FDA fully approves Pfizer COVID-19 vaccine
News, Press Release August 23, 2021Today, 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 Ag Commissioner Gary Black launches Senate campaign
News June 4, 2021JEKYLL ISLAND, GA – Gary Black, Georgia’s Agriculture Commissioner who received more votes than any candidate for U.S. Senate or Governor in 2018 and 2014, today launched his campaign for the U.S. Senate seat currently held by Raphael Warnock.
“Warnock and Biden promised to ‘fundamentally change America,’” Black said. “They’re five months into it and job growth and opportunity are down, inflation, debt and gas prices are up, the Middle East is back at war. Satisfied? Or sickened? I fundamentally object. I’ll stand in the gap and say the wave comes this far, and no further.”
A longtime champion of agribusiness — Georgia’s largest economic driver — Black has made the “Georgia Grown” brand one of the most successful marketing efforts of its kind in the nation.
Black was a founding member of President Trump’s rural and agriculture advisory group started in June of 2016. He also hosted President Trump in a visit with Georgia farmers hit hard by Hurricane Michael and worked with the administration to utilize China tariff money on expanded marketing efforts in Taiwan. He was a vocal backer of Congressman Doug Collins’ Senate campaign last year.
He received more votes than any candidate for U.S. Senate or Governor of either party in Georgia in 2018 and 2014.
Biography of Gary Black
Gary W. Black has championed innovation, solutions, support, and growth in Georgia’s largest industry for over 40 years.
Gary grew up on his family’s beef cattle farm in Commerce, GA where he and his wife Lydia also raised their children, Ward and Caroline. He is a University of Georgia graduate, and a past president of the college’s alumni society.
Under Gary’s leadership, the Georgia Department of Agriculture’s divisions for information technology, animal health, homeland security and food safety have garnered national acclaim. Commissioner Black has led innovation in domestic and international promotion through the renowned Georgia Grown branding program, helping Georgians start businesses and expand markets. Since taking office in 2011, Gary has also improved the department’s fiscal responsibility and performance, as well as strengthened career paths for employees.
Gary Black is a Leadership Georgia Pattillo Award recipient and the 2017 Georgia Trend Magazine Georgian of the Year. He currently serves on advisory committees for the United States Department of Agriculture, Environmental Protection Agency and the Export Import Bank of the United States.
Gary and Lydia continue to raise commercial beef cattle at Harmony Grove Farms, and serve together in various ministries at Maysville Baptist Church.
Ralston and leadership issue Israel statement of support
News, Press Release May 12, 2021ATLANTA – Speaker David Ralston (R-Blue Ridge), Speaker Pro Tempore Jan Jones (R-Milton) and the leadership of the House Majority Caucus issue the following statement in support of Israel:
“In the last two days, more than 1,000 rockets have been fired at innocent men, women and children in Israel. The Israeli people are being attacked by Hamas terrorists bent on killing as many civilians as possible. It is appalling, and it must end.
“We send our love and prayers to our friends in Israel — a nation that remains one of the most loyal and important allies the United States has ever known. May God protect them and keep them safe.
“We call on the White House to denounce these barbaric acts of terrorism and to rally the peace-loving nations of the world in defense of Israel and its people.”
The House Majority Caucus leadership team includes Majority Leader Jon Burns (R-Newington), Majority Caucus Chairman Matt Hatchett (R-Dublin), Majority Whip Trey Kelley (R-Cedartown), Majority Caucus Vice Chairman Micah Gravley (R-Douglasville) and Majority Caucus Secretary-Treasurer Bruce Williamson (R-Monroe).
Commissioner King Seeking Help from Public for Blairsville Home Explosion Investigation
News, Press Release May 4, 2021ATLANTA – Insurance and Safety Fire Commissioner John F. King today asked for assistance from the public for his office’s investigation into Sunday morning’s home explosion on Pauline Lane in Blairsville.
“We are asking that anyone in the area with video or audio footage of Sunday morning’s explosion in Blairsville to reach out to our office at 1-800-282-5804,” said Commissioner King. “Our investigators are working around the clock to determine the cause of this incident and any new audio or video could prove instrumental to these efforts.”
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The mission of the Office of the Insurance and Safety Fire Commissioner is to protect Georgia families by providing access to vital insurance products and safe buildings through fair regulation that creates economic opportunities for all Georgians.
April 11 to17 is National Public Safety Telecommunicators Week
Community, Press Release April 14, 2021Kelvin King announces campaign for U.S. Senate in Georgia
News, Press Release April 12, 2021Marietta, GA – Today, Kelvin King announced his campaign for the U.S. Senate in Georgia. King, a Georgia native, proud veteran, Republican activist, and successful business owner, had the following to say about his campaign.
“Republicans in our state are at a crossroads. We’ve seen what’s at stake in our country. The Biden Administration is currently wrecking our economy, creating a crisis at our border, and systematically dismantling every bit of the “America First” agenda implemented over the last four years. Career politicians, woke corporations, and the cancel culture are all empowered while our families and small businesses are left to pay the price. As the GOP, we have to decide right now if we are knocked down or knocked out. Personally, I am ready to take back our state and fight for the future of our country!
Many of you across Georgia know my wife, Janelle, and me. I am a graduate of the United States Air Force Academy, a proud veteran, and the owner of a successful construction company. At the same time, my story includes being born to a teenage mother, raised in a single parent home, and overcoming the challenge of poverty. Statistically speaking, I shouldn’t have made it. I truly am a product of the American dream, which makes me the fiercest defender of freedom, opportunity, and American exceptionalism.
I believe our nation deserves better than President Biden and his weak leadership, just as I believe our state deserves better than Senator Warnock’s divisive far left representation. This election for the U.S. Senate is bigger than you and me. Georgia truly is ground zero for taking back our country. Let’s win for America.”
Kelvin King was born in Macon, GA and raised in Mableton, GA. His mom, Janet, was a teenager when she had Kelvin. His mother, at a young age, had the courage to leave an abusive marriage, becoming a single mother to two children, Kelvin and his younger sister Tameisha. Kelvin spent most of his childhood in a single parent home and they oftentimes struggled to make ends meet. Though he became the man of the family early, his mother and grandmother worked hard to instill in him the values needed to grow into a successful young adult. It was these values he credits with earning him an appointment to the United States Air Force Academy where he was an All-Conference football player.
Kelvin graduated from the Academy and served 5 years in the Air Force as a Contracting Officer. He made the rank of Captain before deciding to leave the military and transition to corporate America. Upon completion of his service, he returned to Georgia to begin building his life as a civilian. He worked in procurement, business development and eventually became the General Manager of an international construction firm where he achieved numerous honors including being named to the Top 20 Under 40 in ENR Magazine and Manager of the Year in his company. After several years in this role, he decided to save enough money to start his own construction firm, Osprey Management. Kelvin’s firm has twice been named the fastest-growing business by the Atlanta Business Chronicle.
Kelvin is married to Janelle who serves as a panelist and commentator on Fox 5 Atlanta’s “The Georgia Gang.” The two of them have been entrenched in Georgia politics as leading conservative activists and are passionate about spreading the Republican message throughout the minority community. They founded “Speak Georgia”, a 501c3 organization designed to educate and provide resources to the community directly from subject matter experts.
The Kings attend the Church of the Apostles and in their free time enjoy cooking out with friends. Kelvin is also the proud father of a fellow Air Force veteran Christian Ward – GO AIR FORCE!
State employees and teachers paid parental leave passes General Assembly
News, Press Release, State & National March 29, 2021ATLANTA – Speaker David Ralston (R-Blue Ridge) and State Representative Houston Gaines (R-Athens) announced that House Bill 146 received final passage in the General Assembly today. House Bill 146 provides three weeks of paid parental leave as a new benefit to full-time state employees and teachers. This is the Georgia’s first paid parental leave benefit for state employees and teachers.
“This paid parental leave benefit speaks to our hardworking state employees and teachers and tells them that we value their contributions and the sacrifices they make to serve our citizens,” said Speaker David Ralston. “I commend Representative Gaines for taking the lead on this important initiative which demonstrates our unyielding commitment to families and giving children the best possible start in Georgia.”
This new paid parental leave benefit would provide some 245,000 state employees and teachers with three weeks of paid leave upon the birth, adoption, or foster care placement of a child. It applies to all employees with six months of creditable service regardless of the employee’s gender. It is limited to once in any 12-month period. This benefit does not impact the employee’s accrued leave or rights under any family medical leave policy.
“I am proud that this legislation received such overwhelming bipartisan support in the General Assembly,” said Rep. Houston Gaines. “We know this benefit will make a difference in the lives of young families across our state. This is a pro-family, pro-jobs bill that will set the right example in the nation’s #1 state for business.”
Co-sponsors of House Bill 146 included Rep. Sharon Cooper (R-Marietta), Speaker Pro Tempore Jan Jones (R-Milton), Rep. Marcus Wiedower (R-Watkinsville), Rep. Bonnie Rich (R-Suwanee), and Rep. Terry England (R-Auburn). House Bill 146 was carried in the State Senate by President Pro Tempore Butch Miller (R-Gainesville).
Speaker David Ralston announced a paid parental leave benefit for employees of the Georgia House of Representatives in July 2019. That benefit went into effect in January 2020. The State Senate implemented a similar policy at that time.
House Bill 146 now goes to Governor Brian Kemp for his consideration. More information about House Bill 146 may be found here.
District 2 public health announces appointments available for vaccine
Community, News, Press Release March 8, 2021GAINESVILLE – The 13 District 2 county health departments have appointments available now for the COVID-19 vaccine. “Recent shipments have given us enough vaccine to open up more appointments for residents,” said Alan Satterfield, Director of Nursing. “We hope that residents who are eligible to be vaccinated will take this opportunity to make an appointment.” Eligible residents can make appointments by calling 1-888-426-5073 OR online at www.phdistrict2.org OR by calling their local health department.
To see if you are eligible, go to https://dph.georgia.gov/
On March 8, eligibility was expanded to include pre-K through 12 educators and staff of public and private schools, adults with intellectual or developmental disabilities and their caregivers, and parents of children with complex medical conditions.
Union Fire/Rescue and EMA COVID-19 Response
Community, Press Release February 24, 2021Prescribed burn scheduled for February 25, northwest of Blairsville
Community, News, Press Release February 25, 2021BLAIRSVILLE, Ga – The US Forest Service is planning a prescribed burn on Thursday, February 25th, 2021. The 127 acre Chapman Ford prescribed burn unit is along the east side of Lake Nottely, in Union County, approximately six miles northwest of Blairsville, along Chapman Ford Road and Gray Road. The burn is expected to start at 11 a.m. till approximately 3 p.m. Based on the weather forecast, smoke may be visible anywhere around Lake Nottely, from Murphy Highway 129, and could potentially be smelt in and around the Blairsville area. Motorists are advised to use safe speeds and caution on any roadways if smoke is present.
NGTC Names John Wilkinson as New President
Community, Press Release January 25, 2021ATLANTA, GA—Technical College System of Georgia (TCSG) Commissioner Greg Dozier has appointed former Georgia State Senator and Career, Technical, and Agricultural Education (CTAE) specialist John Wilkinson as the new President of North Georgia Technical College (NGTC).
“Senator Wilkinson has spent his professional life advancing and advocating for CTAE here in Georgia,” said TCSG Commissioner Greg Dozier. “He is one of Georgia’s leading CTAE experts and we are excited for him to lead North Georgia Technical College as we serve the needs of business and industry in the region and across the state. I know he will continue the lasting legacy left by Dr. Mark Ivester by providing opportunity for every student that comes through the college’s doors.”
Wilkinson began serving in Georgia’s General Assembly in 2011 as State Senator representing District 50. Senator Wilkinson served as the Chairman of the Agriculture and Consumer Affairs Committee and as Vice-Chairman of the Education and Youth Committee. In 2012, he was named “Policy Maker of the Year” by the Georgia Association for Career and Technical Education. Prior to being elected State Senator, Wilkinson was a program manager at the Georgia Department of Education, where he oversaw the state’s agricultural education programs. He also worked as the executive secretary for the Georgia Future Farmers of America (FFA) Association.
“I am truly honored to be chosen to lead North Georgia Technical College,” said Wilkinson. “Technical education is near and dear to my heart as I have seen how it transforms the lives of students. It is my goal to continue in the footsteps left by Dr. Mark Ivester by providing business and industry with a skilled workforce and by helping more students realize their full potential through postsecondary education.”
In 2017, Senator Wilkinson was presented the Outstanding Service Award by the Georgia Vocational Agriculture Teachers Association and was later named the Region V national award winner by the National Association of Agricultural Educators. The University of Georgia College of Agricultural and Environmental Sciences honored Senator Wilkinson with an Award of Excellence in 2009. He is a member of the Georgia Agricultural Education Hall of Fame and was recognized as the Outstanding Member of the National Association of Supervisors of Agricultural Education in 2006.
A lifelong advocate of CTAE, Wilkinson began his career teaching Agriculture and serving as an FFA advisor in Banks County and Forsyth County public high schools. Wilkinson received his Bachelor of Science in Agriculture and Masters in Education at the University of Georgia.
The State Board of the Technical College System of Georgia approved Commissioner Dozier’s appointment of John Wilkinson on Thursday, January 14 in Atlanta. Wilkinson assumes his new role as President on February 1.
Sen. Steve Gooch Assumes Additional Duties in State Senate
News, Press Release January 25, 2021ATLANTA (January 25, 2021) | Recently, Sen. Steve Gooch (R – Dahlonega) received his committee assignments for the 2021 legislative session.
Sen. Gooch will serve as the Vice Chairman of the Senate Appropriations Committee, Vice Chairman of the Senate Transportation Committee, and as a member of the Ethics, Finance, Reapportionment and Redistricting, and Regulated Industries and Utilities Committee. Additionally, Sen. Gooch will serve as an Ex- Officio member of the Rules and Natural Resources and the Environment Committees. Sen. Gooch will also continue to serve as the Senate Majority Whip.
“I am grateful for the Lt. Governor’s office and the Senate Committee on Assignments for allowing me to serve our community, as well as our state, through these committee appointments,” said Sen. Gooch. “This session will be unlike any other that we have experienced and will require careful, responsible leadership, particularly when it comes to our state budget. I am honored to have an opportunity to lend my experience to the service of our state through these committees, as well as through my role as the Senate Majority Whip.”
“Sen. Gooch, as well as all members receiving committee assignments, have proven their ability to provide meaningful solutions to issues citizens face across the state,” said Lt. Governor Geoff Duncan. “Sen. Gooch brings a host of experience and knowledge to each committee he serves on and I look forward to continuing to work alongside him as he works tirelessly to advance policies in the best interest of all Georgians.”
The first session of the 156th Georgia General Assembly convened on January 11, 2021, at the Georgia State Capitol.
District 2 Health Department Statement to Patients concerning COVID-19 vaccine
Community, News January 11, 2021GAINESVILLE, GA – The following is a statement from the District 2 Health Department:
“Due to the huge response for the COVID-19 Vaccine, all District 2 Public Health Departments’ phone lines, call center, and the website is overwhelmed and unable handle the demand.
We ask that everyone be patient. We understand that everyone is anxious, but everyone who wants the vaccine will be given the opportunity to get vaccinated.
Currently, there is a limited supply of vaccine available at a small number of providers. As more vaccine is shipped to additional enrolled providers, access to appointments will improve over the days and weeks ahead.
Again, we ask that residents be patient for the next couple of weeks as vaccine and appointments become more readily accessible.
ADDITIONAL INFORMATION:
It is important to remember that this is a two-dose vaccine, given 21 or 28 days apart, depending on the manufacturer. For the Pfizer vaccine, it is 21 days apart and the Moderna vaccine is 28 days apart. This means that appointments for the second dose must be scheduled when the first dose is received. This process also places some limits on the speed at which the vaccine can be given.
We are adding staff to help with vaccine administration.
We are planning with other health care providers, colleges and universities to utilize nursing students, paramedics, and other health care professionals to help vaccinate residents.
In addition, we are scheduling special clinics where we can vaccinate larger groups of people at one time. An announcement will be made about these clinics when we have staffing and vaccine on hand. Appointments will be required.
The special clinics will require larger venues where people can safely social distance while being vaccinated and then wait the required observation time after being vaccinated.
We continue to place orders for more vaccine as we administer the vaccine on hand. This will keep our vaccine supply line going.”
Image courtesy of WiR_PIXS.