Maine Medicine Weekly Update - Maine Medicine Weekly Update: 12/24/2021  (Plain Text Version)

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In this issue:
HAPPY HOLIDAYS FROM THE MMA
•  Enjoy The Holidays, Our Weekly Newsletter & Thank You For All You Do
COVID-19 CORNER
•  FDA Updates: Pfizer & Merck Oral Antivirals Authorized; Omicron & Monoclonal Antibodies
•  Maine CDC Updates & Guidance
•  Reminder: Everyone Ages 16 and Older Can Get a Booster Shot
•  US CDC Reduces Time for Health Care Workers to Isolate & Updates School Guidelines
•  English Study: Booster Shots Protect Against Omicron for About 10 Weeks
•  Patients Vaccinated for COVID-19 Have Shorter Hospital Stays Than Unvaccinated Patients
•  JAMA Internal Medicine - Illness Severity With SARS-CoV-2 Infection, Delta vs Beta Variant
•  US Supreme Court to Take Up Federal COVID-19 Vaccine Rules
WHAT'S NOT COVID RELATED
•  CDC: Physicians Should Discuss Meds to Reduce HIV Risk
•  HHS: $48 Million Available to Increase the Public Health Workforce in Rural and Tribal Communities
•  MaineCare: Payment Cycle Reminder: Christmas and New Year's Day Holidays
IN THE NEWS
•  Medicine in the Media
•  Walgreens Pharmacy Hours Change: Call Ahead Before Picking Up Your Medication
MAINE MEDICAL ASSOCIATION JOB OPPORTUNITY
•  Maine Medical Education Trust (MMET) CME Program Coordinator
HEALTH COVERAGE
•  Open Enrollment For 2022 Individual Health Plans
UPCOMING EVENTS
•  Upcoming Specialty Society Meetings
•  Governorís Opioid Response Seminar Webinar Series Continues (Jan 7)
HEALTHCARE EMPLOYMENT OPPORTUNITIES
•  Psychiatric Nurse Practitioner (PNP) - Greater Portland Health
•  Transformational OB/GYN or Maternal Fetal Medicine Physician leader

 

FDA Updates: Pfizer & Merck Oral Antivirals Authorized; Omicron & Monoclonal Antibodies

The FDA authorized two oral antivirals for the treatment of COVID-19 in certain patients. Pfizer’s Paxlovid – authorized for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients 12 and older, and Merck’s molnupiravir – authorized for the treatment of mild-to-moderate COVID-19 in adults with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19.

Paxlovid is the first oral, at-home treatment to be authorized by the agency

The FDA authorized two oral antivirals for the treatment of COVID-19 in certain patients. Pfizer’s Paxlovid – authorized for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients 12 and older, and Merck’s molnupiravir – authorized for the treatment of mild-to-moderate COVID-19 in adults with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19.

Paxlovid is the first oral, at-home treatment to be authorized by the agency

The FDA released a joint statement on the circulating SARS-CoV-2 viral variants, including Omicron, and how the variants may be associated with resistance to monoclonal antibodies.

The FDA has updated the SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests web page to share new information regarding:

·       Background information on the SARS-CoV-2 omicron variant

·       Impact of the SARS-CoV-2 omicron variant on antigen diagnostic tests

The update revised:

·       The FDA’s recommendations for clinical laboratory staff and health care providers.

·       Information on the impact of the SARS-CoV-2 omicron variant on molecular diagnostic tests.

The FDA continues to monitor and evaluate the impact of genetic variants on antigen tests and released further information on the Omicron variant and its impact on antigen diagnostic tests

Deeper Dive

The FDA authorized two oral antivirals for the treatment of COVID-19 in certain patients. Pfizer’s Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) is authorized for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms or about 88 pounds) with positive results of direct SARS-CoV-2 testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. Merck’s molnupiravir is authorized for the treatment of mild-to-moderate COVID-19 in adults with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate. Both treatments are available by prescription only and should be initiated as soon as possible after diagnosis of COVID-19 and within five days of symptom onset.

The FDA released a joint statement on the circulating SARS-CoV-2 viral variants, including Omicron, and how the variants may be associated with resistance to monoclonal antibodies. Data show that it is unlikely that bamlanivimab and etesevimab administered together or REGEN-COV will retain activity against this variant. Based on similar cell culture data currently available, sotrovimab appears to retain activity against the Omicron variant. FDA updated the Health Care Provider Fact Sheets for bamlanivimab and etesevimab administered togetherREGEN-COV, and sotrovimab with specific information regarding expected activity against the Omicron variant (B.1.1.529/BA.1). Based on this information, ASPR will pause any further allocations of bamlanivimab and etesevimab together, etesevimab alone, and REGEN-COV pending updated data from the CDC. Shipments of sotrovimab did resume this week, and delivery of 55,000 doses of product has begun. An additional 300,000 doses of sotrovimab will be available for distribution in January. As additional data become available, FDA and ASPR will provide updates and further recommendations and consider if additional actions are warranted.

The FDA is collaborating with the National Institutes of Health’s (NIH) RADx program to study the performance of antigen tests with patient samples that have the omicron variant. Our RADx partners are currently evaluating the performance of antigen tests with patient samples containing live virus, which is the best way to evaluate true test performance.

Omicron Variant: Impact on Antigen Diagnostic Tests (As of 12/22/2021)

Resources:

  • FDA’s Coronavirus Disease 2019 (COVID-19) webpage