: Are They Equal?

October 12, 2021

(Kaiser Health News) – That said, evidence is growing that contracting SARS-CoV-2, the virus that causes covid-19, is generally as effective as vaccination at stimulating your immune system to prevent the disease. Yet federal officials have been reluctant to recognize any equivalency, citing the wide variation in covid patients’ immune response to infection. Like many disputes during the covid pandemic, the uncertain value of a prior infection has prompted legal challenges, marketing offers and political grandstanding, even as scientists quietly work in the background to sort out the facts. (Read Full Article)

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US Reports Highest Weekly Vaccinations Since Early July

October 12, 2021

(Medscape) – The U.S. administered the highest number of weekly COVID-19 vaccinations during the past week since early July, according to ABC News. More than 7 million doses were given throughout the week. On Saturday, more than 1.15 million new vaccinations were reported from the day before, including 316,000 newly vaccinated people and 502,000 booster shots. (Read Full Article)

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Global Plan Aims to Slash Meningitis Toll with Help of New Five-in-One Vaccine

October 11, 2021

(Science) – A new “global road map,” launched by WHO and many partners on 28 September, could help prevent such tragedies in the future. With the help of a new vaccine targeting five serotypes of N. meningitidis, including W, it aims to eliminate epidemics of bacterial meningitis, which kill an estimated 250,000 a year in Africa, by 2030. It would also step up the fight against sporadic cases and small clusters of the disease that occur around the world. Cases worldwide—now some 5 million per year—would be halved by 2030 and deaths reduced by 70%. (Read Full Article)

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Moderna Has No Plans to Share Its COVID-19 Vaccine Recipe

October 11, 2021

(Associated Press) – Moderna has no plans to share the recipe for its COVID-19 vaccine because executives have concluded that scaling up the company’s own production is the best way to increase the global supply, the company’s chairman said Monday. In an interview with The Associated Press, Noubar Afeyan also reiterated a pledge Moderna made a year ago not to enforce patent infringement on anyone else making a coronavirus vaccine during the pandemic. (Read Full Article)

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One in Five of England’s Most Critically Ill Covid Patients Are Unvaccinated Pregnant Women, a Study Finds

October 11, 2021

(New York Times) – Unvaccinated pregnant women make up nearly 20 percent of the most critically ill Covid-19 patients in England, according to data released by the National Health Service on Monday. Since July, approximately one in five coronavirus patients who received an intensive lung-bypass treatment, or Extracorporeal Membrane Oxygenation (ECMO), were unvaccinated and pregnant. (Read Full Article)

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Rates of Depression and Anxiety Climbed Across the Globe in 2020, Analysis Finds

October 11, 2021

(STAT News) – Rates of depression and anxiety climbed globally by more than 25% in 2020, a devastating ripple effect of the Covid-19 pandemic that has particularly affected women and young people, according to a new study. “We knew Covid would have an impact on these mental disorders, we just didn’t know how big the impact was going to be,” said Alize Ferrari, a lead researcher at the Queensland Center for Mental Health Research in Australia and co-author of the study, published Friday in the Lancet. (Read Full Article)

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Merck Seeks First U.S. Authorization for COVID-19 Pill

October 11, 2021

(Reuters) – Merck & Co Inc (MRK.N) said on Monday it has applied for U.S. emergency use authorization for its drug to treat mild-to-moderate patients of COVID-19, putting it on course to become the first oral antiviral medication for the disease. An authorization from the U.S. Food and Drug Administration could help change clinical management of COVID-19 as the pill can be taken at home. The treatment, molnupiravir, cut the rate of hospitalization and death by 50% in a trial of mild-to-moderately ill patients who had at least one risk factor for the disease, according to data released earlier this month. (Read Full Article)

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‘Naively Ambitious’: How COVAX Failed on Its Promise to Vaccinate the World

October 11, 2021

(STAT News) – The Bureau of Investigative Journalism and STAT reviewed confidential internal documents and spoke with officials from two dozen countries, many of whom described confusion and frustration with COVAX. Although grateful for what COVAX is trying to do, they describe struggling to get information from COVAX personnel and being left in the dark over when, if ever, deliveries would arrive. Conceived at the start of the pandemic, COVAX had lofty goals, promising fair and equitable access to Covid-19 vaccines for every country worldwide, and giving them for free to the poorest. For richer nations, COVAX would be an insurance policy, buying vaccines from multiple manufacturers to boost the chances some of them would work. For poorer ones, it would be a lifeline. (Read Full Article)

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Pandemic Fuels Activity in Health Care’s Billing Industry

October 8, 2021

(Axios) – Money is flowing heavily into the business of medical billing as hospitals and doctors — whose revenues were disrupted by the coronavirus — focus on maximizing every dollar they can collect from patients and insurers. The big picture: The rise and even existence of the billing industry is the result of a fragmented system that is designed around multiple types of insurance plans and a system that has increasingly forced patients to shoulder more of the costs of their care. (Read Full Article)

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Pfizer Asks FDA to Authorize COVID Vaccine for Kids Aged 5 to 11

October 8, 2021

(Medscape) – Pfizer asked the FDA on Thursday to expand emergency use authorization of its COVID-19 vaccine to children ages 5 to 11. The request comes after the drugmaker submitted clinical trial data to the FDA on Sept. 28. Pfizer said the study of 2,268 children showed the vaccine was safe and produced a robust immune response. Participants in the studies received a lower dose of the vaccine, 10 micrograms. Their response 2 weeks after a second dose was reportedly equal to the immune protection in a control group of 16- to 25-year-olds who received the fully approved 30-microgram doses. (Read Full Article)

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‘We Have Failed Yemen’: UN Human Rights Council Ends War Crime Probe

October 7, 2021

(The Guardian) – Bahrain, Russia and other members of the UN human rights council have pushed through a vote to shut down the body’s war crimes investigations in Yemen, in a stinging defeat for western states who sought to keep the mission going. Members narrowly voted to reject a resolution led by the Netherlands to give the independent investigators another two years to monitor atrocities in Yemen’s conflict. It marked the first time in the council’s 15-year history that a resolution was defeated. (Read Full Article)

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People Who Want Organ Transplants Must Get the COVID-19 Vaccine, a Hospital Says

October 7, 2021

(NPR) – A large hospital system in Colorado says people on its organ transplant wait list won’t be offered an organ if they refuse to get the COVID-19 vaccine, citing the “significant risk the virus poses to transplant recipients.” UCHealth, which operates 12 hospitals from its headquarters in Aurora, Colo., says it has long been standard practice to require many organ recipients or donors to get vaccines such as hepatitis B or the MMR shot. (Read Full Article)

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Merck’s New COVID Pill: ‘Game-Changer’ or Just One More Tool?

October 7, 2021

(Medscape) – Soon after Merck announced on October 1 that it would ask federal regulators for emergency use authorization (EUA) for its auspicious new COVID-19 pill, the accolades began. Former US Food and Drug Administration (FDA) chief Scott Gottlieb, MD, told CNBC the drug was “a profound game-changer.” Top infectious disease expert Anthony Fauci, MD, called the early data “impressive.” The World Health Organization termed it “certainly good news,” while saying it awaits more data. Merck, partnering with Ridgeback Biotherapeutics on the investigational oral antiviral medicine molnupiravir, plans also to submit applications to regulatory agencies worldwide, hoping to deliver the first oral antiviral medication for COVID-19. (Read Full Article)

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Moderna to Build Vaccine-Manufacturing Plant in Africa

October 7, 2021

(Wall Street Journal) – Moderna Inc. MRNA 2.29% plans to spend up to $500 million to build a new manufacturing plant in Africa to supply doses of its Covid-19 vaccine and potential additional vaccines to a continent that has grappled with a shortage. The Cambridge, Mass., drug company said Thursday it will build a state-of-the-art facility that could produce up to 500 million doses annually of vaccines, using its gene-based technology, known as messenger RNA. Moderna’s only current product is its Covid-19 vaccine, but the company is developing other vaccines against Zika, influenza, cytomegalovirus and other pathogens that could be made at the plant and meet demand in Africa. (Read Full Article)

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