Teenagers won’t be able to get a COVID-19 vaccine when adults do, because there’s not yet proof of safety and efficacy.
But teen volunteers like San Jose’s Allyson Eisenman are bringing it within closer reach, participating in a Kaiser study that could accelerate the vaccine’s potential use in young people.
“I really wanted to do what I can help us get out of this” pandemic, said Eisenman,17, “and hopefully get back to what will be the new normal.
“I’m not the best with needles,” she confessed. “But it was like any other shot.”
Until now, vaccination has focused on adults. Why? It’s because they fare worse than adolescents when infected – and also because that’s how research is traditionally conducted. Vaccine and drug testing in youth typically starts only after a product is proven completely safe and effective in adults.
Yet pediatricians say it is essential for teens to be included, early on, in COVID-19 vaccine testing. Cases are climbing in young people, they say, with thousands of illnesses and over 100 deaths reported since the pandemic’s early days.
Without research, it’s not known if they will respond like adults do. Children aren’t just miniature adults – they may experience different side effects, or require smaller doses.
“We know that teenagers can get infected. We know that everyone is susceptible to this disease,” said Dr. Nicola Klein, director of the Kaiser Permanente Vaccine Study Center and principal investigator for the trial in Northern California.
“Teenagers and younger children are not thought to get as much disease,” she said, “but they do get disease and they do transmit. It has really impacted their lives, just like it’s impacted everyone else in the world.”
In September, the American Academy of Pediatrics wrote a letter to the Department of Health and Human Services and Food and Drug Administration urging vaccine research in children.
Allyson and others are enrolled in a trial with Pfizer Inc., the first pharmaceutical company in the United States to receive approval from the FDA to test its vaccine on children as young as 12. The second promising vaccine, made by Moderna, is not yet slated for testing in youth.
Pfizer recently announced preliminary results showing their vaccines appear more than 90% effective, at least for short-term protection against the virus.
The FDA will evaluate the data — collected from adults — in December, and could quickly give the go-ahead to distribution of limited, rationed supplies. Youth will be offered the vaccine only after their trial results are analyzed.
Kaiser aims to test the vaccine in 100 youth between the ages of 16 and 17 at its Santa Clara and Sacramento facilities. Over the next several weeks, the trial will be expanded to include 100 younger teens, ages 12 to 15. The overall goal for the Pfizer trial is to enroll a total of 2,000 adolescents.
“We should have a vaccine for children. Children can die of this virus,” said Dr. Paul A. Offit, director of the Vaccine Education Center and professor of pediatrics in the Division of Infectious Diseases at Children’s Hospital of Philadelphia. “The number …read more
Source:: The Mercury News – Entertainment