FDA fully approves Pfizer COVID-19 vaccine
Featured News, Featured Stories, News, Press 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.”
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
Featured News, Featured Stories June 4, 2021
JEKYLL 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, 2021
ATLANTA – 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
Featured News, News, Press Release April 12, 2021
Marietta, 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!
Rep. Clyde to Take Metal Detector Fine Case to Federal Court Following Rejected Appeal
News, Press Release April 12, 2021
WASHINGTON, D.C. – Rep. Andrew Clyde released the following statement on April 12th, 2021:
“I recently learned that the formal appeal of my fines incurred as a result of refusing to comply with
Speaker Nancy Pelosi’s unconstitutional placement of metal detectors at the entrance to the floor of the
House of Representatives was rejected. This now provides the legal standing which I needed to challenge
this unconstitutional resolution.
Another aspect that greatly concerns me is the unequal enforcement and selective manner these fines have
been implemented, as noted in House Administration Ranking Member Rodney Davis’ letter to Acting
Sergeant at Arms Timothy Blodgett on February 10, 2021 noting the existence of closed-circuit footage
providing irrefutable proof that Speaker Pelosi bypassed her own screening procedures.
While my team and I continue to await an announcement of a fine levied on the Speaker, we are preparing
for the next stage of this fight. I will take my case to federal court where I am confident justice will be
served.”
State employees and teachers paid parental leave passes General Assembly
News, Press Release, State & National March 29, 2021
ATLANTA – 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.
Georgia Expands COVID Vaccine Eligibility
News, Press Release March 11, 2021
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.
Rep. Andrew Clyde formally appeals fines incurred for refusing to abide by Capitol’s metal detectors
News, Press Release February 24, 2021
WASHINGTON, D.C. – Rep. Andrew Clyde (GA-09) released the following statement regarding his appeal of fines incurred resulting from his refusal to abide by Speaker Pelosi’s unlawful placement of magnetometers outside the entrance to the Floor of the House of Representatives:
“Today, with the assistance of my private counsel, I appealed the fines I incurred as a result of my refusal to abide by Speaker Nancy Pelosi’s unconstitutional placement of magnetometers in front of the entrance to the Floor of the House of Representatives. Per House Resolution 73, which established this ridiculous break in Congressional precedent, I filed my appeal with the House Ethics Committee.
While my name formally appears on the documentation, I am filing this appeal symbolically on behalf of my constituents in the Ninth Congressional District of Georgia, because it is their vote that is being impeded by Speaker Pelosi’s egregious actions.
As I have said before, the installation of the magnetometers is part of the Democratic Party’s ongoing attempt to treat Republicans as a threat when no such threat exists. The ongoing militarization of Capitol Hill, including the placement of metal fencing, razor wire, and the deployment of National Guard troops, are also part of this perverse strategy. The Democratic Party’s motive in crafting this narrative is to silence us through fear and intimidation, with the ultimate goal being the creation of domestic terrorism legislation and a political litmus test for all elected officials, public servants, and members of the Armed Forces. Make no mistake, Democratic Party leaders would rid anyone who does not agree with their fringe ideology from public service and the political sphere if given the opportunity.
I look forward to continuing the appeal process, and I trust the Committee will review my case with the same fairness and due process they will surely afford the Speaker once her fine for allegedly breaking her own rule is processed.”
Feature image courtesy of the Associated Press.
Sen. Steve Gooch Assumes Additional Duties in State Senate
News, Press Release January 25, 2021
ATLANTA (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.
More Georgians to Become Eligible to Receive COVID-19 Vaccine
News, Press Release December 31, 2020
Atlanta – Governor Brian Kemp and Commissioner Kathleen Toomey, M.D., M.P.H., announced plans to add adults aged 65 and older, law enforcement officers, firefighters, and first responders to the current group of individuals eligible to receive the COVID-19 vaccine. Healthcare workers and staff and residents of long-term care facilities are already in this highest priority group. The expanded administration of the vaccine is expected to begin within the next two weeks provided there is adequate vaccine supply available.
The Georgia Department of Public Health (DPH) is following the recommendations of the Centers for Disease Control and Prevention (CDC) and the Advisory Committee on Immunization Practices (ACIP) for prioritizing vaccination. States have the flexibility to tailor these recommendations based on their specific needs and available vaccine.
“Following the expert guidance of Dr. Toomey, the CDC, and the Advisory Committee on Immunization Practices, Georgia will move to expand Phase 1a vaccination criteria within the next two weeks to include the elderly, law enforcement officers, firefighters and first responders – provided the state continues to receive adequate vaccine supplies,” said Governor Kemp. “We will continue to monitor the administration efforts of our public health workers and partners in the private sector, and the supply chain of both the Moderna and Pfizer vaccines to ensure eligible Georgians are vaccinated without delay.”
“Different areas of the state are completing Phase 1a at different times based on the number of healthcare workers and LTCF residents and staff they have to vaccinate,” said Commissioner Toomey. “This expansion of 1a eligible vaccination criteria will allow vaccine to be administered as quickly as possible to our most at-risk populations in terms of exposure, transmission and severity. It also gives healthcare providers and public health staff time to plan and work with local communities across the state to ensure safe and efficient deployment of limited vaccine supplies.”
It is critical that even as vaccine becomes available to more people, all Georgians must continue to wear a mask, practice social distancing and wash your hands frequently. While the COVID-19 vaccine is 95% effective in preventing illness in the individual being vaccinated, it is not yet known if the vaccine fully prevents person to person transmission or asymptomatic infections.
For updates on COVID-19, follow @GaDPH and @GovKemp on Twitter and @GaDPH and @GovKemp on Facebook.
Secretary of State unveils new absentee ballot request portal
News, Press Release August 31, 2020
ATLANTA-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.