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Thursday, April 15, 2021

Michigan expanding use of monoclonal antibody therapy in fight against COVID-19

Governor Gretchen Whitmer and Dr. Joneigh Khaldun, chief medical executive and chief deputy for health, give a COVID-19 Update on April 14, 2021, during a press conference. (Photo courtesy Michigan Executive Office of the Governor)

LANSING -- Governor Gretchen Whitmer and the Michigan Department of Health and Human Services announced on April 14 that the state is working to expand the use of a medical intervention designed to significantly reduce hospitalizations and deaths due to COVID-19. This involves additional doses of monoclonal antibodies being made available to providers and requests to providers to expand the number of infusion sites in the state.

"We are using every mitigation strategy, every medication, and every treatment option to fight the virus here in Michigan," said Governor Gretchen Whitmer. "These antibody treatments could keep you out of the hospital and save your life, and my administration and I will continue working with the federal government to make sure we are using all the tools in our toolbox to keep you and your family safe and get back to normal sooner." 

Monoclonal antibodies (mAb) are laboratory-produced molecules that can restore, enhance or mimic the immune system's attack on cells. mAb targets different parts of the virus and prevents the virus from bonding with cells in the body, effectively neutralizing it. Clinical trials have shown promising data that this therapy works for the treatment of COVID-19 in patients who are at high risk for progressing to severe symptoms and/or hospitalization, including older Michiganders. To date, preliminary data suggests more than 6,600 Michiganders have received this treatment with 65 percent reporting feeling better with two days of treatment and less than 5 percent of them requiring hospitalization following treatment.

Gov. Whitmer joined Dr. Joneigh Khaldun, chief medical executive and chief deputy for health, and Dr. Adnan Munkarah, executive vice president and chief clinical officer, Henry Ford Health System, in a press conference on COVID-19 updates Wednesday, Apr. 14.*

"When administered to non-hospitalized patients within 10 days of symptom onset, monoclonal antibodies may reduce symptoms and the risk of hospitalizations and emergency room visits associated with the virus," Dr. Khaldun said. "Michiganders who contract COVID-19 should ask their health care providers about receiving this treatment, and I urge providers to assess if their patients qualify. We have seen successful use of this therapy in long-term care facilities and even in home use by EMS providers. This therapy can help save the lives of more Michigan residents as we work to vaccinate 70 percent of Michiganders age 16 and older with the safe and effective COVID-19 vaccine as quickly as possible."

This slide from the Governor's April 14 COVID-19 Update illustrates what people should do if they test positive for COVID-19 (at left) and, if not, the importance of getting vaccinated and continuing to mask up and social distance for prevention. (Photo courtesy Michigan Executive Office of the Governor)

Dr. Munkarah noted success in treating patients with monoclonal antibodies over the last five months.

"This treatment has the potential not only to help patients who are suffering from the severe effects of COVID-19, but also to ease the burden on our hospitals and caregivers," Dr. Munkara reported. "At the same time, we must stay vigilant by getting vaccinated and following the safety measures we have in place."

The therapy has been used successfully to help address COVID-19 outbreaks in Michigan long-term care facilities and to treat patients at home. In seven long-term care facility outbreaks, 120 vulnerable patients with high mortality rates were treated with mAb. Only three of those patients needed to be hospitalized, with one death.

Michigan was also one of the first states in the nation to issue an EMS protocol to allow paramedics to administer this medication to further increase access. In St. Clair County, Tri-Hospital EMS treated 50 patients at home over a nine-day period. The state is also using EMS to provide paratransit or ambulance transport to infusion clinics for patients who don’t have access to transportation.

The therapy is administered through an intravenous infusion and is designed for people who have tested positive for COVID-19 and have mild to moderate symptoms. It is not intended for hospitalized patients. These treatments are allowed by the U.S. Food and Drug Administration (FDA) under an Emergency Use Authorization. According to the FDA, mAb therapy is effective against the B.1.1.7 (UK) variant, the predominant form of COVID currently seen in Michigan.   

The National Institutes of Health recently recommended that patients with mild to moderate COVID-19 who are at high risk of worsening disease should be treated with combination therapy -- either Lilly or Regeneron. 

Michigan continues to monitor and track patients within 14 days of COVID-19 antibody treatment administration to assess the impact of COVID-19 antibody treatments on the state’s COVID-19 hospitalization rate. Additionally, the state is now conducting follow-up phone interviews conducted by volunteer medical and pharmacy students to more effectively assess patient response to mAb.

During the Apr. 14 press conference some reporters questioned Gov. Whitmer on why she has not added new restrictions on travel, restaurants, etc., since the state now has a very high rate of COVID-19 positivity -- recently called the highest in the U.S.

Gov. Whitmer replied that people are tired and are abandoning protocols of protective behavior, dropping their guard, while new variants of the virus are easier to catch. This necessitates prioritizing vaccinations. She said the state is now emphasizing three things: 1) vaccinations, 2) masking up, hand washing and social distancing, and 3) monoclonal antibody therapies available to those who test positive and are at high risk. The Governor stressed there are still public health laws in place to mitigate the spread of COVID including a mask mandate, capacity limits on indoor gatherings, and mandatory testing for sports.

"Don't eat inside of a restaurant," the Governor added.

She advised getting take-out or eating outside if possible. That was one recommendation she made last Friday, Apr. 9 -- along with urging high schools to shift to remote learning and recommending youth sports suspend in-person activities for the next two weeks.**

Additional information on monoclonal antibody therapy can be found at the U.S. Department of Health and Human Services' Combating COVID website and Michigan.gov/COVIDTherapy.

Michigan residents seeking more information about the COVID-19 vaccine can visit Michigan.gov/COVIDvaccine. Information around this outbreak is changing rapidly. The latest information is available at Michigan.gov/Coronavirus and CDC.gov/Coronavirus.

Editor's Notes:

*
This Apr. 14 press conference and COVID-19 Update is available on YouTube HERE.

** See: "Gov. Whitmer calls on Federal Government to surge more vaccines to Michigan, urges voluntary 2-week suspension of some activities."

Tuesday, April 13, 2021

Western UP Health Department pauses use of Johnson and Johnson vaccine

BARAGA, GOGEBIC, HOUGHTON, KEWEENAW and ONTONAGON Counties -- Western Upper Peninsula Health Department (WUPHD) is pausing all use of the Johnson and Johnson COVID-19 vaccine until more is known. The FDA and CDC have recommended this pause, and the Michigan Department of Health and Human Services (MDHHS) has confirmed it. There is no impact on the use of the Pfizer or Moderna vaccines.

The homebound visits that were scheduled for today, Apr. 13, in Houghton County have been postponed.

The vaccination clinic scheduled for Thursday, Apr. 14, at Michigan Tech’s Student Development Complex (SDC) will operate and will offer the Moderna vaccine. Individuals with appointments will be contacted and offered the Moderna vaccine or be rescheduled as soon as possible.

"We are stopping all use of the Johnson and Johnson vaccine until we have more information on the few incidents of concern and clear recommendations on future use," says Robert Van Howe, MD, MS, FAAP, medical director with the Western Upper Peninsula Health Department (WUPHD). "This does not change the fact that COVID-19 vaccination overall is safe and effective. Millions have been vaccinated."

The Advisory Committee on Immunization Practices (ACIP) is scheduled to meet Wednesday, Apr. 14. Pending the Committee recommendation, all scheduled Johnson and Johnson clinics are tentative. In addition, all current scheduling for vaccine appointments with the WUPHD is paused while staff assess supplies and contact those scheduled today.

The risk of the side effect for people who got the Johnson and Johnson vaccine more than a month ago is very low. People that received the vaccine within the last few weeks should be aware of any symptoms. If you have received the vaccine and develop severe headache, abdominal pain, leg pain, or shortness of breath, you should contact your healthcare provider and seek medical treatment.

This side effect has not been seen in the Pfizer or Moderna vaccines. People who are scheduled to receive either of these vaccines should continue with their appointments.

Residents can visit https://coppercountrystrong.com/vaccine to locate a vaccine provider in their area. Those without computer access should call 211 or their healthcare provider for assistance in scheduling an appointment.*

For more information on COVID-19 please visit wuphd.org, michigan.gov/coronavirus, or cdc.gov/coronavirus.

*Editor's Note: The Copper Country Strong vaccine locator may indicate Johnson and Johnson vaccine availability in some places because the page has not been updated.