|
Healthcare Professional Newsletter |
|
|
This Healthcare Professional Newsletter is a bi-weekly combined effort between the former Therapeutics updates and Covid- 19 Vaccine Provider Updates. For newsletter sign-ups please click here . To access archived newsletters click here.
|
|
 COVID-19 Vaccine Updates
- Monovalent Deauthorization and Wastage
- Monovalent mRNA COVID-19 vaccines are no longer authorized as a booster dose for individuals 12 years of age and older. As a result, providers may only use this monovalent vaccine as part of a primary vaccine series. Providers may suddenly find themselves with a large amount of monovalent vaccine doses and a need to order the new updated bivalent booster doses. Over the next few months, larger than usual doses of the primary series COVID-19 vaccine may expire and need to be disposed of according to state and local regulations. Remember to check the expiration dates of your inventory regularly using the manufacturer expiry look up pages.
- Expiry Lookup Tools
-
For questions about VaxMaX and its functionality, please visit the VaxMaX Help website, which includes reference guides and tutorial videos.
|
|
Upcoming Events
- National Network of STD Clinical Prevention Training Centers (NNPTC): Monkeypox Clinical Update Webinar - NNPTC faculty will provide a clinical update on monkeypox with time for a facilitated Q&A session.
Helpful Resources
|
|
COVID-19 Therapeutics Update
Process and Logistics Updates
- Process and logistics Updates
- Bebtelovimab Batch Numbers
- With the transition of Bebtelovimab to the commercial market, the VDH COVID-19 Therapeutics Team wants to provide some distinction between the batch numbers of commercially purchased Bebtelovimab and that supplied by the United States Government (USG).
- Please note that there was no change to the packaging or NDC number for commercially available Bebtelovimab. However, the commercially purchased supply does have unique batch numbers compared to the USG supply (see lists below).
- We encourage you to check the www.covid19.lily.com/bebtelovimab/hcp/resouces and the ASPR webpage as new batches will become available.
- USG Purchased Batch Numbers
- D476887
- D476886
- D487999
- D480382
- D488000
- D492098
- D494710
- D493128
- Commercially Purchased Batch Numbers
- Total Allocations to Therapeutic Administration Sites
Clinical Updates
- Two Recent Studies Show Paxlovid, Molnupiravir Benefits Older COVID-19 Patients
- A pair of new studies describes the clinical benefits of two oral antiviral drugs in COVID-19 patients amid the Omicron period. One study is from Israel and suggests that nirmatrelvir-ritonavir (Paxlovid) reduced rates of hospitalization and death in people 65 years or older. The second research study from Hong Kong demonstrated that Paxlovid and molnupiravir lowered the rates of death, disease progression, and the need for supplemental oxygen in older hospitalized patients.
- FDA Authorizes Shelf Life Extension for Certain Lots of Paxlovid
- The Administration for Strategic Preparedness and Response (ASPR) and the Food and Drug Administration (FDA) announced the authorization of an extension to the shelf life from 12 months to 18 months for certain lots of the Pfizer antiviral therapy, Paxlovid (nirmatrelvir tablets and ritonavir tablets co-packaged for oral use), which is currently authorized for emergency use for the treatment of mild-to-moderate COVID-19 in certain adults and pediatric patients (12 years of age and older weighing at least 40 kg).
- As a result of this extension, lots of Paxlovid with dates of expiry from July 2022 to May 2023 may be stored for an additional six months from the labeled date of expiry. Per the requirements in the emergency use authorization, unopened cartons of Paxlovid (300 mg nirmatrelvir and 100 mg ritonavir, or 150 mg nirmatrelvir and 100 mg ritonavir) must be appropriately held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers.
- FDA granted this extension following a thorough review of data submitted by Pfizer. Review the table with updated expiration dates here.
Resources and Tools
- Link to Sign Up for the Newsletter
- Did a colleague share this newsletter with you, and you’d like to sign up to receive it directly? Do you know of a colleague that would benefit from receiving information on therapeutics from VDH? Click here to sign up!
- VDH Therapeutics Website for Healthcare Providers
- VDH Therapeutics Website for the Public
- COVID-19 Therapeutics Webinars and Open Forum Calls for Providers
- VDH continues to facilitate webinars and open forums monthly. See below for links to register!
-
-
October 5 VDH Healthcare Provider COVID-19 Therapeutics Webinar: Register here.
-
October 19 VDH Healthcare Provider Open Forum with Evusheld focus and guest speaker from AstraZeneca: Register here.
|
|
 Topics of Public Health Interest
- Monkeypox
- The Centers for Disease Control and Prevention (CDC) have developed the Monkeypox Vaccine Equity Pilot Program to “support innovative, non-traditional ways to address disparities” with regards to monkeypox vaccinations. The CDC is accepting applications from local, state, and territorial health departments, as well tribal governments and local non-governmental organizations in an effort to increase vaccination access to populations most at risk for monkeypox virus. Additional information about this program can be found here. Organizations interested in submitting a proposal should email [email protected].
- CDC Health Alert Network (HAN) 474: Severe Respiratory Illnesses Associated with Rhinoviruses and/or Enteroviruses Including EV-D68 – Multistate, 2022
- Situation Summary
-
CDC is reporting a recent increase in pediatric hospitalizations in patients with severe respiratory illness who also tested positive for rhinovirus (RV) and/or enterovirus (EV). Upon further typing, some specimens have been positive for enterovirus D68 (EV-D68).
- EV-D68 has been associated with cases of acute flaccid myelitis (AFM), which peaks in the summer and fall months.
- Increases in EV-D68 respiratory illnesses have typically preceded cases of AFM, indicating that increased surveillance for AFM in the coming weeks will be essential.
- Recommended Action
- Consider EV-D68 as a possible cause of acute, severe respiratory illness (with or without fever) in children. Adults may also become infected with EV-D68, but it is thought to be more commonly detected in adults with underlying conditions.
- Consider laboratory testing of respiratory specimens for RVs and EVs (typically part of multiplex respiratory assays) when the cause of respiratory infection in severely ill patients is unclear, if not already part of typical diagnostic routine.
-
Strongly consider AFM in patients with acute flaccid limb weakness, especially after respiratory illness or fever, and between the months of August and November 2022.
- Maintain vigilance and report possible cases of AFM to your local health department as soon as possible.
- 2022 Pink Book Web-on-Demand Series: Polio and Hib Now Live
- The Pink Book Web-on-Demand Series Update on Polio and Hib is now live. Elisha Hall, PhD, RD, Health Education Specialist, Communication and Education Branch (CEB), Immunization Services Division (ISD), National Center for Immunization and Respiratory Diseases (NCIRD) provides an update on these vaccine-preventable diseases and the vaccines used to protect against them. Laura Daniel moderates this session.
- There is no registration process to view this presentation. Questions about the material presented can be submitted to [email protected].
- A new video will be released every Tuesday through November 1, 2022. Join us next week for the Varicella presentation.
|
|
|
|
