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.
NASHVILLE, Tenn. – Over the weekend, Tennessee Governor Bill Lee traveled to the U.S. Southern Border to meet with Tennessee National Guards troops and receive briefings regarding the skyrocketing rate of illegal crossings and criminal activities.
“Tennesseans serve on the front lines of the Southern border crisis, and it has rapidly escalated to not just a matter of public safety but a threat to our country’s national security,” said Gov. Lee. “Americans owe these troops a debt of gratitude for their service, and the federal government owes Americans a plan to restore both our border security and our standing as a global power.”
Tennessee Adjutant General Jeff Holmes accompanied Gov. Lee and First Lady Maria Lee to spend time with troops and thank them for their service. Gov. Lee and Major Gen. Holmes also participated in a series of briefings regarding illegal crossings with origins from 56 countries, drug seizures and other exploitive crimes like human trafficking.
“What I saw at the border is unsustainable for our country and should be number one priority for national security,” said Gov. Lee. “Tennessee will always step up and serve, but we need immediate reinforcements, like a finished border wall, to ensure our men and women in uniform have the tools they need to do their job.”
Tennessee National Guard serve at the Southern border in the following support capacities:
- 269th Military Police Company – Routinely augments law enforcement by conducting training and providing a presence along the border
- 913th Engineer Company – Capabilities lend to myriad road building efforts and border wall projects
- 2-151 Aviation Battalion – Provides an aerial platform to assist Customs and Border Protection with a number of their logistical and operational priorities
NASHVILLE, Tenn. – Today, Tennessee Governor Bill Lee outlined key administration bills in his 2021 legislative package.
“We have a number of conservative proposals for consideration that will reduce crime, support strong families and get our economy back up to speed,” said Gov. Lee. “These proposals will also position us well to continue the recovery that has already begun across our state.”
In addition to legislative proposals, Gov. Lee’s programmatic initiatives are outlined in his State of the State address.
Key legislative highlights are included below:
Supporting Tennessee Families
Foster Youth Reach Act, SB0722/HB0139: provides higher education support for youth aging out of the foster care system through a pilot outreach program.
Temporary Assistance for Needy Families Proposal, SB0751/HB0142: supports families in need by reforming our TANF program to promote economic mobility and improved outcomes for recipients.
Supporting Quality Education
Common Core Supplemental Materials, SB0769/HB0782: prohibits the local selection of supplemental education materials by schools and districts that are aligned to Common Core, closing a loophole in state law.
Serving Tennessee Heroes
STRONG Act Expansion, SB0755/HB0083: enhances education opportunities for Tennessee National Guard members by expanding tuition reimbursement to include technical certificates and master’s programs.
National Guard Reemployment Act, SB0754/HB0082: ensures Tennessee National Guard members retain employment after returning from active state duty.
Volunteer Firefighter Reimbursement, SB0778/HB0772: provides $600 payments to volunteer firefighters who successfully complete forty hours of in-service training.
Strengthening Tennessee Businesses and Workforce
Tennessee Apprenticeship Act, SB0752/HB0771: expands access and improves quality of apprenticeship programs in Tennessee by registering apprenticeships through the state rather than the federal government.
Business Supports and Taxation, SB0775/HB0776: supports economic recovery of Tennessee small businesses by permitting the deduction of state business relief payments from the state’s franchise and excise tax.
Entertainment Tax Credit, SB0736/HB0141: creates a sales and use tax exemption and a franchise and excise tax credit for film production in Tennessee.
Building Safe Neighborhoods
Constitutional Carry, SB0765/HB0786: advances Second Amendment rights by allowing law-abiding citizens to carry a handgun without a permit while enhancing penalties for firearm theft.
Reentry Success Act, SB0768/HB0785: improves outcomes for formerly incarcerated individuals by increasing transparency in the parole process and enhancing practices that support success post-release.
Alternatives to Incarceration, SB0767/HB0784: expands treatment services and community-based supervision for offenders as alternatives to incarceration.
Addressing Foreign Influences and Confucius Institutes on College Campuses
Transparency in Foreign Investment Act, SB1191/HB1238: requires greater transparency for any foreign investment activity on college campuses, particularly programs and partnerships with Confucius Institutes that have concerning ties to communist regimes.
NASHVILLE, Tenn. – Tennessee Governor Bill Lee today announced the first bill of his administration’s legislative package for the 2021 General Assembly. The Reemployment Act from the Department of the Military will provide reemployment protections to Tennessee National Guard service members who are called to state active duty.
“Over the coming weeks, we will be offering a preview of policy proposals that will streamline Tennessee government and ensure that we are good stewards of taxpayers’ dollars,” said Gov. Lee. “Our National Guard servicemen and women have been front and center in our COVID-19 response and this bill will support their efforts and help ensure the very best continue to serve in the Tennessee National Guard.”
The Reemployment Act will:
- Amend Tennessee law to provide reemployment protections for service members called to state active duty;
- Close the gap in benefits by providing state active duty benefits more closely aligned to those provided while in federal status.
- Keep the Tennessee National Guard competitive in recruiting top talent that might otherwise serve in a neighboring state National Guard that does provide protection