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).

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).