Combating the Novel Coronavirus (COVID-19): Week of Nov. 15

MHA Covid-19 update

MHA Covid-19 updateMichigan 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.

Additional information on the COVID-19 pandemic is available to members on the MHA Community Site and the MHA COVID-19 webpageQuestions on COVID-19 and infectious disease response strategies may be directed to the MDHHS Community Health Emergency Coordination Center (CHECC).

Combating the Novel Coronavirus (COVID-19): Week of Oct. 11

MHA Covid-19 update

MHA Covid-19 updateAs 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 stateSeventy-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.

Additional information on the COVID-19 pandemic is available to members on the MHA Community Site and the MHA COVID-19 webpageQuestions on COVID-19 and infectious disease response strategies may be directed to the MDHHS Community Health Emergency Coordination Center (CHECC).

Combating the Novel Coronavirus (COVID-19): Week of Sept. 20

MHA Covid-19 update

MHA COVID-19 UpdateThe 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.

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).

Combating the Novel Coronavirus (COVID-19): Week of Aug. 23

MHA Covid-19 update

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 Issues Full Approval of Pfizer COVID-19 Vaccine

The U.S. Food and Drug Administration (FDA) Aug. 23 issued full approval of the Pfizer COVID-19 vaccine for individuals 16 and older, making it the first shot to move past the emergency use authorization phase. In doing so, the FDA reviewed hundreds of thousands of pages of safety and efficacy data, reaffirming the mRNA vaccine to be highly safe and effective. The MHA issued a media statement about the approval shortly after the announcement. For children ages 12 to 15, the shot remains under emergency use authorization. Emergency authorization of this and other vaccines for anyone younger than 12 remains outstanding and could come by the end of 2021.

The required vaccine fact sheets for providers’ use have been updated and are posted to the state’s Pfizer-focused webpage.

The lack of FDA approval has been a primary talking point for individuals delaying getting their COVID-19 vaccines. The MHA is communicating with media outlets and on its social media channels about the approval and where individuals can get vaccinated, especially as children head back to school. As of Aug. 23, the rate for children ages 12 to 15 who are fully vaccinated was 30%, and the rate for children ages 16 to 19 was 39.2%.

First doses of the vaccine continue to be administered at a slow but steady pace, with Michigan having administered nearly 154,000 first doses from Aug. 1-26. Providers – especially those who see younger patients – are urged to do direct patient outreach to increase vaccination rates and ensure those who are immunocompromised get a third dose if they received an mRNA vaccine. The MHA is developing provider outreach tools for practice settings to assist with these efforts.

Members with vaccine questions may contact Ruthanne Sudderth at the MHA.

Bridge Magazine Hosting Youth Mental Health Conversation Aug. 31

Bridge Magazine, which the MHA supports as an underwriter of its Health Watch series, is hosting a free, online, one-hour conversation on youth mental health in Michigan from noon to 1 p.m. Aug. 31. MHA members are invited to participate in the online event by registering online.

The dialogue will include a description of the state of youth mental health services in Michigan as well as potential solutions for improving the availability of mental healthcare for youth and their families. Improved access to high-quality behavioral health services for Michiganders remains a top priority of the MHA, as evidenced by its proposal for an additional $125 million in the state budget dedicated to this issue. The MHA Board of Trustees held a robust discussion on behavioral health at its recent meeting, and more details on how the association will be dedicating resources to this issue are forthcoming.

Panelists for the event include Zakia Alavi, staff psychiatrist at LifeWays Community Mental Health in Jackson; Kevin Fischer, executive director of the National Alliance on Mental Illness, Michigan Chapter</a>; and Tim Michling, research associate – Health Affairs at the Citizens Research Council of Michigan. The hour-long discussion will be moderated by Bridge health reporter Robin Erb.

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 Michigan Department of Health and Human Services Community Health Emergency Coordination Center (CHECC).

MHA Statement on Full FDA Approval of Pfizer's COVID-19 Vaccine

MHA CEO Brian Peters

The following statement can be attributed to Brian Peters, CEO of the Michigan Health & Hospital Association. 

MHA CEO Brian PetersThe MHA and our member hospitals and health systems across Michigan are pleased that the FDA this morning issued full approval of the Pfizer COVID-19 vaccine. The agency reviewed hundreds of thousands of pages of safety and efficacy evidence and reaffirmed that this vaccine is extremely safe and effective at preventing COVID-19 – especially hospitalization and death. This particular vaccine is currently available for anyone aged 12 and older. Currently, a large majority of the people in Michigan hospitals with COVID are NOT fully vaccinated. We urge everyone eligible to get their vaccines – which are free and readily available through pharmacies, health departments, local clinics, health systems and more – as quickly as possible. The delta variant is quickly spreading in Michigan; we now have more than 1,000 of our neighbors and friends in hospital beds fighting this virus. Please support our healthcare workers, protect yourself and your family and stop this virus by getting your vaccine immediately and putting a mask on in public when appropriate. The evidence proves that these two simple steps work. We can beat this together.

Combating the Novel Coronavirus (COVID-19): Week of Aug. 2

MHA Covid-19 update

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.

Case Numbers Increase, MHA Members Release Consensus Statement on Vaccination

In response to the rapid spread of the COVID-19 delta variant, Michigan hospitals and health systems released a consensus statement Aug. 5 that reflects the urgent need for individuals to be vaccinated. The statement notes that currently available vaccines are effective against the delta variant and could prevent the loss of thousands more loved ones, urging people to get vaccinated now. The Detroit Free Press and MiBiz both published stories that included the statement.

As in the rest of the nation, new COVID-19 cases and hospitalizations are rising in Michigan. The state reported more than 3,960 new cases from Aug. 4-6, bringing the daily average cases to about 1,321 – far exceeding June and July daily averages. Hospitalizations for confirmed or suspected cases of COVID-19 are also slowly increasing, with 600 hospitalizations statewide, 10 of which are pediatric.

The state has indicated that roughly 90 percent of samples recently sequenced were confirmed to be the delta variant, demonstrating its rapid spread in Michigan. Nearly half the counties in the state are now urged to have residents wear masks indoors, regardless of vaccination status. 

The MHA is continuing to monitor the data and stay in close communication with state officials. Members with data questions may contact Jim Lee at the MHA.

Full FDA Approval of Pfizer Vaccine Likely to Come in Early September

The Food and Drug Administration (FDA) officials recently told media outlets that the rapid spread of the delta variant of the coronavirus has led them to commit more resources to the approval review process for the Pfizer vaccine. This is accelerating the timeline, and the vaccine is now expected to be approved by early September.

A recent national poll by the Kaiser Family Foundation found that about 30% of unvaccinated people would be more likely to get the vaccine if it were fully approved by the FDA.

Vaccination rates have increased again in recent weeks with increased spread of the virus. The country reached President Joe Biden’s goal of 70% adult vaccination Aug. 2. Although just under 64% of Michigan’s 16 and older population had received at least one dose as of Aug. 5, first doses administered in the state have increased by several thousand doses per week since July 24 compared to the several weeks prior.

The MHA does not have new information on when vaccines are expected to be authorized for children under 12 but will keep members apprised of any announcements on vaccine approval or new authorizations as they become available. Members with vaccine questions may contact Ruthanne Sudderth at the MHA.

AHA Video Highlights Back-to-school Check-ups as Opportunities for COVID-19 Vaccines

The American Hospital Association (AHA) Aug. 6 launched a video encouraging families with children 12 and older to add COVID-19 vaccinations to their back-to-school preparations. This video is part of the AHA’s continuing effort to encourage vaccine confidence. Additional resources and answers to common vaccine questions are available online.

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 Michigan Department of Health and Human Services Community Health Emergency Coordination Center (CHECC).

Combating the Novel Coronavirus (COVID-19): Weeks of May 24 and 31

MHA Covid-19 update

MHA COVID-19 UpdateWith approximately 8.4 million doses of COVID-19 vaccine administered in the state, more than 59% of Michiganders ages 16 and over have received at least one dose. Since the beginning of the pandemic, nearly 890,000 cases of the disease had been confirmed as of June 3. 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.

MIOSHA Releases New Emergency Rules for Employers, MDHHS Updates Masking Order

Gov. Gretchen Whitmer May 24 announced updates to the COVID-19 emergency rules from the Michigan Occupational Safety and Health Administration (MIOSHA) to guide employers as they allow employees to return to in-person work. She also announced an updated Michigan Department of Health and Human Services (MDHHS) COVID-19 Gatherings and Face Masks epidemic order, effective June 1.

The updated MIOSHA COVID-19 emergency rules took effect May 24 and are set to expire Oct. 14, in accordance with the MI Vacc to Normal plan and recent health guidelines and orders. Because Michigan has vaccinated more than 55% of adults, the MIOSHA removed the requirement that employers must create a “policy prohibiting in-person work for employees to the extent that their work activities can feasibly be completed remotely.” The agency has also rescinded the draft permanent COVID-19 rules and canceled the public hearing that was scheduled for May 26.

The MIOSHA has updated other aspects of the emergency rules to reflect the recent order from the MDHHS and guidance from the Centers for Disease Control and Prevention (CDC). The rules include:

  • Excessive requirements for personal protective equipment use in the healthcare setting have been removed, along with all industry-specific references.
  • Employers may allow fully vaccinated employees to not wear face coverings and social distance provided they have a policy deemed effective to ensure unvaccinated individuals continue to follow these requirements.
  • Employers should continue to have and implement a written COVID-19 preparedness and response plan in accordance with the updated rules.
  • Of note for hospitals, the emergency rules state that “fully vaccinated persons must continue to wear face coverings when in the healthcare setting where patients may be present and when using airplane or public transportation if required by the latest CDC guidance.”
  • Employers must still screen all employees and contractors daily. However, the rules state that a record of health screenings must only be maintained for unvaccinated employees.
  • Employees must maintain six feet of separation only if unvaccinated.

The MHA has identified several areas of confusion with the new rule set and is seeking a frequently asked questions document from the MIOSHA for clarification. For example, although the rules require screening all employees regardless of vaccination status, they only require record-keeping for unvaccinated employees and contractors. The MHA will apprise members of any clarifications from the administration. Members with questions on the new rules may contact Adam Carlson at the MHA.

The updated MDHHS COVID-19 Gatherings and Face Masks epidemic order eliminates outdoor capacity limits entirely and increases capacity for indoor social gatherings to 50%. Under the new order, which will be in effect from June 1 through July 1, masks will continue to be required indoors for individuals who are not yet vaccinated. MHA members are reminded that the MDHHS order regarding hospital visitation policies remains in effect. That order requires health screenings for visitors entering healthcare facilities, among other things.

MDHHS Cautions Providers Regarding False COVID-19 Vaccine Cards

The MDHHS distributed an alert May 27 urging healthcare providers to watch for false vaccine cards/records. The department has received reports of individuals selling false COVID-19 vaccination record cards that may be presented at provider offices, local health departments and other vaccination locations. It has also received reports of blank copies of the CDC COVID-19 Immunization Record cards in circulation, which provides opportunities for entering false information.

These activities make it even more important that providers verify an individual’s immunization status in the Michigan Care Improvement Registry (MCIR) prior to vaccine administration. Accessing the MCIR record ensures the correct immunization status is available and allows providers to verify whether the person has received a dose of COVID-19 vaccine. Out-of-state COVID-19 vaccination record cards should be reviewed for completeness and to ensure that the doses are accurate before entering the information into the MCIR.

Some important points to keep in mind while reviewing the COVID-19 vaccination record card include:

  • Review the record in the MCIR to compare immunization data.
  • Look for completeness of COVID-19 vaccine information.
  • Review vaccinator information.
  • Look for any abnormalities such as alterations to the text or documentation on the card.
  • If the vaccination location is listed on the vaccine record card, verify with the facility that the vaccine was administered there. The facility may wish to follow up with its legal counsel if it is determined to be a false record.
  • If given the opportunity, attempt to learn where the person obtained the card. Any false information found should be reported to local law enforcement.
  • If given the opportunity, make a copy of the card. When the COVID-19 vaccination record is handed to a COVID-19 vaccine provider, it becomes part of the medical appointment and, thus, part of the appointment documentation, including the potential falsification of immunization documentation.

All COVID-19 vaccine providers and medical professionals must report any false medical information as soon as possible. An FBI Public Service Announcement was issued in March alerting the public that selling false COVID-19 vaccination record cards is illegal.

The MDHHS also has related resources available in the MCIR:

Pfizer Vaccine Now Available in 450-Dose Minimum Orders

The Pfizer COVID-19 vaccine is now available in shipments of 450 doses, while the 1,170-dose shipment will continue to be available. Both options were expected to be available for Michigan COVID-19 vaccine providers to order through the MCIR by May 28.

Healthcare providers are encouraged to review the following information regarding the new 450-dose shipment quantities:

  • The new 450-dose packs include three trays of 25 vials each (75 vials total).
  • Vials will be shipped in the same thermal shipping container as the 1,170-dose orders and will include the same Controlant temperature monitor.
  • There will be no dry ice replenishment (shipped 24 hours after receipt) for the 450-dose pack.
  • The newly extended refrigerator storage temperatures should decrease the need for dry ice. Therefore, Pfizer asks that the thermal shipping containers and Controlant monitors be returned within 10 days. For storage and handling guidance, including the updated refrigerator storage timeframe, see the CDC’s Pfizer-BioNTech Storage & Handling Summary.
  • The Product Information Guide has been updated with this configuration, National Drug Code information, dimensions and more.

New ancillary kits have been created to support the 450-dose minimum order size. A complete list of the items in the kits is available on page 12 of the Product Information Guide.

Questions about these ordering guidelines and ancillary kits should be directed to the MDHHS immunizations team. Members with other vaccine questions may contact Ruthanne Sudderth at the MHA.

June 14 COVID-19 Summit to Review Mi-COVID19 Data Registry Findings

In continued partnership with the Michigan Hospital Medicine Safety Consortium, the MHA and the Michigan Chapter of the Society for Critical Care Medicine will host a virtual COVID-19 Summit following up on the Mi-COVID19 webinar series. The COVID-19 Summit will be held virtually from 9 to 11 a.m. June 14.

This summit will share key findings and crucial lessons learned from the Mi-COVID19 data registry and review the current state of COVID-19 in Michigan. The MHA will lead a session dedicated to public policy in pandemics. More information is available in the event’s agenda.

Anyone involved with caring for patients with COVID-19 is welcome to attend. Registration for the COVID-19 Summit is available at no cost to MHA members. Questions about the event should be directed to Josh Suire 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).

Combating the Novel Coronavirus (COVID-19): Week of May 3

MHA Covid-19 update

MHA Coronavirus UpdateAs of May 6, more than 7.2 million doses of COVID-19 vaccine have been administered in Michigan, and more than 51% of Michigan adults have received at least one dose of a vaccine. 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.

Pediatric, Primary Care Providers Should Prepare to Give Adolescent Vaccinations

The Food and Drug Administration (FDA) is expected to issue an emergency use authorization (EUA) to administer the Pfizer vaccine to children ages 12-15 as early as the week of May 10. Pediatric and primary care settings that wish to participate in the vaccine program are encouraged to enroll as soon as possible to ensure they are prepared to appropriately receive, store, track and administer vaccines for adolescents.

In response to this impending expansion, the Michigan Department of Health and Human Services (MDHHS) announced it has designated “Pfizer Regional Hubs” across the state to support efforts to make the vaccine available to 12- to 15-year-olds. These local health departments will maintain stock of Pfizer vaccine to share with COVID-19 vaccine providers that can manage it appropriately. Hospitals that need the Pfizer vaccine to offer to Michiganders ages 12 through 17 may request a supply from the Immunization Action Plan Coordinator at these hubs, which include:

  1. Grand Traverse Health Department
  2. Ingham County Health Department
  3. Kalamazoo Health Department
  4. Kent County Health Department (Fuller)
  5. Marquette Health Department
  6. Oakland Health Division
  7. Saginaw County Health Department
  8. Sanilac County Health Department
  9. Wayne County Health Department

It is the requestor’s responsibility to contact the regional hub to assess vaccine availability and to perform appropriate transport of vaccine for redistribution. Contact information for all local health departments is available online. The requestor is also responsible for ensuring the site is enrolled as a Michigan COVID-19 Vaccination Provider; has a redistribution agreement in place with the regional hub; and can meet all requirements for vaccine transport, storage, handling and documentation.

The MHA will keep members apprised of developments on the expansion of the Pfizer vaccine EUA. Vaccine-related questions may be directed to Ruthanne Sudderth at the MHA.

Medicare Payments Increased for mAb Therapies

The Centers for Medicare & Medicaid Services (CMS) recently announced an increase in the Medicare payment rate for administering monoclonal antibody (mAb) treatment to COVID-19 patients, effective May 6. The payment rate will increase 45%, from $310 to $450, for most healthcare settings. The CMS will also establish a $750 payment rate for this service when administered in the patient’s home or other temporary residence. Patients will incur no out-of-pocket cost for these services. Members with questions about these payments may contact Jason Jorkasky at the MHA.

A recording of a recent webinar explaining the operational processes required to provide mAb therapy is available online. Cohosted by the MHA and the MDHHS, the hour-long webinar reviewed a variety of resources for providers interested in providing the treatments. To receive copies of these documents, contact Laura Appel at the MHA.

Pfizer, Moderna Seek Full FDA Approval of Their COVID-19 Vaccines

Pfizer has asked the FDA for full approval of its COVID-19 vaccine for people ages 16 and over, which would allow the manufacturer to market the vaccine directly to the public. Pfizer is now studying the vaccine in children as young as 6 months and has said it expects more results from these studies by September.

According to news reports, Pfizer has shared data with the FDA about the vaccine's long-term effectiveness and possible changes in handling requirements, such as evidence that the vaccine can be refrigerated for longer periods, rather than requiring ultra-cold storage temperatures.

Moderna has also requested full FDA approval of its vaccine, which is currently approved for ages 18 and older. It is currently studying the vaccine in 12- to 17-year-olds. In addition, Moderna has shared promising updates from its study of a booster of its vaccine to help prevent some of the most contagious variants of the virus.

While FDA approval reviews typically take six months or more, the agency could act quickly on approving the vaccines, since they had already received emergency authorization. The MHA will keep members apprised of this issue as it develops. For more information on vaccines, 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).

Combating the Novel Coronavirus (COVID-19): Week of April 12

MHA Covid-19 update

A somber milestone was reached April 17 when, according to Johns Hopkins University data, the global number of deaths caused by COVID-19 surpassed 3 million. 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.

MHA Board of Trustees Focuses on COVID-19 Data, Vaccines

The MHA Board of Trustees held a virtual meeting April 14, where much of the agenda focused on COVID-19 as the spring surge continues to challenge Michigan communities and health system resources (see related article). Board members heard presentations on hospitalization and other surge-related COVID-19 data, which may be starting to show signs of improvement as growth rates and emergency department visit rates begin to slow and plateau. Despite these encouraging signs, healthcare providers must continue to urge their communities to stay vigilant in preventive actions.

Board members also discussed vaccine-related issues, including the Johnson & Johnson pause and how it may impact conversations around equity, hesitancy, safety/effectiveness and more. They also discussed efforts health systems can pursue to encourage as many employees as possible to be voluntarily vaccinated. For more information on the board meeting, contact Amy Barkholz at the MHA.

Board members also met April 12 via Zoom with U.S. Sen. Gary Peters (D-West Bloomfield), who expressed interest in the experience of hospitals and health systems during the current surge of infection. Members shared the damage the pandemic has done to staffing capacity by causing exhaustion and early retirements; the need for post-COVID-19 care for brain health including seizures, anxiety and depression; and the younger average age of hospitalized patients. Peters announced his Committee on Homeland Security and Governmental Affairs is doing a complete after-action study of the COVID-19 pandemic to improve preparedness and communications for future long-term crises. For more information about federal advocacy and policy, members may contact Laura Appel at the MHA.

J&J Vaccine Paused While Investigation Continues on Six Blood Clot Events

The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA), out of an abundance of caution, issued a statement April 13 that providers should halt administration of Johnson & Johnson (J&J) COVID-19 vaccines while they investigate six instances of blood clots in previously vaccinated individuals. More than 6.8 million J&J vaccines have been administered to date nationally, meaning these instances are extremely rare. All those affected were women between the ages of 18 and 48, and their symptoms developed six to 13 days after vaccination.

The CDC Advisory Committee on Immunization Practices (ACIP) met April 14 to discuss and review these incidents and, after several hours of debate, concluded that it would take additional time to review the cases and make a final recommendation for continued use of the vaccine. A decision is expected by the end of April.

Because the ACIP is an advisory committee, it is permissible, but highly unlikely, that the CDC and FDA would advise providers to resume use of the vaccine without a new recommendation from the ACIP. In the meantime, providers should continue to only use Pfizer and Moderna vaccines, and store/label J&J vaccines as instructed by recent alerts from the Michigan Department of Health and Human Services (MDHHS). The department stated, in part, “Clinics that are scheduled to administer J and J vaccine should be rescheduled to use a different vaccine. If you have inventory of this vaccine, please separate in your storage unit, mark do not use and store appropriately until further notice.”

The MHA will keep members apprised of recommendations as they become available. Members with questions on vaccines may contact Ruthanne Sudderth at the MHA.

Pfizer Requests Emergency Use Authorization for Younger Children

Pfizer recently asked the FDA to grant expanded emergency use authorization (EUA) of its COVID-19 vaccine for use in adolescents between the ages of 12 and 15. The request is based on data from Pfizer’s late-stage trial of the vaccine in children in this age group with or without prior evidence of COVID-19 infection, which demonstrated 100% efficacy and robust antibody response after vaccination.

The participants tolerated the vaccine with the incidence of side effects similar to adults, and Pfizer continues to monitor these adolescents. The company is also confident the vaccine will deliver long-term protection for as long as two years after the completion of dosage, although currently available data supports at least six months of protection. Since the vaccine is currently allowed to be used for anyone ages 16 and older, young Michiganders are urged to get vaccinated with the Pfizer vaccine as quickly as possible to prevent further spread among this age group, as well as illness, hospitalization and death.

Given the speed at which the expanded EUA could take effect, making 12- to 15-year-olds eligible for vaccination, health systems are encouraged to educate their family practice/pediatric care settings on administration of the Pfizer vaccine. The MHA will work with the Michigan Association of Family Physicians and the Michigan Chapter of the American Association of Pediatrics to coordinate messaging and resources. Members with vaccine questions may contact Ruthanne Sudderth at the MHA.

FDA Recommends Moving Away from Decontaminated N95 Respirators

The FDA recently issued guidance recommending that healthcare personnel and facilities transition away from crisis capacity conservation strategies for N95 respirators. Due to an increased supply of respirators approved by the National Institute for Occupational Safety and Health, the FDA believes there is a sufficient domestic supply to allow organizations to transition away from decontamination or bioburden reduction and reuse of respirators intended as single-use items. The guidance does not specify a “days on hand” calculation for when the recommendations should be implemented; it simply references moving away from the crisis capacity strategy.

To date, the Michigan Occupational Safety and Health Administration (MIOSHA) has not issued guidance or statements on how it will interpret this FDA letter in Michigan. The MHA will continue to advocate with state leaders for organizational flexibility in determining their supply needs and crisis capacity strategies.

Organizations that have concerns about their supply of personal protective equipment (PPE) should contact the appropriate Regional Health Care Coalition. Members with questions or concerns on PPE may also contact Adam Carlson at the MHA.

MIOSHA Issues Permanent COVID-19 Workplace Rules

The MIOSHA released draft rules that would make permanent workplace regulations governing the use of PPE, physical distancing, contact tracing and other pandemic-related modifications. The MHA participated in a work group on the development of the permanent rules, but its suggestions to allow the rules to be flexible for updated CDC guidelines and to set an end date to the rules were not adopted in the draft rule set. The association followed up by submitting its recommendations to the MIOSHA in writing.

Emergency rules already in place on this topic were slated to expire April 14 and are expected to be extended to Oct. 14, 2021. The MHA hosted a webinar in December on that rule set for members, and the association will review the renewed emergency rules when they are available. The MHA will compile additional recommended changes to the permanent rule set prior to a public hearing being scheduled. Members with questions on the emergency or permanent MIOSHA rules may contact Adam Carlson 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).

Combating the Novel Coronavirus (COVID-19): Week of Jan. 18

MHA Covid-19 update

Among the many actions President Joseph R. Biden took on his first day in office Jan. 20 was creating a White House COVID-19 response team to coordinate federal and state efforts to fight the pandemic. With this and other expected action by the new administration, the state of Michigan anticipates improvements in the production, distribution and operations for the COVID-19 vaccine. As the battle against the evolving virus continues, the MHA keeps members apprised of pandemic-related developments affecting hospitals through email updates and the MHA Coronavirus webpage. Important updates are outlined below.

Updates Provided as Vaccines Administration Continues

President Biden has indicated he will immediately be activating the federal Defense Production Act to significantly increase the supply of vaccine available to Americans. Gov. Gretchen Whitmer’s administration is working closely with the Biden team to increase Michigan’s weekly allocation of vaccine as soon as possible. The state is mapping details on how to support each of Biden’s points and how this plan can support Michigan’s plan to administer 50,000 or more shots per day.

The U.S. Department of Health and Human Services notified the Michigan Department of Health and Human Services (MDHHS) Jan. 20 that modified vaccine supply kits would begin being included that week with the shipments of the Pfizer vaccine to assist in administering the potential sixth dose of vaccine from vials originally labeled for five doses. In January, the Food and Drug Administration amended the emergency use authorization to reflect the additional dose, and McKesson increased the individual Pfizer ancillary kit contents from a kit that supported 975 doses to a kit supporting 1,170 doses. Members with vaccination supply chain questions can contact Adam Carlson or Rob Wood at the MHA.

The MDHHS is working toward using the Centers for Disease Control & Prevention (CDC) Social Vulnerability Index to identify areas and individuals in Michigan that may have less access to COVID-19 vaccine. The department will be encouraging vaccinating providers to use this data to find and vaccinate these individuals and communities. This work is in the early stages, and updates will be provided during the biweekly MDHHS calls with providers. The MHA will provide details on how to reach vulnerable individuals and communities as they become available.

The MHA will conduct a members-only event from 11 a.m. to noon Jan. 29 for an in-depth discussion on the status of COVID-19 vaccine distribution, coordination, coverage, communication and more. Members will receive participation information prior to the event.

In addition, the association (@MIHospitalAssoc) will host a Twitter chat from 1 to 2 p.m. Jan. 28 to inform Michiganders about the COVID-19 vaccine and promote to the public and media the excellent work of hospitals and health systems in leading this effort. The goal of the virtual conversation is to answer frequently asked questions and give hospitals an opportunity to share their experiences and resources related to the COVID-19 vaccine all in one place. Members may preview the chat questions, and those with Twitter accounts are encouraged to join the event to share about hospitals’ role in Michigan’s COVID-19 vaccine effort and be a source of trusted information about the vaccine itself. Members are asked to confirm their participation with Lucy Ciaramitaro at the MHA by Jan. 26.

Local health departments use an online registry to recruit volunteers for COVID-19 vaccine clinics. Vaccine volunteers do not necessarily need to be licensed health professionals, but do need to complete all training to ensure they can appropriately educate, administer, prepare, handle and report vaccine. Anyone interested in volunteering to assist in vaccine administration is encouraged to register. Training materials are available on both the MDHHS and CDC websites.

Members with vaccine questions may contact Ruthanne Sudderth at the MHA.

MDHHS Issues Updated List of COVID-19 Relief Facilities

The MDHHS issued an updated list of COVID Relief Facilities (CRFs), such as nursing homes and rehab facilities, approved to admit and accept transfers of individuals who remain subject to Transmission Based Precautions for COVID-19. The MDHHS will issue its next updated list the week of Feb. 1.

The CRF designation is defined as part of Public Act 231 of 2020. These facilities may care for COVID-19-positive residents of nursing facilities by retaining or admitting those residents. An appropriate CRF resident is a COVID-19-positive person who does not need the acute-care hospital level of services.

CRFs are designed to care for COVID-19-positive residents in-place with enhanced infection control measures for individuals who have not met criteria for discontinuing Transmission-Based Precautions and have limited access to the state’s Care and Recovery Centers. All CRFs may retain or readmit their own residents. Facilities that meet enhanced requirements may receive new admissions from other facilities or hospital discharges. Many other CRFs can retain their own residents even if they become COVID-19-positive. To request a copy of the list of CRFs accepting new admissions, contact Erin Emerson at the MDHHS. For more information on these facilities, contact Kelsey Ostergren 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).