GAINESVILLE – Booster vaccine doses for the Pfizer-BioNTech COVID-19 vaccine have been approved for specific groups of fully vaccinated individuals. Although the booster dose is not required, it will help fully vaccinated people maintain protection over the coming months.
It is important to note, COVID-19 vaccines are working well to prevent severe illness, hospitalization, and death, but with the introduction of the Delta variant, public health experts noticed a reduction of protections against mild and moderate disease.
Booster vaccine doses are approved for the following groups of people who received their second Pfizer vaccine at least 6 months ago: Recommendations will only apply to individuals who received the Pfizer-BioNTech COVID-19 vaccine for their primary series
- 65 years and older
- Residents of long-term care facilities
- 18 and older with underlying medical conditions that put a person at high-risk
- 18 and older who have an occupational or institutional exposure risk
The approval is for the Pfizer vaccine ONLY. Moderna and Johnson and Johnson (J&J) vaccines have not been approved for additional booster doses, right now there is not enough data to support a booster dose recommendation. Both Moderna and J&J are expected to submit data to the FDA in support of booster doses in the coming weeks.
District 2 Public Health and Northeast Georgia Health System want to provide the community an opportunity to be vaccinated with ease and remind the community it is important to get fully vaccinated to keep our communities safe and to stop the spread of COVID-19. District 2 will re-open mass vaccination sites in most of its 13 counties as of September 27.
The following counties will begin administering all doses of the Pfizer vaccine and will have first dose Moderna and J&J vaccines available upon request on September 27:
All Health Departments will be vaccinating every other Saturday. Hall and Forsyth health departments will be vaccinating every Saturday starting October 2. Check with your local health department for Saturday hours and location.
- Banks County – City of Homer Fire Department – 243 Sycamore St., Homer, GA 30547
Monday, Wednesday, and Thursday 9:00 a.m. to 3:00 p.m. and Tuesday 9:00 a.m. to 5:00 p.m.
- Dawson County – Fire Station #2 – 8388 Hwy 53, Dawsonville, GA 30534
Tuesday, Wednesday, and Thursday 9:00 a.m. to 4:00 p.m.
- Franklin County – Franklin Co. Recreation Department – 557 Rocky Ford Rd., Carnesville, GA 30531
Monday, Wednesday, and Thursday 8:30 a.m. to 3:00 p.m.
- Forsyth County – Northside Forsyth Hospital – 1800 Northside Forsyth Dr. suite 360, Cumming, GA 30041
Monday – Friday 8:30 a.m. to 4:30 p.m.
Saturday – 8:30 am to 12:00 pm (at the Forsyth Co. Health Department, October 2)
- Habersham County – Cornelia First Presbyterian – 469 N. Main St. Cornelia GA, 30531
Monday, Tuesday, and Wednesday 9:00 a.m. to 3:00 p.m.
- Hall County – Chicopee Woods Agricultural Center – 1855 Calvary Church Rd., Gainesville, GA 30507
Monday – Friday 8:30 a.m. to 4:30 p.m.
Saturday – 8:30am to 12:00pm (Starts on October 2)
- Hart County – Flat Shoals Baptist Church – 2999 Bowersville Hwy, Bowersville, GA 30516
Monday, Wednesday, and Thursday 9:00 a.m. to 3:00 p.m. and Tuesday 9:00 a.m. to 5:00 p.m.
- Towns County – Towns County Recreations Department – 150 Foster Park Rd. Hiawassee, GA 30512
Monday and Wednesday 1:00 p.m. to 4:15 p.m. and Tuesday 1:00 p.m. to 5:00 p.m.
- White County – The Bridge Church – 607 Hulsey Rd. Cleveland, GA 30528
Monday 9:00 a.m. to 2:00 p.m. and Tuesday 9:00 a.m. to 6:00 p.m.
Lumpkin, Rabun, and Union Counties will continue offering COVID vaccines at the health departments until demand requires a move to a larger location.
Appointments are not required. If an individual prefers to schedule an appointment, they may do so using the VRAS scheduling system via the District 2 Public Health website. Hours of operation and locations may change due to demand. Reference the schedule of locations and hours posted on the public health website to ensure the vaccine site in your county is operational.
For more information on the COVID-19 booster dose visit the CDC website to learn more.
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.
GAINESVILLE, Ga. – As the number of COVID-19 cases across the region, state and nation continue to climb, Northeast Georgia Health System (NGHS) leaders are asking for your help – and warning another post-holiday spike may force them to start rationing care.
“We’re struggling to find staff and space to care for people, and our frontline workers are exhausted,” said Clifton Hastings, MD, Chief of Medical Staff for Northeast Georgia Medical Center (NGMC). “If COVID cases continue to increase, we may be forced to start making decisions about who we can treat effectively and who we have to send elsewhere or turn away. That’s a decision no physician should have to make, and a situation no one in our community should have to face.”
On November 24, two days before Thanksgiving, NGMC hospitals and long-term care locations were treating 133 COVID-positive patients. That total has more than doubled in the following month, up to a record 296 patients as of December 23. The average percentage of tests the Health System administer that come back positive has also risen sharply, up from 16% to 28% during the same timeframe – matching the previous record set in July.
“Early in the pandemic, we learned that limiting some services and expanding others can create additional space to care for patients – which we’ve continued to do – but we’re still faced with the challenge of maintaining enough qualified physicians and nurses to provide high-quality care,” says John Delzell, MD, COVID-19 Incident Commander for NGHS. “We’re extremely thankful for the staffing support the state has supplied, and we will continue to request additional help, but hospitals across the state all need those same resources.”
NGHS received nearly 5,000 doses of Pfizer’s COVID-19 vaccine on December 17 and has vaccinated approximately 2,000 frontline workers during the past week. The Health System also received around 1,500 doses of the Moderna vaccine on December 23. More shipments are expected in early January.
“It’s important to remember that vaccination isn’t a magic bullet that will end the pandemic immediately,” says Supriya Mannepalli, MD, NGMC’s Medical Director of Infectious Disease Medicine. “People are tired of hearing this, but the best way to protect yourself, the people you love and your community this holiday season is to not visit family and friends outside your household, or take precautions if you do.”
According to Wednesday’s COVID-19 Daily Status Report on the Georgia Department of Public Health’s website, Hall County has seen more COVID activity than any county in the state outside the metro Atlanta area. Hall County ranks:
#4 in Confirmed Cases per 100K – 7,847
#5 in Confirmed Cases – 16,193
#5 in Hospitalizations – 1,526
#9 in Deaths – 210
Other counties in the northeast Georgia region that also appear among the top 30 in those categories include Gwinnett, Forsyth, Jackson, Barrow, Stephens, Habersham and Franklin.
“It’s clear that Hall and surrounding counties have been hit especially hard during the pandemic,” says Richard Higgins, Hall County Commission Chairman. “There are a variety of factors at play, but one common factor we can all control are the personal steps we take wear a mask, wash our hands and watch our distance.”
“We all want to keep working, keep our local businesses open and keep our kids in school,” says Kit Dunlap, President of the Greater Hall Chamber of Commerce. “Taking small, inconvenient steps now, like not having large holiday gatherings, will help our community avoid bigger and more difficult steps in the future – like rationing care. Please celebrate safely.”
Get holiday tips, vaccine information and more helpful resources at nghs.com/COVID.
ABOUT NORTHEAST GEORGIA HEALTH SYSTEM
Northeast Georgia Health System (NGHS) is a non-profit on a mission of improving the health of our community in all we do. Our team cares for more than 1 million people across the region through four hospitals and a variety of outpatient locations. Northeast Georgia Medical Center (NGMC) has campuses in Gainesville, Braselton, Winder and Dahlonega – with a total of more than 700 beds and more than 1,100 medical staff members representing more than 50 specialties. Learn more at www.nghs.com.