- Written by FDA U.S. FOOD & DRUG ADMINISTRATION
- Category: Press Room
- Approval Signifies Key Achievement for Public Health
- FDA NEWS RELEASE
- For Immediate Release: August 23, 2021
Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.
“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” said Acting FDA Commissioner Janet Woodcock, M.D. “While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”
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- Written by Jennifer King, District Public Information Officer
- Category: Media Releases
Para leer este mensaje en Español, haga clic en 'Español' en la parte superior de esta página a la derecha
North GA – North Georgia Health District officials announced that public health departments in Cherokee, Fannin, Gilmer, Murray, Pickens and Whitfield counties will provide a third dose of the Pfizer-BioNTech or Moderna COVID-19 vaccine to certain patients with weakened immune systems.
The Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) recommend that people who are moderately to severely immunocompromised receive an additional dose of Pfizer or Moderna COVID vaccine at least 28 days after completion of the initial two doses. This recommendation does not include Johnson and Johnson vaccine recipients.
Eligible immunocompromising conditions for an additional dose of COVID-19 vaccine include:
- Active treatment for solid tumor and hematologic malignancies
- Receipt of a solid-organ transplant and taking immunosuppressive therapy
- Receipt of CAR-T-cell or hematopoietic stem cell transplant (within 2 years of transplantation or taking immunosuppression therapy)
- Moderate or severe primary immunodeficiency (such as DiGeorge syndrome, Wiskott-Aldrich syndrome)
- Advanced or untreated HIV infection
- Active treatment with high-dose corticosteroids (≥20mg prednisone or equivalent per day), alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutic agents classified as severely immunosuppressive, tumor-necrosis (TNF) blockers, and other biologic agents that are immunosuppressive or immunomodulatory
Eligible patients must request a third dose of the vaccine, and to receive it, they may either provide documentation from their physician or self-attest to one of the medical conditions above by signing a consent form.
The vaccine is free, and no appointment is needed to receive COVID-19 vaccine at the county health departments in the North Georgia Health District; however, an appointment may be arranged, if desired, by calling ahead. Phone numbers and addresses for county health departments in North Georgia are available here on our home page.
NOTE: THE 3RD COVID-19 VACCINE DOSE IS NOT THE SAME AS THE COVID-19 BOOSTER SHOT. THE 3RD DOSE OF PFIZER OR MODERNA COVID-19 VACCINE IS ONLY FOR CERTAIN PEOPLE WITH WEAKENED IMMUNE SYSTEMS WHO MEET THE CONDITIONS LISTED ABOVE. THE TENTATIVE NATIONAL PLAN FOR COVID-19 BOOSTER SHOTS IS TO OFFER A BOOSTER TO ALL AMERICANS. PLEASE LEARN MORE ABOUT THE BOOSTER SHOT HERE.
- Hits: 3166
- Written by U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
- Category: Media Releases
Joint Statement from HHS Public Health and Medical Experts on COVID-19 Booster Shots
For Immediate Release: Wednesday, August 18, 2021
Contact: Media Relations
(404) 639-3286
Today, public health and medical experts from the U.S. Department of Health and Human Services (HHS) released the following statement on the Administration’s plan for COVID-19 booster shots for the American people.
The statement is attributable to Dr. Rochelle Walensky, Director of the Centers for Disease Control and Prevention (CDC); Dr. Janet Woodcock, Acting Commissioner, Food and Drug Administration (FDA); Dr. Vivek Murthy, U.S. Surgeon General; Dr. Francis Collins, Director of the National Institutes of Health (NIH); Dr. Anthony Fauci, Chief Medical Advisor to President Joe Biden and Director of the National Institute of Allergy and Infectious Diseases (NIAID); Dr. Rachel Levine, Assistant Secretary for Health; Dr. David Kessler, Chief Science Officer for the COVID-19 Response; and Dr. Marcella Nunez-Smith, Chair of the COVID-19 Health Equity Task Force:
“The COVID-19 vaccines authorized in the United States continue to be remarkably effective in reducing risk of severe disease, hospitalization, and death, even against the widely circulating Delta variant. Recognizing that many vaccines are associated with a reduction in protection over time, and acknowledging that additional vaccine doses could be needed to provide long lasting protection, we have been analyzing the scientific data closely from the United States and around the world to understand how long this protection will last and how we might maximize this protection. The available data make very clear that protection against SARS-CoV-2 infection begins to decrease over time following the initial doses of vaccination, and in association with the dominance of the Delta variant, we are starting to see evidence of reduced protection against mild and moderate disease. Based on our latest assessment, the current protection against severe disease, hospitalization, and death could diminish in the months ahead, especially among those who are at higher risk or were vaccinated during the earlier phases of the vaccination rollout. For that reason, we conclude that a booster shot will be needed to maximize vaccine-induced protection and prolong its durability.
- Hits: 2054
- Written by Jennifer King, District Public Information Officer
- Category: Press Room
UPDATE for FREE Testing In Ellijay: Site is Moving as of Monday, Aug. 30th
Para leer este mensaje en Español, haga clic en 'Español' en la parte superior de esta página a la derecha
Ellijay, GA – Since MAKO Medical began Free COVID-19 Drive-thru Testing at the Gilmer County Health Department on August 18th, hundreds of residents have received testing at the new site. Now, to better facilitate testing, the site will move from the health department to a new location and the hours of operation will slightly change.
Please note the following updated MAKO Medical COVID-19 Drive-thru Testing site and hours of operation in Ellijay, as of Monday, August 30th:
This is PCR testing done by nasal swab to determine the presence of the virus that causes COVID-19. The operation in Ellijay is the third MAKO Medical testing site established in North Georgia through a partnership with the Georgia Department of Public Health. The other two testing sites in North Georgia operated by MAKO are in Dalton and Canton.
Anyone who has COVID-19 type symptoms or has been in close contact recently with a person infected with the virus needs to be tested for COVID-19, even if they are fully vaccinated. There are no eligibility requirements other than having a Georgia address and registering online at https://mako.exchange/splash/GAmakotesting/ (PLEASE REGISTER ONLINE AT THIS LINK FOR TESTING - ONLY USE THE PHONE NUMBER PROVIDED AT THE MAKO WEBSITE AS A LAST RESORT -- pre-registration is preferred, however, anyone who does not have access to the internet or is not able to navigate the online registration form can be registered by staff onsite at the MAKO Medical testing location).
Log on here to the North Georgia Health District website at https://nghd.org/news/media-releases/free-covid-19-testing-available-in-north-georgia for more information.
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