SAN DIEGO (KGTV) -- Parents can begin booking COVID-19 vaccine appointments for kids aged 12 to 15 through California’s MyTurn website on Thursday morning, state health officials said.
That’s after the Food and Drug Administration announced Monday that safety and efficacy data submitted by Pfizer supported an expansion of its emergency authorization down to 12 year olds.
The authorization won’t become official until the Centers for Disease Control and Prevention issues its own stamp of approval, which is expected to come after a public meeting of its advisory group on Wednesday.
“Every shot counts,” California Health and Human Services Secretary Dr. Mark Ghaly said Wednesday.
Vaccinating this age group is a critical step toward achieving herd immunity and returning life to normal for children and adults alike, he said.
Although infections in children rarely result in severe disease, “we still know that COVID remains an important threat to younger Californians,” he added.
Nearly 500 children in California have experienced severe outcomes from COVID like multisystem inflammatory syndrome, or MIS-C, according to California State Epidemiologist Dr. Erica Pan.
Parents will need to provide consent before children can receive a shot. Dr. Ghaly said he was encouraged by data showing more than 30 percent of 16 and 17-year-olds in California had received at least one shot after about one month of eligibility.
Pfizer conducted a study of 2,260 children aged 12 to 15 where half got vaccinated and half got a placebo. The FDA confirmed that none of the vaccinated children developed a COVID-19 infection compared to 16 cases in the placebo arm, meaning the vaccine demonstrated an efficacy of 100 percent.
“It’s almost as though the vaccine is even better in [kids] than it is in adults, but statistically they're equivalent,” said Dr. John Bradley, a pediatrician at Rady Children’s Hospital.
The emergency authorization is based on two months of data, but regulators will continue to track the study participants for two years.
Side effects “were consistent with those reported in clinical trial participants 16 years of age and older,” the FDA said in a statement.
Among adolescents, the most common side effects were pain at the injection site, tiredness, headache, chills, muscle pain, fever and joint pain. The side effects were typically mild and lasted one to three days.
As with adults, side effects were more common after the second dose.
Questions about the FDA’s process
Before the FDA authorized Pfizer’s vaccine for people 16 and older, there were hours of public presentations on how safe and effective the shots were.
Regulators released a 53-page report with data on virtually every possible side effect and how often they happened. (Injection site reactions, for example, occurred in 84.1 percent of the volunteers, 62.9 percent experienced fatigue and 14.2 percent of the volunteers developed fever.)
But when the FDA authorized the Pfizer vaccine in kids 12 to 15, there was no public hearing of the agency’s outside advisory committee, just a press release with less than two pages on safety and effectiveness.
It’s “a little disappointing because I don't get to see the data with my own eyes, but I think that's just kind of a procedural thing,” said Dr. Christian Ramers of Family Health Centers of San Diego.
Dr. Ramers said he expects more data will be released soon. The agenda for Wednesday’s meeting of the CDC’s Advisory Committee on Immunization Practices shows there will be a presentation of safety and efficacy data.
But some experts think the FDA missed an opportunity for transparency at a time when polls show parents still have questions.
A Kaiser Family Foundation poll conducted in April found only 30 percent of parents planned to get their 12 to 15 year olds vaccinated right away. One quarter of the respondents said they planned to wait a while to see how the vaccine is working, and another 18 percent said they would only get their child vaccinated if their school required it.
“I think it was fine what the FDA did,” said Dr. Bradley.
Bradley has served on FDA advisory committees before, and says their purpose is to weigh in when the risks and benefits are a close call.
“The FDA tells you that they need your opinion if they've got a problem with interpretation or there's controversy,” he said.
But in this case, he says it was a slam dunk: the efficacy was 100 percent.
Dr. Bradley says it’s no surprise the side effects in adolescents mirrored those adults. For the last few years, major pediatrics groups have been calling on the FDA to include 12-year-olds in most adult drug trials because they’re biologically very similar.
“Psychologically they're a bit different,” he said. “But the function of the liver, kidneys, immune system itself actually is pretty similar to adults.”
So between the millions of adults and older teens who have been vaccinated and the new study on 12 to 15-year-olds, he says parents can rest assured: these shots are safe and effective.
What about younger kids?
Biologically speaking, kids 11 and younger do respond differently to vaccines, Dr. Bradley said. That’s why vaccine makers are testing lower doses in these age groups.
Because drug makers first need to find the optimal dose, these studies will take longer. And the doses may vary by age group; kids aged 6 to 12 years old may get one dose, while children 2 to 6 may get another.
“We don't expect the next vaccines for younger kids to come out until very late this year or early next year,” he said.
