In The News

Breaking: CDC ACIP Recommends RSV Vaccination for Older Adults

Drug Topics | By Lauren Biscaldi

The first RSV vaccines were approved by the FDA earlier this year.

Members of the CDC’s Advisory Committee for Immunization Practices (ACIP) have voted in favor of recommending recently approved respiratory syncytial virus (RSV) vaccines for use in adults aged 60 years and older after consulting with their health care provider.1 The first 2 RSV vaccines, from manufacturers GSK and Pfizer, were approved by the FDA earlier this year.2,3

Although some committee members were hoping for a broader recommendation, other members expressed concerns around a lack of data on vaccine effectiveness for adults over the age of 75 years as well as those in other high-risk groups.

Arexvy (respiratory syncytial virus vaccine, adjuvanted), manufactured by GSK, was approved by the FDA on May 3, 2023 to prevent lower respiratory tract disease caused by RSV in adults aged 60 years and older. The vaccine contains a recombinant subunit prefusion RSV F glycoprotein antigen (RSVPreF3) in combination with GSK’s priority AS01E adjuvant.

FDA approval of Arexvy was based on data from AReSVi-006 (NCT04886596), a landmark phase 3 clinical trial. Trial results showed that the vaccine demonstrated both statistically significant and clinically meaningful overall efficacy against RSV-associated lower respiratory tract disease in adults aged 60 years and older, as well as efficacy in older adults with at least 1 underlying comorbid condition.

Additional studies of Arexvy evaluated the coadministration of Arexvy and an FDA-approved influenza vaccine; 2 participants developed acute disseminated encephalomyelitis and 1 developed Guillain-Barré syndrome. As a result, the FDA is requiring GSK to conduct postmarketing studies to evaluate the signals of serious risks for each of these conditions.

On June 1, the FDA approved Abrysvo, a bivalent RSV vaccine manufactured by Pfizer, also for the prevention of lower respiratory tract disease caused by RSV in adults aged 60 years and older. Approval for Abrysvo was based on data from the phase 3 RENOIR clinical trial (NCT05035212), a global, randomized, double-blind, placebo-controlled study evaluating the efficacy, immunogenicity, and safety of a single vaccine dose in older adults. Study participants—over 34,000 adults—were randomly assigned 1:1 to receive the bivalent RSVpreF vaccine 120 µg or placebo.

Interim results published in the New England Journal of Medicine demonstrated efficacy against RSV-associated lower respiratory tract illness with at least 2 or 3 signs and symptoms; the vaccine group had 1.19 RSV cases per 1000 person-years compared with 1.52 per 1000 person-years in the placebo group. Adverse event rates were similar through 1 month after injection in in each group.

RSV is a highly contagious respiratory disease with seasonal circulation. Transmission typically begins in the fall and peaks during the winter months. In older adults, RSV can cause lower respiratory tract infections, leading to life-threatening pneumonia and bronchiolitis. Data suggest that RSV is responsible for 14,000 deaths in adults aged 65 years and older.

In terms of pricing, GSK expects their vaccine to be priced between $200 and $295 per dose. suggested a range of $180 to $270 a dose, but could not guarantee that the final price would remain within that range.

 

FACING A THREAT: Nationwide Shortage of Medications 

Healthcare Ready

Oncology Shortage: 

In the fight against cancer, chemotherapy plays a crucial role in saving lives. But here is the harsh reality: accessing this life-saving treatment has become more challenging than ever. According to a report by the American Cancer Society (ACS), the use of chemotherapy after surgeries for breast and colon cancer has contributed to a significant decrease in fatality risks. This trend gives hope to the millions affected by cancer in the United States, however, there it comes with a major obstacle.  

Drug shortages across the country have reached an all-time high. A few months ago, hospitals were forced to ration albuterol sulfate, a vital medication for treating respiratory conditions, due to a critical shortage caused by supply chain disruptions. The same alarming scenario is now unfolding with chemotherapy medications.  

Carboplatin and cisplatin, two essential chemotherapy drugs, are in short supply. The National Comprehensive Cancer Network (NCCN) revealed that 93% of centers are currently experiencing shortages of carboplatin, while 70% are facing shortages of cisplatin. This crisis is forcing doctors to make complex decisions, delay treatments, or seek alternative care plans. Our hearts go out to those affected by this uncertainty.  

More concerning is that cisplatin and carboplatin are often used interchangeably. This flexibility has been a strength in the past, allowing doctors to switch between the two when supplies ran low. However, with both drugs facing scarcity, finding alternatives has become increasingly difficult. There are multiple factors contributing to these drug shortages, including manufacturing disruptions and policy implementation that spans national borders. The shutdown of Accord Healthcare Inc.'s manufacturing facility in India, a major supplier of cisplatin and carboplatin, has left a significant void. Other manufacturers have struggled to fill the gaps, leading to delays. But there is a glimmer of hope on the horizon!  

The FDA has been collaborating with Qilu Pharmaceutical Co. Ltd. and Apotex Corp. to increase the availability of cisplatin in the U.S. market. Temporary importation of the drug aims to alleviate the shortage and provide relief to patients in need. While progress is being made, any further delays in manufacturing and delivery could prolong the timeline for accessing these vital drugs. This would disrupt patient care and threaten the availability of other cancer medications used as substitutes. We must remain vigilant and advocate for solutions to ensure that every patient receives the treatment they deserve.  

Penicillin Shortage: 

 According to Pfizer's recent letter to clinicians, there is a limited supply and impending stock out situation for Bicillin L-A and Bicillin C-R Prefilled Syringes. The rise in syphilis infection rates and increased demand are the main reasons behind this shortage.  

The impact of this shortage is far-reaching, especially for children who may run out of supply by the end of June 2023. It is crucial to understand that Bicillin is the recommended treatment for preliminary stages of syphilis, including primary, secondary, and early latent syphilis. Bicillin L-A is not only the most effective antibiotic but also the only product available to treat pregnant patients with syphilis. This shortage is forcing doctors to carefully ration Bicillin L-A for critical cases.  

Unfortunately, the situation does not seem to be improving anytime soon. Pfizer estimates that all Bicillin C-R will be depleted by the end of Q3 2023, and Bicillin L-A pediatric prefilled syringes may run out by the end of Q2 2023. The estimated resupply dates are projected to be between Q2 and Q3 2024. 

 

Know the Science: How Medications and Supplements Can Interact

National Center for Complementary and Integrative Health

Introduction

Many Americans take dietary supplements along with prescription or over-the-counter medications.

Sometimes, taking medications and supplements together may have unintended effects, including:

  • Increasing the medication’s effects
  • Decreasing the medication’s effects
  • Interacting with the medication in harmful ways

That’s why you should talk with your health care providers about all dietary supplements and medications you take.

Learn more about talking with your providers, the different ways supplements and medications can interact, and how to read and understand labels on supplements—then test your knowledge.

Visit Website: https://www.nccih.nih.gov/health/know-science/how-medications-and-supplements-can-interact/introduction?nav=govd

 

Home and Community Based Services

U.S. Department of Veterans Affairs

There are many Home and Community Based Services and resources to help Veterans remain independent and live safely at home, such as A Guide for Families: Keeping the Person with Memory Loss Safer at Home.

For example, one service offered by Veterans Health Administration (VHA) is Home Based Primary Care (HBPC). This health care service is provided to Veterans in their home. The program is for Veterans who need team based in-home support for ongoing diseases and illnesses that affect their health and daily activities.

Most times, Veterans have difficulty making and keeping clinic visits because of the severity of their illness and are often homebound, but that is not required. Watch this video to hear what HBPC providers, the Veterans they care for, and their families have to say about this program.

Other Home and Community Based Services include:

Many Veterans receive more than one Home and Community Based Service at the same time. And VA also provides support for family caregivers. Your VA physician or social worker can tell you if a Home Based Primary Care program is available in your area.

Need more help or information? Find a VA social worker in your area or visit www.va.gov/Geriatrics.

 

Study Suggests Depression After Traumatic Brain Injury Could Represent a New, Distinct Disease

Brigham and Women's Hospital

A new study led by Shan Siddiqi, MD, from Brigham and Women's Hospital, a founding member of the Mass General Brigham health care system, suggests that depression after traumatic brain injury (TBI) could be a clinically distinct disorder rather than traditional major depressive disorder, with implications for patient treatment. The findings are published in Science Translational Medicine.

"Our findings help explain how the physical trauma to specific brain circuits can lead to development of depression. If we're right, it means that we should be treating depression after TBI like a distinct disease," said corresponding author Shan Siddiqi, MD, of the Brigham's Department of Psychiatry and Center for Brain Circuit Therapeutics.

"Many clinicians have suspected that this is a clinically distinct disorder with a unique pattern of symptoms and unique treatment response, including poor response to conventional antidepressants—but until now, we didn't have clear physiological evidence to prove this."

Siddiqi collaborated with researchers from Washington University in St. Louis, Duke University School of Medicine, the University of Padua, and the Uniformed Services University of the Health Sciences on the study.

The work started as a side project seven years ago when Siddiqi was motivated by a patient he shared with David Brody, MD, Ph.D., a co-author on the study and a neurologist at Uniformed Services University. The two started a small clinical trial that used personalized brain mapping to target brain stimulation as a treatment for TBI patients with depression. In the process, they noticed a specific pattern of abnormalities in these patients' brain maps.

A unique brain network architecture in depression after traumatic brain injury: the study and the story behind the science. Credit: Shan H. Siddiqi

The current study included 273 adults with TBI, usually from sports injuries, military injuries, or car accidents. People in this group were compared to other groups who did not have a TBI or depression, people with depression without TBI, and people with post-traumatic stress disorder.

Study participants went through a resting-state functional connectivity MRI, a brain scan that looks at how oxygen is moving in the brain. These scans gave information about oxygenation in up to 200,000 points in the brain at about 1,000 different points in time, leading to about 200 million data points in each person. Based on this information, a machine learning algorithm was used to generate an individualized map of each person's brain.

The location of the brain circuit involved in depression was the same among people with TBI as people without TBI, but the nature of the abnormalities was different. Connectivity in this circuit was decreased in depression without TBI and was increased in TBI-associated depression. This implies that TBI-associated depression may be a different disease process, leading the study authors to propose a new name: "TBI affective syndrome."

"I've always suspected it isn't the same as regular major depressive disorder or other mental health conditions that are not related to traumatic brain injury," said Brody. "There's still a lot we don't understand, but we're starting to make progress."

One limitation of the trial is that with so much data, the researchers were not able to do detailed assessments of each patient beyond brain mapping. As a future step, investigators would like to assess participants' behavior in a more sophisticated way and potentially define different kinds of TBI-associated neuropsychiatric syndromes.

Siddiqi and Brody are also using this approach to develop personalized treatments. Originally, they set out to design a new treatment in which they used this brain mapping technology to target a specific brain region for people with TBI and depression, using transcranial magnetic stimulation (TMS). They enrolled 15 people in the pilot and saw success with the treatment. Since then, they have received funding to replicate the study in a multi-center military trial.

"We hope our discovery guides a precision medicine approach to managing depression and mild TBI, and perhaps even intervene in neuro-vulnerable trauma survivors before the onset of chronic symptoms," said Rajendra Morey, MD, a professor of psychiatry at Duke University School of Medicine, and co-author on the study.

 

 
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