Emergency Preparedness and Response:
May 12, 2021 |
|
|
|
|
|
FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Adolescents
On Monday, the U.S. Food and Drug Administration expanded the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) to include adolescents 12 through 15 years of age. The FDA amended the EUA originally issued on Dec. 11, 2020 for administration in individuals 16 years of age and older.
“The FDA’s expansion of the emergency use authorization for the Pfizer-BioNTech COVID-19 Vaccine to include adolescents 12 through 15 years of age is a significant step in the fight against the COVID-19 pandemic,” said Acting FDA Commissioner Janet Woodcock, M.D. “Today’s action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic. Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations.”
From March 1, 2020 through April 30, 2021, approximately 1.5 million COVID-19 cases in individuals 11 to 17 years of age have been reported to the Centers for Disease Control and Prevention (CDC). Children and adolescents generally have a milder COVID-19 disease course as compared to adults. The Pfizer-BioNTech COVID-19 Vaccine is administered as a series of two doses, three weeks apart, the same dosage and dosing regimen for 16 years of age and older.
The FDA has determined that Pfizer-BioNTech COVID-19 Vaccine has met the statutory criteria to amend the EUA, and that the known and potential benefits of this vaccine in individuals 12 years of age and older outweigh the known and potential risks, supporting the vaccine’s use in this population.
“Having a vaccine authorized for a younger population is a critical step in continuing to lessen the immense public health burden caused by the COVID-19 pandemic,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “With science guiding our evaluation and decision-making process, the FDA can assure the public and medical community that the available data meet our rigorous standards to support the emergency use of this vaccine in the adolescent population 12 years of age and older.”
The FDA has updated the Fact Sheets for Healthcare Providers Administering the Vaccine (Vaccination Providers) and for Recipients and Caregivers with information to reflect the use of the vaccine in the adolescent population, including the benefits and risks of the Pfizer-BioNTech COVID-19 Vaccine.
The EUA amendment for the Pfizer-BioNTech COVID-19 Vaccine was issued to Pfizer Inc. The issuance of an EUA is not an FDA approval (licensure) of a vaccine. The EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biologics for prevention and treatment of COVID-19 is terminated, and may be revised or revoked if it is determined the EUA no longer meets the statutory criteria for issuance or to protect public health or safety.
Read More |
|
|
|
|
|
|
|
Health Director Quintana Stewart
Honored in Pop-Up Art Walk
More than 80 pieces of original art appeared along Franklin Street in downtown Chapel Hill last Friday, thanks to a team of local organizers and artists of all ages. This pop-up art walk is designed to celebrate and thank scientists, healthcare workers, teachers, and local business owners - everyone whose leadership and innovation helped the community and the country make it through the past year. Included in the walk are tribute pieces thanking pandemic leaders like Dr. Anthony Fauci (NIAID), Dr. Kizzy Corbett (NIH), Dr. Mandy Cohen (NCDHHS), and Quintana Stewart (Orange County Health Director).
“Developing a vaccine in less than a year is an incredible feat,” said art walk organizer Mary Parry. “The feeling of excitement that so many people now have from being vaccinated and safely back outside, in the community, together is only possible because of science and the determination of leaders who pushed forward in the face of uncertainty.”
Parry says the art walk is like a mile-long thank-you card that stretches along Franklin, Henderson and Graham Streets. The art can be found along sidewalks and the barrier-lined pedestrian path, created during the pandemic to help businesses use sidewalk space for outdoor dining. Organizers hope the art will remain up through the end of May.
Included among the art is encouragement for everyone in the community to get vaccinated. Art walk organizers joined the NCDHHS “Bring Back Summer” Initiative and offer links to vaccination information in their social media promotion (@ science.hope.art.walk).
Everyone is invited to vote on their favorite art walk pieces using a link available through social media. Local restaurant gift certificates will be offered with weekly drawings of the participants who submit votes and share the art walk in their social media accounts. Downtown business owners are welcoming this creative engagement from the community as they continue to focus on economic recovery.
"The last year has been incredibly challenging for the restaurant industry, but nothing compared to arts and culture - complete closures, lack of funding, and more," said Sarah Boak, owner of Blue Dogwood Public Market. "This art walk brings folks back to downtown Chapel Hill for a unique, community-focused experience. We’re excited to see everyone, to bring art back to Chapel Hill, and to celebrate with our friends who have supported our community through these tough times.”
Learn more about The Art of Science and Hope
|
|
|
|
|
|
|
|
Countywide Racial Equity Plan Open for
Public Comment
One Orange is a commitment by Orange County, Carrboro, Chapel Hill and Hillsborough leaders and staff to uncover and address implicit racial biases in our institutions and to create a community where race no longer predicts life outcomes in our community. For the past few months, representatives from these local governments have been working on a framework for engaging the community to move these efforts forward. Much of the preliminary work and vision utilize the GARE (Government Alliance for Racial Equity) methodology and all of the jurisdictions have joined to work together as members of GARE.
A fundamental part of this work is meaningful engagement and participation with all of the community, particularly members of the community most impacted by racial bias and discrimination. You and your organization are critical to this work and we hope you will provide us with feedback on our community engagement efforts and will help guide us as we develop strategies to meet the vision of true racial equity in our community.
How do we move forward?
First, we hope you will join us in this work. We recognize that many organizations are working on similar issues and hope you can join us to mobilize local governments as together we advance our common goals.
We would like to receive feedback on our framework and work so far (see attached).
We would also like you to consider these questions and share your thoughts with us. We welcome written comments and are open to other ways to engage.
• What three results would you like to see as a result of this plan?
• What sections of this plan will help us achieve those results?
• Who should be involved in future community engagement?
• Who is negatively affected by using this framework/plan?
• What do you see as the most critical racially equitable outcomes?
• Would you want to participate in a meeting for further discussion?
Our comment period for this stage of the work will end on May 19, 2021 and can be submitted by email to: OneOrange@orangecountync.gov. There will also be an information session on May 11, 2021 at 11:00, and we invite you or others you identify to join us at a virtual meeting (see details below). Our team members are also available to meet with you or members of your organization in whatever avenues work for you.
The members of the local GARE team are very excited to be part of local governments committed to addressing systemic racism and inequity. We hope we can count on you to help inform our work so together we can create a community where race does not determine the quality of life. Please be aware you may receive this notice several times because we are trying to capture as many people as possible. Thank you for your patience.
To Register for Virtual Meetings:
One Orange Racial Equity Team is inviting you to a scheduled Zoom meeting.
Topic: One Orange Countywide Racial Equity Plan: A Framework For Moving Forward
Time: May 11, 2021 11:00 AM Eastern Time (US and Canada)
Join Zoom Meeting
https://orangecountync.zoom.us/j/94771240799?pwd=TWI0Z2JzV3RjR2ZlUFdYR0FmRVhKUT09
Meeting ID: 947 7124 0799
Passcode: 417536
One tap mobile
+13126266799,,94771240799# US (Chicago)
+16468769923,,94771240799# US (New York)
Dial by your location
+1 312 626 6799 US (Chicago)
+1 646 876 9923 US (New York)
+1 301 715 8592 US (Washington DC)
+1 346 248 7799 US (Houston)
+1 408 638 0968 US (San Jose)
+1 669 900 6833 US (San Jose)
+1 253 215 8782 US (Tacoma)
Meeting ID: 947 7124 0799
Find your local number: https://orangecountync.zoom.us/u/asOqgUB31
Thank you for your participation,
One Orange Countywide Racial Equity Team Leads
Annette Moore Nancy Coston, Orange County
Anita Jone-McNair, Carrboro
Sarah Vinas Rae Buckley, Chapel Hill
Jen Della Valle Haley Bizzell, Hillsborough
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Orange County Health Department Offers
Self-Scheduling of COVID Vaccine Appointments
If you would like a COVID vaccine you can now easily schedule your own appointment at a time and date that work for you!
- Visit https://myspot.nc.gov.
- Search for zip code 27278
- Choose a time and date that work for your schedule!
- You can also call (919) 913-8088 for assistance in obtaining an appointment. The phone line is operated daily from 8:30 a.m. to 4:30 p.m. Spanish and other languages available.
Related Links |
|
|
|
|
|
|
|
Be Ready For Hurricane Season
|
|
|
|
|
|
North Carolina COVID-19 Cases
The North Carolina Department of Health and Human Services (NCDHHS) reports 986,443 COVID-19 cases, 12,830 deaths, and 968 hospitalizations.
40.3% of North Carolina's population is at least partially vaccinated, and 35.6% is fully vaccinated.
There are currently 8,534 confirmed cases of COVID-19 and 101 deaths in Orange County. 47.7% of Orange County residents are at least partially vaccinated, and 44.4% are fully vaccinated.
For more information regarding live updates (NCDHHS updates the site every day around noon), please visit the NCDHHS website.
Orange County Health Department also has a COVID-19 dashboard webpage, with information on COVID-19 data in the county.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share on Facebook
Share on Twitter
Share via Email
