The ongoing COVID-19 vaccine trial at the Cincinnati Children’s Hospital Medical Center has begun, including adolescents.
On Wednesday, Cincinnati Childrens began a new phase of vaccine trials with a 16-year-old girl who was either vaccinated or placedbo, officials said Friday.
“We are launching a COVID vaccine trial in children aged 12 to 17 years,” said the Cincinnati Children’s National Institute of Health-funded vaccine and treatment evaluation unit and gambling program for clinical research. Said Dr. Robert Frenck, director of the.
Starting next week, teens aged 16 and 17 will participate in the program.
The center will enroll children of those ages, Frenck said, but the jury must first approve vaccine trials for 12 to 15 years old.
Pfizer announced on Monday The FDA has given permission to extend clinical trials of the COVID-19 vaccine to children aged 12 to 15 years. The Cincinnati Pediatric Institution Review Board must give approval to children of that age group before the medical center can begin immunization. The Board of Directors will meet on October 22 to consider this issue. Frenck, who leads the trial, will withdraw from consideration.
Hospital officials said the dose for children aged 12 to 15 years would be the same as the vaccine for the group aged 16 to 17 years, which would be the same dose given to adults. They stated that there was no physiological reason for different doses.
Cincinnati Childrens has a 20-year history as a vaccine treatment and evaluation unit. Pfizer has selected the Cincinnati Children’s Unit for local vaccine testing. It started in May with a healthy adult. The center is one of the leading vaccine research institutes in the United States, Frenck said.
Approximately 600 children aged 16 to 17 are enrolled in the study and approximately 2,000 children aged 12 to 15 are enrolled nationwide. Of these totals, there is no limit to the number of Cincinnati Children that can be registered.
Frenck said that vaccination of children with a safe and effective COVID-19 vaccine helps children, but vaccination of children also helps adults.
Vaccines have direct and indirect effects. Directly, it is the protection provided to those who receive the vaccine. Indirect is to protect the people around the vaccinated person.
“COVID is less likely to be serious in children than in adults, but it is still at risk,” he said. “Approximately 500,000 children in the United States have recorded COVID infections … and as of July 30, 120 children have died of COVID. Therefore, the powerful direct effect of the vaccine is undoubtedly. There is.
But that’s not all, Frenck said.
“My concern is that children don’t know they have COVID, so they spread the infection to parents, grandparents, school teachers, coaches and others,” Frenck said. .. “So, by immunizing and preventing children’s infections, we can have a great indirect effect if they don’t spread (it) to others.”
He encouraged adolescents and their adult families to learn more about the COVID-19 vaccine trial by completing a survey on the Cincinnati Children’s website. https://is.gd/covid19researchstudy..
Meanwhile, Pfizer said Friday it was ready to apply for an emergency license for the vaccine by late November, the Wall Street Journal reported. According to the journal, it was the first time that it or any other major Western vaccine developer provided such a particular timeline.
How the Pfizer vaccine works
Vaccines generally work by injecting a subject with a specific viral or bacterial fragment. These fragments, proteins known as antigens, stimulate the body’s immune system to produce antibodies that prevent future infections by the virus or bacteria.
This established process is used to produce vaccines that most people receive against measles, tetanus, seasonal flu, and many other infectious diseases.
Pfizer vaccine involves another process in which a molecule known as messenger RNA or mRNA is injected into a subject. mRNA directs the subject’s own body to make an antigen.
To date, no mRNA vaccine has been approved for use in humans, but proponents say it is safe and can make vaccine production faster and cheaper. The selling point is that it is not made of real virus fragments like traditional vaccines.
According to experts, mRNA-made vaccines have been used in human subjects in cancer and flu studies without significant side effects.
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