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).

Safe Table to Address Pediatric Care During COVID-19

PSO

The MHA Keystone Center Patient Safety Organization (PSO) is hosting a safe table to investigate and discuss healthcare adversities facing the pediatric population, especially during the COVID-19 pandemic. The safe table will be held virtually from 2:30 to 4 p.m. Oct. 28.

Safe tables allow hospitals to come together, share ideas with peers, engage in safe discussions and obtain advice to make improvements to reduce or eliminate harm. This event is offered to MHA Keystone Center PSO members only. Registration is available online.

Members with questions may contact the MHA Keystone Center PSO.

Combating the Novel Coronavirus (COVID-19): Week of April 26

MHA Covid-19 update

Gov. Gretchen Whitmer announced during an April 29 news conference that future epidemic order actions will be based on four vaccination-based milestones that will enable the state of Michigan to return to normalcy. Dubbed the “MI Vacc to Normal” challenge, the program’s goal is to reach a point where 70% of adults in the state are vaccinated and broad mitigation measures are lifted unless unanticipated circumstances arise. Meanwhile, Michigan’s hospitalization rates, testing positivity rates and other important measures are improving, although relatively high levels of acuity and pediatric admissions continue to cause high levels of stress on hospital staff and resources.

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.

Administration of Johnson & Johnson Vaccine Resumes

The Centers for Disease Control and Prevention Advisory Committee on Immunization Practices (CDC ACIP) voted April 23 to recommend that providers resume vaccinations using the Johnson & Johnson (J&J) single-dose COVID-19 vaccine for anyone 18 and older. The CDC issued an updated Morbidity and Mortality Weekly Report April 27 providing the most recent recommendations for use of the J&J vaccine. The Michigan Department of Health and Human Services (MDHHS) also issued an alert advising providers to resume use of the vaccine.

The J&J vaccine was placed on a pause April 13 while experts conducted a thorough safety review after reports of a rare blood clotting syndrome in some people. The CDC and the Food and Drug Administration (FDA) confirmed that 15 cases of the blood clots have been reported to the Vaccine Adverse Reporting System, including the six cases originally reported, and that all occurred in women between the ages of 18 and 59. Due to the unique treatment required for these adverse events, the agencies also ensured providers and clinicians were made aware of their potential and could properly recognize and manage them. Shipments of the J&J vaccine are scheduled to resume during the week of May 3.

Both the Janssen COVID-19 Vaccine Fact Sheet for Healthcare Providers Administering Vaccine and the Fact Sheet for Recipients and Caregivers have been revised to include information about the risk of the blood clotting syndrome and should be reviewed prior to administration of the J&J vaccine.

CDC and MDHHS Provide Updated Vaccine Information

The CDC has issued updated interim clinical considerations for COVID-19 vaccines authorized for use in the United States. Providers are encouraged to review these considerations, as they cover such topics as interchangeability of vaccines, people vaccinated outside the U.S., antiviral therapy and vaccination, vaccination of pregnant or lactating individuals, and much more.

In addition, the MDHHS issued an alert on several updates to Moderna vaccines, including vaccine vial fill volume, updated labeling, and storage and handling modifications.

A recent emergency use authorization (EUA) revision indicates the Moderna vaccine will be available in two different vials by early May. Shipments of the new vials could occur as early as May 3, including the current maximum 11-dose vial and a new maximum 15-dose vial. Details about these new vials and packaging are available in the updated Moderna EUA fact sheet for providers.

Updated guidance for storage and handling of the Moderna COVID-19 vaccine have also been issued that include changes to time frames. The MDHHS clarified vaccine temperatures and storage time frames with the manufacturer, and an updated storage and handling summary and preparation/administration Moderna documents are available online.

Share Children’s Hospital Clinical Collaborative Open Letter on MIS-C

Leaders from a group of children’s hospitals and hospitals with extensive pediatric care programs together penned an open letter to clinicians and families across Michigan to raise awareness of multisystem inflammatory syndrome in children (MIS-C) as the spring surge continues to recede. These clinicians warn that Michigan could see children across the state experiencing MIS-C symptoms two to five weeks following the surge’s peak as children are exposed to the virus.

The letter offers details of the symptoms to be aware of, when to seek medical care, and links to appropriate treatment guidelines for clinicians. The MHA is distributing this letter on behalf of this group of pediatric clinical leaders from across the state and thanks them for their leadership around this critical issue.

Member hospitals and health systems are encouraged to distribute this letter to their physicians and ambulatory or primary care practices. The association will also share it on its social media channels to promote greater awareness among Michigan residents, especially families with children.

Members with questions may contact Laura Appel at the MHA.

Recording Vaccines on Michigan Care Improvement Registry is Important Step

Because increasing numbers of patients are seeking second doses at providers other than the one that provided their first dose, members are encouraged to review the proper procedures for looking up and recording vaccinations in the Michigan Care Improvement Registry (MCIR). The MDHHS has shared that it is receiving growing numbers of incorrect or duplicate vaccination records and wants to ensure an accurate reporting of the populations that have been vaccinated. Several detailed training guides are available online that vaccination teams can review at their convenience.

When patients present without their COVID-19 vaccine card, vaccination providers are urged to check MCIR to confirm the date and brand of their first dose to avoid medication errors that impact the effectiveness of the vaccine and other issues. Patients should also be encouraged to keep their vaccine card in a safe place and take a photo of it in the event it is misplaced.

Vaccinating Those Who Have Recovered from COVID-19

Although previous guidance recommended waiting 90 days before administering a vaccine to someone who recently had COVID-19, providers are now advised to vaccinate patients as soon as their symptoms have subsided and they are well enough to receive a shot. The change is due to the vaccine no longer being in limited supply.

However, patients who received monoclonal antibody (mAb) treatments for COVID-19 should not be vaccinated until 90 days after treatment, per CDC and MDHHS recommendations. It is not yet known how effective vaccines are in those who have previously received an antibody treatment for a COVID-19 infection or whether the antibody treatment could interfere with the body's immune response to a vaccine.

The MHA recently cohosted a webinar with the MDHHS on mAb therapies and how to execute a successful mAb therapeutics clinic. A recording of the webinar is available online for those who were unable to participate.

Vaccination Rates Declining

As of May 1, more than 6.9 million doses of COVID-19 vaccine had been administered in Michigan, resulting in more than 4 million Michiganders having received at least one dose and more than 3 million getting all recommended doses of vaccine. Nearly 50% of adult residents have received at least one dose. However, the number of vaccinations administered in Michigan in the last week has dropped significantly, and supply has outpaced demand for the vaccines.

Because Black and Hispanic residents are being vaccinated at a slower pace than white Michiganders, the Protect Michigan Commission continues to make vaccine equity a high priority and has engaged partners to assist with doing door-to-door sign-ups, education and more. MHA members that are working with community partners are encouraged to ensure some of those partners are focused on reaching people of different races, ethnicities and cultures where they are in their communities.

Members with questions regarding vaccines should 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).