FDA Approves Second COVID-19 Vaccine
Moderna To Be Marketed as Spikevax COVID-19 Vaccine For Ages 18+
Today (Jan. 31, 2022), the U.S. Food and Drug Administration approved a second COVID-19 vaccine. The vaccine has been known as the Moderna COVID-19 Vaccine; the approved vaccine will be marketed as Spikevax for the prevention of COVID-19 in individuals 18 years of age and older.
Key points
- Spikevax meets the FDA’s rigorous standards for safety, effectiveness and manufacturing quality required for approval.
- Moderna COVID-19 Vaccine has been available under emergency use authorization (EUA) for individuals 18 years of age and older since Dec. 18, 2020.
“The FDA’s approval of Spikevax is a significant step in the fight against the COVID-19 pandemic, marking the second vaccine approved to prevent COVID-19. The public can be assured that Spikevax meets the FDA’s high standards for safety, effectiveness and manufacturing quality required of any vaccine approved for use in the United States,” said Acting FDA Commissioner Janet Woodcock, M.D. “While hundreds of millions of doses of Moderna COVID-19 Vaccine have been administered to individuals under emergency use authorization, we understand that for some individuals, FDA approval of this vaccine may instill additional confidence in making the decision to get vaccinated.”
Spikevax has the same formulation as the EUA Moderna COVID-19 Vaccine and is administered as a primary series of two doses, one month apart. Spikevax can be used interchangeably with the EUA Moderna COVID-19 Vaccine to provide the COVID-19 vaccination series. Moderna COVID-19 Vaccine remains available under EUA as a two-dose primary series for individuals 18 years of age and older, as a third primary series dose for individuals 18 years of age and older who have been determined to have certain kinds of immunocompromise, and as a single booster dose for individuals 18 years of age and older at least five months after completing a primary series of the vaccine. It is also authorized for use as a heterologous (or “mix and match”) single booster dose for individuals 18 years of age and older following completion of primary vaccination with a different available COVID-19 vaccine.
“The FDA’s medical and scientific experts conducted a thorough evaluation of the scientific data and information included in the application pertaining to the safety, effectiveness, and manufacturing quality of Spikevax. This includes the agency’s independent verification of analyses submitted by the company, our own analyses of the data, along with a detailed assessment of the manufacturing processes, test methods and manufacturing facilities,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “Safe and effective vaccines are our best defense against the COVID-19 pandemic, including currently circulating variants. The public can be assured that this vaccine was approved in keeping with the FDA’s rigorous scientific standards.”
FDA Evaluation of Effectiveness Data for Approval for Individuals 18 Years of Age and Older
The Spikevax biologics license application (BLA) builds upon the data and information that supported the EUA, such as preclinical and clinical data, as well as details of the manufacturing process and the sites where the vaccine is made. The FDA evaluates and conducts its own analyses of the data to determine whether the safety and effectiveness of the vaccine has been demonstrated and meets the standard for approval, and whether the manufacturing and facility information assure vaccine quality and consistency.
The approval of Spikevax is based on the FDA’s evaluation and analysis of follow-up safety and effectiveness data from the ongoing randomized, placebo-controlled, blinded clinical trial that supported the December 2020 EUA for the Moderna COVID-19 Vaccine and information from post EUA experience to further inform safety and effectiveness.
The updated analyses to determine effectiveness of Spikevax included 14,287 vaccine recipients and 14,164 placebo recipients 18 years of age and older who did not have evidence of SARS-CoV-2 infection prior to receiving the first dose. The data used for the analyses were accrued before the Omicron variant emerged. These data demonstrated that Spikevax was 93% effective in preventing COVID-19, with 55 cases of COVID-19 occurring in the vaccine group and 744 COVID-19 cases in the placebo group. The vaccine was also 98% effective in preventing severe disease.
FDA Evaluation of Safety Data for Approval for Individuals 18 Years of Age and Older
The FDA’s safety analysis of Spikevax included approximately 15,184 vaccine recipients and 15,162 placebo recipients 18 years of age and older, more than half of these participants were followed for safety outcomes for at least four months after the second dose. Approximately 7,500 participants originally assigned to receive Spikevax in the blinded phase of the clinical trial completed safety follow-up for at least 6 months after the second dose.
The most commonly reported side effects by clinical trial participants were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, nausea/vomiting, swollen lymph nodes under the arm and fever.
Additionally, the FDA conducted a rigorous evaluation of the post-authorization safety surveillance data pertaining to myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of tissue surrounding the heart) following vaccination with the Moderna COVID-19 Vaccine and has determined that the data demonstrate increased risks particularly within seven days following the second dose, with the observed risk highest in males 18 through 24 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 Spikevax Prescribing Information includes a warning about these risks.
The FDA conducted its own benefit-risk assessment using modeling to predict how many symptomatic COVID-19 cases, hospitalizations, intensive care unit (ICU) admissions and deaths from COVID-19 the vaccine in individuals 18 years of age and older would prevent versus the number of potential myocarditis/pericarditis cases, hospitalizations, ICU admissions and deaths that might be associated with the vaccine. FDA has determined that the benefits of the vaccine outweigh the risk of myocarditis and pericarditis in individuals 18 years of age and older.
The FDA is requiring the company to conduct postmarketing studies to further assess the risks of myocarditis and pericarditis following vaccination with Spikevax. These studies will include an evaluation of long-term outcomes among individuals who develop myocarditis following vaccination with Spikevax. In addition, although not FDA requirements, the company has committed to conducting additional post-marketing safety studies, including conducting a pregnancy registry study to evaluate pregnancy and infant outcomes after receipt of Spikevax during pregnancy.
The FDA granted this application Priority Review. The approval was granted to ModernaTX, Inc.
Additional Resources:
Information From the Paris Junior College Sulphur Springs Campus
PJC-Sulphur Springs Center secretary Dana Smock welcomes new student Decker Hendricksmeyer, standing at right, and his mom, Tammy Hendricksmeyer. Dana helps complete Decker’s papers for enrollment into the Sulphur Springs campus.
Paris Junior College — located in Paris, Texas, about 100 miles northeast of Dallas — has been a part of the Lamar County community since 1924.
Paris Junior College offers Associate in Arts, Associate in Science and Associate in Applied Science degrees, as well as Certificates of Proficiency in technical/workforce fields. The college has expanded its academic curriculum through the years to encourage associate degree and university transfer candidates. Since establishing its first vocational program — jewelry and watchmaking in 1942 — the college has been aggressive in adding technical/workforce programs that will benefit students entering the workforce.
The campus of 54 tree-shaded acres includes 20 major buildings and residence halls and provides students a unique and pleasant environment for learning.
Paris Junior College also operates centers in Sulphur Springs, Texas, and in Greenville, Texas.
Vision
To be the educational provider of choice for the region.
Mission
Paris Junior College is a comprehensive community college serving the region’s educational and training needs while strengthening the economic, social and cultural life of our diverse community.
HHSC Launches License Plate Art Contest to Help Victims of Human Trafficking
AUSTIN – Texans can help raise awareness about human trafficking and support young survivors of human trafficking by participating in a new license plate design contest.
The design contest, hosted by the Texas Health and Human Services Commission in conjunction with the Texas Department of Motor Vehicles (DMV), will help create the Stop Human Trafficking Specialty License Plate, which was authorized by House Bill 2633 from the 87th Texas Legislature.
“Human trafficking is an issue that is often hidden in plain sight,” said Megan Bermea, director of Texas HHSC’s Office of Family Services. “We hope this specialty license plate will bring the issue to light and get the attention of more people who can help prevent the exploitation of vulnerable people.”
“We are proud to announce this specialty license plate design contest to raise awareness around the issue of human trafficking,” said Rep. Ann Johnson, who authored HB 2633. “The funds generated by these donations are dedicated to providing shelter and recovery services to some of our most vulnerable and neglected children.”
Texans who want to participate in the contest must create original designs that include the website iWatchTX.org. The iWatchTX.org website is operated by the Texas Department of Public Safety for people to report suspicious activity. The winning design will be used on the specialty license plate, which will be available for purchase through the Texas DMV in the fall of 2022.
HHSC also recently launched the Stop Human Trafficking donation fund to raise money for youth survivors of human trafficking. The fund will be used to provide grants to service providers committed to the recovery and protection of children and adolescents impacted by human trafficking. Proceeds from the sale of the specialty license plate will go toward this fund.
The deadline for contest submissions is April 30, 2022. All entries must follow rules and formatting requirements posted on the HHS website. To enter, visit the HHSC Human Trafficking Resource Center website.
HHSC and organizations involved in helping survivors of human trafficking will select and announce the contest winner in the summer of 2022.
SSMS Lady Cats Basketball Have a Shot Monday to Complete Undefeated Season
Eighth grade Lady Cats basketball have the opportunity to wrap up an undefeated season Monday, Jan. 31 at home.
Coach Nickie Pannell’s eighth grade A and B teams have already clenched the district as champions, but her squads also have the shot at completing an undefeated season.
The middle school coach hopes everyone can pack the SSMS gym Monday afternoon in the hopes of witnessing the second middle school squad this season to go undefeated.
Games start at the middle school gym Monday, Jan. 31 against Hallsville at 4:30 P.M.
Last week the eighth grade A-team raced past Pine Tree 51-8 and B-team got a solid 28-14 win over the Pirates at SSMS.
The Lady Cats hope to complete an undefeated district season Monday, Jan. 31 when they host Hallsville.
KSST is proud to be the official Wildcat and Lady Cat Station. We broadcast Sulphur Springs ISD games year round live on radio. When allowed, we also broadcast games via our YouTube channel.
2 Zoning Requests, 2 Grant Applications, Tax Abatement Policy On Feb. 2 City Council Agenda
Two zoning requests, two grant applications, designation of election judges and early voting dates for the May 2022 city council election, review of the tax abatement policy, seven 380 agreements and bids for materials and contracts for the first phase of the College Street road rebuilding and sidewalk projects are all on Tuesday night’s regular Sulphur Springs City Council agenda.
The City Council will first meet at 6:30 p.m. Feb. 1, 2022, in executive session to consult with an attorney on real property, acquisition of real property for drainage purposes and to consider Project Superman economic development project.
The council will then convene in regular open session at 7 p.m. Tuesday in Sulphur Springs Municipal Building (City Hall) to tackle the rest of the 3-page agenda.
Zoning Issues
The City Council is slated to consider on second and, if approved final, reading Ordinance No. 2795, which grants John Heilman’s request for a 0.97-acre property he owns at 1381 West Industrial Drive to be rezoned from heavy commercial to light industrial. Heilman has been approached by more than one business representative interested in purchasing and developing the property. Heilman plans to have the property replatted in order to make it one parcel. Rezoning to light industrial would match the zoning designation of other adjacent property, making it easier to sell as one parcel. The ordinance was proposed and approved on first reading at the Jan. 4, 2022, City Council meeting.
Sulphur Springs City Council too is being asked to approve on final reading Ordinance No. 2796 which would establish a reinvestment zone for D6, Inc. The business received tax incentives in 2020 to open a branch of the business on Industrial Drive. In October 2021, Gov. Gregg Abbott announced that D6, Inc. had been awarded two grants to help relocate the entire operation from its Portland, Oregon headquarters to Sulphur Springs, Texas, as well as an additional expansion. In order to do so, the business is asking for tax incentives from local taxing entities. Hopkins County Commissioners Court earlier this month approved a 10-year tax incentive for the business. In order to be eligible to apply to the hospital district for a tax abatement, a reinvestment zone is needed. The City Council on Jan. 4 approved Ordinance No. 2796 establishing a reinvestment zone for D6, Inc. The City Council is slated to consider approving the ordinance on second and, if approved, final reading Tuesday night.
Tax Abatement Policy, 380 Agreements
The agenda also calls for discussion and adoption of a Tax Abatement Policy for the City of Sulphur Springs. Taxing entities that offer these types of tax incentives for economic development are required every couple of years to review and adopt a Tax Abatement Policy. Hopkins County Commissioners Court and Hopkins County Hospital District each approved the tax abatement policies recommended earlier this month by Sulphur Springs-Hopkins County Economic Development Corporation Executive Director Roger Feagley.
As part of the consent agenda, Sulphur Springs City Council will be asked to consider approving seven requests for 380 agreements. The infill housing agreements allow builders to request repayment of certain city fees, such as utility tap and permitting fees, in exchange for development of single family homes on vacant and underutilized lots within the city upon successful completion of the project within 3 years of the agreement. Delinquent city taxes and liens on the property and demolition costs associated with clearing a lot to redevelop may also be requested. The seven properties the council is being asked to consider granting 380 agreements for include: 801 Putman Street, 409 Sheffield Street, 115/119 Nicholson Street, 408 Houston Street, 412 Houston Street, 204 West Beckham and 950 Church Street.
Grant Applications
The City of Sulphur Springs earlier this month completed, following a public hearing, a Community Development Block Grant CARES Act grant application to Texas Department of Housing and Community Affairs for the Community Resiliency Program. If approved, Sulphur Springs would receive $3 million in additional funding for construction of the new Senior Citizens Center on Oak Avenue. The application was submitted by the Jan. 19 deadline. Award notifications are expected to be made around March 10, 2022, with grant contracts to start five days later.
On Feb. 1, 2022, the City Council will be asked to approve two resolutions giving city staff approval to submit grant applications to help fund costs of new portable radios for police officers. Resolution No. 1288 would authorize a grant application to be submitted to the Office of the Governor- Homeland Security Division for the purchase of 10 portable radios to be used by the police patrol division. Resolution No. 1289 would authorize an application to be submitted to the Office of the Governor-Criminal Justice Division to purchase eight portable radios to be used by the patrol division.
Also on the Agenda
Bids for excavation, stabilization, concrete pavement and sidewalks for Phase 1 of College Street rebuilding project are to be presented along with city staff’s recommendations on who should be awarded contracts for those services are on the Feb. 1 council agenda.
The City Council also is asked to approved three additional resolutions Tuesday night:
- Resolution No. 1290 adopting the Hopkins County Mitigation Action Plan Five Year Update.
- Resolution No. 1293 calling for a general election for City Council Places 4, and 5, naming election judges, and setting dates for early voting; and
- Resolution No. 1294 authorizing continued participation with the Atmos cities steering committee; and authorizing the payment of five cents per capita to the Atmos cities steering committee to fund regulatory and related activities related to Atmos energy corporation.
A racial profiling report to be submitted to Texas Commission on Law Enforcement, and proclamations designating February as Black History Month and for Adam Henry-USD are also on the Feb. 1 City Council agenda.
And, if any action is needed on the items discussed during the 6:30 p.m. executive session the City Council would vote on them during the regular open forum.
Should anyone wish to address the City Council, they should fill out a card prior to the meeting to let them know they plan to speak during public forum.
This Year’s AARP Foundation Tax Aide Program Begins Soon
This year’s AARP Foundation Tax Aide program begins soon. (This is NOT sponsored by the library, they are merely the site). They are currently taking appointments! Taxpayers can go by the Sulphur Springs Public Library to make an appointment and pick up a packet of paperwork. It is possible to make an appointment online but individuals still need to go by and get their paperwork.
They will open Tuesday, February 8 at 9:30 a.m. – 1:30 pm. Saturday hours are 9:30-12:30. The last day this year this program will be offered is Tuesday, April 12. It is by appointment only, no walk-ins. They do have to follow safety protocols that are required by the AARP Foundation. The counselors are certified by the IRS and have completed over 40 hours of training. There are tax returns they aren’t allowed to complete, such as self-employed with employees or a loss, but they can do returns for all ages, not just older clients. The service is free! AARP Foundation funds pay for training and equipment.
Please contact Mary Lou Foster if you have any questions.
Mary Lou Foster
Local Coordinator
AARP Foundation Tax Aide
Winnsboro Police Department Media Report – Jan. 24-30, 2022
Winnsboro Police Department provided the following media report for the week of Jan. 24-30, 2022:
Arrests
- Jared Lowrance, 23 years of age, of Gilmer, was arrested on 1-25-2022 for Possession of less than 2 ounces of Marijuana.
- Vincent Jones, 21 years of age, of Winnsboro, was arrested on 1-26-2022 on a Winnsboro Municipal Warrant.
- Justin Williamson, 25 years of age, of Tyler, was arrested on 1-26-2022 on 8 Winnsboro Municipal Court Warrants.
Calls for Service
The Winnsboro Police Department responded to a total of 149 calls for service during this reporting period.
Citations
The Winnsboro Police Department issued 39 citations and 57 warnings during this reporting period.
Slaton Pledges To Re-File Legislation To Completely Abolish Abortion In Texas
GREENVILLE, TEXAS – House District 2 Representative Bryan Slaton pledged this weekend to re-file legislation that would completely abolish abortions in Texas, if passed. The bill would “end discrimination against the life of innocent children, and will guarantee the equal protection of the laws to all Texans from the moment of conception,” according to a press release from Slaton’s office.
Rep. Slaton stated, “Throughout the 87th legislature, I fought for the complete abolition of abortion, and looked for every opportunity to advance this righteous cause. The laws of God and nature are clear that life begins at conception, and abortion is murder, plain and simple. We must start acting like it. I pledge to re-file legislation in the 88th legislature to completely abolish abortion and ignore the erroneous opinion of Roe v Wade. Texas must lead on this issue, and we cannot wait for the courts to do the right thing.”
Meal A Day Menu – Jan. 31-Feb. 4, 2022
Volunteers prepare meals at the Sulphur Springs Senior Citizens Center and deliver them five days a week to Meal A Day program recipients in Sulphur Springs and Hopkins County. The Meal A Day Menu for Jan. 31-Feb. 4, 2022, includes:
- Monday – Salisbury Steak, Mashed Potatoes, Normandy Vegetables and a Roll.
- Tuesday – Sweet and Sour Chicken, On a Bed of Rice, Asian Vegetables and Egg Rolls.
- Wednesday – Sliced Ham, Baked Sweet Potatoes, Green Beans and a Roll.
- Thursday – Beef Lasagna, Italian Vegetables and Garlic Sticks.
- Friday – Cheeseburgers, Lettuce, Tomato, Onion, Pickles, Baked Beans and Chips.
The Sulphur Springs Senior Citizens Center is a place where Senior Citizens age 50 and over can have a good time with old friends and make some new ones. Meal-A-Day is just one service the center provides. The coffee pot is always on and a smile is on each face. The SCC has a full library with all different kinds of reading books that can be taken, read and returned. Take as many as you like and bring some of your books in to share with others. Click here to find more information for seniors citizens.
New Sonography Program Approved by Paris Junior College Regents
A five-year plan to create a new Diagnostic Medical Sonography program at Paris Junior College was approved by the Board of Regents during their monthly meeting Monday, Jan. 24.
“The closest sonography programs are at Tyler or Dallas and members of the local medical and veterinary community have asked PJC for it,” said Dr. Pam Anglin, PJC President.
An advisory committee worked for a year to put together a proposed curriculum for the associate degree; this was approved by the PJC Curriculum Committee, the program startup costs and enrollment projections have been put together to submit to the Texas Higher Education Coordinating Board for approval. The first-year equipment outlay is estimated to be around $390,000.
In other business, the regents:
• Received good news on the 2020-2021 audit of Paris Junior College and the PJC Memorial Foundation from Teffany Kavanaugh with McClanahan and Holmes, LLP, as they accepted the audit.
“You have a clean opinion on the financial statements,” Kavanaugh told the regents.
• Approved the interlocal agreement with the City of Paris, consenting in advance to the re-sale of tax foreclosed properties to persons and entities for the purpose of developing affordable housing in accordance with the City of Paris 5 In 5 Housing In-fill Development Program. The regents thanked Paris Mayor Paula Portugal, Assistant City Manager Rob Dine, and Director of Planning and Community Development Andrew Mack for their attendance in support of the agreement.
• Heard the report from Pfluger Architects CEO Terry Hoyle, AIA, on plans for a seven-unit apartment building and restroom remediation plans as called for in the recent Office of Civil Rights Americans with Disabilities Act audit. After discussion, the regents accepted the plans and also approved moving forward with competitive sealed proposals for the project.
• Gave required annual approvals to both the Investment Policy – CAK (LOCAL) and the list of Authorized Brokers / Dealers for Investments.
• Approved updated admissions selection criteria for the licensed vocational nursing and associate degree (RN) nursing programs. For both, greater weight was given to grades in prerequisite courses and HESI A2 (LVN) and HESI LPN to ADN Mobility Exam (ADN) test scores.
“The majority of the points are placed solely on the prerequisites and the HESI assessment which are the two primary indicators of success within nursing,” said PJC Workforce Education Vice President John Spradling.
• Adopted the Local Policy Update 42 provided by the Texas Association of School Boards Policy Service. The updates were made in response to state legislative changes.
• Heard a report on the latest Integrated Postsecondary Education Data System (IPEDS) report comparing PJC to 23 peer community colleges in Texas. PJC spends less in all categories than peers and yet has a graduation and retention rate higher than the peer group.
• Accepted employment of Instructor and Women’s Soccer Coach Paul Burns, effective Jan. 18 and Licensed Vocational Nursing Instructors Amanda Jackson and Madelyn Loschke, effective Jan. 31; the retirement of Workforce Training Director Bettye Finnell effective Jan. 31; and the resignations, with admonishment for breaking contracts, of Mathematics Instructor Charla Holzbog effective Dec. 17, 2021, and LVN Instructor Casey Escobedo effective Feb. 22.
Paris Junior College — located in Paris, Texas, about 100 miles northeast of Dallas — has been a part of the Lamar County community since 1924.
Paris Junior College offers Associate in Arts, Associate in Science and Associate in Applied Science degrees, as well as Certificates of Proficiency in technical/workforce fields. The college has expanded its academic curriculum through the years to encourage associate degree and university transfer candidates. Since establishing its first vocational program — jewelry and watchmaking in 1942 — the college has been aggressive in adding technical/workforce programs that will benefit students entering the workforce.
The campus of 54 tree-shaded acres includes 20 major buildings and residence halls and provides students a unique and pleasant environment for learning.
Paris Junior College also operates centers in Sulphur Springs, Texas, and in Greenville, Texas.
Vision
To be the educational provider of choice for the region.
Mission
Paris Junior College is a comprehensive community college serving the region’s educational and training needs while strengthening the economic, social and cultural life of our diverse community.
