[ad_1]
Leng Vong Reiff had just received his second dose of the Covid vaccine, and he was thinking about his two teenage sons, who weren’t vaccinated with guilt. So he started banging on his keyboard.
Like countless parents across the country, she was looking for vaccine clinical trials for children. Managed to find one, applied and got a call back.
“They said a clinic in Nebraska had an opening right now, four hours away,” he recalled. Better still, this was a placebo-free trial, so he knew his sons would be given the real vaccine.
Clive, Iowa resident Ms. Vong Reiff put 9-year-old Logan and 5-year-old Quentin in her car and drove west on Interstate 80 to the clinic, where her sons were given their first shots of the Pfizer-BioNTech vaccine. They returned for their second shoot three weeks later and retained them for the next school year. And they will be back in December for antibody testing.
Families are facing difficult situations as most schools reopen after 13 months of distance learning. Since the highly contagious Delta variant has taken hold, Dozens of schools across the country have closed classes or paused sessionsespecially in states with low vaccination rates.
48 million children in the United States are under the age of 12 and are not yet eligible for a Food and Drug Administration-approved vaccine.
In early September, nearly 252,000 children, including teenagers, tested positive. American Academy of Pediatrics analysis.
Roughly 54 percent of people aged 12-17 who were eligible for the Covid vaccine received at least one dose. But public health experts say it will take months for the FDA to decide whether the results of various clinical trials for those aged 5 to 11 and 2 to 5 allow vaccines for the youngest age groups.
With few options other than taking precautions like wearing a mask, some parents have even sought out adult doses of off-label shots through their pediatricians. The FDA was discouraged on Friday. The agency warned that “children are not young adults” and that currently commonly used adult doses have not been fully studied for potential safety risks in young children.
No doubt this summer has been particularly challenging for parents, especially after public health experts warned that the Delta variant is highly contagious, even from vaccinated household members. While children, especially older adults, are still less likely than adults to be hospitalized or die from Covid, about 30,000 children She was admitted to hospitals with Covid in August, the highest level ever during the pandemic.
The hospitalization rate in mid-August for children and adolescents diagnosed with COVID was about five times the rate at the end of June. a study It was released earlier this month by the Centers for Disease Control and Prevention. The report found that this rate increased almost tenfold among newborns to 4-year-olds.
In mid-August, Covid-related emergency room visits and hospital admissions also increased among children. a second CDC study.
The researchers found that geography plays a role. These visits and admissions were 3.4 and 3.7 times higher in states with lower vaccination rates.
Parental anxiety has increased the demand for places in children’s vaccine trials and made appointments scarce. A spokesperson said, for example, that Pfizer’s clinical trial is fully booked.
So Miss Vong Reiff has most likely caught a cancellation slot in Nebraska.
Mother of two, Dr. Tina Sosa didn’t have to travel far to get her son vaccinated in one try. A pediatric hospital specialist, Dr. Sosa was on a fellowship at Cincinnati Children’s Hospital Medical Center when Pfizer began a trial there.
He said his 3-year-old elder son, Brandon, had no side effects from the two injections he received in April. “I even squeezed his arm and asked if it hurt, he said no.”
Dr. Sosa has since moved to Rochester, NY, where she has worked at the University of Rochester Medical Center. Dr. Sosa said his 7-month-old son, Leo, will begin the Moderna trial next month, while Brandon will follow up with his trial in Cincinnati via an app and phone.
In his push on vaccine duties on Thursday, President Biden voiced the need to develop vaccines to protect children as young as 12.
“Now, if you’re a parent of a young child and are wondering when it will happen, when — the vaccine — is available to them, I strongly support independent scientific review for vaccine uses for children under 12,” he said. said. “We can’t take shortcuts to this scientific work.”
The three major pharmaceutical companies in the US are at different stages when it comes to trials for children.
A spokesperson, Kit Longley, said Pfizer is currently running a single trial for children under 12.
The first phase of the study included 4,500 children: 3,000 children ages 5 to 11; 750 from 2 to 5; and 750 from 6 months to 2 years. The second and third stages involve 4,500 children.
Ms Longley said Friday that the company expects trial data for children ages 5 to 11 to be available later this month, and will potentially seek FDA emergency use authorization for that age group after further review.
Moderna announced on Thursday reports that the company has completed enrollment of a total of 4,000 children ages 6 to 11 for its trial. The company said it expects to apply for an FDA emergency use clearance for this age group by the end of this year.
The company said another application should be submitted in early 2022, based on the results of a trial for children ages 5 and younger. A company spokesperson, Colleen Hussey, said she expects Moderna to enroll around 12,000 children in total.
Johnson & Johnson has begun its Phase 3 clinical trial in adolescents aged 12 to 17 years and will present the findings to regulators when finished, according to Jake Sargent, a company spokesperson.
He said the company is also planning other studies. One will include children aged 6 to 11, followed by children aged 2 to 5. Another will look after children under 2 years old.
Impatient parents looking for off-label adult vaccines for their children, Dr. It worries officials like Sean O’Leary.
D., professor of pediatrics at the University of Colorado Anschutz Medical Campus and Colorado Children’s Hospital. “There’s a bit of the Wild West out there,” O’Leary said.
Understand Vaccine and Mask Instructions in the USA
-
- vaccination rules. On August 23, the Food and Drug Administration Pfizer-BioNTech’s coronavirus vaccine granted full approval It paves the way for people aged 16 and over to increase their tenure in both the public and private sectors. became private companies increasingly mandatory vaccines for employees. Such powers legally allowed and upheld in court appeals.
- Mask rules. Centers for Disease Control and Prevention in July suggested The fact that all Americans, regardless of vaccination status, wear masks in public in areas with outbreaks was a reversal of the guidance it presented in May. See where the CDC guidance applies, and where states created their own mask policies. The battle over masks has become contentious in some states. local leaders defying state bans.
- Colleges and universities. More than 400 colleges and universities require their students to be vaccinated against Covid-19. Nearly all in states that voted for President Biden.
- Schools. Both of them California and New York City imposes vaccination requirements for education personnel. A survey published in August found that many American parents with school-age children are against compulsory vaccinations for students, but More support for mask missions for unvaccinated students, teachers and staff.
- Hospitals and medical centers. Many hospitals and major healthcare systems require their employees to be vaccinated against Covid-19. By citing increased caseloads fueled by the delta variant and stubbornly low vaccination rates in their communities, even within the workforce.
- New York City. Proof of vaccination is required for workers and customers. indoor dining, gyms, performances and other indoor situations, but the app doesn’t start until September 13. Teachers and other education workers The city’s large school system will need at least one dose of the vaccine by September 27, with no weekly testing option. City hospital staff they should also be vaccinated or undergo weekly tests. Similar rules apply to New York State employees.
- at the federal level. The Pentagon has announced that it will try to make coronavirus vaccines mandatory for the country. 1.3 million active-duty soldiers No later than mid-September. President Biden announced all civilian federal employees would have to get vaccinated against coronavirus or subject to regular testing, social distancing, mask requirements and restrictions on most trips.
Jennifer Macklom of Cedar Park, Texas was determined to get her three daughters enrolled in a lawsuit. Memories of 2016, when his daughter Miriam fell ill with an adenovirus at the age of 2½, haunted him. Concurrently, her daughter, Naomi, who was only 6 weeks old at the time, contracted a pre-Covid form of coronavirus at the same time.
Miriam was taken by ambulance to the Dell Children’s Medical Center in Austin. Naomi was admitted by the emergency room.
Ms. Macklom remembered that both girls were connected to the oxygen and feeding tubes at the same time.
“I said I can’t do that again. I can’t let anyone I love or know emotionally get attached to one of these,” said Ms. Macklom, a high school math teacher.
So, with the outbreak of the pandemic, she met with her pediatrician and put her three children on a waiting list for a vaccine trial. Miriam is now 8, Naomi is 5, and Ruth is 2.
Five months have passed. Then the phone rang and Ms. Macklom learned that her daughters were at the top of the list to receive the Pfizer vaccine at a branch of the Austin Regional Clinic in central Texas.
According to clinic spokesperson Heidi Shalev, many parents were interested in this trial for the under-12 group, and staff didn’t need to hire them.
Ruth was too young to get vaccinated in that area. Now she spends weekdays with Ms. Macklom’s family to avoid the risk of contracting the virus at the nursery.
Miriam and Naomi fired two shots. Because this trial required one-third of the vaccines to be placebo, they don’t know if they included the vaccine. The children had to wait an hour after the injections, and the staff gave them a coloring book and rice cereal treats.
The girls will find out in early winter whether they have received the vaccine or the placebo. If it’s a placebo, they’ll get shots of the real thing.
“Going into work was very life changing,” said Ms. Macklom. “We actually went camping.”
Ms. Vong Reiff, who owns her own marketing firm, said she decided to enroll her sons in the hearing to protect her husband, who had surgery and radiation for non-malignant meningioma.
In mid-August, the entire family went to Maine, to Bar Harbor and Acadia National Park, and then to Boston for the duck boat tour.
“We wouldn’t have gone if we hadn’t vaccinated the kids,” said Ms. Vong Reiff. “For us, getting vaccinated, slowly getting back to who we are, was a kind of celebration.”
[ad_2]
Source link