Dec. 14, 2020


COVID-19 Vaccine News
Eli Lilly Simplifies Bamlanivimab Use
Eli Lilly and Company recently released its new simplified preparation for bamlanivimab, the monoclonal antibody therapy that received its Emergency Use Authorization (EUA) last month.

Originally, the EUA required those who are preparing the drug to withdraw 70 mL from a 250 mL normal saline bag. The new guidance allows for the addition of the 20 mL bamlanivimab directly to the 250 mL, without withdrawing 70 mL volume. This results in a new administration infusion rate of 270 mL/hour.

For more information, consult Eli Lilly's Fact Sheet.
MDHHS Educational Updates on Pfizer Vaccine
The Michigan Department of Health and Human Services has released important education updates regarding the COVID-19 Vaccination Program and the recent Emergency Use Authorized (EUA) Pfizer Vaccine. In this email you will find:

  • A short recap of the ACIP meeting
  • Information regarding the EUA which will include the EUA fact sheets
  • MDHHS Prioritization Guidance
  • CDC’s Communication Toolkit
  • An update on CDC’s education materials
  • MDHHS FAQ
  • Update on Ancillary Kits
  • COCA call information
  • Upcoming IMPORTANT Webinars
  • Medical Management Guidance for Managing a Vaccine Reaction
ACIP Meeting Recap
In emergency meeting on Saturday, Dec. 13, the Center for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) met, discussed and voted on recommendations for the Pfizer-BioNTech COVID-19 vaccine. The ACIP members received an update on safety and efficacy data and they voted for use for people 16 years of age and older in the U.S. This recommendation comes one day after the Food and Drug Administration (FDA) authorized the EUA for the Pfizer COVID-19 vaccine.
 
The vote from the ACIP passed with 11 votes in favor and three recusals. A separate vote to amend the adult and childhood immunization schedule passed unanimously by the full voting group. The CDC is expected to release detailed communications to state and local health leaders in the coming days that will provide further guidance on the clinical use of the vaccine.

Find additional meeting on the ACIP meeting homepage and a summary of this meeting here.

CDC released Interim Recommendations for the Use of Pfizer BioNTech COVID-19 Vaccine on Sunday, Dec. 13, 2020.

  • ACIP issued interim recommendations, linked below, for the use of the Pfizer-BioNTech COVID-19 vaccine in persons aged ≥16 years for the prevention of COVID-19.
  • To guide deliberations regarding the vaccine, ACIP employed the Evidence to Recommendation (EtR) Framework, using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach.
  • Vaccination with the Pfizer-BioNTech COVID-19 vaccine consists of 2 doses (30 μg, 0.3 mL each) administered intramuscularly, 3 weeks apart.
  • Providers should counsel Pfizer-BioNTech COVID-19 vaccine recipients about expected systemic and local reactogenicity.
  • Adverse events that occur in a recipient after receipt of COVID-19 vaccine should be reported to the Vaccine Adverse Events Reporting System (VAERS).
  • FDA requires that vaccination providers report vaccination administration errors, serious adverse events, cases of multisystem inflammatory syndrome, and cases of COVID-19 that result in hospitalization or death after administration of COVID-19 vaccine under EUA.
  • Reporting is encouraged for any clinically significant adverse event, whether or not it is clear that a vaccine caused the adverse event.
  • Information on how to submit a report to VAERS is available at: https://vaers.hhs.gov/index.html or 1-800-822-7967.
  • In addition, CDC has developed a new, voluntary smartphone-based tool, v-safe, that uses text messaging and web surveys to provide near real-time health check-ins after patients receive COVID-19 vaccination. Information on v-safe is available at: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/vsafe.html.
  • The ACIP recommendation for the use of the Pfizer-BioNTech COVID-19 vaccine under EUA is interim and will be updated as additional information becomes available.
 
Morbidity and Mortality Weekly Report

EUA Fact Sheets
On Friday, Dec. 11, the U.S. FDA authorized the Pfizer-BioNTech COVID-19 vaccine for emergency use to permit active immunization to prevent COVID-19 in individuals 16 years of age and older. Below you will find the Emergency Use Authorization (EUA) fact sheet that should be given to everyone that receives the vaccine. Note that Michigan EUA Fact Sheet for Recipients must be provided. This version includes the information state about the Michigan Care Improvement Registry (MCIR).

We have also provided a link to the EUA fact sheet for health care providers that details vaccine use.

MDHHS Prioritization Guidance
Below you will find the link to the interim COVID-19 vaccination prioritization guidance from the Michigan Department of Health and Human Services (MDHHS). This guidance outlines the strategy for vaccine prioritization for the State of Michigan and will be used by MDHHS, as well as public health and health care, as they allocate and administer vaccines. This guidance may change as information evolves and more vaccine types become available. MDHHS is following the Centers for Disease Control and Prevention (CDC) recommendations.

CDC Communication Toolkit
CDC has developed a communication toolkit for medical centers, clinics, and clinicians. This toolkit can be used or adapted to meet your needs. It includes ready-made materials to build confidence about COVID-19 vaccination among your healthcare teams and other staff. For detailed information within the toolkit see the link below.


  • A guide for building vaccine confidence within health systems, medical offices, and clinics
  • Turn-key slide decks for healthcare personnel with information about COVID-19 vaccines, tips for building vaccine confidence, and tips for having effective vaccine conversations with patients
  • Posters, fact sheets, FAQs, and social media
  • Printable buttons/stickers for staff to wear once they have gotten their vaccine
  • A video describing how ACIP makes recommendations and advises CDC on the use of vaccines
CDC’s NEW Web Page for COVID-19 Vaccination Education
The Centers for Disease Control and Prevention (CDC) created a new webpage, which contains COVID-19 vaccination education materials. This page links to several CDC pages such as the storage and handling toolkit, vaccine administration, ACIP recommendations and more. It also has a link specific to Pfizer COVID-19 vaccine information where you can find the following:

  • BUD Guidance and Labels
  • Storage and Handling Labels
  • Vaccine Expiration Date Tracking Tool
  • Ultra-Cold Temperature Logs (both Celsius and Fahrenheit)
  • Storage and Handling Summary
  • Dry Ice Safety
 
Pfizer-BioNTech COVID-19 Important Information for Healthcare Professionals:

Pfizer recently released a website for providers that includes very detailed information on vaccine storage and handling, including videos. In addition, the site contains information on the following:

  • Safety Information
  • Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers)
  • Fact Sheet for Recipients and Caregivers
  • Full EUA Prescribing Information
  • Product Storage & Dry Ice
  • Adverse Event Reporting
MDHHS Frequently Asked Questions (FAQs)

MDHHS has developed a public FAQ on COVID-19 Vaccine with frequently asked questions for the public. It was last updated on Dec. 13.

Vaccine Packaging Images at left: Click graphic to find images of what the COVID-19 Vaccine packaging for Pfizer and Moderna will look like.
Update on Ancillary Kits
The ancillary supply kits for the Pfizer COVID-19 vaccine are beginning to arrive at sites that will be administering the vaccine. McKesson is getting questions regarding the contents of the kits.

Below, left, is the product information guide that CDC distributed to public health partners and an update from McKesson.

Below, right, is the McKesson update on the Mega Kit contents for Pfizer Vaccine. All questions related to the ancillary supply kits should be directed to McKesson customer service. Here is that contact information:

McKesson Customer Service

Pfizer Daily Webinars on Pfizer/BioNTech COVID-19 Vaccine
Pfizer will be hosting a Manufacturer COVID-19 Vaccine Training & Education Series. Webinars for Pfizer COVID-19 providers.

  • Pfizer will be holding daily webinars this week at 10 a.m. and 5 p.m. EST.
  • Providers receiving Pfizer vaccine should receive communication from Pfizer with details.
  • These webinars are a series of training sessions to review information and answer questions about their COVID-19 vaccine.
  • Please click on one of the links below to join the sessions at the designated times. 
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Upcoming Important Webinars
COCA Calls/Webinars

The CDC provides Clinician Outreach and Communication Activity (COCA) calls. COCA provides timely, accurate, and credible information to clinicians related to emergency preparedness and response and emerging public health threats. To receive updates from COCA and hear about upcoming education opportunities, sign up for emails. COCA offers several relevant and frequent webinars for clinicians. To sign up for COCA Calls/Webinars and receive future notices, visit https://emergency.cdc.gov/coca/calls/index.asp.

MDHHS COVID-19 Vaccine Webinars:

MDHHS will be hosting three webinars. A flyer was recently sent out (please at left). There is no registration needed. Please click on the attached flyer for further details and links to access the following webinars:

  • Monday, Dec. 21: An Update on the Moderna COVID-19 Vaccine
  • Tuesday, Dec. 22: Talking Points for Common COVID-19 Vaccine Concerns
Medical Management Guidance for managing a Vaccine Reaction:
Administering any medication, including vaccines, has the potential to cause an adverse reaction. When adverse reactions do occur, they can vary from minor (e.g., soreness, itching) to rare and serious (e.g., anaphylaxis). Be prepared. Vaccine providers should know how to recognize allergic reactions, including anaphylaxis.

Have a plan in place and supplies available to provide appropriate medical care should such an event occur.


**We are awaiting CDC clinical guidance and hope to have further clarification from CDC on the use of COVID-19 vaccines.
Thank you for all your hard work to protect Michiganders from vaccine-preventable diseases!

Please direct Coronavirus (COVID-19) related inquiries to the DHHS COVID-19 hotline at 1-888-535-6136. For the most up-to-date information, facts and FAQs, go to www.michigan.gov/Coronavirus