Bay Area family making history in Pfizer pediatric vaccine trial

Bay Area siblings describe participation in childhood vaccination experiment

COVID vaccines are not yet available for children under 12, but there is a medical test that monitors a small group of children who have received the vaccination. That reports KTVU’s Jana Katsuyama.

Oakland, California. – They are only in primary school, but 6-year-old Sofia Chavez and her 9-year-old brother Nico are already helping to make history.

Since June, the children have been part of Pfizer’s pediatric COVID-19 vaccine trial at Stanford for children ages 5 to 11.

“I’m proud of myself for doing it because I’m very nervous with shots,” said Sofia, who is in first grade.

“You’re going to be part of saving the world,” said Nico, a fourth-grader, “I think it’s pretty cool to be the first kids under 12 to get the vaccine.”

Thousands of children have participated in Pfizer’s clinical trials to test the safety of the mRNA vaccine.

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Renee and Miguel Chavez say investigators made sure their children and others in the study weren’t forced into the shooting.

“They made sure they were okay with it and throughout the process they asked if they were comfortable,” Miguel said.

“They had to sign a consent form…that they wanted to participate,” Renee said.

The first shot was in June and the second shot was in July. Parents were not told whether their children received the Pfizer vaccine or a placebo shot.

Renee and Miguel said they were monitoring their children for symptoms.

Nico says he felt fatigue and chills, but was fine after a few days. Renee is a pediatric ICU nurse and says that while some parents may be concerned about the vaccine and its safety, for her seeing COVID cases at work was a factor in wanting her children to participate in the trial.

“The alternative is the possibility of COVID, which is more unknown. We don’t know what the long-term effects are in children,” Renee said.

As children return to school, there are increasing concerns about transmission among children.

According to the American Academy of Pediatrics, there were 204,000 COVID cases among children in the United States last week. That’s over 38,000 in July. The American Academy of Pediatrics says that children make up nearly 15% of all cases. Children represent between 1.6% and 3.6% of hospital admissions nationwide.

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Many parents wonder when their children might be able to get a COVID vaccine.

“The clinical trials should be completed by September,” said Dr. Yvonne Maldonado, the Stanford Professor of Infectious Diseases who is leading the pediatric clinical trial at Stanford, “The company should be able to provide the data to the FDA by October.”

After that, the FDA will review the data for safety to decide whether to grant emergency use consent.

“Especially in children, we want to look for an immediate response to the vaccine, such as fever or chills or flu-like symptoms,” Maldonado said. them with you?

Renee says that as part of the study, they received cell phones to send weekly reports of the children’s health.

They were also given a covid test at home in case the children show symptoms.

The Chávez family said they were told they will learn in December whether they received the vaccine or a placebo. Security oversight is expected to last for another two years.

“We’re going to monitor short-term and long-term safety, we’re going to monitor immune responses, whether kids need boosters,” Maldonado said.

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