The number of confirmed COVID-19 cases in Michigan since the beginning of the pandemic surpassed 1 million Sept. 20 and has continued to rise, hitting 1,008,069 by Sept. 24. Hospitalizations due to confirmed COVID-19 cases in the state have increased from 1,356 adults and 17 children Sept. 17 to 1,467 adults and 27 children Sept. 24. The percentage of Michiganders ages 16 and above who have received at least one dose of a COVID-19 vaccine has risen slowly in recent weeks to 67.4% as of Sept. 24.
The MHA continues to keep members apprised of pandemic-related developments affecting hospitals through email updates and the MHA Coronavirus webpage. Important updates are outlined below.
Weekly Allocation Model Set for Monoclonal Antibody Therapy
According to an alert shared Sept. 21 by the Michigan Department of Health and Human Services (MDHHS), the U.S. Department of Health and Human Services (HHS) has announced it will transition to a weekly allocation strategy for the distribution of monoclonal antibody therapy. The direct ordering feature through AmerisourceBergen has been suspended and will no longer accept orders. Sites that are actively administering monoclonal antibody therapy and need resupply must complete the updated mAb Allocation Request Form in its entirety. The form should be obtained from the MDHHS and submitted to the same address by noon ET each Wednesday to be considered to receive a supply. Submitting sites will be informed of approved product type and quantities upon review.
All sites requesting supply will be required to comply with the following data collection tools. Accurate utilization and inventory data will not only inform the MDHHS allocations and decision making, it will also impact allocations being made at the federal level.
- EMResource (hospitals and healthcare systems): Questions should be directed to the MDHHS Community Health Emergency Coordination Center.
- HHS-Protect TeleTracking (all sites, unless a hospital/healthcare system has elected for passthrough feature via EMResource): Questions should be directed to the HHS Protect Service Desk or the TeleTracking Technical Support team.
- MDHHS Patient Profile Forms: Monoclonal Antibody Therapy – Patient Profile (Revised 8/23/2021).
The alert also contained information on redistribution of excess supplies of either of the approved monoclonal antibody therapy products, as well as the following topics.
- Importance of Racial Equity and Monoclonal Antibody Therapy.
- Emergency Use Authorization for Bamlanivimab + Etesevimab Expanded to Include Post-Exposure Prophylaxis.
- Guidelines on Subcutaneous Administration of REGEN-COV Monoclonal Antibody Therapy.
- Public Readiness and Emergency Preparedness Act Declaration: 9th Amendment.
- U.S. Food and Drug Administration (FDA) Authorizes Shelf-Life Extension for Bamlanivimab.
MHA members may contact Ruthanne Sudderth at the MHA for more information.
Federal Agencies Grant Full Approval for Booster Shots for Older and At-risk Americans
The FDA and the Centers for Disease Control and Prevention (CDC) completed the approval processes for providing Pfizer COVID-19 booster shots Sept. 24, authorizing them for people aged 65 and older, long-term care facility residents, people aged 18-64 years old with underlying medical conditions that raise their chances of severe COVID-19, and people at risk because of on-the-job exposure, including healthcare workers.
The FDA earlier officially accepted the recommendations of its independent review panel, which voted to approve the extra shot of Pfizer. The CDC’s Advisory Committee on Immunization Practices (ACIP) voted Sept. 23 to recommend the Pfizer booster, but voted against allowing the booster for those at risk because of on-the-job exposure, which differed from the FDA’s decision Wednesday to allow the booster for people with high-risk jobs. However, the CDC Director made the rare decision to contradict the ACIP’s recommendation and endorsed the use of Pfizer COVID-19 booster shots for workers at high risk of severe COVID-19, while formally accepting the remaining recommendations of ACIP for people 65 and older, nursing-home residents and people between 18 and 64 with underlying health conditions.
The CDC stated that providers may administer the booster dose of Pfizer to previous recipients of the Pfizer two-dose series who qualify (by age or health/risk status). The booster dose shouldn’t be administered until at least six months have passed since the recipient completed the two-dose primary series. Healthcare workers do qualify based on their regular exposure to the virus. There is no specific definition of healthcare worker in the authorization. Healthcare organizations and facilities have discretion to determine who in their settings should be able to receive the booster.
At this time, no other brand of vaccine is approved for an additional dose, though that is likely to change in the months ahead as more data becomes available.
The MDHHS has advised that health systems/hospitals should work to provide the booster to their own employees and to their patients to whatever degree is possible. Members should watch for MI Health Alert Network communications in the coming days for more information about the rollout of these Pfizer doses. Members can also regularly check the CDC’s Pfizer website for updated clinical information about the booster and the administration of these doses.
Members with vaccine questions may contact Ruthanne Sudderth at the MHA.
Additional information on the COVID-19 pandemic is available to members on the MHA Community Site and the MHA COVID-19 webpage. Questions on COVID-19 and infectious disease response strategies may be directed to the MDHHS Community Health Emergency Coordination Center (CHECC).