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Teens are the youngest volunteers in the COVID-19 vaccine trial | National
San Jose, CA — Teenagers cannot be vaccinated against the COVID-19 vaccine in adults due to lack of proof of safety and efficacy.
However, teenage volunteers such as Allyson Eisenman from San Jose are taking part in the Kaiser study, which has the potential to accelerate the potential use of vaccines, to bring it closer.
“I really wanted to do what I could to get out of it,” Eisenmann said.
“I’m not good at needles,” she confessed. “But it was like any other shot.”
So far, vaccination has focused on adults. why? That’s because when you get infected you’re less lucky than youth. Also, that’s the way traditional research is done. Vaccine and drug testing in adolescents usually begins only after the product has proven to be completely safe and effective in adults.
Still, pediatricians say it is imperative that teens be included in the COVID-19 vaccine test early. Thousands of illnesses and more than 100 deaths have been reported since the early days of the pandemic, and the number of youth cases is increasing, they say.
Without research, we wouldn’t know if they would react like adults. Children are not the only miniature adults — they may experience different side effects or require lower doses.
“We know that teens can get infected. Everyone knows that they are susceptible to the disease,” said the director of the Kaiser Permanente Vaccine Research Center in Northern California. Said Dr. Nikola Klein, Principal Investigator of the California.
“Children under the age of teens are not thought to get so many illnesses, but they get sick and get infected. Just as they affect everyone in the world, they do. It really has an impact on my life. “
In September, the American Academy of Pediatrics wrote to the Department of Health and Human Services and the Food and Drug Administration to encourage children’s vaccine research.
Allyson and colleagues are enrolled in a trial by Pfizer Inc., the first pharmaceutical company in the United States, and have been approved by the FDA to test vaccines in children up to 12 years of age. There is still no second promising vaccine produced by Moderna. Tests are planned for young people.
Pfizer recently published preliminary results that suggest that vaccines are more than 90% effective, at least for short-term protection against the virus.
The FDA will be able to evaluate the data collected from adults in December and quickly take the initiative in distributing limited ration supplies. Vaccines are given to adolescents only after the test results have been analyzed.
Kaiser aims to test the vaccine in 100 young people aged 16 and 17 at facilities in Santa Clara and Sacramento. In the coming weeks, the trial will be expanded to include 100 young teens between the ages of 12 and 15. The overall goal of the Pfizer Trial is to enroll a total of 2,000 adolescents.
“We need a vaccine for children. Children can die from this virus,” said Dr. Paul A. Ofitt, director of the Vaccine Education Center and professor of pediatrics in the Department of Infectious Diseases at Philadelphia Children’s Hospital. I am. “The number of children who died of the virus last year was about the same as those who died of the flu, and we think it’s worth preventing.”
Children should not be injected with inactive placebo if vaccination is safely deployed in adults, Ofitt added at a Friday briefing at the National Press Foundation. Instead, the study should be transformed into a so-called “wedge trial”, where the number of young volunteers is steadily increasing and should be compared to the response of unvaccinated adolescents.
Alison’s mother and father, who have a career in nursing and information technology, have already participated in the vaccine trial and supported the decision to enroll Alison after experiencing no adverse effects other than lethargy.
“This is our opportunity to contribute to the situation,” Jeff Eisenmann said in a news briefing on Friday.
“I’ve seen vaccines work, whether measles or polio,” he said. “In my opinion, someone needs to do it. Volunteers are needed.”
Allison is unsure if she is protected because the study is a “placebo control” and half of the participants are vaccinated and the other half are on the Inactive drug. She was given twice every 21 days.
For safety, Branham High School juniors are still wearing masks and socially distanced during gymnastics exercises and Girl Scouts meetings.
Once a week she checks in to Kaiser. She reports her temperature and symptoms on the Kaiser app. She will be followed for 2 years. “It’s easy,” she said.
“I’m not really a scientist,” she admitted. “It’s definitely my worst subject in my freshman year.
“But the health and safety of the people around me is important to me,” she said. “It has influenced me to contribute.”
(C) 2020 The Mercury News (San Jose, CA)
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