FDA Expands Eligibility For COVID Booster Shot

Presented By Classic Brands

(Washington D.C.) — The U.S. Food and Drug Administration has amended the emergency use authorizations (EUA) for both the Moderna and Pfizer-BioNTech COVID-19 vaccines authorizing use of a single booster dose for all individuals 18 years of age and older after completion of primary vaccination with any FDA-authorized or approved COVID-19 vaccine. The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices was expected to meet Friday afternoon to discuss further clinical recommendations.

“Throughout the course of the COVID-19 pandemic, the FDA has worked to make timely public health decisions as the pandemic evolves. COVID-19 vaccines have proven to be the best and highly effective defense against COVID-19. Authorizing the use of a single booster dose of either the Moderna or Pfizer-BioNTech COVID-19 vaccine for individuals 18 years of age and older helps to provide continued protection against COVID-19, including the serious consequences that can occur, such as hospitalization and death,” said Acting FDA Commissioner Janet Woodcock, M.D.

Prior to Friday’s authorizations, a single booster dose of the Moderna and Pfizer-BioNTech COVID-19 vaccines was authorized for administration to individuals 65 years of age and older, individuals 18 through 64 years of age at high risk of severe COVID-19 and individuals 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2. Today’s action expands the use of booster doses of both vaccines to include all individuals 18 years of age and older at least six months after completion of the primary vaccination series of the Moderna COVID-19 Vaccine or Pfizer-BioNTech COVID-19 Vaccine or at least two months after completion of primary vaccination with the Janssen COVID-19 Vaccine.

“The FDA has determined that the currently available data support expanding the eligibility of a single booster dose of the Moderna and Pfizer-BioNTech COVID-19 vaccines to individuals 18 years of age and older,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “Streamlining the eligibility criteria and making booster doses available to all individuals 18 years of age and older will also help to eliminate confusion about who may receive a booster dose and ensure booster doses are available to all who may need one.”

Data Supporting Effectiveness

The EUA for a single booster dose for individuals 18 years of age and older for the Moderna (administered as half of the dose of a primary series dose) and Pfizer-BioNTech COVID-19 vaccines is based on the FDA’s analysis of immune response data that supported use in the previously authorized populations for boosters. 

For the Moderna COVID-19 Vaccine booster dose, the FDA analyzed the immune response data from 149 participants 18 years of age and older from the original clinical studies who received a booster dose at least six months after their second dose and compared it to the immune responses of 1,055 study participants after completing their two-dose series. The antibody response against the SARS-CoV-2 virus 29 days after a booster dose of the vaccine demonstrated a booster response. 

For the Pfizer-BioNTech COVID-19 Vaccine booster dose, the FDA analyzed the immune response data from approximately 200 participants 18 through 55 years of age who received a single booster dose about six months after their second dose. The antibody response against the SARS-CoV-2 virus one month after a booster dose of the vaccine when compared to the response one month after the two-dose primary series in the same individuals demonstrated a booster response.

FDA Evaluation of Benefits and Risks

Since Moderna and Pfizer-BioNTech initially submitted safety and effectiveness data on a single booster dose following primary vaccination to the FDA, additional real-world data have become available on the recently increasing number of cases of COVID-19 in the U.S. and on the risk of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the outer lining of the heart) following vaccination with these vaccines. These additional data enabled the FDA to reassess the benefits and risks of the use of these vaccines in the general adult population. The FDA has determined that the benefits of a single booster dose of either the Moderna or Pfizer-BioNTech COVID-19 vaccines outweigh the risks of myocarditis and pericarditis in individuals age 18 years of age and older when used following completion of primary vaccination to provide continued protection against COVID-19 and the associated serious consequences that can occur including hospitalization and death.

Both Pfizer and Moderna are conducting post-authorization/post-marketing studies to assess known serious risks of myocarditis and pericarditis. In addition, the FDA and the CDC have several systems in place to continually monitor COVID-19 vaccine safety and allow for the rapid detection and investigation of potential safety concerns.

The fact sheets for both vaccines for recipients and caregivers and for healthcare providers contain information about the potential side effects, including the risk of myocarditis and pericarditis. The most commonly reported side effects by individuals who received a booster dose of the vaccines were pain, redness and swelling at the injection site, as well as fatigue, headache, muscle or joint pain and chills. Of note, swollen lymph nodes in the underarm were observed more frequently following the booster dose than after the primary two-dose series. 

The FDA did not hold a meeting of the Vaccines and Related Biological Products Advisory Committee on these actions as the agency previously convened the committee for extensive discussions regarding the use of booster doses of COVID-19 vaccines and, after review of both Pfizer’s and Moderna’s EUA requests, the FDA concluded that the requests do not raise questions that would benefit from additional discussion by committee members.

The amendments to the EUAs were granted to ModernaTX Inc. and Pfizer Inc.

Chillicothe Transit Service Update Survey

Presented By Hometown-Motors, Inc.

(Chillicothe) — Additional service updates to the Chillicothe Transit System would include modified and expanded county service, under a current proposal.

These changes are proposed to go into effect January 3, 2022.

(Chillicothe Transit System)

To see full service updates proposed, please visit https://www.chillicothe.com/departments/transit_department/updates.php

The public comment period remains open until December 10th. 

Feedback can be shared online here:  https://docs.google.com/forms/d/e/1FAIpQLSeUiepKvYMjDce44dgJfOoPvgrR4Lgz49wuafof9g4IUlCTmQ/viewform

Miracle On 34th Street- The Musical, Presented By Chillicothe Civic Theatre

Presented By Atomic Speedway

(CTC) — A holiday classic from the writer of the musical theatre classic, The Music Man!, and based on the movie of the same name, Miracle on 34th Street features a book and score by none other than Meredith Willson.

This year’s presentation will be December 9th-12th at Chillicothe’s Majestic Theatre.

Single mother, Doris Walker, doesn’t want her six-year-old Susan’s head filled with romantic notions. Their neighbor, Fred Gailey, tries to woo Doris by charming Susan and taking her to see Santa Claus at Macy’s, where Doris works. Doris is not impressed, but when it turns out that Macy’s Santa may, in fact, be the real Kris Kringle, a wave of love spreads across New York City that melts even the most cynical hearts.

Filled with humor, spectacle and such beloved songs as “Pinecones and Hollyberries,” “It’s Beginning to Look a Lot Like Christmas” and “My State, My Kansas,” this joyous, heartwarming musical is pure family entertainment, wholesome without being cloying. A star-vehicle for a female actress that features great roles for children, the show is a cast- and crowd-pleaser. With its built-in audience base, Miracle on 34th Street The Musical is the perfect holiday treat for any theatre.

CAST LIST
Doris Walker – Amanda Betz
Fred Gailey – Matt Harper
Kris Kringle – Todd Tinker
Susan Walker – Mattylynn McKee
Marla Shellhammer – Jade Berry
R. H. Macy – Matt McKee
Sawyer – Kristen Tedesco
Crookshank – Haley Whitt
Tammany O’Halloran – Kristin Rusk
Thomas Mara, Sr. – Michael Paulus
Alvin (Marine) – Quincy Newsome
Whitey (Marine) – Michael Paulus
Climber (Marine) – Asher Pendell
Clara – Millane Berry
Tommy- Zavier Wallace
Miss Sims – Cassie Beyer
Harry Finer – Josie Oliver
Hendrika – Mia Zielinski
Ms. Gimble- Gabby Goshorn
Hendrika’s Mother – Kennedy Moss
Judge – Drew Davis
Majorette – Ellie Ward
Ms. Beehler – Jenni Bennett

As the COVID-19 pandemic continues, The Majestic Theatre Board of Directors follows recommendations provided by the Centers for Disease Control & Prevention along with Ohio Department of Health and the Ross County Health District.

At this time, the Board of Directors have implemented the following:
• Barriers at the Box Office and Concession Stand
• Hand sanitizing stations throughout patron areas of the theatre
• Frequent cleaning and sanitation of high touch surfaces

Patrons:
• Masks are strongly recommended for all patrons regardless of vaccination status.
• If you are sick please stay home.

For purchasing tickets online, CLICK HERE:

State Fire Marshal Offer Fire Prevention Tips For Holiday Cooking Seasons

Presented By Rathkamp Financial

(Columbus) –  A golden-brown turkey with delicious sides may set the stage for the perfect Thanksgiving feast, but state officials urge Ohioans to make fire safety the real centerpiece of holiday festivities by staying alert and practicing patience in the kitchen.

A fire in an oven


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“More cooking fires occur on Thanksgiving than any other day of the year, and it’s not hard to see why,” said State Fire Marshal Kevin S. Reardon. “Between cleaning, taking care of children and cooking multiple dishes at a time, there’s no shortage of distractions in and around the kitchen. Staying alert and paying attention to what you’re cooking can go a long way in ensuring those distractions don’t have tragic consequences.”

According to the National Fire Protection Association, on Thanksgiving Day alone, around 1,400 home cooking fires were reported to U.S. fire departments in 2019, more than three times an average day.

In Ohio, although smoking is still the number one known cause for fire fatalities, cooking-related home fires throughout the month of November went up in 2020 markedly from 2019, increasing from 391 in 2019 to 434 last year.

There were 38 reported house fires, with no fatalities, on Thanksgiving last year, up from 22 in 2019.

“Many wonderful holiday celebrations this time of year can be ruined by fires that are most often preventable, so it’s important to remain vigilant and stay safe in the kitchen,” said Reardon.

“Homeowners insurance generally covers cooking fire damage, but it’s always a good idea to review your insurance protection with an insurance agent,” Ohio Department of Insurance Director Judith L. French said.

There are steps you can take to stay safe:

  • Do not leave any cooking area unattended.
  • Set a timer as a reminder of the food you are preparing.
  • Maintain a “kid-free zone” of 3 feet around the stove or areas where hot food or drinks are being prepared.
  • Keep paper towels and napkins away from hot surfaces.
  • Keep deep-fried turkey cooking out of the garage, away from your home, and wooden structures.
  • Before frying a turkey, place it in the fryer and cover it with water to determine the exact amount of oil you will need to prevent a fire caused by overflow.
  • Have an appropriate fire extinguisher handy. 
  • If the situation becomes more serious, evacuate and call 911.

If you have to file an insurance claim, take photographs or video of the damage and immediately contact your insurance agent or company. Provide complete and accurate information when submitting a claim to avoid delay.

You can call the Ohio Department of Insurance at 1-800-686-1526 or visit www.insurance.ohio.gov if you have insurance questions and concerns. Additional safety tips are available from the State Fire Marshal’s Office at www.com.ohio.gov/fire/Prevention.aspx