What does the Pfizer Adolescent Vaccine Approval mean for my child?

Q: The federal government approved the Pfizer vaccine for 12 to 15 year olds. What does this mean for my child?

This story also ran on PolitiFact. It can be republished for free.

Expanding the emergency use of the Pfizer BioNTech vaccine to adolescents and young adolescents will add nearly 17 million more Americans to the pool of those who can be immunized against Covid-19, helping to build a vaccinated population closer to herd immunity comes. Moderna and Johnson & Johnson are also testing the effectiveness of their vaccines in teenagers and children.

Although children appear to be less likely to catch Covid and develop milder symptoms than adults, they can develop a rare, severe inflammatory reaction or long-range Covid symptoms. It also remains to be seen what long-term effects these younger patients may have on Covid, if any.

The proportion of Covid cases in children and adolescents is increasing – almost a quarter of the new weekly Covid cases were found in this age group, the American Academy of Pediatrics and the Children’s Hospital Association reported on May 6.

And while children are less likely to have serious illnesses, they can still pose a risk to vulnerable people around them as they may not even know they are carrying the virus, as documented by the Centers for Disease Control and Prevention.

Dr. Margaret Stager, pediatrician and director of adolescent medicine at MetroHealth Medical Center in Cleveland, said she needed to explain to her young patients that vaccination would help her community contain the spread, reduce the risk of variants, and help reopen society.

“I’m talking about you doing your part,” said Stager. “That all of this is a part of you that contributes to the common good.”

The fine print

The CDC recommended the use of the Pfizer vaccine for children ages 12-15 this week after the Food and Drug Administration extended its approval for emergency use to these adolescents and young adolescents. This means that this age group can now receive the same images as adults in the same time frame – with an interval of 21 days.

In a reversal of the previous guidance, teenagers and adults don’t have to wait 14 days before or after the Covid shot to get a vaccine against another condition. This could be a boon to health care providers where child patients lag behind other routine vaccines, which has been an ongoing problem during the pandemic.

“It’s a tremendous opportunity to catch up,” said Stager.

CDC officials, in the Advisory Committee on Immunization Practices Recommendation dated May 12, noted that they have no data specifically addressing possible side effects in patients immunized concomitantly against Covid and other diseases. However, the agency made the decision based on the strong safety data from the Pfizer BioNTech shot and previous experience with other vaccinations.

This question becomes more important as covid vaccines are studied in younger children. Studies are planned to test the vaccine in children 6 months of age.

As with adults, how long immunity lasts in children is unknown, said Dr. Rebecca Wurtz, professor of infectious diseases at the University of Minnesota. However, she said it was likely that any dwindling immunity seen in adults would also be seen in young people.

“Whatever we learn from adults,” said Wurtz, “children will not be far behind.”

Whether that approval will cause schools to require vaccination against Covid for K-12 students returning to the classroom this fall is an open question, Stager said. It is unclear whether federal law allows state agencies to commission a vaccine that has not yet been fully approved. Government consent is also likely to play a role in parents’ decisions about sending their children to summer camp.

What did the process find out?

Pfizer tested the vaccine in 2,260 teenagers and young adolescents living in the United States. The researchers followed the participants for two months or more, the FDA said. Pfizer’s clinical protocol says the company will continue to follow participants for two years after the second dose.

The results show that the vaccine is safe to use in this age group and causes side effects similar to those in young adults for whom it has already been approved, the FDA said in a press release. The vaccinated also produced a strong immune response – the amount of antibodies recorded in this age group was even higher than in 16-25 year olds.

The vaccinated group also had no Covid cases when tested seven days after their second dose. 16 of 978 participants who did not receive the shot but were observed as controls in the study tested positive for the virus. In short, the vaccine was 100% effective in preventing Covid, according to the FDA.

Why so few children?

One data point that can give parents a break is the number of participants in the study. The relatively small number – especially when compared to the tens of thousands who participated in adult studies – reflects what the researchers wanted to achieve, said Dr. Kawsar Talaat, Assistant Professor of International Health at the Johns Hopkins University School of Public Health.

It doesn’t take a large study group to assess whether the shot is safe for kids and whether it creates a strong immune response, she said. Statisticians can calculate how many people a study needs to get meaningful results without exposing people to unnecessary dangerous pathogens like the coronavirus.

In addition, the results for the younger age group build on the findings of previous studies.

“It’s just not practical to do 30,000-person studies over and over with the same vaccine,” Talaat said. Big trials are expensive, she added. The inclusion of minors is also an additional challenge, according to Stager, such as obtaining parental consent.

Jerica Pitts, a Pfizer spokeswoman, said in an email that the company is taking a “cautious, step-by-step approach” to including minors in clinical trials.

According to Stager, physiological similarities have already been documented between 12- to 15-year-olds in response to vaccines. Studies related to a vaccine against the human papillomavirus have shown that children of this age elicit similar, strong immune responses.

Giving the vaccine to adolescents and young adolescents in large numbers may reveal additional effects not seen in clinical trials, said A. Oveta Fuller, associate professor of microbiology and immunology at the University of Michigan Medical School.

That said, when you weigh the threat from the virus against the proven safety of the vaccine, the choice is clear.

“The danger really isn’t so much the vaccines as what they protect against,” said Fuller, “and that’s a covid disease.”

KHN (Kaiser Health News) is a national newsroom that produces extensive journalism on health issues. Alongside Policy Analysis and Polling, KHN is one of the three most important operational programs of the KFF (Kaiser Family Foundation). KFF is a foundation that provides health information to the nation.


This story can be republished for free (details).

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