COVID-19 vaccines for kids 5-11 are heading to Texas after FDA gives Pfizer shot emergency use authorization
By Karen Brooks Harper
The U.S. Food and Drug Administration on Friday authorized the emergency use of the Pfizer-BioNTech COVID-19 vaccine on children ages 5-11, marking a long-awaited milestone in the nearly two-year fight against the deadly virus that experts say has likely already infected nearly half the population in that age group.
In Texas, that makes up to 2.9 million children eligible for the vaccine.
The federal regulatory agency said the vaccine is safe and effective for children in that age group. The Pfizer test results shared with the FDA show that its vaccine prevents symptoms in most children and causes no side effects more serious than those already seen in older age groups. FDA panelists decided that the benefits of the vaccine for children ages 5-11 — many of whom have suffered isolation, depression and learning loss throughout the course of the pandemic — outweigh the risks associated with the Pfizer shot.
Still uncertain, however, is whether the U.S. Centers for Disease Control and Prevention will limit the shots to only children with preconditions that put them at high risk of serious disease from COVID-19 — a decision expected next week.
"As a mother and a physician, I know that parents, caregivers, school staff, and children have been waiting for today's authorization. Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy," said Acting FDA Commissioner Janet Woodcock, M.D. "Our comprehensive and rigorous evaluation of the data pertaining to the vaccine's safety and effectiveness should help assure parents and guardians that this vaccine meets our high standards."
The FDA's announcement, which follows a recommendation by its vaccine advisory panel earlier this week, triggers an initial federal allocation of more than a million doses destined for children ages 5-11 to providers in nearly half of Texas counties. Those will start landing in Texas pharmacies, pediatrics offices, health clinics and hospitals within a few days, state health officials said.
After the first federal shipment, others will continue on a weekly basis. The amounts will vary based on providers' requests, officials said.
As with other age groups authorized to receive the vaccine, the shots will be free and require two doses to be fully effective.
The vaccines cannot be given to kids, however, until the U.S. Centers for Disease Control and Prevention releases the rules for administering the shot: who qualifies for it, what information must be disclosed to parents at the time it's given and other safety parameters not outlined in the FDA's decision.
CDC advisers are expected to meet next week, with an announcement by the agency to follow shortly after. The agency could decide that the vaccine is appropriate for all or most children, limit its use to only those determined to be at a high risk for death or hospitalization from COVID-19, or impose other limitations or guidelines.
Data from the CDC presented during the FDA panel meeting suggested that as many as 40% of the nation's 28 million children ages 5-11 had already caught the virus and that about one-third of those hospitalized from it had no prior medical history that would have flagged them as high risk.
Only the Pfizer-BioNTech vaccine has been recommended for use in minors, including the 5-11 age group. The Moderna and Johnson & Johnson vaccines are still authorized for use only in adults.
FDA: Safe and effective
This version of the Pfizer vaccine contains one-third of the dosage given to people ages 12 and up. But Pfizer officials say it still offers the same level of antibody response triggered in 18- to 24-year-olds. The Pfizer data is based on a test sample of about 2,200 children.
Pfizer told panel members both in remarks Tuesday and in briefing documents that its vaccine is 91% effective in preventing symptomatic transmission in kids. The test group showed no new side effects — nothing worse than had been seen in older groups — and no incidents of myocarditis, a rare heart inflammation that has occurred in some male adolescents and young adults after taking one of the mRNA vaccines.
There have been no reported deaths from vaccine-induced myocarditis, FDA experts said this week.
Any side effects were described by Pfizer as "mild to moderate" and typical of those experienced by children after receiving common childhood vaccines. If symptoms appeared, they arose in the first two days and went away quickly, the trials showed. Most common among them was pain around the injection area, while other reactions sometimes included fatigue, headache, muscle pain and chills.
Providers will be strictly prohibited from administering diluted adult-sized doses to children. Providers who violate these instructions could have their COVID-19 vaccine provider authorization pulled.
The kid doses are being packaged with smaller needles and orange packaging to differentiate them from purple-topped adult doses.
Moderna and Johnson & Johnson are conducting their trials for the same age group but have not yet released their test data. Pfizer is already doing trials for two younger age groups: 6 months to 2 years, and 2-5 years. The pharmaceutical company's data on the older segment is expected early next year.
No school mandates in Texas
The FDA ruling did not address whether the vaccine should be mandated for school attendance or other activities, and the CDC's decision next week will not address that either. Leaders of both of those agencies have said it is not their responsibility to make those decisions.
In Texas, there is no indication that Republican lawmakers and state leaders, who have adamantly opposed all COVID-19 vaccine mandates, will require children to receive the COVID-19 vaccine to attend school in the state.
Since the vaccine was approved for children 12-15 earlier this year, there have been no moves to require it at middle or high schools.
Texas already requires some vaccines — such as hepatitis C, polio and measles — for children attending school but has many exceptions for parents who wish to opt out.
School districts across the state are already making plans to administer the vaccine. The Austin Independent School District will host vaccine clinics just as it did when COVID-19 vaccines were first approved for children over the age of 12 at the beginning of summer. Since then, these clinics have vaccinated more than 9,000 children in the Austin area.
In Big Spring Independent School District, which has about 3,700 students, Superintendent Jay McWilliams said a section of the district's high school will be used as a vaccine clinic.
Cassidy McBrayer, superintendent for the Hawley Independent School District, north of Abilene, said there won't be a big push in her district to set up any clinics because they're not sure if there will be a demand for them.
In Texas, the Legislature determines which vaccines are mandatory for school, not the state's health agency.
Young children and COVID-19
Federal health experts said this week that children ages 5-11 are "at least as likely" as adults to catch the virus, contradicting some early theories that they were less susceptible to transmission.
Nationally, 8,300 children ages 5-11 have been hospitalized with COVID-19 to date, Dr. Fiona Havers, a viral disease specialist at the CDC, told FDA panelists.
Native American, Hispanic and Black children were three times more likely than white children to be hospitalized, she said.
While the Texas Department of State Health Services maintains unreliable information on age breakdowns of positive COVID-19 cases, schools have regularly reported infections on campuses and can offer an idea of the spread among minors.
Three months into this school year, the number of total COVID-19 cases reported among students surpassed the total from the entire 2020-21 school year. As of Oct. 17, Texas schools had reported around 200,000 total student cases, or roughly 4% of students, since the beginning of this semester.
Some 272 school districts nationwide have had unplanned closures this school year due to COVID-19, with more than 2,000 schools and 1 million students affected, Havers said. That includes at least 45 small districts in Texas that shut down in the first few weeks of this school year.
After reaching their highest hospitalization numbers of the entire pandemic earlier this summer, Texas hospitals have reported that the number of kids showing up with COVID-19 is starting to decrease.
As of Oct. 22, DSHS data shows that 31 out of nearly 69,000 COVID-19 deaths reported in Texas were children younger than 10, a very small fraction of the statewide death toll.
According to the Pfizer brief filed with the FDA, there was a 419% increase in COVID-19 cases among children younger than 18 in the United States in August and September compared to June and July. COVID-19 was among the top 10 leading causes of death for children 5-14 years of age nationwide between January and May, according to the CDC, although the mortality rate from COVID-19 for that age group remains small.
Among children 5-11 years old nationally, there have been nearly 2 million confirmed and reported cases of COVID-19 and at least 143 deaths.
The Texas Tribune's Mandi Cai and Brian Lopez contributed to this report.
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It's official, jack-of-all-trades Matthew McConaughey is staying out of politics and not running for Texas governor.
In a video posted to social media on Sunday, the Academy award-winning actor set the record straight that he would not be running for governor after greatly considering so by listening and learning about Texas and U.S. politics.
"As a simple kid born in Uvalde, Texas, it never occurred to me that I would one day be considered for political leadership. It's an inspiring and humbling path to ponder," McConaughey said. "It is also a path I am choosing not to take at this moment."
Instead, McConaughey says he will continue to invest in entrepreneurs, businesses and foundations he believes are supporting people in different ways.
The announcement puts an end to the months of speculation that he could announce a bid for governor. While he's previously called politics a "bag of rats" and little indicated he was mulling a run as the Dec. 13 deadline to file was approaching, he still fared well among some voters.
The latest poll by the University of Texas and Dallas Morning News showed he would beat Gov. Greg Abbott by eight percentage points in a head-to-head matchup and would fare even better alone against former congressman Beto O'Rourke, with nearly 50% of respondents choosing McConaughey.
The primaries for the election will take place in March before the November 2022 election for governor. So far, O'Rourke is running as a Democrat against Michael Cooper, president of the Beaumont NAACP, and Deirdre Gilbert, an educator from the Houston area. On the other side, Gov. Greg Abbott is up against conservative commentator Chad Prather and former Texas GOP Chairman Allen West.
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There is a fearless declaration of the obvious in “Being Texan: Essays, Recipes, and Advice for the Lone Star Way of Life,” a book that invites its readers to recall the power and panache of the late Texas Gov. Anne Richards, before getting schooled on no less than twenty types of taco.
Released this month, “Being Texan” is the first of several Texas Monthly titles to come in the build-up to the magazine's upcoming 50th anniversary in 2023. It is divided into four sections: Identity & Culture, Town & Country, Arts & Entertainment and Food & Drink.
In the introduction, titled “What Does it Mean to Be Texan?,” Texas Monthly editor Dan Goodgame addressed the eclectic aspirations of the book, writing: “Our modest goal was to craft a well-informed, thoughtful sampling of the best the state has to offer.” To this humble end, forty-two editors were utilized to cover fifty-five topics, which tackle everything from the various dress codes that make up “Texas chic” to Selena’s ongoing appeal.
The resulting richness is all over the map, running from Texas Monthly Senior Editor John Nova Lomax’s frustration over the frequent mispronunciations of Texas cities (“From Amarila to Wad-a-loop”) to Oscar Casares’s bittersweet essay on Dia de Los Muertos in the time of COVID (“Souls of the Departed”).
The book goes from silly to serious fast, and the pace might unseat some readers who would otherwise just enjoy the ride of pride that comes from being reminded that Texas gave the world Cheetos, Fritos, Doritos, Dr. Pepper, Liquid Paper and the microchip.
So, in a book that switches from the state’s early instance on remaining a slave republic to a piece about collecting San Antonio ghost stories, it perhaps goes without saying that the essays on brisket and beer are the easiest to digest.
“Being Texan” does, in truth, contain some delicious and downright literary food writing.
Joe Galvan’s “Ode to the Raspa,” treats the summertime shaved ice staple as nothing less than a kind of edible ambassador of U.S. cuisine. “They serve as an important and necessary reminder of the fluctuating, imprecise words that American food inhabits,” he writes like some semiotics professor, before waxing poetic on how raspas embody childhood innocence as well as “the humidity of a July evening that finds itself at the bottom of a Styrofoam cup.”
But readers who are tempted to skim the section on “Strong Texas Women” or “The Evolution of Juneteenth” to get to Paula Forbes’ warning not to skip the processed cheese when slow cooking queso, will have missed out on some deep insight into what it means to embrace all the appealing and uneasy aspects of the state.
In “A Tale of Two High Schools,” Dan Q. Dao, details how, as a Vietnamese kid growing up in Houston, he employed the tropes of Texas culture as a tool of survival. “Perhaps out of a sense of self-preservation, I became enamored with the gilded mythology of Texas, from the folklore of the Alamo to the twang of country music. I wore cowboy boots, showed up for Friday night football games, and rarely missed a rodeo,” writes Dao, observing that: “Part of me believed that if I proclaimed my Texanness loudly enough, I would be spared the label of outsider.”
The dilemma of the homegrown Texas outsider is artfully explored in Skip Hollandsworth’s “Why McMurtry Matter,'' a meditation on the ironic popularity of Larry McMurtry, a writer who wrestled with his relationship to Texas--particularly the Hollywood myths and misconceptions that surrounded the state. Speaking about (to his mind) the perplexing success of “Lonesome Dove,” McMurtry said: “All I had wanted to do was write a novel that demythologized the West. Instead, it became the chief source of western mythology. Some things you cannot explain.”
There is much about Texas itself that seems hard to explain.
But David Courtney, a senior editor at Texas Monthly, does a good job of speculating on this rare amalgam of conservative pride and fearless experimentation that tends to run through the state, when he writes “Texans believe they possess something deep within themselves that sets them apart, and therefore they kind of do.”
Despite the surface-level accessibility of a book that addresses the cultural significance of Neiman Marcus and the extreme brand loyalty to Whataburger, “Being Texan” offers rare input regarding Texas and its citizenry, as well as handy advice for breaking in a pair of cowboy boots.
'Not a band, an experience': Musician Pete Monfre pushes the boundaries of making it in the music industry
In a city where live music is heralded above all else, Pete Monfre was surprised to find local musicians working for free that he quit the industry for 10 years in 2006.
Local musicians tended to be underpaid before COVID-19 sent the music industry reeling, but the fallout from the pandemic exasperated the existing problems. Musician and marketer Monfre knows—he’s been behind that shaking tip jar, trying to turn a profit while doing what he loves. He’s tackling the problem with a unique brand of live shows, which go against the grain, mix business with pleasure and help bring home the bacon.
The shows, called Stories from the Road, are an informal storytelling jam session at The Saxon Pub that encourages interaction between the artist and audience.
After a brief hiatus due to ongoing woes of the pandemic Stories from the Road came back to The Saxon Pub on Saturday. It was the first of 23 consecutive shows that didn’t sell out, which Monfre attributes to the break of not having shows.
“We called it Stories from the Road—not a band, an experience,” Monfre said. “We're not going to rehearse, we're not going to have a list, we're not going to prepare, every show is a one-off and you will never see it again.”
His shows start early at 6 p.m., with a rotating group of musicians playing blues or Americana who need not rehearse. This time it featured Mark "Kaz" Kazanoff on saxophone and harmonica, bassist Mark Epstein, drummer Kevin Hall and Adam Pryor on Hammond Organ.
You’ll probably end up spending a bit more than the typical show at the Saxon Pub, around $30 per person, but each show goes directly to supporting the artists that made it.
“Part of the mission was to advocate for fair wages for musicians and to help musicians understand their economic value,” Monfre said. “Now I can afford to pay musicians a modest guarantee and we call that the Fair Play approach to live music.”
Monfre moved to Austin as a young adult with the intention of “conquering the music industry” in 1981, which he told Austonia he did not do but did meet “a lot of interesting people.” He left Austin to tour for a few years, then moved to Milwaukee, where he continued to play music.
After returning to Austin in 2006, Monfre discovered some musicians were playing shows for free.
“I'm playing in Chicago and Michigan and hardcore blues places, and we don't play for free,” Monfre said. “So I actually quit for 10 years. There is no reason to play for free whatsoever if you just get the model right.”
Having already tried to conquer the music industry once, Monfre took a business-forward approach the second time. The model also caters to what he believes is an underserved group: working professionals who want to meet like-minded individuals but also be home by 9 p.m.
Chief Technology Officer for Economic Transformation Technologies David Smith, who has been coming to other Monfre shows since they started in 2016, said he enjoys the improvisational nature of the shows because it reminds him of old Austin.
“The Stories from the Road get back to the root of what music is: the fact that you can sit and jam, make music with musicians because they understand music, and that's the soul of Austin,” Smith said. “It really is a celebration of music.”
Monfre said the informality is what makes his shows so popular—you’ll hear the musicians ask the key for a song, take a request from the crowd, make a lighthearted jab at one another or create a song from scratch.
“They want to see the sausage being made, it's really funny I would have never thought it,” Monfre said.
Price (right) said he was happy the show ended early so he could make it home to Lampasas. (Laura Figi/Austonia)
“I am knocked out. It just really didn't get any better than what we just had—this band was so good, the crowd was so good,” Price said. “That's what Austin in the ‘60s and ‘70s was all about, just everybody throwing it together.”
Stories from the Road is returning to The Saxon Pub stage on Dec. 18, with a completely new group of musicians. The show, like always, will start at 6 p.m.
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