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).