As of June 22, there were 714 adults and 27 children in Michigan with confirmed or suspected cases of COVID-19, with new cases averaging 1,780 per day the previous week. Over 100 hospitalized adults were being cared for in intensive care units. According to the state’s vaccine tracker, 67.4% of Michigan residents had received at least one dose of a COVID-19 vaccine as of June 22.
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.
Children Ages Six Months Through Five Years Eligible for COVID-19 Vaccine
The Michigan Department of Health and Human Services (MDHHS) announced June 21 that all Michiganders ages six months and up are now eligible for a COVID-19 vaccine. The pediatric vaccine, which received emergency use authorization for this age group from the Food and Drug Administration, was recommended by the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices June 18. The MHA released a media statement following the CDC recommendation, which makes 500,000 more Michigan children eligible for vaccination.
The MDHHS is recommending providers begin vaccinating children ages six months and older as soon as possible. The Moderna series is two doses given 28 days apart for ages six months through five years. For children six months of age through four years, the Pfizer series is three doses, with the first two given three weeks apart and the third dose administered at least eight weeks after the second dose. For ages five and older, the Pfizer series is two doses given 21 days apart.
The current surge of hospitalizations due to COVID-19 has continued its downward trend. The seven-day average of hospitalizations in the U.S. as of Feb. 13 was 80,185, down from 136,534 Jan. 20. Michigan hospitalizations for confirmed and suspected cases of COVID-19 included 1,896 adults and 71 children as of Feb. 16, down from the Jan. 20 totals of 4,554 adults and 130 children.
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.
Governor Signs Supplemental Budget Dedicating $300 Million to Healthcare Workforce
Gov. Gretchen Whitmer Feb. 16 signed House Bill 5523, a $1.2 billion supplemental funding bill that includes$300 million for healthcare providers for recruitment, retention and training purposes, $225 million of which will be specifically for acute-care and behavioral health hospitals. MHA Board Chair and BHSH System President & CEO Tina Freese Decker provided comments of appreciation for the governor signing the bill in the official announcement. (See related article.)
MDHHS Rescinds Indoor Mask Advisory with Exceptions
The statewide indoor masking advisory that the Michigan Department of Health and Human Services (MDHHS) issued earlier in the omicron surge was rescinded Feb. 16. However, the state continues to recommend masking in healthcare settings and some other high-risk indoor locations.
While hospitalizations have improved significantly recently, the MHA continues to encourage people to voluntarily wear high-quality masks when in indoor public spaces, especially if they are immunocompromised or haven’t yet been fully vaccinated.
The state also announced that it will monitor and act on COVID-19 cycles in the following three key phases:
Response — Local and state public health implement rapid response to a surge. The public may be advised to increase masking, testing and social distancing.
Recovery — Post-surge. No immediate resurgence predicted. Local and state public health will monitor conditions that could lead to future surges.
Readiness — A surge in cases is expected, with implications for severity of illness and hospital capacity. Increased communication to the public regarding possible new risks.
More Data Sought on Pfizer Vaccine for Children 6 Months through 4 Years
The MHA continues to monitor Pfizer’s actions to seek approval for a vaccine for kids aged 6 months through 4 years. Pfizer recently sought federal approval of the vaccine for this age group, but paused its request days later due to efficacy questions related to dosage. It is now awaiting further data about three doses for this age group before renewing its request for approval under emergency use authorization. The association will keep members apprised of any developments on this or related issues. Members with vaccine questions may contact Ruthanne Sudderth at the MHA.
Michigan is once again among the states with the highest numbers of COVID-19 cases in the nation, with the New York Times reporting that Michigan and Minnesota lead the country in cases per capita. On Nov. 19, there were 3,424 adults hospitalized with confirmed cases of COVID-19, in addition to 50 children. Meanwhile, 60.3% of Michiganders aged 5 and older had been fully vaccinated as of Nov. 19.
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.
FDA Amends EUA to Allow Booster Shots to Fully Vaccinated People Aged 18 and Up
The Food and Drug Administration (FDA) amended the COVID-19 vaccine emergency use authorizations (EUAs) Nov. 19 to allow all individuals 18 years of age and older to receive booster shots of both the Pfizer and Moderna vaccines. The Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) was scheduled to meet later that day to discuss additional clinical recommendations.
In its news release, the FDA said the expanded authorization for the booster doses is based on its analysis of immune response data that supported use in the previously authorized populations for boosters. Groups previously included in the EUAs were fully vaccinated individuals who are 65 years of age and older and who are 18 through 64 years of age at high risk of severe COVID-19 and/or experience frequent exposure to the coronavirus through living situations or workplaces.
Prior to the FDA announcement, Gov. Gretchen Whitmer encouraged residents to plan to get the booster doses as soon as they are authorized. The governor noted that more than a million booster doses have been administered within the state and urged everyone to get vaccinated and receive the booster shot.
Booster doses should be administered at least six months after the second dose of either the Pfizer or Moderna vaccine and at least two months following the single-dose Johnson & Johnson vaccine. Updated information for both the Pfizer and Moderna vaccines are available on the FDA website that provide details on the booster shots.
Members with questions on vaccines may contact Ruthanne Sudderth at the MHA.
MDHHS Announces Face Mask Advisory for Holiday Season
As both COVID-19 and influenza cases rise throughout the state, the Michigan Department of Health and Human Services (MDHHS) will issue a face mask advisory and offer guidance to prevent the spread of respiratory diseases during the holidays.
The department’s news release indicates it recommends everyone over the age of 2 wear a face mask at indoor gatherings regardless of their vaccination status. Establishments are also urged to implement policies to ensure that customers, employees and visitors wear masks. The advisory will remain in effect until further notice.
During a Nov. 19 news conference, MDHHS Director Elizabeth Hertel, Chief Medical Executive Natasha Bagdasarian, MD, and others also urged Michigan residents to get vaccinated against COVID-19 and the flu as soon as possible. The two vaccines can be administered simultaneously. Darryl Elmouchi, MD, MBA, president of Spectrum Health West Michigan, shared information about the unprecedented numbers of patients hospitals are seeing. He said Spectrum Health has 370 patients hospitalized with COVID-19, 86% of whom are unvaccinated against the disease.
As federal regulatory agencies evaluate COVID-19 vaccine and treatment possibilities, more than 5.5 million Michigan residents ages 16 and older have received at least one dose of a vaccine to protect them against the deadly disease, equating to 68.2% of that population as of Oct. 15. Meanwhile, despite the rate of new cases decreasing in many of the states that had been experiencing a surge in hospitalizations and deaths, cases in Michigan have been increasing. Nearly 8,300 new cases were reported for Oct. 14 and 15, with 2,010 adults and 29 children hospitalized in the state Oct. 15. Total deaths in Michigan attributed to confirmed cases of COVID-19 reached 21,563 Oct. 15.
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.
Moderna Expiration Date Extended for Frozen Vaccines
The Michigan Department of Health & Human Services (MDHHS) announced Oct. 13 that Moderna received approval for a two-month extension of FROZEN Moderna COVID-19 vaccine. Some lots with an initial expiration of September or October will be extended if stored in frozen state. Seventy-eight lots are impacted by this extension.
The MDHHS does not have a list of these lot numbers, but Moderna is working diligently to get the extended lots updated in their tools and databases, with a priority on older lots first. To look up Moderna expiration, scan the QR code located on the carton or use the company’s expiration date lookup feature on its website. Healthcare providers are encouraged to continue checking these resources to determine whether they have lots that are impacted by this extension. Moderna vaccine should not be disposed of until an accurate expiration date is assessed.
Providers who have vaccines that are unexpired under the extension should update their outbreak inventory in the Michigan Care Improvement Registry (MCIR) with a new expiration date, following the instructions on the tip sheet How to Correct a COVID-19 Vaccine Expiration Date in the MCIR. Questions about the extension or the MCIR process can be directed to the MDHHS Division of Immunization team. Members with other vaccine-related questions may contact Ruthanne Sudderth at the MHA.
Merck Requests FDA Approval for COVID-19 Treatment Pill
Merck formally requested approval from the U.S. Food and Drug Administration (FDA) Oct. 13 for a groundbreaking antiviral medication that effectively treats COVID-19. Trials demonstrate the treatment regimen, which comes in pill form that patients can take themselves at home, reduced risk of hospitalization and severe illness by at least 50%.
Approval would add a new effective treatment to providers’ toolboxes in keeping patients with COVID-19 out of the hospital. Unlike currently available antibody treatments that require providers to set up and staff infusion clinics, the pill could help provide relief to providers struggling with staffing and other treatment resources. If approved, the MHA will advocate that all payers, both public and private, cover the drug for all covered lives.
The MHA will keep members apprised of developments on this issue.
CDC Releases Planning Information for Vaccinating 5- to 11-year-olds
The Centers for Disease Control and Prevention (CDC) recently issued an initial planning document for jurisdictions to prepare for the distribution of vaccines for children ages 5 to 11. The document provides initial information pertaining to pediatric COVID-19 vaccines, as well as several assumptions that can be made about the pediatric COVID-19 vaccination program. Specifically, the document highlights the packaging changes and storage requirements for the Pfizer pediatric COVID-19 vaccine for kids ages 5 to 11. The Pfizer vaccine for this age group is currently under review at the FDA, and a decision on whether an emergency use authorization (EUA) for the product will be granted is expected in the coming weeks.
Ordering of the Pfizer vaccine and any subsequent pediatric COVID-19 vaccines will begin when the FDA issues an EUA. Vaccine administration will begin once the CDC director makes a determination after reviewing recommendations from the Advisory Committee on Immunization Practices. The MHA will keep members apprised of developments on the vaccine for younger children. Members with questions may contact Ruthanne Sudderth at the MHA.
U.S. Homeland Security & Governmental Affairs Committee Requests Provider Input
Sen. Gary Peters (D-MI), chairman of the Committee on Homeland Security & Governmental Affairs, and the committee’s ranking member Sen. Rob Portman (R-OH) are seeking firsthand accounts from individuals and organizations (healthcare providers, state and local governments, first responders, etc.) who experienced challenges securing personal protective equipment and other medical products during the early months of the COVID-19 pandemic. Currently, the committee request is open-ended.
This is part of the committee’s ongoing oversight of federal pandemic preparedness and the COVID-19 response. The committee will examine reports of fraud, exploitation, and faulty equipment and medical supplies. To this end, providers can report issues about vendors, counterfeit medical products, price-gouging or other challenges obtaining supplies during the response. The information received will help inform the senators’ bipartisan oversight and efforts to strengthen U.S. medical supply chains, improve emergency preparedness, highlight new and successful supply chain methods, and prevent bad actors from taking advantage of future national crises. Members interested in submitting their experiences can do so online.
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.
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.
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.