Combating the Novel Coronavirus (COVID-19): Week of May 17

MHA Covid-19 update

MHA COVID-19 UpdateAs of May 20, the Michigan Vacc to Normal Tracker indicated more than 57% of Michiganders ages 16 and over had been given at least one dose of a COVID-19 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.

MHA Board of Trustees Holds Special Meeting on COVID-19

At a special meeting on COVID-19 issues held May 18, the MHA Board of Trustees received updates on and discussed COVID-19 case data and trends, vaccine progress, return-to-work policies, state budget matters and health equity commitments. Board members confirmed the need for the MHA to continue advocating for clear and consistent public health rules related to mask wearing and vaccine status, especially for healthcare facilities, and remain heavily engaged in the promotion of COVID-19 vaccines.

On the issue of return to work, the MHA is in communication with both the Michigan Department of Health and Human Services (MDHHS) and the Michigan Occupational Safety and Health Administration (MIOSHA) about the need for prompt guidance that considers health facilities as it relates to gathering sizes, mask wearing and more. The MIOSHA has stated it is working on updated emergency rules to reflect new federal mask-wearing guidance, but said until then, “MIOSHA will consider compliance with the MDHHS order as good faith to comply when responding to employee complaints or conducting investigations related to COVID-19.” The MHA will keep members informed of progress on the return-to-work rules.

The next MHA Board of Trustees meeting will occur June 23, the day prior to the 2021 MHA Annual Membership Meeting. Members with questions about the Annual Meeting may contact Erin Steward at the MHA.

State to Reopen Faster than Original “Vacc to Normal” Plan

Gov. Gretchen Whitmer May 20 announced modifications to the recently implemented Vacc to Normal campaign that ties reopening measures to the state’s vaccination rate, providing specific dates for increasing capacity limits. Starting June 1, capacity limits will be lifted completely for outdoor gatherings and indoor capacity limits will be increased to 50%. As of July 1, the state’s broad indoor masking requirement will expire. The announcements did not specifically address healthcare; the MHA continues to advocate strongly for healthcare settings involved in patient care to be given special consideration in the crafting of the MIOSHA rules. MDHHS Director Elizabeth Hertel is expected to sign the order May 24.

The MHA will notify members know as soon as the MIOSHA issues new guidance. Members with questions may contact Adam Carlson at the MHA.

Vaccine Orders Must Comply with Shipping Timelines; No Memorial Day Shipments

The MDHHS immunizations team recently reminded healthcare providers to observe the Centers for Disease Control and Prevention’s stated shipping hours when ordering first and second doses of COVID-19 vaccine through the Michigan Care Improvement Registry (MCIR). Beginning May 24, the MDHHS will reject any orders with noncompliant shipping hours. Questions on this requirement may be addressed to the immunizations team.

The MDHHS announced there will be no vaccines shipped May 31 due to the Memorial Day holiday. Healthcare providers should take the following schedule into consideration for their vaccination planning efforts.

  • Pfizer Vaccine: No vaccine deliveries will occur Monday, May 31.
  • Moderna Vaccine: No vaccine deliveries will occur Monday, May 31, or Tuesday, June 1. (Ancillary kits may arrive June 1 for vaccine orders arriving Wednesday, June 2.)
  • Johnson & Johnson (J&J) Vaccine: No vaccine deliveries will occur Monday, May 31, or Tuesday, June 1. (Ancillary kits may arrive Tuesday, June 1, for vaccine orders arriving Wednesday, June 2.)

Providers needing to place vaccine orders for clinics scheduled during the holiday weekend must ensure the orders are entered into the MCIR, approved by the local health department and approved/processed by the MDHHS by Tuesday, May 25, for the Pfizer vaccine and by Wednesday, May 26, for the Moderna or J&J vaccines. Questions about these ordering requirements should be directed to the MDHHS immunizations team.

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

FDA Updates Certain COVID-19 Monoclonal Antibody Authorizations

The Food and Drug Administration (FDA) recently updated its emergency use authorizations for two intravenous infusion therapies for outpatients at risk for progressing to severe COVID-19 disease. Included were updates on the patient selection criteria and safety summary for the monoclonal antibodies bamlanivimab and etesevimab administered together and the patient selection criteria for the monoclonal antibodies casirivimab with imdevimab (REGEN-CON) administered together.

For details on the changes, see the FDA fact sheets for bamlanivimab and etesevimab and REGEN-COV.

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 Feb 1

MHA Covid-19 update

MHA Coronavirus UpdateThe MHA keeps members apprised of pandemic-related developments affecting hospitals through email updates and the MHA Coronavirus webpage. Important updates are outlined below.

State Changes Hospitals’ Share of Vaccines Distributed

The Michigan Department of Health and Human Services (MDHHS) has adjusted the number of COVID-19 vaccine doses available to each type of vaccination provider.

Although the MDHHS considered shifting to an allocation model of 70% of vaccines going to health departments and 30% going to hospitals, the department confirmed Feb. 4 that it will continue the allocation process it implemented the week of Feb. 1, with 60% of the available vaccine going to health departments and 40% to hospitals, until further notice. The MHA and members have advocated against moving a large allocation away from hospitals, which have administered more than a half million doses to Michigan residents. The MHA will also continue to identify and assist the MDHHS in using the most equitable sources of data to determine vaccine allocations. Member hospitals are encouraged to build partnerships with their local health departments to share resources and vaccine allocations to best serve their communities.

The MDHHS has developed a weekly survey for hospitals and health departments to guide the department’s decision-making on vaccine issues. The survey requests information about COVID-19 vaccine events hosted in the past week, the eligible populations the events targeted, where they were held and more. The hospital survey will be distributed each Friday, and responses to the first survey are due by 5 p.m. Feb. 8. If possible, the survey should be completed for individual facilities rather than at the health system level.

Members who would like assistance in fostering relationships with their local health department, have questions on the new vaccine survey or would like more information on the COVID-19 vaccine should contact Ruthanne Sudderth at the MHA.

FDA Considers EUA for New Vaccine, Revises Authorization for Convalescent Plasma

Johnson & Johnson subsidiary Janssen Biotech has requested emergency use authorization (EUA) from the Food and Drug Administration (FDA) for its COVID-19 vaccine. If approved, the vaccine will be the first single-dose immunization available to fight the pandemic.

The FDA is scheduled to meet Feb. 26 to discuss the EUA request for this vaccine, which trials have shown to be 66% effective in preventing overall moderate to severe COVID-19. The company said the vaccine demonstrated complete protection against COVID-19 serious enough to require hospitalization and was 85% effective in preventing severe forms of the disease.

This vaccine also presents far fewer logistical and cold chain challenges than the Pfizer and Moderna vaccines, as it is estimated to remain stable for two years at minus four degrees Fahrenheit (minus 20 degrees Celsius) and can be stored for three months under standard refrigeration at 36 to 46 degrees Fahrenheit (two to eight degrees Celsius). Johnson & Johnson initially will provide 2 million doses to the U.S., followed by 100 million doses by midyear.

In addition, the FDA recently updated its EUA for convalescent plasma as a COVID-19 treatment. The revision reflects new data regarding the treatment’s efficacy and application and has been included in the agency’s provider fact sheet.

The new EUA for COVID-19 convalescent plasma limits the authorization to the use of plasma with a high concentration of antibodies for the disease, known as “high titer” COVID-19 convalescent plasma. It is authorized only for the treatment of hospitalized patients with COVID-19 early in the disease course and those hospitalized patients whose bodies cannot produce an adequate antibody response. According to the latest data, plasma with low levels of antibodies has not been shown to be helpful in COVID-19. Therefore, low titer COVID-19 convalescent plasma is no longer authorized under the EUA.

Monoclonal Antibody Treatment Encouraged; Mi-COVID19 Initiative Webinar to Discuss

The educational webinar series from the Mi-COVID19 Initiative will continue from noon to 1 p.m. Feb. 10 on the topic Approach to Monoclonal Antibody Treatment. Speakers include Dr. William Fales from the MDHHS and Drs. Tejal Gandhi and Lindsay Petty from Michigan Medicine. Registration is available online, as are recordings from previous events in this series.

Members are encouraged to use monoclonal antibodies as eligible cases of COVID-19 present in their facilities and to consider posting information on the COVID-19 sections of their organizations’ websites for interested and possibly eligible patients. The MDHHS recently issued a letter with information on this type of treatment and sends weekly alerts from the Michigan Health Alert Network about how to request a supply of the antibodies. Members with questions may contact Rob Wood.

Epic Scheduling Loophole Under Investigation

Beaumont Health announced Feb. 1 that an individual had used unauthorized “backdoor” access to Beaumont Health’s Epic patient portal to schedule a COVID-19 vaccine appointment, then shared the pathway publicly. The breach resulted in more than 2,700 unauthorized appointments being made, all of which have now been canceled. Beaumont Health shared the information to help other hospitals ensure a similar issue does not occur in their systems. The health system has contacted Epic and is working to safeguard the system against future unauthorized accessibility. No medical records were compromised due to the incident, and no valid vaccine appointments were affected. Members with questions or concerns about their Epic platform may contact Jim Lee at the MHA.

Moderna Vaccine Doses Thought to be Compromised are Deemed Viable

The Centers for Disease Control and Prevention has notified the MDHHS that Moderna vaccine shipped to Michigan in mid-January and thought to be ruined by a temperature excursion have been determined to be viable and can be used to vaccinate residents. McKesson Corp., which is responsible for shipping the vaccine, completed an internal investigation and determined the cause and lower limit of the cold excursion in these shipments. Based on data provided as part of that investigation, Moderna agreed that the vaccine in this shipment was viable upon arrival and remains viable under either of the following circumstances:

  • Doses are confirmed to have been stored in quarantine at -20C.
  • Doses are confirmed to have been stored in quarantine at 2-8C and the doses were placed in refrigerated storage within 30 days.

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).