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
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).
Kelvin 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.
News Release – Appalachia Georgia Friends of the Bears
Press Release March 15, 2021Ellijay, GA – 03-15-21 – The Appalachia Georgia Friends of the Bears would like to remind the public that March marks the time for the Black Bears to emerge from den. The first to wake up are the adult males and Subadults in early to mid-March. Second to emerge are solitary females and Sows with Yearlings in late March-mid-April. Finally, are the Sows with Cubs of the Year in mid-April-early May. They will be out, about, and hungry.
Attractants like birdseed, hummingbird feeders, pet food, livestock food, greasy barbecues, smokers and fish cookers, and other wildlife foods can be accessed by black bears. Minimize attractants and the availability of food rewards throughout your yard and neighborhood. Appalachia Georgia has approximately 3,000 black bears. Help us save a bear’s life and remove the attractants.
The intentional and unintentional feeding of bears teaches them to approach homes and people for food which is a recipe for Human-Bear conflict. Studies in Canada have shown that two-thirds of Human-Bear conflict were related to improperly stored garbage. In addition, it destroys their teeth, digestive tracts, and results in a slow and painful death. Store garbage in a sturdy building or place in an approved bear-resistant trash receptacle and put it out on the day of pick up goes a long way.
The Appalachia Georgia Friends of the Bears mission is to reduce Human-Bear conflict through proactive educational outreach programs, increase public awareness about coexisting with black bears, the use of humane bear deterrents, and advocacy. Visit BearWise.org and agfriendsofthebears.com for more information on reducing Human-Bear Conflict.
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.
Fannin and Gilmer arts organizations awarded vibrant communities grants
Community, Press Release October 22, 2020ATLANTA – Speaker David Ralston and the Georgia Department of Economic Development’s (GDEcD) Georgia Council for the Arts announced that arts organizations in Fannin and Gilmer counties received Vibrant Communities grant awards to support arts programming for fiscal year 2021.
In Fannin County, the Blue Ridge Community Theater received a $5,000 grant to support its 2021 production of “It’s Time for Laughter: Trouble in the Tropicabana.” The Blue Ridge Mountains Arts Association received a $5,000 grant to support the 2021 Blue Ridge Writers’ Conference. In Gilmer County, the Gilmer Arts & Heritage Association received a $5,000 grant to support its production of “Good Rockin’ Tonight Christmas Show.”
“Our area is rich with creative arts and cultural opportunities, and I am very proud of these organizations and the contributions they make to our community,” said Speaker David Ralston. “These grants demonstrate our continuing commitment to the arts and the opportunities for enrichment and entertainment they provide.”
“A thriving arts community creates thousands of jobs and contributes to a healthy and diverse economy. The Georgia Council for the Arts is proud to continue to support our state’s arts organizations through the distribution of Vibrant Communities and Cultural Facilities grants,” said GDEcD Commissioner Pat Wilson. “The arts community needs our support more than ever, and this funding offers immediate assistance in housing and facilitating arts programs that provide meaningful experiences for Georgians.”
Following precedent set by the National Endowment for the Arts (NEA), the Georgia Council for the Arts used Peer Review Panels to adjudicate applications. These panels included fellow professionals who are experienced in the arts discipline or type of grant being reviewed, or are Georgia citizens with a record of involvement in arts activities, experience and knowledge.
Georgia’s creative industries have a reported $62.5 billion impact on the economy, generating roughly $37 billion in revenue and accounting for about 200,000 jobs in the state.
The Georgia Council for the Arts (GCA) is a division of the Georgia Department of Economic Development whose mission is to cultivate the growth of vibrant, thriving Georgia communities through the arts. GCA provides grant funding, programs and services statewide that support the vital arts industry, preserve the state’s cultural heritage, increase tourism and nurture strong communities. Funding for Georgia Council for the Arts is provided by appropriations from the Georgia General Assembly and the National Endowment for the Arts.
Feature image courtesy of the Blue Ridge Community Theater.
Secretary of State unveils new absentee ballot request portal
News, Press Release August 31, 2020ATLANTA-Georgia Secretary of State Brad Raffensperger unveils a new online portal to make it easier for Georgia voters to request absentee ballots for the November elections. Georgia voters with a driver’s license or state ID card will now be able to request an absentee ballot entirely online.
“Georgia is constantly searching for new and innovative ways to expand access to the ballot and uphold the integrity of the vote,” said Raffensperger. “We are encouraging Georgia voters who are particularly vulnerable to the COVID-19 threat to use our new online absentee ballot request portal to request absentee ballots safely and securely from their computers or phones. This new tool will help counties stay on top of the several million absentee ballot requests expected in November.”
Secretary of State Brad Raffensperger has developed a website that will allow Georgia voters to request an absentee ballot entirely online. Georgia voters will be able to request their ballot via the portal using their first and last name, date of birth, county where they are registered, and Georgia State ID or Georgia Driver’s License number. Voters will get a confirmation email that their request has been entered into the system. Also, voters can monitor their ballot status on My Voter Page.
The portal is available here: http://www.securevotega.com/secureabsentee/
Absentee ballots requested for the November 2020 presidential election cannot be sent out before September 15.
In the past, Georgia voters had to download and print an absentee ballot request, then scan and email it or put it in the mail. This new portal saves voters effort and postage and will increase confidence that the request has been received by county elections officials. It also makes it easier and faster for county election official to process absentee ballot requests by minimizing the possibility of data entry errors.
While the State ID or driver’s license number provide a secure safeguard for requesting ballots, the ballots themselves will still be verified by matching the voter signature to their signature on file upon submission. A record 1.6 million absentee ballot requests were received for the June primary, inundating county elections officials. This portal will make processing the large number of absentee ballot requests expected for the November election easier for county election officials to process quickly and accurately.
Kevin Johnson Announces His Candidacy for the 2020 Gilmer County Chief Magistrate Elections
Election February 14, 2020Kevin Johnson proudly announces his candidacy for the 2020 elections for Chief Magistrate of Gilmer County.
As a veteran of the Marine Corps and with over 30 years of law enforcement experience, his dedication to service continues on as he humbly asks for support in his campaign to further his community that he cares so much for.
As a former Georgia State Patrol Trooper, he has received annual training in courtroom demeanor, case law, affidavits, arrest warrants, search warrants, and courtroom testimony. He is very experienced in courtroom demeanor and procedures as it relates to trial law. During his career, he has often been called upon to give expert testimony in both criminal and civil court cases.
His background establishes a solid foundation to serve as your Chief Magistrate. He has the experience that makes him the right choice to serve our community in this role.
Election day is Friday, May 19, 2020. The elections will be held concurrently with the statewide primary election.
Learn more about Kevin Johnson and his campaign by visiting www.facebook.com/badgetobench
Contact info:
Name: Kevin Johnson
Organization: Kevin Johnson for Chief Magistrate
Email: [email protected]
State Senator John Wilkinson Announces for Congress
Politics, Press Release January 29, 2020GEORGIA NINTH DISTRICT – State Senator John Wilkinson announced today that he plans to run for the Ninth District Congressional seat. This election will be to replace Congressman Doug Collins, who has announced that he will be running for a seat in the United States Senate. Senator Wilkinson, who was elected to the State Senate in a special election in 2011 and has been re-elected to 4 additional terms, was raised on a small farm in Stephens County. Working with projects in 4-H and FFA, he learned the value of hard work, cooperation, and responsibility at an early age. Those values have stayed with him during his career in agriculture, education and politics. He has not missed a day of work during his eight years of service in the Senate.
“This is a critical time for our country, and we need an experienced, conservative voice willing to stand up for the values that residents of North Georgia hold dear”, said Wilkinson. “For the past eight years in Atlanta, I have fought to eliminate useless red tape and regulation of business, defended the sanctity of all life, and fought for our constitutional rights guaranteed by the 2nd Amendment. I look forward to continuing that fight in Washington.”
A native of Toccoa and graduate of Stephens County High School, Wilkinson earned degrees in agriculture and education from the University of Georgia. He has experience as a classroom teacher and served on the State Agricultural Education staff for 26 years. He has served as State Advisor to the Georgia FFA Association, as well as the Georgia Young Farmer Association. He was recognized as the Outstanding Member of the National Association of Supervisors of Agricultural Education in 2006. He and his wife Debbie have two children and five grandchildren. John and Debbie are active members of Tates Creek Baptist Church.
Senator Wilkinson has served as Chair of the Agriculture and Consumer Affairs Committee in the Senate for the past eight years. He also serves as Vice Chairman of the Education and Youth Committee, as well as a member of the Natural Resources and the Environment, Appropriations and Rules Committees. He has served as Secretary of the Senate Majority Caucus for the past 6 years.
The Ninth Congressional District includes all of Banks, Dawson, Elbert, Fannin, Franklin, Gilmer, Habersham, Hall, Hart, Jackson, Lumpkin, Madison, Rabun, Stephens, Towns, Union, White and parts of Clarke, Forsyth and Pickens counties. To learn more about Senator John Wilkinson, please visit www.VoteWilkinson.com.