Pfizer and BioNTech Provide Update on Booster Program in Light of the Delta-Variant

Angie SzumlinskiAnnouncements

Pfizer and BioNTech have seen encouraging data in the ongoing booster trial of a third dose of the current BNT162b2 vaccine. Initial data from the study demonstrate that a booster dose given 6 months after the second dose has a consistent tolerability profile while eliciting high neutralization titers against the wild type and the Beta variant, which are 5 to …

Several LeadCare Blood Lead Tests Recalled

Angie SzumlinskiAnnouncements

On July 1, 2021, the U.S. Food and Drug Administration (FDA) issued a notice that Magellan Diagnostics, Inc., is recalling its LeadCare II, LeadCare Plus, and LeadCare Ultra Blood Lead Tests due to a significant risk of falsely low results. FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious …

Essential Caregivers Act

Angie SzumlinskiAnnouncements

Congresswoman Claudia Tenney hosted a press conference on June 30, 2021 to call for Congress to pass the Essential Caregivers Act. The Act would amend the Social Security Act to create an Essential Caregiver Program that grants residents in long-term care facilities the right to designate two essential caregivers to be permitted access to the resident. This is largely in …

2021 Morley Awards

Angie SzumlinskiAnnouncements, Featured

Two papers published last year in JAMA, one on sarcopenia and the other on visitors in the nursing home during the COVID-19 crisis, have won JAMDA’s 2021 Morley Award for their relevance and impact on policy and practice in post-acute and long-term care medicine. The Asian Working Group for Sarcopenia’s “2019 Consensus Update on Sarcopenia Diagnosis and Treatment” published in …

AMDA’s Statement on Aducanumab Approval

Angie SzumlinskiAnnouncements

On June 24, 2021, The Society for Post-Acute and Long-Term Care Medicine posted a statement regarding the approval of dementia medication aducanumab. Below is a segment of their statement: “The Society for Post-Acute and Long-Term Care Medicine is compelled to comment on the recent approval of the controversial parenteral Alzheimer’s Dementia (AD) medication, aducanumab. After considering the evidence, we conclude …

Not out of the Woods Yet!

Angie SzumlinskiAnnouncements, Studies

According to a research letter published in The Lancet, the National Institute for Health Research (NIHR) UCLH Biomedical Research Centre states that levels of antibodies in the blood of vaccinated people, able to recognize and fight the new SARS-CoV-2 Delta variant are lower than those against previously circulating variants. Additionally, the level of antibodies is lower with increasing age and …

Monoclonal Antibody Therapy Paused

Angie SzumlinskiAnnouncements, News

“As of June 25, 2021, the CDC has identified that the combined frequencies of the SARS-CoV-2 P.1/Gamma variant (first identified in Brazil) and the B.1.351/Beta variant (first identified in South Africa) throughout the United States now exceed 11% and are trending upward. Results from in vitro assays that are used to assess the susceptibility of viral variants to particular monoclonal …

Varenicline (Chantix) Recall

Angie SzumlinskiAnnouncements

On July 2, 2021, the U.S. Food and Drug Administration (FDA) issued an alert notifying patients and health care professionals to Pfizer’s voluntary recall of Varenicline, also known as Chantix. According to the alert, “the company is recalling varenicline because it may contain levels of a nitrosamine impurity, called N-nitroso-varenicline, above FDA’s acceptable intake limit. N-nitroso-varenicline may be associated with …

World Health Assembly – May 24, 2021

Angie SzumlinskiAnnouncements, Featured

Tedros Adhanom Ghebreyesus, PhD, the Director-General of The World Health Organization (WHO), addressed the World Health Assembly on May 24th and stated “the pandemic is not over, and will not be over, until virus transmission is controlled in every country. That’s because the longer the virus spreads uncontrolled, the more opportunity there is for new variants to emerge”. “So far, …

Genetic Variations: Background and Considerations

Angie SzumlinskiAnnouncements

The below information is sourced from the U.S. Food and Drug Administration’s “SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests:” Genetic Variations: Background and Considerations The SARS-CoV-2 virus has mutated over time, resulting in genetic variation in the population of circulating viral strains over the course of the COVID-19 pandemic. Molecular, antigen, and serology tests are affected by viral mutations differently …