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FDA Limits Authorized Use of Janssen COVID-19 Vaccine

The Michigan Department of Health and Human Services (MDHHS) is updating vaccine providers across the state about the U.S. Food and Drug Administration (FDA) limiting the authorized use on the administration of the Janssen (Johnson & Johnson) COVID-19 vaccine.

On May 5, FDA released a statement that it has revised its Emergency Use Authorization (EUA) and limited the authorized use of the Janssen COVID-19 vaccine.  The updated EUA limits use to:

  • Individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate; or
  • Individuals 18 years of age and older who elect to receive the Janssen COVID-19 vaccine because they would otherwise not receive a COVID-19 vaccine.

Based on its investigation, the FDA has determined that the risk of thrombosis with thrombocytopenia syndrome (TTS), warrants limiting the authorized use of the vaccine. TTS is a syndrome of rare and potentially life-threatening blood clots in combination with low levels of blood platelets.  TTS linked with the Janssen COVID-19 vaccine has most frequently presented within 10 days to two weeks following vaccine administration.

The FDA and Centers for Disease Control and Prevention (CDC) have identified 60 confirmed TTS cases following the administration of Janssen COVID-19 vaccine, including nine fatal cases. The FDA has determined that the reporting rate of TTS is 3.23 per million doses of vaccine administered and the reporting rate of TTS deaths is 0.48 per million doses of vaccine administered.

“Throughout the pandemic, our federal partners have been committed to ensuring that science and data guided their decisions,” said Dr. Natasha Bagdasarian, MDHHS chief medical executive. “These new guidelines further underscore the robust safety review process in place for these vaccines. We continue to urge all Michiganders ages 5 and older to get their safe and effective COVID-19 vaccine as soon as possible and to get boosted if eligible.”

For individuals who have received the Janssen COVID-19 vaccine as their primary dose, it is recommended they receive a COVID-19 vaccine booster dose. mRNA vaccines are preferred for the first booster dose. Additionally, if Janssen COVID-19 vaccine was used for both the primary and booster doses, individuals are eligible for an additional dose of an mRNA vaccine. In both instances, vaccine protection has been shown to increase following administration of an mRNA vaccine.

Background & Safety Monitoring for Janssen (Johnson & Johnson) EUA

  • On Feb. 27, 2021, Janssen COVID-19 vaccine was authorized for emergency use. On April 13, 2021, FDA and CDC recommended a pause in administration of the vaccine to investigate six reported cases of TTS, and to help ensure that health care providers were made aware of the potential for TTS, and could plan for proper recognition and management due to the unique treatment required for TTS.
  • On April 23, 2021, following a thorough safety evaluation, FDA and CDC lifted the recommended pause regarding the use of the Janssen COVID-19 vaccine. The agencies confirmed a total of 15 cases of TTS had been reported to the Vaccine Adverse Event Reporting System, including the original six reported cases, out of approximately 8 million doses administered.
  • In December 2021, after reviewing updated vaccine effectiveness and safety data, the CDC’s Advisory Committee on Immunization Practices made a recommendation for the use of mRNA COVID-19 vaccines over the Janssen COVID-19 vaccine.

To date, nearly 6.7 million Michiganders (67%) have received their first does of COVID-19 vaccine. More than 393,000 residents have received the Janssen COVID-19 vaccine.

Michigan residents seeking more information about the COVID-19 vaccine can visit Michigan.gov/COVIDvaccine.

Submitted by Michigan Dept. of Health and Human Services

May is Gold Star Awareness Month

The month of May is Gold Star Awareness Month, a time to honor and recognize the sacrifice that Gold Star families make when a father, mother, brother, sister, son, daughter or spouse dies during active military service.

The Gold Star symbol originated during World War I when families hung banners with blue stars in their windows to represent an immediate family member serving in the U.S. Armed Forces. If a family member died in combat, the blue star was replaced with a gold star.

U.S. Army Maj. Gen. Paul D. Rogers, adjutant general and director of the Michigan Department of Military and Veterans Affairs, said, “No one has given more to our nation than our service members lost in combat and the Gold Star families left behind. These heroes paid the ultimate sacrifice in order to protect our freedoms and we remain in service to their families as they carry on with courage and dignity despite their devastating loss.”

The Michigan National Guard Family Programs Office provides support and care for service members and families of the Michigan National Guard while enhancing the readiness and well-being of their military families through information, education, programs and resources. Gold Star families can learn more about the Gold Star Family Support Program by contacting 1-888-MICH-FAM.

Governor Whitmer said, “This month, we honor those who lost a family member in the United States Armed Forces and extend our gratitude for the sacrifices made by our Gold Star families. Michiganders remember our fallen heroes and stand together in support of our Gold Star families so they know their sacrifice is not forgotten.”

 

Prepare for Day of Caring in Sarnia

United Way of Sarnia-Lambton is excited to announce the return of the Day of Caring after a  two-year pandemic break. The event which mobilizes hundreds of volunteers into the  community will take place on Tuesday, September 20, 2022. 

This is a unique opportunity for workplaces to support United Way to build both a sense of  community and teamwork through community service projects. “Day of Caring gives us all  the chance to roll-up our sleeves and work collectively to make a difference in the lives of  those in need,” said Pamela Bodkin, Community Investment and Finance Director for  United Way. Bodkin has organized Day of Caring in Sarnia-Lambton for 26 years. “We are  excited to have this annual impact event return to its traditional in person format bringing  people together who are looking to give back to the community in a very hands-on way.” 

Since 1993, United Way of Sarnia-Lambton Day of Caring has completed projects ranging  from painting, cleaning, gardening, and yard work to building wheelchair ramps, decks,  storage sheds or minor plumbing installations. Each year, applications are reviewed, jobs  are assessed and individuals having work done have completed a means test.  

To learn more about sponsoring a team or to submit applications for work, contact: Pamela  Bodkin pam@theunitedway.on.ca or 519-336-5452 ext. 5.

Submitted by United Way of Sarnia-Lambton

Flint Water Crisis Claim Deadline Extended to June 30th

The claims period for the Flint Water Settlement has been extended to June 30, 2022. There is a little more time to file for compensation for those affected by lead-contaminated municipal water.

Those who file won’t know how much money they could get until the claims process ends. The individual settlement amounts will depend on the number of claims submitted and found to be eligible.

The agreement with the State of Michigan, the City of Flint, McLaren Regional Medical Center, and Rowe Professional Services Company specifies that about 80% of the net settlement fund will go to children who were minors first exposed to Flint River water, with a large majority going to children age six and under. Two percent of the settlement is earmarked for special education services.

The defendants are contributing $626.25 million to the settlement fund.

A telephone line has been established to help filers get their paperwork obtained and submitted.

Registrants are encouraged to submit their claims as soon as possible. The claims administrator has established a telephone help line that registrants can call for assistance in any aspect of the claims process. That telephone number is (800) 493-1754. 

Reporting for WGRT – Jennie McClelland

Free Exercise Classes At the McMorran Plaza This Summer

The McMorran Plaza in downtown Port Huron is the place to be this summer. Along with evening entertainment, a beer garden, a splash pad, and more, there will be free exercise classes offered by the City of Port Huron through a collaboration with the YMCA of the Blue Water Area. 

The wellness classes include Ultimate Cardio Jam, Kickboxing, Boot Camp, Yoga, and Yo “Latte”, which is a Yoga and Pilates hybrid. 

There are also classes for those aged 60 and up and Qi Gong, which is a Chinese exercise that is designed to improve overall mental & physical health. 

Burn and Brew is held at the end of the workday and could end with a visit to the beer garden on the plaza. There are several other classes, including YMCA standards like Butts and Guts, Dance Aerobics, and Cardio and Core classes. The class times range from early morning to early evening. 

The classes start May 31st and run through September 2nd. Signup is requested. A link to the full schedule and signup can be found below. 

https://www.mcmorran.com/plaza

Reporting for WGRT – Jennie McClelland

Aerial Treatments for Spongy Moths Start Mid-May

The St. Clair County Spongy Moth Suppression Program has scheduled the application of a biological control agent by airplane mid-May. Exact treatment dates will be determined based on the weather and the development of Spongy Moth caterpillars this spring.

The biological control agent Btk, or Bacillus thuringiensis var. kurstaki, will be sprayed from an airplane flying low above the treetops on over 5,100 acres in the county. You can see a map of the locations that will be treated here: www.stclaircounty.org/caterpillars

The county will spray when average wind speeds are less than 10 miles per hour and relative humidity is more than 50%, and they will release exact dates for spraying when they are determined.

The biological control agent being used to suppress spongy moths is a water-based insecticide used in certified organic food productions. It has low impact on humans, pets, birds, fish, and other insects, and it will only affect caterpillars that are feeding on tree canopies when it’s applied.

Reporting for WGRT – Jessie Wiegand.