Parents want covid wax test for kids before official authorization

“This trial is our best shot at getting the vaccine as soon as possible,” said Ms. DiFrancisco, who said she wishes Sybil could spend more time with other children and extended family. We give some glimpse of normalcy for her. want.”

Many parents across the US are rushing to get into COVID-19 vaccine trials to try to protect their children from the virus as soon as possible.

The shots have not been proven to work safely for young people, and child volunteers may receive a placebo instead of the vaccine in the later stages. Yet parents said they were ready to take the chance and submit tests’ blood draws, COVID-19 tests and appointments to protect their children as well as their families and classmates.

Parents said the infectious Delta version and the start of a new school year have added to the urgency.

Children under the age of 12 are the last group in the US to not have access to an authorized COVID-19 vaccine. Young people, although at relatively low risk of serious illness and hospitalization, are going to hospital in greater numbers than earlier in the pandemic as the delta spreads mainly to unvaccinated people.

Partly because of the prevalence of delta, many parents have expressed disappointment that vaccines are not authorized for children under the age of 12.

Pfizer Inc. has said it expects early results from a study of the vaccine developed with partner BioNTech SE in 5- to 12-year-olds by the end of this month and will seek emergency authorization in early October.

Pfizer said data for children under six months could come as early as October, although researchers at some trial sites said it could take longer because enrollment in that age group is slower than older children. Used to be.

A company spokesperson said Moderna expects to seek authorization for emergency use of its vaccine for children ages 6 to 12 by the end of this year and for children ages 6 to 6 months early next year. Will go

Some parents are so eager to protect young children that after the Food and Drug Administration issued full approval for Pfizer and BioNtech’s COVID-19 vaccines, they pressured them to vaccinate them, even though the label is only 16. Specifies use for people aged 1 year and above. . The FDA said last week it was “working around the clock” to help make COVID-19 shots available to children under the age of 12 but said the testing and regulatory process needed to come into play.

Some parents have also sought out research sites looking for young volunteers to test the shots, though not all have been successful. C. Buddy Creech, an infectious disease specialist at VUMC, said more than 3,000 families contacted Vanderbilt University Medical Center to volunteer for about 150 slots in Moderna’s pediatric trial. Strong interest means the medical center turns most parents away, but contacts them from the waiting list when the spot opens, Dr. Creech, who is leading the research for on-site testing.

Some parents who were successful said they felt confident that their children had the chance to get vaccinated. In June, Robbie Lindemann of Erie, Pa., enrolled his son Nico, then 7, and his 11-year-old daughter, Neveh, in a Pfizer trial at nearby St. Vincent’s Hospital, part of the Allegheny Health Network. Now, he said, he feels more comfortable going to school with her in person as the infectious Delta version airs.

To be more confident that the shot was safe, Ms. DiFrancisco said she waited for Pfizer to finish its initial trial of the vaccine in a small group of children before enrolling Sybil in the pivotal study of more than 4,500 children.

A few weeks later, earlier this month, she signed up her 5-year-old daughter, Charlotte, in an effort to protect her by making the transition from virtual kindergarten to in-person this winter.

“It helps our child to be as safe as possible, but it also helps other children to be as safe as possible,” said Ms. DiFrancisco, a former assistant college professor who is now staying at home with her children. Rahi, who said they knew their children might receive a placebo.

According to researchers studying vaccines and parents putting their children on trials, a combination of personal and public reasons piqued interest. Parents wanted to help the scientific community answer whether shots work safely, while making a major head start on protecting their children.

“I know the science is strong enough that I want to let my kids get involved in testing to make sure it’s safe for other kids,” said Dr. Samir Bakhda, an emergency room physician in Monterey, Calif. , whose sons Ajay, 9, and Kian, 8, enrolled in a Pfizer trial at Stanford Medicine in August.

Some families were particularly eager to put their children in studies because parents have jobs in health care, education and other areas of work that increase the risk of exposure.

When the two spots opened at Duke University in August, Sonali Bracken quickly accepted them over the phone for their 3-year-old son Javian and 9-month-old daughter Karina. She scheduled appointments for the next week.

“As soon as they could get something in their arms, I wanted them to do that,” said Dr. Bracken, an immunologist and rheumatologist at Duke. “I wanted my kids to have a chance to get the vaccine as soon as possible, especially knowing that rolling out to the public probably won’t happen until late fall, early winter.”

Pierce Sandwith, a Nashville attorney, said he enrolled his 2-year-old daughter, Carolyn, in the early-stage Moderna study in June, less than an hour after VUMC researchers informed him that a spot was available due to cancellation. Was.

Every child in the study was vaccinated, as the trial was exploring the dose to use. Mr. Sandwith hoped that Caroline, now that she has been vaccinated, will better protect her 4-year-old sister, Louise, who is undergoing treatment for leukemia, is at high risk for COVID-19 infection and is not eligible for enrollment. was not eligible. In studies.

“It looks like we’re not going to get out of the pandemic unless children are vaccinated,” he said.