The FDA approves Pfizer’s COVID-19 vaccine for children ages 5-11

WASHINGTON (AP) – The Food and Drug Administration on Friday paved the way for children ages 5 to 11 to get Pfizer’s COVID-19 vaccine.

The FDA approved child-sized doses – only a third of the amount given to teens and adults – for emergency use, and up to 28 million more American children could be eligible for vaccinations as early as next week.

Another regulatory hurdle remains: On Tuesday, advisers to the Centers for Disease Control and Prevention will make more detailed recommendations on which young people should be vaccinated, with a final decision from the agency’s director expected shortly after.

“With this vaccine, children can return to something better than being locked up at home in remote school, not being able to see their friends,” said Dr. Kawsar Talaat from Johns Hopkins University. “The vaccine will protect them and also protect our society.”

A few countries have started using other COVID-19 vaccines for children under 12, including China, which has just begun vaccinations for 3-year-olds. However, many who use the vaccine made by Pfizer and its partner BioNTech are keeping an eye on the US decision, and European regulators are just beginning to consider corporate doses in child size.

With FDA action, Pfizer plans to start sending millions of vials of the pediatric vaccine – in orange caps to avoid confusion with the purple caps for everyone else – to doctors’ offices, pharmacies and other vaccination sites. Children get two shots at three-week intervals.

While children are at lower risk of serious illness or death from COVID-19 than older people, 5- to 11-year-olds are still severely affected – including over 8,300 admissions, about a third requiring intensive care and nearly 100 deaths since the onset of the coronavirus pandemic, according to the FDA.

And with the extra contagious delta variant in circulation, the government has counted more than 2,000 coronavirus-related school closures since the beginning of the school year, affecting more than a million children.

Earlier this week, the FDA’s independent scientific advisers voted that the promised benefits of the pediatric vaccine outweigh any risks. However, several panelists said that not all young people should be vaccinated and that they preferred that the shots were aimed at those at higher risk for the virus.

Nearly 70% of 5- to 11-year-olds hospitalized for COVID-19 in the United States have other serious medical conditions, including asthma and obesity, according to federal tracking. In addition, more than two-thirds of inpatients are young black or Hispanic, reflecting long-term differences in the effect of the disease.

The question of how widely Pfizer’s vaccine should be used will be a key consideration for the CDC and its advisers, who make formal recommendations to pediatricians and other medical professionals.

A Pfizer study of 2,268 school children found that the vaccine was almost 91% effective in preventing symptomatic COVID-19 infections, based on 16 cases of COVID-19 among children who received dummy shots compared to only three who had was vaccinated.

The child dose also proved safe, with similar or fewer temporary reactions – such as sore arms, fever or soreness – that teenagers experience.

However, the study was not large enough to detect any extremely rare side effects, such as heart inflammation, which occasionally occurs after the second full-strength dose, mostly in young men and teenage boys. It is unclear whether younger children receiving a smaller dose will also face the rare risk.

Some parents are expected to vaccinate their children prior to the family vacation and the cold winter season.

But a recent study by the Kaiser Family Foundation suggests that most parents will not rush to get shots. About 25% of parents surveyed earlier this month said they would have their children vaccinated “immediately.” But the remaining majority of parents were roughly divided between those who said they would wait to see how the vaccine works and those who said they “definitely” do not want their children vaccinated.

The similarly manufactured Moderna vaccine is also being tested in young children, and both Pfizer and Moderna are also testing shots for babies and preschoolers.

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institutes Department of Science Education. AP is solely responsible for all content.

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