Hall County Health Department providing vaccines on Labor Day

News, Press Release
Labor Day vaccines

HALL COUNTY – Labor Day weekend will look a little different this year due to an increased need to be vaccinated due to the Delta surge.  Hall County Health Department will be working on Labor Day to vaccinate the community.

On Friday, September 3, Governor Kemp is providing paid time off for state employees to receive their COVID-19 vaccines.  For this reason, District 2 Public Health Departments will remain open from 8:00 am until 12:00 pm to vaccinate all state employees and the public.

On Monday, September 6, Hall County Health Department will be providing COVID-19 vaccinations and gas gift cards in the amount of fifty dollars for the first 100 Georgia residents, 18 years and older, that wish to receive their vaccine.  The health department will be vaccinating from 8:00 am to 5:00 pm. They will be closed for lunch from 12:00 pm to 1:00 pm.

As Labor Day approaches, it is as important as ever to avoid crowds, wear a mask, wash your hands, and watch your distance. If you have not gotten a COVID-19 vaccine this is the weekend to get vaccinated.

To find more information regarding COVID-19 for your county, please visit phdistrict2.org.

District Two Cases by County

Banks

Cases (last 2 weeks): 137

Cases Per 100k (last 2 weeks):  686

Positive PCR Tests (last 2 weeks): 20.4%

Vaccines Administered:  9, 788

One Dose:  5,452(29% of residents)

Fully:  4,626 (25% of residents

Deaths (Duration of COVID):  44

Overall Hospitalizations  (March 2020-Aug 31) :  234

 

Dawson

Cases (last 2 weeks): 375

Cases (last 2 weeks) Per 100k: 1388

Positive PCR Tests (last 2 weeks):  23.1%

Vaccines Administered:  17,662

One Dose:  9, 596 (39% of residents)

Fully:  8,423 (34% of residents)

Deaths (Duration of COVID):  49

Overall Hospitalizations  (March 2020-Aug 31) :  276

 

Forsyth

Cases (last 2 weeks): 1,918

Cases (last 2 weeks) Per 100k: 760

Positive PCR Tests (last 2 weeks):  17.6%

Vaccines Administered:  236,504

One Dose:  125,601 (55% of residents)

Fully:  113,488 (50% of residents)

Deaths (Duration of COVID):  206

Overall Hospitalizations  (March 2020-Aug 30) :  1,096

 

Franklin

Cases (last 2 weeks): 162

Cases (last 2 weeks) Per 100k: 694

Positive PCR Tests (last 2 weeks):  20.8%

Vaccines Administered:  14,552

One Dose:  8,086 (36% of residents)

Fully:  6,916 (30% of residents)

Deaths (Duration of COVID):  50

Overall Hospitalizations  (March 2020-Aug 30) :  190

 

Habersham

Cases (last 2 weeks): 300

Cases (last 2 weeks) Per 100k: 655

Positive PCR Tests (last 2 weeks):  19.0%

Vaccines Administered:  31,352

One Dose:  17,448 (39% of residents)

Fully:  14,869 (33% of residents)

Deaths (Duration of COVID):  160

Overall Hospitalizations  (March 2020-Aug 30) :  528

 

Hall

Cases (last 2 weeks): 1555

Cases (last 2 weeks) Per 100k: 754

Positive PCR Tests (last 2 weeks):  18.3%

Vaccines Administered:  160,642

One Dose:  87,756 (44% of residents)

Fully:  76,519 (39% of residents)

Deaths (Duration of COVID):  487

Overall Hospitalizations:  2,742

 

Hart

Cases (last 2 weeks): 126

Cases (last 2 weeks) Per 100k: 483

Positive PCR Tests (last 2 weeks):  18.1%

Vaccines Administered:  17,449

One Dose:  9,502 (37% of residents)

Fully:  8,314 (32% of residents)

Deaths (Duration of COVID):  40

Overall Hospitalizations (March 2020 -August 2021):  142

 

Lumpkin

Cases (last 2 weeks): 370

Cases (last 2 weeks) Per 100k: 1,095

Positive PCR Tests (last 2 weeks):  18.1%

Vaccines Administered:  20,990

One Dose:  11439 (35% of residents)

Fully:  10,011 (31% of residents)

Deaths (Duration of COVID):  73

Overall Hospitalizations (March 2020 -August 2021):  353

 

Rabun

Cases (last 2 weeks): 63

Cases (last 2 weeks) Per 100k: 371

Positive PCR Tests (last 2 weeks):  14.9%

Vaccines Administered:  14,613

One Dose:  7,750 (47% of residents)

Fully:  6,906 (41% of residents)

Deaths (Duration of COVID):  45

Overall Hospitalizations (March 2020 -August 2021):  174

 

Stephens

Cases (last 2 weeks): 253

Cases (last 2 weeks) Per 100k: 961

Positive PCR Tests (last 2 weeks):  27.8%

Vaccines Administered:  18,592

One Dose:  10,099 (39% of residents)

Fully:  8,687 (34% of residents)

Deaths (Duration of COVID):  80

Overall Hospitalizations (March 2020 -August 2021):  280

 

Towns

Cases (last 2 weeks): 103

Cases (last 2 weeks) Per 100k: 856

Positive PCR Tests (last 2 weeks):  26.2%

Vaccines Administered: 11,159

One Dose:  5,883 (51% of residents)

Fully:  5,343 (46% of residents)

Deaths (Duration of COVID):  52

Overall Hospitalizations (March 2020 -August 2021):  167

 

Union

Cases (last 2 weeks): 253

Cases (last 2 weeks) Per 100k: 999

Positive PCR Tests (last 2 weeks):  33.6%

Vaccines Administered:  20, 586

One Dose:  11,011 (47% of residents)

Fully:  9,962 (43% of residents)

Deaths (Duration of COVID):  83

Overall Hospitalizations (March 2020 -August 2021):  274

 

White

Cases (last 2 weeks): 339

Cases (last 2 weeks) Per 100k: 1,067

Positive PCR Tests (last 2 weeks):  24.5%

Vaccines Administered:  19,565

One Dose:  10,640 (36% of residents)

Fully:  9,334 (32% of residents)

Deaths (Duration of COVID):  76

Overall Hospitalizations (March 2020 -August 2021):  343

FDA fully approves Pfizer COVID-19 vaccine

News, Press Release
pfizer

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.” 

Since Dec. 11, 2020, the Pfizer-BioNTech COVID-19 Vaccine has been available under EUA in individuals 16 years of age and older, and the authorization was expanded to include those 12 through 15 years of age on May 10, 2021. EUAs can be used by the FDA during public health emergencies to provide access to medical products that may be effective in preventing, diagnosing, or treating a disease, provided that the FDA determines that the known and potential benefits of a product, when used to prevent, diagnose, or treat the disease, outweigh the known and potential risks of the product.

FDA-approved vaccines undergo the agency’s standard process for reviewing the quality, safety and effectiveness of medical products. For all vaccines, the FDA evaluates data and information included in the manufacturer’s submission of a biologics license application (BLA). A BLA is a comprehensive document that is submitted to the agency providing very specific requirements. For Comirnaty, the BLA builds on the extensive data and information previously submitted that supported the EUA, such as preclinical and clinical data and information, as well as details of the manufacturing process, vaccine testing results to ensure vaccine quality, and inspections of the sites where the vaccine is made. The agency conducts its own analyses of the information in the BLA to make sure the vaccine is safe and effective and meets the FDA’s standards for approval.

Comirnaty contains messenger RNA (mRNA), a kind of genetic material. The mRNA is used by the body to make a mimic of one of the proteins in the virus that causes COVID-19. The result of a person receiving this vaccine is that their immune system will ultimately react defensively to the virus that causes COVID-19. The mRNA in Comirnaty is only present in the body for a short time and is not incorporated into – nor does it alter – an individual’s genetic material. Comirnaty has the same formulation as the EUA vaccine and is administered as a series of two doses, three weeks apart.

“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine. We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnaty’s safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities,” said Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research. “We have not lost sight that the COVID-19 public health crisis continues in the U.S. and that the public is counting on safe and effective vaccines. The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S.”

FDA Evaluation of Safety and Effectiveness Data for Approval for 16 Years of Age and Older

The first EUA, issued Dec. 11, for the Pfizer-BioNTech COVID-19 Vaccine for individuals 16 years of age and older was based on safety and effectiveness data from a randomized, controlled, blinded ongoing clinical trial of thousands of individuals.

To support the FDA’s approval decision today, the FDA reviewed updated data from the clinical trial which supported the EUA and included a longer duration of follow-up in a larger clinical trial population.

Specifically, in the FDA’s review for approval, the agency analyzed effectiveness data from approximately 20,000 vaccine and 20,000 placebo recipients ages 16 and older who did not have evidence of the COVID-19 virus infection within a week of receiving the second dose. The safety of Comirnaty was evaluated in approximately 22,000 people who received the vaccine and 22,000 people who received a placebo 16 years of age and older.

Based on results from the clinical trial, the Pfizer vaccine was 91% effective in preventing COVID-19 disease.

More than half of the clinical trial participants were followed for safety outcomes for at least four months after the second dose. Overall, approximately 12,000 recipients have been followed for at least 6 months.

The most commonly reported side effects by those clinical trial participants who received Comirnaty were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, and fever. The vaccine is effective in preventing COVID-19 and potentially serious outcomes including hospitalization and death.

Additionally, the FDA conducted a rigorous evaluation of the post-authorization safety surveillance data pertaining to myocarditis and pericarditis following administration of the Pfizer-BioNTech COVID-19 Vaccine and has determined that the data demonstrate increased risks, particularly within the seven days following the second dose. The observed risk is higher among males under 40 years of age compared to females and older males. The observed risk is highest in males 12 through 17 years of age. Available data from short-term follow-up suggest that most individuals have had resolution of symptoms. However, some individuals required intensive care support. Information is not yet available about potential long-term health outcomes. The Comirnaty Prescribing Information includes a warning about these risks.

Ongoing Safety Monitoring

The FDA and Centers for Disease Control and Prevention have monitoring systems in place to ensure that any safety concerns continue to be identified and evaluated in a timely manner. In addition, the FDA is requiring the company to conduct postmarketing studies to further assess the risks of myocarditis and pericarditis following vaccination with Comirnaty. These studies will include an evaluation of long-term outcomes among individuals who develop myocarditis following vaccination with Comirnaty. In addition, although not FDA requirements, the company has committed to additional post-marketing safety studies, including conducting a pregnancy registry study to evaluate pregnancy and infant outcomes after receipt of Comirnaty during pregnancy.

The FDA granted this application Priority Review. The approval was granted to BioNTech Manufacturing GmbH.

Related Information

Georgia Expands COVID Vaccine Eligibility

News, Press Release

Atlanta – The Georgia Department of Public Health (DPH) and Governor Brian Kemp today announced the state will expand its vaccine eligibility March 15, 2021, to include adults aged 55 and older, individuals with disabilities, and certain medical conditions.

Individuals with intellectual and developmental disabilities are already eligible for vaccination. This expansion now includes disabilities caused by an injury (e.g., traumatic brain injury or spinal cord injury), a disability due to a longstanding condition that could cause vision loss, nerve damage or loss of a limb, or a disability due to illness such as ALS or multiple sclerosis.

The medical conditions referenced are:

  • Asthma
  • Cancer
  • Cerebrovascular disease
  • Chronic kidney disease
  • COPD
  • Cystic Fibrosis
  • Diabetes
  • Hypertension
  • Heart Conditions
  • Immunocompromised State
  • Liver Disease
  • Neurologic Conditions
  • Overweight and Obesity
  • Pregnancy
  • Pulmonary Fibrosis
  • Sickle Cell Disease
  • Thalassemia

To find a vaccine location near you or to schedule an appointment, log on to https://dph.georgia.gov/covid-vaccine. For individuals aged 16 and 17 who are in an eligible population for vaccination, Pfizer is the only vaccine currently approved for these ages. Please schedule an appointment at CVS or Walgreens or at one of the GEMA mass vaccination sites to ensure Pfizer vaccine is available to you.

For updates on COVID-19, follow @GaDPH and @GovKemp on Twitter and @GaDPH and @GovKemp on Facebook.

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