Why a Century-Old Vaccine Offers New Hope Against Pathogens

The B.C.G. tuberculosis vaccine may protect against Covid-19 and other infections by broadly bolstering the immune system.

#clinical-trials, #coronavirus-2019-ncov, #diabetes, #immune-system, #tuberculosis, #vaccination-and-immunization, #your-feed-science

U.K. Approves Covid Booster Vaccine That Targets Two Variants

The vaccine, which has been approved for adults, generated a strong immune response against both the original virus and the Omicron variant.

#clinical-trials, #coronavirus-2019-ncov, #coronavirus-omicron-variant, #great-britain, #medicines-and-healthcare-products-regulatory-agency-great-britain, #moderna-inc, #research, #vaccination-and-immunization

The Long, Long Wait for a Diabetes Cure

A documentary captures the desperation and frustration of Type 1 diabetes patients in a clinical trial.

#clinical-trials, #diabetes, #documentary-films-and-programs, #drugs-pharmaceuticals, #insulin, #research, #vertex-pharmaceuticals-inc, #viacyte-inc

What is Tpoxx? The Monkeypox Treatment Drug That’s Hard to Get

Doctors who want to prescribe tecovirimat, or Tpoxx, must navigate a gantlet of bureaucratic hurdles that experts say could be quickly lifted.

#centers-for-disease-control-and-prevention, #clinical-trials, #drugs-pharmaceuticals, #food-and-drug-administration, #monkeypox, #smallpox, #stockpiling, #your-feed-science

Why Monkeypox Vaccine Shortage May Threaten the Immunocompromised

People with H.I.V. and other immune-system problems may need the full two-dose regimen, researchers say. But the shots, particularly second doses, are hard to come by.

#acquired-immune-deficiency-syndrome, #clinical-trials, #immune-system, #monkeypox, #shortages, #smallpox, #vaccination-and-immunization, #viruses, #your-feed-science

Vitamin D Supplements Don’t Help Another Condition, Study Finds

The vitamin pills do not prevent bone fractures in most people or protect against many other diseases, adding to questions about medical guidance many now take for granted.

#bone-fractures, #bones, #clinical-trials, #new-england-journal-of-medicine, #osteoporosis, #preventive-medicine, #research, #vitamin-d

Psychedelics for Depression: Can They Work Without Hallucinations?

Inside scientists’ efforts to capture the benefits of psychedelics without the trip.

#alternative-and-complementary-medicine, #anxiety-and-stress, #clinical-trials, #depression-mental, #psychedelic-and-hallucinogenic-drugs, #therapy-and-rehabilitation

Updated Covid Shots Are Coming. Will They Be Too Late?

The government has greenlit new vaccines to defend against the latest Omicron variants. But the shots won’t arrive until the fall, and cases are rising now.

#clinical-trials, #coronavirus-2019-ncov, #coronavirus-omicron-variant, #regulation-and-deregulation-of-industry, #vaccination-and-immunization, #your-feed-healthcare

CRISPR, 10 Years On: Learning to Rewrite the Code of Life

The gene-editing technology has led to innovations in medicine, evolution and agriculture — and raised profound ethical questions about altering human DNA.

#biology-and-biochemistry, #broad-institute, #clinical-trials, #crispr-dna, #dna-deoxyribonucleic-acid, #doudna-jennifer-a, #ethics-and-official-misconduct, #genetic-engineering, #genetics-and-heredity, #he-jiankui, #nobel-prizes, #science-and-technology, #university-of-california, #your-feed-health, #your-feed-science

Experimental Psychedelic Therapy Returns to the V.A.

A series of clinical trials using MDMA and psilocybin mushrooms represent a resurrection of promising research abandoned in the 1960s.

#anxiety-and-stress, #clinical-trials, #ecstasy-drug, #lsd-lysergic-acid-diethylamide, #mental-health-and-disorders, #psilocybin-mushrooms, #psychedelic-and-hallucinogenic-drugs, #therapy-and-rehabilitation, #veterans, #veterans-affairs-department

Vaccines for Young Children Are Coming, but Many Parents Have Tough Questions

The vaccines seem safe for children and are likely to protect against severe illness. But data on efficacy are thin, and most children have already been infected.

#biontech-se, #centers-for-disease-control-and-prevention, #children-and-childhood, #clinical-trials, #coronavirus-2019-ncov, #moderna-inc, #parenting, #pfizer-inc, #united-states, #vaccination-and-immunization, #your-feed-science

A Better Way to Measure Immunity in Children

Some scientists believe that a clearer picture of Covid vaccine efficacy could have emerged sooner if investigators had tracked certain immune cells, not just antibodies.

#antibodies, #biontech-se, #children-and-childhood, #clinical-trials, #coronavirus-2019-ncov, #immune-system, #moderna-inc, #parenting, #pfizer-inc, #tests-medical, #vaccination-and-immunization, #your-feed-science

F.D.A. Panel Recommends Pfizer and Moderna Vaccines for Youngest Children

States have already ordered millions of doses; if the agency authorizes them in the coming days, babies, toddlers and preschoolers could start receiving shots next week.

#biontech-se, #centers-for-disease-control-and-prevention, #clinical-trials, #coronavirus-2019-ncov, #food-and-drug-administration, #moderna-inc, #pfizer-inc, #vaccination-and-immunization, #walensky-rochelle

New Experimental Therapy for A.L.S. Approved in Canada

The F.D.A. is also reviewing the treatment, Albrioza, but the agency’s scientists have raised questions about its effectiveness.

#amylyx-pharmaceuticals-inc, #amyotrophic-lateral-sclerosis, #canada, #clinical-trials, #drugs-pharmaceuticals, #food-and-drug-administration, #health-canada, #united-states, #your-feed-science

Blood Tests That Detect Cancers Create Risks for Those Who Use Them

The tests screen for cancers that often go undetected, but they are expensive and some experts worry they could lead to unnecessary treatments without saving patients’ lives.

#blood, #cancer, #clinical-trials, #prostate-gland, #tests-medical

Revised Moderna Vaccine Works Better Against Omicron, Trial Suggests

The findings indicate that the updated vaccine produced a significantly stronger immune response against Omicron, but it is unclear how it will fare against future versions of the virus.

#clinical-trials, #coronavirus-2019-ncov, #coronavirus-omicron-variant, #moderna-inc, #united-states, #vaccination-and-immunization

A Cancer Trial’s Unexpected Result: Remission in Every Patient

The study was small, and experts say it needs to be replicated. But for 18 people with colorectal cancer, the outcome led to “happy tears.”

#american-society-of-clinical-oncology, #clinical-trials, #colon-and-colorectal-cancer, #drugs-pharmaceuticals, #glaxosmithkline-plc, #immunotherapy, #new-england-journal-of-medicine, #research

Can Stimulating the Vagus Nerve Improve Mental Health?

On social media, exercises that aim to “tone” one of our body’s longest nerves have been touted as a cure-all for anxiety and other psychological ailments. Here’s what the research says.

#anxiety-and-stress, #clinical-trials, #content-type-service, #depression-mental, #psychology-and-psychologists, #research, #vagus-nerve

Doctors Transplant 3-D Printed Ear Made of Human Cells

3DBio Therapeutics, a biotech company in Queens, said it had for the first time used 3-D printing to make a body part with a patient’s own cells.

#3-d-printers, #clinical-trials, #ears-and-hearing, #factories-and-manufacturing, #implants, #surgery-and-surgeons, #tissue-human, #your-feed-science

Celiac Disease Treatment: Are We Close to a Cure?

Recent advances in understanding the condition have brought a surge of potential therapies to the drug development pipeline.

#autoimmune-diseases, #celiac-disease, #clinical-trials, #content-type-service, #diet-and-nutrition, #digestive-tract, #gluten, #research

A Balm for Psyches Scarred by War

MDMA-assisted treatment for post-traumatic stress disorder “represents real hope for long-term healing,” health experts say.

#clinical-trials, #drugs-pharmaceuticals, #ecstasy-drug, #iraq-war-2003-11, #johns-hopkins-university, #mental-health-and-disorders, #mithoefer-michael, #multidisciplinary-assn-for-psychedelic-studies, #post-traumatic-stress-disorder, #psychiatry-and-psychiatrists, #therapy-and-rehabilitation, #traumatic-brain-injury, #united-states-defense-and-military-forces, #united-states-marine-corps, #united-states-navy, #veterans, #veterans-affairs-department, #vietnam-war, #your-feed-health, #your-feed-science

Long Covid Symptoms and Treatment: What We Know So Far

There is no universal definition of the complex condition, but clues about causes and potential treatments are beginning to emerge.

#chronic-condition-health, #clinical-trials, #content-type-service, #coronavirus-2019-ncov, #immune-system, #long-covid, #molnupiravir-drug, #paxlovid-drug, #research, #tests-medical, #vaccination-and-immunization

F.D.A. Expected to Soon Clear Pfizer Booster for Children Ages 5 to 11

Given that the age group has the lowest coronavirus vaccination rate of all eligible Americans, public health experts are not expecting a rush for the booster.

#biontech-se, #clinical-trials, #coronavirus-2019-ncov, #food-and-drug-administration, #pfizer-inc, #united-states, #vaccination-and-immunization

When Hope Hinges on an Unapproved Drug

The limits of expanded access to experimental drugs.

#clinical-trials, #death-and-dying, #drugs-pharmaceuticals

F.D.A. Sets Aside June for Potential Decisions on Vaccines for Children Under 5

Both Moderna and Pfizer-BioNTech have asked the agency to approve their vaccines for the youngest children.

#biontech-se, #children-and-childhood, #clinical-trials, #coronavirus-2019-ncov, #food-and-drug-administration, #moderna-inc, #pfizer-inc, #united-states, #vaccination-and-immunization

Scientists Question Data Behind an Experimental Alzheimer’s Drug

Studies linked to Cassava Sciences, once a stock market favorite, have been retracted or challenged by medical journals.

#academic-and-scientific-journals, #alzheimers-disease, #biotechnology-and-bioengineering, #cassava-sciences-inc, #clinical-trials, #drugs-pharmaceuticals, #elderly, #journal-of-alzheimers-disease, #journal-of-neuroscience, #short-selling, #united-states, #your-feed-science

Bill Gates: We Must Develop Drugs Much Faster in the Next Pandemic

The more rapidly we are able to produce safe, effective drugs for quick-spreading pathogens like the coronavirus, the more lives we can save.

#clinical-trials, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #research, #science-and-technology

New Drug Slashed Deaths Among Patients With Severe Covid, Maker Claims

A late-stage trial was halted after strong early results, according to the company, but outside scientists have not yet seen the data.

#clinical-trials, #coronavirus-2019-ncov, #disease-rates, #drugs-pharmaceuticals, #food-and-drug-administration, #united-states, #veru-inc, #your-feed-science

Medicare Officially Limits Coverage of Aduhelm to Patients in Clinical Trials

Officials cited data showing the new Alzheimer’s drug has serious safety risks and may not help patients.

#aduhelm-drug, #alzheimers-assn, #alzheimers-disease, #biogen-inc, #centers-for-medicare-and-medicaid-services, #clinical-trials, #drugs-pharmaceuticals, #food-and-drug-administration, #health-insurance-and-managed-care, #medicare

F.D.A. Panel Weighs Challenges of Revamping Covid Vaccines for Fall

A meeting of the committee underscored how many uncertainties lie ahead, including whether a vaccine that works better against variants can be ready by fall.

#centers-for-disease-control-and-prevention, #clinical-trials, #coronavirus-2019-ncov, #food-and-drug-administration, #health-and-human-services-department, #moderna-inc, #pfizer-inc, #united-states-politics-and-government, #vaccination-and-immunization

 New ALS Treatment, AMX0035, Lacks Evidence of Benefit, FDA Panel Finds

With a 6-4 vote, the group of independent advisers to the agency narrowly concluded that results from another clinical trial are needed to assess whether the therapy, called AMX0035, can help patients.

#amyotrophic-lateral-sclerosis, #clinical-trials, #drugs-pharmaceuticals, #placebos, #research, #your-feed-healthcare, #your-feed-science

Ivermectin Does Not Reduce Risk of Covid Hospitalization, Large Study Finds

“At some point it will become a waste of resources to continue studying an unpromising approach,” one expert said.

#clinical-trials, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #ivermectin-drug, #research, #your-feed-science

Moderna to Seek Authorization of Its Coronavirus Vaccine for Young Children

The company said the vaccine produced a strong immune response in children younger than 6, but proved only about 40 percent effective in preventing symptomatic Covid-19.

#biontech-se, #centers-for-disease-control-and-prevention, #clinical-trials, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #food-and-drug-administration, #pfizer-inc, #vaccination-and-immunization

Reporting bias makes homeopathy trials look like they work

Image of bottles with leaves in them.

Enlarge / If homeopathic remedies had this much nonwater material in them, we probably wouldn’t be having this discussion. (credit: Iryna Veklich / Getty Images)

One of the more productive ways that the methods of science can be used is to look at the scientific process itself. A “meta-science” study (like a recent one published on brain scans) can help tell us when research approaches aren’t producing reliable data and can potentially show what we might need to change to get those approaches to work.

Now, someone’s applied a bit of meta-science to an area of research where we shouldn’t expect to see improvements: homeopathy. A group of Austrian researchers looked into why a reasonable fraction of the clinical trials on homeopathy produce positive results. The biggest factor, the researchers found, is that the trials that show homeopathy is ineffective are less likely to get published.

A method to the madness

There are plenty of ways to test potential treatments but, over the years, problems have been identified in almost all of them. That’s left the double-blind, randomized clinical trial as the most trusted method of getting rid of some of the biases that make other approaches less reliable. But even in double-blind trials, problems can creep in. There’s always a bias toward publishing positive results—ones where the treatments have an effect.

Read 11 remaining paragraphs | Comments

#clinical-trials, #homeopathy, #medicine, #science

We’re Entering a Period of Relatively Low Covid Risk for Kids

Despite so-so vaccine news for children 5-11.

#clinical-trials, #coronavirus-omicron-variant, #instagram-inc, #internal-sub-only-nl, #masks, #new-york-city, #pfizer-inc, #twitter, #vaccination-and-immunization

There’s Smarter Statistics for the Under-5 Vaccine

We need to embrace a Bayesian approach to the child vaccine data.

#clinical-trials, #coronavirus-2019-ncov, #statistics, #vaccination-and-immunization

Covid Vaccines for Kids Under 5: What Parents Should Know

Here’s what families should know about the delay.

#biontech-se, #children-and-childhood, #clinical-trials, #coronavirus-2019-ncov, #coronavirus-risks-and-safety-concerns, #food-and-drug-administration, #pfizer-inc, #vaccination-and-immunization

F.D.A Delays Review of Pfizer’s Covid Vaccine for Children Under 5

The agency will wait for data on whether three doses of Pfizer-BioNTech’s Covid vaccine are effective in young children after new, disappointing data.

#biontech-se, #children-and-childhood, #clinical-trials, #coronavirus-2019-ncov, #coronavirus-omicron-variant, #drugs-pharmaceuticals, #food-and-drug-administration, #pfizer-inc, #vaccination-and-immunization

FDA Panel Rejects Lilly’s Cancer Drug Tested Only in China

The panel debated whether overseas trials could be applied to a more diverse U.S. population. The decision may affect other Chinese drug trials, and spotlights the high cost of immunotherapy.

#clinical-trials, #drugs-pharmaceuticals, #eli-lilly-and-company, #food-and-drug-administration, #immunotherapy, #lung-cancer, #new-england-journal-of-medicine, #pazdur-richard-1952, #prices-fares-fees-and-rates, #your-feed-healthcare

The Next Vaccine Debate: Immunize Young Children Now, or Wait?

It’s not clear whether three doses of the Pfizer-BioNTech vaccine will adequately protect young children. But the F.D.A. may authorize the first two doses anyway.

#biontech-se, #children-and-childhood, #clinical-trials, #coronavirus-2019-ncov, #coronavirus-omicron-variant, #drugs-pharmaceuticals, #food-and-drug-administration, #immune-system, #pfizer-inc, #united-states, #vaccination-and-immunization, #your-feed-science

A Cancer Treatment Makes Leukemia Vanish, but Creates More Mysteries

Two early recipients of CAR T immunotherapy were free of a blood cancer nearly a decade after receiving the therapy.

#cancer, #clinical-trials, #immune-system, #immunotherapy, #leukemia, #nature-journal, #research, #your-feed-health, #your-feed-science

Pfizer Asks F.D.A. to Clear 2 Vaccine Doses for Young Children as a Start

The Food and Drug Administration asked to review Pfizer’s data on two doses now, while the company continues to assess whether three doses would be more effective.

#centers-for-disease-control-and-prevention, #children-and-childhood, #clinical-trials, #coronavirus-2019-ncov, #coronavirus-omicron-variant, #food-and-drug-administration, #pfizer-inc, #vaccination-and-immunization

How The mRNA Vaccines Were Made: Halting Progress and Happy Accidents

The stunning Covid vaccines manufactured by Pfizer-BioNTech and Moderna drew upon long-buried discoveries made in the hopes of ending past epidemics.

#acquired-immune-deficiency-syndrome, #clinical-trials, #coronavirus-2019-ncov, #fauci-anthony-s, #graham-barney-s-1953, #kariko-katalin-1955, #mers-middle-east-respiratory-syndrome, #national-institutes-of-health, #vaccination-and-immunization, #weissman-drew-1961, #your-feed-science

How Psychedelic Drugs Can Be Used for Mental Health

Many recreational drugs known for mind-altering trips are being studied to treat depression, substance use and other disorders. Here’s what you need to know.

#alternative-and-complementary-medicine, #anxiety-and-stress, #brain, #clinical-trials, #depression-mental, #ecstasy-drug, #ketamine-drug, #lsd-lysergic-acid-diethylamide, #mental-health-and-disorders, #psychedelic-and-hallucinogenic-drugs, #psychiatry-and-psychiatrists, #serotonin-chemical

Cannabis to Help You Diet? One Edibles Company Thinks So

An edibles company says one of its products will lead not to the “the munchies” but to weight loss. There’s just one problem: the science.

#advertising-and-marketing, #cannabis-foods-and-products, #clinical-trials, #colorado, #drug-enforcement-administration, #food-and-drug-administration, #marijuana, #medical-marijuana, #national-institutes-of-health, #science-and-technology, #university-of-mississippi

J. & J. Booster Protects Against Severe Omicron, Study Says

Two shots of the vaccine reduced the risk of hospitalization from the fast-spreading variant by 85 percent, a clinical trial found.

#clinical-trials, #coronavirus-2019-ncov, #coronavirus-omicron-variant, #drugs-pharmaceuticals, #johnsonjohnson, #research, #south-africa, #vaccination-and-immunization

Israel Study Will Test Effectiveness of 4th Vaccine Dose

A decision on whether to offer the additional shot, and for whom, is expected within days.

#clinical-trials, #coronavirus-2019-ncov, #israel, #vaccination-and-immunization

F.D.A. Clears Pfizer’s Covid Pill for High-Risk Patients 12 and Older

The first-of-its-kind treatment, Paxlovid, has been found to be highly protective against severe illness. It could be available within a few days.

#clinical-trials, #coronavirus-delta-variant, #coronavirus-omicron-variant, #drugs-pharmaceuticals, #molnupiravir-drug, #paxlovid-drug, #pfizer-inc, #your-feed-science

A Popular Test Claims to Boost I.V.F. Success. The Science Is Unclear.

I.V.F. patients are faced with a growing list of costly “add-ons.” For one such test, some say more robust research is needed to support its effectiveness.

#clinical-trials, #in-vitro-fertilization, #infertility, #pregnancy-and-childbirth, #reproduction-biological, #research, #tests-medical

Pfizer’s Covid Pill Works Well, Company Confirms in Final Analysis

The treatment, called Paxlovid, is likely to work against Omicron and could be available in the United States before the end of the year.

#clinical-trials, #coronavirus-delta-variant, #coronavirus-omicron-variant, #drugs-pharmaceuticals, #molnupiravir-drug, #paxlovid-drug, #pfizer-inc, #your-feed-science