Medicine

FDA Could Okay Moderna Vax As Soon As Tomorrow

The Washington Post reports: A Food and Drug Administration panel of outside experts is meeting Thursday to review the Moderna coronavirus vaccine. The panel is discussing the vaccine’s safety and efficacy and, if all goes as expected, the shots could get emergency clearance as soon as Friday. The FDA, in a report Tuesday, confirmed that in Moderna’s clinical trial, the …

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Pfizer Vax Vials Contain Extra Doses, FDA Okays Use

The Washington Post reports: The Food and Drug Administration said Wednesday that pharmacists can draw additional doses from vials of the Pfizer coronavirus vaccine, potentially expanding the country’s supply by millions of doses as the Trump administration negotiates with Pfizer to speed up the next round of vaccine deliveries. The government’s existing supply of the first authorized vaccine can be …

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Wealthy Nations Accused Of Hoarding Vaccines

NBC News reports: Lost among the jubilation of America’s vaccine rollout this week is an uncomfortable reality: The world’s poorest countries will have to wait months and possibly years to see any doses at all. The U.S., Canada, Britain and the European Union have pre-ordered enough Covid-19 shots to inoculate their populations several times over, subject to regulatory approvals. In …

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First Vaccine Shipment Leaves Pfizer’s Michigan Plant

CNN reports: Freight trucks carrying about 184,275 vials of coronavirus vaccine departed a Pfizer plant in Portage, Michigan, on Sunday, a landmark moment in the fight against the deadly virus. The combined 189 boxes of vaccine vials are expected to arrive in all 50 states on Monday, and another 3,900 vials are expected to ship later Sunday to United States …

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BREAKING: FDA Advisory Panel OK’s Pfizer Vaccine

Forbes reports: Members of FDA’s Vaccine and Related Biological Products Advisory Committee endorsed Pfizer and BioNTech’s Covid-19 vaccine candidate on Thursday, clearing the last hurdle before emergency use authorization from the federal agency. The committee, also called VRBPAC, met for nine hours to discuss all aspects of the new Covid-19 vaccine, from risk and safety to how Pfizer and BioNTech …

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Recall: Antidepressant Accidentally Mixed With Viagra

Via press release from the FDA: AvKARE, Pulaski, TN is voluntarily recalling one lot of Sildenafil 100 mg tablets and one lot of Trazodone 100mg tablets to the consumer level. These products have been recalled due to a product mix-up of the listed two separate products inadvertently packaged together during bottling at a 3rd party facility. Unintentional consumption of sildenafil …

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Canada Approves Pfizer Vax, Rollout Next Week

The Wall Street Journal reports: Pfizer Inc. and BioNTech SE, racing ahead of the U.S. Food and Drug Administration and Europe’s main regulator to approve shots for its most vulnerable citizens. Canada will now begin its immunization rollout as early as next week—a daunting challenge for a country that is the second-largest in the world in terms of land mass …

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China’s COVID Vaccine Reportedly 86% Effective

The Wall Street Journal reports: A Chinese vaccine candidate showed to be 86% effective in protecting people against Covid-19, according to interim results of a Phase 3 trial in the United Arab Emirates, in a boost for China as it races with Western nations to slow the spread of the coronavirus. The U.A.E. said it has registered the vaccine from …

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How The Connected Wealthy Will Game The Vax Line

STAT News reports: Athletes, politicians, and other wealthy or well-connected people have managed to get special treatment throughout the pandemic, including preferential access to testing and unapproved therapies. Early access to coronavirus vaccines is likely to be no different, medical experts and ethicists told STAT. It could happen in any number of ways, they said: fudging the definition of “essential …

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Nasal Drug May Offer Short-Term COVID Protection

The Arizona Republic reports: The treatment, called KEPTIDE, is a nasal spray that works by stopping the virus from attaching onto and entering cells. Studies done in mice, primate cells, and human lung cells have all been promising so far, the company said, showing 100% effectiveness with no negative side effects. One hitch: The treatment won’t offer long-term protection. Its …

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Fauci Gets Lifetime Achievement Award From Elton John Foundation For His Historic Efforts On HIV/AIDS Crisis

CNN reports: Dr. Anthony Fauci’s effort to educate the public on the coronavirus pandemic has earned him scores of admirers, but his work on the global HIV/AIDS crisis saw him cheered on Tuesday by one star-studded fan — Elton John. “What a wonderful and fitting way to mark World AIDS Day, by honoring one of the biggest champions in the …

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Blood Test To Detect Alzheimer’s Goes On Sale To Labs

The Associated Press reports: A company has started selling the first blood test to help diagnose Alzheimer’s disease, a leap for the field that could make it much easier for people to learn whether they have dementia. It also raises concern about the accuracy and impact of such life-altering news. Independent experts are leery because key test results have not …

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Moderna To Seek FDA Approval For Vaccine Today

Forbes reports: Moderna will submit its Covid-19 vaccine for emergency use approval in the U.S. Monday after new trial data showed it to be 94% effective at preventing the disease, findings that are consistent with earlier data from the Phase 3 clinical trial. New findings from the Phase 3 clinical trial, which involved over 30,000 participants, showed the vaccine to …

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Doctors Worry Vaccine Side Effects May Deter Patients

CNBC reports: Public health officials and drugmakers must be transparent about the side effects people may experience after getting their first shot of a coronavirus vaccine, doctors urged during a meeting Monday with CDC advisor. Dr. Sandra Fryhofer of the AMA noted that both Pfizer’s and Moderna’s vaccines require two doses at varying intervals. She said she worries whether her …

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Trials Show Oxford Vax Is 70% Effective On Average

CNBC reports: British pharmaceutical giant AstraZeneca on Monday said an interim analysis of clinical trials showed its coronavirus vaccine has an average efficacy of 70% in protecting against the virus. It comes after a string of encouraging vaccine results in recent weeks, following late-stage trial readouts from Pfizer-BioNTech and Moderna. The AstraZeneca vaccine, developed in collaboration with the University of …

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FDA Approves Antibody Treatment Given To Trump

The New York Times reports: The Food and Drug Administration has granted emergency authorization for the experimental antibody treatment given to President Trump shortly after he was diagnosed with Covid-19, giving doctors another option to treat Covid-19 patients as cases across the country continue to rise. The emergency authorization for Regeneron’s drug is limited in scope: It is for people …

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TODAY: Pfizer To Seek Vaccine Approval From FDA

CNBC reports: Pfizer and BioNTech will apply Friday for an emergency use authorization from the Food and Drug Administration for their coronavirus vaccine. If Pfizer’s application is approved, the vaccine will likely be limited and rolled out in phases, with health-care workers, the elderly and people with underlying health conditions getting the first inoculations. Essential workers, teachers and people in …

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UK’s Oxford Vaccine Shows Strong Immune Response

The BBC reports: The Oxford coronavirus vaccine shows a strong immune response in adults in their 60s and 70s, raising hopes that it can protect age groups most at risk from the virus. Researchers say the Lancet phase two findings, based on 560 healthy adult volunteers, are “encouraging”. They are also testing whether the vaccine stops people developing Covid-19 in …

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Pfizer Says Vax Has No Serious Side Effects, Works In 94% Of Older Adults, Will Seek FDA Approval In Days

The New York Times reports: The drug maker Pfizer said on Wednesday that its coronavirus vaccine was 95 percent effective and had no serious side effects — the first set of complete results from a late-stage vaccine trial as Covid-19 cases skyrocket around the globe. The data showed that the vaccine prevented mild and severe forms of Covid-19, the company …

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Gallup: Willingness To Get COVID Vax Rose In October

Just in from Gallup Polling: Americans’ willingness to be vaccinated against COVID-19 rebounded a bit in October, as seen in Gallup polling conducted before Pfizer/BioNTech and Moderna made promising announcements about the likely effectiveness of their coronavirus vaccines. Fifty-eight percent of Americans in the latest poll say they would get a COVID-19 vaccine, up from a low of 50% in …

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