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).