Pfizer asked the U.S. government Thursday to allow use of its COVID-19 vaccine in children ages 5 to 11 in what would be a major expansion that could combat an alarming rise in serious infections in youngsters and help schools stay open.
If regulators give the go-ahead, reduced-dose kids’ shots could begin within a matter of weeks for the roughly 28 million children in that age group.
Many parents and pediatricians are clamoring for protection for youngsters under 12, the current age cutoff for COVID-19 vaccinations in the U.S.
The Food and Drug Administration will have to decide whether the shots are safe and effective in elementary school-age children. An independent expert panel will publicly debate the evidence Oct. 26.
Pfizer and its German partner BioNTech said their research shows younger kids should get one-third of the dose now given to everyone else. After their second dose, the 5- to 11-year-olds developed virus-fighting antibody levels just as strong as those that teens and young adults get from regular-strength shots.
While kids are at lower risk of severe illness or death than older people, COVID-19 does sometimes kill children – at least 520 so far in the U.S., according to the American Academy of Pediatrics. And cases in youngsters have skyrocketed as the delta variant has swept through the country.
While some mothers and fathers will take a hard stand against vaccinating their children, many parents of elementary students are eagerly awaiting authorization of the shots after 18 months of remote learning, COVID-19 scares and infections, mask debates and school quarantines.
They are looking forward to regular visits to grandparents again, worry-free playdates, vacations and the peace of mind of dropping children at school without the constant fear they will get sick. Principals are hoping the shots will allow schools to stay open and return to normal.
Sarah Staffiere of Waterville, Maine, said she can’t wait for her children to get vaccinated, especially her 7-year-old, who has a rare immune disease that has forced the family to be extra cautious throughout the pandemic.
“My son asked about playing sports. ‘After you’re vaccinated.’ He asked about seeing his cousins again. ‘After you’re vaccinated.’ A lot of our plans are on hold,” said Staffiere, a laboratory instructor at Colby College. “When he’s vaccinated, it would give our family our lives back.”
Gib Brogan of Wayland, Mass., said he is constantly worried about getting a call from his 10-year-old son’s school about virus exposure or infection, and he is hoping his child can be vaccinated in time for the holidays.
“I know our school district has careful protocols and procedures in place,” he said, “but every time we send him off to school, I’m thinking, ‘Are we going to get a phone call?’ ”
Pfizer studied the lower dose in 2,268 volunteers ages 5 to 11 and said there were no serious side effects. The study isn’t large enough to detect any extremely rare side effects, such as the heart inflammation that sometimes occurs after the second dose of the regular-strength vaccine, mostly in young men.
Cindy Schilling, an elementary school principal in West Virginia, which ranks last among the states in the percentage of fully vaccinated residents, said she doesn’t think many parents will take their children to get the shot.
She said she often hears them say they are more concerned about the effects of the vaccine than COVID-19, mainly because they haven’t seen any young children get dangerously sick.
“Some parents are all for it and getting it for peace of mind,” she said, “but the majority of parents I’ve talked to will not be getting it.”
Heather Miller, a mother from Dexter, Maine, said no one in her family of six is rushing to get the vaccine. She said she wants to wait for follow-up studies on the formula.
“I’m not 100% against getting it eventually, but I kind of fall into the ‘not right now, wait and see’ category,” Miller said.
Offering shots to elementary school children would be another big expansion of the U.S. vaccination drive at a time when many poor countries are desperately short of vaccine. The U.S. has just begun dispensing booster shots to tens of million of senior citizens and other vulnerable Americans.
If the FDA authorizes emergency use of the kid-size doses, the Centers for Disease Control and Prevention will make a final decision, after hearing from its outside advisers.
To avoid mix-ups, Pfizer is planning to ship the lower-dose vials specially marked for use in children.
Moderna has requested FDA permission to use its vaccine in 12- to 17-year-olds and also is studying its shots in elementary school children. Pfizer and Moderna are studying even younger children as well, down to 6-month-olds. Results are expected later in the year.
“It makes me very happy that I am helping other kids get the vaccine,” said Sebastian Prybol, 8, of Raleigh, N.C. He is enrolled in Pfizer’s study at Duke University and doesn’t yet know if he received the vaccine or dummy shots.
“We do want to make sure that it is absolutely safe for them,” said Sebastian’s mother, Britni Prybol.
But she said she will be “overjoyed” if the FDA clears the vaccine.
Med Center Health has created a breast clinic in hopes of consolidating services and serving patients more efficiently.
Dr. Diego Cabrera, medical oncologist at The Medical Center at Bowling Green and de facto leader of the clinic, said Med Center Health officials thought there was a need in the community for individuals to receive all of their necessary cancer treatment in one location.
“Between all of the back and forth, it would take two to three months to get their treatment,” Cabrera said. “There was a significant delay in receiving the care they needed. I figured I would start a dedicated breast clinic that would take a multi-disciplinary approach to assist patents who have breast cancer.”
The clinic is open for walk-ins on Tuesdays and Thursdays from 1 to 2 p.m. Appointments can also be made throughout the week.
Cabrera said the clinic provides a variety of services such as screenings, mammograms, ultrasounds and oncology surgeries.
“It’s not just myself going over these patients, but several other doctors are commenting on the characteristics of the case,” he said. “I think we can definitely expedite and streamline the care of these cancer patients.”
Cabrera referred to the “cancer commute” many local residents take to places such as Nashville or Louisville to receive the necessary care for breast cancer issues or concerns.
He said the clinic is a showcase of how The Medical Center can eliminate those long travel times.
“We at The Medical Center have the right equipment needed to treat patients here in Bowling Green,” Cabrera said. “There are patients with a strong family history of breast cancer and they want to know if they have an increased risk of breast cancer. I think we have enough medical professionals that can deal with patients properly without having to go someplace else.”
Another reason he said the clinic’s opening is timely is because of the decrease in cancer screenings during the coronavirus pandemic. October is Breast Cancer Awareness Month.
With people being less motivated to go to health care facilities in recent months, many individuals were not detecting cancer as quickly as possible.
“Throughout the pandemic, we realized how important screenings are – particularly for breast cancer,” Cabrera said. “There is so much more we can do when it’s found in its initial stages. The most important way to fight breast cancer is through screenings and mammograms.”
He said the plan for the clinic is for it to eventually have its own building on The Medical Center campus.
Now, the clinic is located at the Medical Arts Building in the Medical Center Hematology and Oncology Unit at 350 Park St., Suite 106.
“We have a blueprint for it now,” Cabrera said. “Many exciting things are happening at The Medical Center when it comes to cancer care. If we get the volume of patients we think we are going to get, we will continue to get more personnel to assist as well. With some of these cancers – time is of the essence. I think we can improve their outcomes through this.”
– Appointments can be made by calling the clinic’s reception desk at 270-796-2557.
– Follow reporter John Reecer on Twitter @JReecerBGDN or visit bgdailynews.com.
WASHINGTON – Senate leaders announced an agreement Thursday to extend the government’s borrowing authority into December, temporarily averting an unprecedented federal default that experts said would devastate the economy.
Republican leader Mitch McConnell said, “The Senate is moving forward.”
The first crucial vote on the measure was expected Thursday night.
In their agreement, Republican and Democratic leaders edged back from a perilous standoff over lifting the nation’s borrowing cap, with Democratic senators accepting an offer from McConnell.
McConnell made the GOP offer a day earlier, just before his Republicans were prepared to block longer-term legislation to suspend the debt limit and as President Joe Biden and business leaders ramped up their concerns that a default would disrupt government payments to millions of people and throw the nation into recession.
The White House signaled the president’s support, with principal deputy press secretary Karine Jean-Pierre issuing a statement that the president would sign a bill to raise the debt limit when it passed Congress.
Earlier, she called the short-term deal a “positive step,” even as she assailed Republicans for blocking Democratic efforts.
“It gives us some breathing room from the catastrophic default we were approaching because of Senator McConnell’s decision to play politics with our economy,” she said.
Wall Street rallied modestly on the news.
The agreement sets the stage for a sequel of sorts in December, when Congress will again face pressing deadlines to fund the government and raise the debt limit before heading home for the holidays.
The agreement will allow for raising the debt ceiling by about $480 billion, according to a Senate aide familiar with the negotiations who spoke on condition of anonymity to discuss them. That is the level that the Treasury Department has said is needed to get to Dec. 3.
“Basically, I’m glad that Mitch McConnell finally saw the light,” said Bernie Sanders, the independent senator from Vermont.
McConnell portrayed it differently.
“The pathway our Democratic colleagues have accepted will spare the American people any near-term crisis, while definitively resolving the majority’s excuse that they lacked time to address the debt limit through (reconciliation),” McConnell said Thursday. “Now there will be no question: They’ll have plenty of time.”
Congress has just days to act before the Oct. 18 deadline when the Treasury Department has warned it would quickly run short of funds to handle the nation’s already accrued debt load.
McConnell and Senate Republicans have insisted that Democrats go it alone to raise the debt ceiling. Further, McConnell has insisted that Democrats use the same cumbersome legislative process called reconciliation that they used to pass a $1.9 trillion COVID-19 relief bill and have been employing to try to pass Biden’s $3.5 trillion measure to boost safety net, health and environmental programs.
McConnell said in his offer Wednesday that Republicans would still insist that Democrats use the reconciliation process for a long-term debt limit extension. However, he said Republicans are willing to “assist in expediting” that process, and in the meantime Democrats may use the normal legislative process to pass a short-term debt limit extension with a fixed dollar amount to cover current spending levels into December.
On Wednesday, Biden enlisted top business leaders to push for immediately suspending the debt limit, saying the approaching deadline created the risk of a historic default that would be like a “meteor” that could crush financial markets.
At a White House event, the president shamed Republican senators for threatening to filibuster any suspension of the $28.4 trillion cap on the government’s borrowing authority. He leaned into the credibility of corporate America to drive home his point as the heads of Citi, JP Morgan Chase and Nasdaq gathered in person and virtually to say the debt limit must be lifted.
Fast-growing Simpson County is growing its available industrial acreage.
The Franklin-Simpson Industrial Authority announced this week that it has purchased 187 acres near the existing Henderson Industrial Park and will develop the land into a new site called Stone-Givens Industrial Park.
The new park is named for former state Rep. Wilson Stone and state Sen. David Givens. Industrial authority Chairman Gary Broady said the two legislators were instrumental in securing funding for infrastructure in the county’s other industrial parks.
“It is only fitting that our new site be named in their honor,” Broady said in a news release.
Industrial authority Executive Director Dennis Griffin said the site had been farmland but is now zoned industrial.
Griffin said the site is on Ky. 100 about one mile from the interchange with Interstate 65. It is adjacent to Henderson Industrial Park, which is just west of the new development.
The industrial authority has applied for a grant through the U.S. Economic Development Administration to help develop roads and other infrastructure in the park.
This development comes on the heels of a July announcement that the industrial authority is receiving $300,000 from the Kentucky Transportation Cabinet to improve access to Henderson Industrial Park.
That industrial park, home to such employers as Hunt Ford, Sumitomo Electric Wiring Systems and Taeyang Metal, has helped fuel the employment boost that has made Simpson County one of Kentucky’s fastest-growing counties.
Simpson County’s population jumped from 17,327 in 2010 to 19,594 in the 2020 U.S. Census Bureau statistics.
That growth is due largely to employers locating in the county’s Henderson, Sanders Interstate and Wilkey North industrial parks, but those are now at or near capacity.
“The new industrial park is a huge addition for our county,” Simpson County Judge-Executive Mason Barnes said. “We can now offer large tracts of land again to major industries looking to locate in this region. The quality jobs that have been brought by industries to our other parks have led to a lot of positive growth for our county.”
Griffin expects the Stone-Givens Industrial Park to have roads and other infrastructure in place by the summer of 2022.