By Carmen Heredia Rodríguez - Politifact
Health authorities have approved the use of Pfizer's vaccine against COVID-19 for children 12-15 years of age. These minors can receive the two-dose vaccine without a waiting period before or after for other routine vaccinations, giving parents the opportunity to immunize their children for summer camps or to return to face-to-face classes at fall. Right now, Pfizer and other drug companies are conducting trials to test the effectiveness of vaccines in younger children.
Licensing the Pfizer vaccine for preteens and teens added nearly 17 million people to the pool eligible to be immunized against COVID-19.
This helps the vaccinated population to be closer to herd immunity.
Modern Pharmaceuticals and Johnson & Johnson are also testing the effectiveness of their vaccines in adolescents and children.
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Although children seem to contract COVID-19 less often and develop milder symptoms than adults, they can develop a rare but severe inflammatory response or have long-lasting symptoms.
It also remains to be seen what long-term effects, if any, younger COVID-19 patients may experience.
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The proportion of infections among children and adolescents is increasing: Nearly a quarter of new weekly cases of COVID-19 were found in this population, the American Academy of Pediatrics and the Association of Children's Hospitals reported May 6.
And while
children are less likely to become seriously ill
, they can still pose a risk of infection to the vulnerable people around them, because they may not even know they carry the virus, as the Centers for Disease Control and Prevention have documented. of Diseases (CDC).
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Dr. Margaret Stager, pediatrician and director of the division of adolescent medicine at MetroHealth Medical Center in Cleveland, says she has had to explain to her young patients that getting vaccinated would help her community stop the spread of the virus, reduce the risk of variants and they contribute to the reopening of usual activities.
"I speak of them doing their part," he said, "contributing to the common good."
Simultaneous vaccination
The CDC recommended the use of the Pfizer vaccine for children ages 12 to 15 on May 12 after the Food and Drug Administration (FDA) extended its emergency clearance to include them in the vaccination process.
They can now receive the same vaccinations in the same time frame (21 days apart) as adults.
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Contrary to what was previously recommended,
adolescents and adults no longer need to wait 14 days before or after receiving the COVID-19 injection
to receive a vaccine for another condition.
This could be a boon for healthcare providers who have child patients who fall behind on other routine vaccinations, which has been a persistent problem during the pandemic.
"It's a great opportunity to catch up," Stager said.
CDC officials noted May 12 that they do not have data specifically looking at potential side effects in patients immunized at the same time against COVID-19 and other diseases.
However, the federal agency made the decision to recommend the vaccine because of Pfizer's strong injection safety data and previous experience with other vaccines.
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This question will become more important as COVID-19 vaccines are studied in younger children.
Trials are planned to test the vaccine in children up to 6 months of age.
As in adults, how long immunity lasts in children is still unknown, said Rebecca Wurtz, a professor of infectious diseases at the University of Minnesota.
However, he said, any lowered immunity seen in adults is likely to be seen in young people as well.
"Whatever we learn in adults," Wurtz said, "children will not be left behind."
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It remains to be seen whether emergency approval of the vaccine will lead schools to require COVID-19 vaccination for students returning to classrooms this fall, Stager said.
It is unclear if federal law allows state authorities to impose a vaccine that has not yet been fully approved.
That said, government approval will likely also influence parents' decisions about whether to send their children to summer camp.
What was found in the trials?
Pfizer tested the vaccine in 2,260 children 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.
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The results show that the vaccine is safe in children and adolescents
, causing side effects similar to those seen in young adults, for whom it had already been approved, according to an FDA news release.
Those vaccinated also produced a strong immune response: the level of antibodies recorded in this age group was even stronger than that observed in young people aged 16 to 25 years.
The vaccinated group also had no COVID-19 cases when it was evaluated seven days after their second dose.
Sixteen of 978 participants who did not receive the vaccine but were followed up as part of the study's control group tested positive for the virus.
That is, the vaccine was 100% effective in preventing COVID-19, according to the FDA.
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Why so few children?
One piece of information that may make parents doubt is the number of trial participants.
The number is relatively low, especially when compared to the tens of thousands of people enrolled in adult trials.
But it's a reflection of what the researchers were trying to accomplish, explained Kawsar Talaat, a professor at the Johns Hopkins University School of Public Health.
Calculating whether the injection was safe for children and whether it elicited a strong immune response did not require a large study group, he said.
Statisticians can calculate how many people a trial needs to generate meaningful results without unnecessarily exposing people to dangerous pathogens like coronavirus.
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Furthermore, the findings about the youngest age group built on what was already learned in previous studies.
"It's just not practical to test 30,000 people over and over with the same vaccine," Talaat said.
Large trials are expensive, he added.
Including minors also poses additional challenges, such as obtaining parental consent, Dr. Stager explained.
Jerica Pitts, a Pfizer spokeswoman, said in an email that the company is using a "careful and tiered approach" to include children in clinical trials.
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Dr. Stager said that physiological similarities between 12- to 15-year-olds in response to vaccines have already been documented.
Studies related to a vaccine for human papillomavirus have shown that children of this age also generate strong immune responses similar to those of adults.
Giving the vaccine to large numbers of children and young adolescents may reveal additional effects that were not detected in clinical trials, said A. Oveta Fuller, professor of microbiology and immunology at the University of Michigan School of Medicine.
But, when weighing the threat of the virus against the proven safety of the vaccine, the choice is clear, Fuller said.
"The danger is not so much the vaccines but what they protect against," Fuller concluded.
