Teens Ages 12 to 15 Should Get Pfizer-BioNTech’s COVID-19 Vaccine, Says a CDC Expert Panel

May 15, 2021 0 Comments

Following the US Food and Drug Administration’s decision on May 10 to extend emergency use authorization for the Pfizer-BioNTech vaccine to include 12- to 15-year olds, the Centers for Disease Control added its recommendation that teens in that age group should be vaccinated with the shot.

The expert panel of the CDC’s Advisory Committee on Immunization Practices makes immunization recommendations, and determined that based on the evidence from a study of more than 2200 teens conducted by Pfizer-BioNTech, that the vaccine was safe and effective. During the day-long meeting, however, the members discussed whether to allow vaccination with the Pfizer-BioNTech shot along with other vaccinations teens may need to get, including against HPV, hepatitis and meningitis. Currently, out of an abundance of caution, CDC recommends that people not get other vaccines 14 days before or after the COVID-19 dose. But based on the safety seen from hundreds of millions of … Read the rest

Sleep-Deprived Adults at Higher Risk for Dementia

May 15, 2021 0 Comments

Adults who sleep 6 hours or less increase their dementia risk by 30% according to a recent study published in Nature Communications.

Existing studies that assess sleep duration over more than 10 years primarily involve adults age 65 and older. The researchers wanted to assess the relationship between sleep and dementia beginning at age 50.

The researchers used data from the Whitehall II cohort study that includes British civil servants and spans 30 years. They assessed the association between sleep duration and dementia at age 50, 60, and 70. They also looked at the relationship between mental disorders in midlife, sleep duration, and dementia.

The study included data from 10,308 individuals — 7,959 had data on sleep duration at age 50.

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Among the participants with sleep data, 521 developed dementia over a mean follow-up period of 24.6 (SD = 7.0) years. The follow-up was 25.7 (SD = … Read the rest

The CDC Says That The Fully Vaccinated Can Shed Masks—Both Indoors and Outdoors

May 14, 2021 0 Comments

In news everyone has been waiting for since last year, the U.S. Centers for Disease Control and Prevention (CDC) said May 13 that people who are fully vaccinated against COVID-19 can ditch their masks, both indoors and outdoors, and stop social distancing as well.

It was welcome news, especially as politicians and many in the public have been criticizing the CDC for moving too slowly to update its guidelines as more people in the U.S.—over 35% as of today—have received a full course of vaccinations. In addition, while initial research only showed that vaccination prevented COVID-19 disease, recent data suggest that vaccinated people are also protected from getting infected with SARS-CoV-2—the virus that causes COVID-19—and are therefore also far less likely to spread it.

In a press briefing, CDC Director Dr. Rochelle Walensky cited the vaccination effort, the real-world data showing the shots are working, the dropping case counts in … Read the rest

Zynrelef Approved to Treat Postoperative Pain for Up to 72 Hours

May 14, 2021 0 Comments

The Food and Drug Administration (FDA) has approved Zynrelef (bupivacaine and meloxicam) extended-release solution for use in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours in adults after bunionectomy, open inguinal herniorrhaphy and total knee arthroplasty.

Zynrelef is a dual-acting local anesthetic that delivers a fixed-dose combination of bupivacaine, an amide local anesthetic, and meloxicam, a nonsteroidal anti-inflammatory drug (NSAID). The needle-free product is intended for single-dose administration only.

The approval was based on data from multiple double-blind, placebo- and active-controlled phase 3 (ClinicalTrials.gov: NCT03295721, NCT03237481) and phase 2 (ClinicalTrials.gov: NCT03015532) studies involving over 1000 patients.

Among patients undergoing unilateral simple bunionectomy (N=412), treatment with Zynrelef was associated with a significant reduction in pain intensity compared with either bupivacaine HCl or saline placebo for up to 72 hours. Additionally, a significant proportion of patients in the Zynrelef arm did not receive opioid … Read the rest

India’s COVID-19 Disaster May Be Turning Into an Even Bigger Global Crisis

May 13, 2021 0 Comments

High in the thin air of the Mount Everest Base Camp in Nepal, Sherpas and climbers used to walk freely from one group of tents to another, holding gatherings, singing and dancing. Now the Sherpas who escort climbers to the summit have a new job: enforcing unofficial social-distancing rules. “Climbing Everest is always a matter of life and death,” says Phunuru Sherpa. “But this year the risk has been doubled due to COVID.”

Already, dozens of people with suspected COVID-19 have been evacuated by helicopter. The outbreak reflects a broader one across Nepal, which shares a long, porous border with India. Daily confirmed cases in the Himalayan nation increased thirtyfold from April 11 to May 11, when 9,300 infections were recorded. It’s a grim omen of how India’s devastating COVID-19 crisis may be turning into an even bigger global emergency.

As countries around the world airlift oxygen, vaccines and medical supplies to … Read the rest

Vaginal pH Regulator Gets Fast Track Status for Gonorrhea Prevention

May 13, 2021 0 Comments

The Food and Drug Administration (FDA) has granted Fast Track designation to EVO100 for the prevention of urogenital gonorrhea in women. 

EVO100 is pH-modulating vaginal gel designed to reduce certain vaginal infections by balancing vaginal pH, thereby maintaining healthy vaginal flora. The designation is supported by data from the double-blind, placebo-controlled phase 2b/3 AMPREVENCE trial (ClinicalTrials.gov: NCT03107377), which assessed the efficacy and safety of EVO100 in reducing the risk of gonorrhea and chlamydia infections in 860 women.

Patients were randomly assigned 1:1 to receive EVO100 (n=426) or placebo (n=434) intravaginally at least 1 hour prior to vaginal intercourse. Results showed that EVO100 met the primary and secondary endpoints with statistically significant reductions in the risk of chlamydia and gonorrhea, respectively.

The chlamydia infection rate for the EVO100 arm was 4.8% (n=14/289) compared with 9.7% (n=28/290) for placebo (P =.0256), indicating a relative risk reduction of 50%. The gonorrhea infection … Read the rest

A New Study Points to MDMA as a Powerful Treatment for PTSD

May 12, 2021 0 Comments

Post-Traumatic Stress Disorder (PTSD), will affect some 26 million Americans at some point in their lives, according to the Department of Veterans Affairs. The condition, characterized by depression, hopelessness, memory problems, difficulty maintaining relationships, and recurrent visions of the trauma-causing event is notoriously hard to treat. Up to a third of people with the condition are still symptomatic 10 years after diagnosis, and the main therapeutic drugs of choice—the selective serotonin reuptake inhibitors sertraline and paroxetine—fail in up to 60% of patients. A study published yesterday, however, suggests that there may be a powerful new medication to battle the condition: MDMA, the primary chemical in the drugs colloquially known as ecstasy and molly.

In a Phase 3 trial led by neurologist Jennifer Mitchell of the University of California, San Francisco, treatment with three doses of MDMA—accompanied by one-on-one therapy—over the course of 18 weeks was significantly more effective in treating … Read the rest

Expert Q&A: MAPS and Psychedelic-Assisted Psychotherapy

May 12, 2021 0 Comments

After decades of limited research and legal roadblocks to medical and recreational use, psychedelic drugs are rapidly remerging as treatments of interest in psychiatry. Cannabis for medical use is widely available across the United States, and in the 2020 elections, a number of states relaxed drug laws, with Oregon allowing psychedelic treatments at medical centers.1

These legal changes, particularly regarding nonmedical or recreational use, will have many physicians worried about the development of substance use disorders in broad swathes of the population. However, relaxed regulations may offer an opportunity to learn more about how the diverse range of psychedelic drugs can be applied as treatments in psychiatric settings.2-4

The first part of this series of articles (Psychedelic Drugs: Lessons From Ketamine and Psilocybin) explored a couple of very different psychedelic treatments for psychiatric disorders, namely esketamine and psilocybin-based treatments for major depressive disorder (MDD).5 Whereas the development … Read the rest

Teens Aged 12 to 15 Can Now Get Pfizer-BioNTech COVID-19 Vaccine in the U.S.

May 11, 2021 0 Comments

On May 10, the U.S. Food and Drug Administration (FDA) extended authorization of the Pfizer-BioNTech COVID-19 vaccine to 12- to 15-year-olds. It’s the first COVID-19 shot authorized for this younger population.

“I cannot tell you how many people have been anxiously awaiting this day to get their kids vaccinated,” says Dr. Flor Munoz, a pediatric infectious disease specialist at Texas Children’s Hospital and Baylor College of Medicine, and a member of the infectious disease committee of the American Academy of Pediatrics.

The green light was based on review of data the two companies released in March showing that two doses of their vaccine provided similar protection from COVID-19 disease among this age group as it did for adults. Among the more than 2,200 teens in the study group the FDA reviewed, 16 developed COVID-19—none of them were in the vaccinated group. The companies’ studies found that levels of virus-fighting antibodies … Read the rest

Tezepelumab BLA Submitted for Severe Asthma

May 11, 2021 0 Comments

The Biologics License Application (BLA) for tezepelumab has been submitted to the Food and Drug Administration (FDA) for patients with severe asthma.

Tezepelumab is an investigational first-in-class human monoclonal antibody that works by blocking thymic stromal lymphopoietin, an epithelial cytokine involved in the initiation and persistence of airway inflammation. 

The BLA submission is supported by data from the PATHFINDER clinical program, which included the double-blind, placebo-controlled phase 3 NAVIGATOR trial (ClinicalTrials.gov: NCT03347279) that assessed the efficacy and safety of tezepelumab in 1061 patients 12 to 80 years of age with severe, uncontrolled asthma who were receiving medium- or high-dose inhaled corticosteroid plus at least 1 additional controller medication with or without oral corticosteroid. The study included patients with both high and low blood eosinophil counts.

Patients were randomly assigned 1:1 to receive tezepelumab or placebo administered by subcutaneous injection, in addition to standard of care. The primary end point of … Read the rest