FDA paves way for Pfizer COVID-19 vaccinations in young kids

By MATTHEW PERRONE and LAURAN NEERGAARD

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

The FDA cleared kid-size doses — conscionable a 3rd of the magnitude fixed to teens and adults — for exigency use, and up to 28 cardinal much American children could beryllium eligible for vaccinations arsenic aboriginal arsenic adjacent week.

One much regulatory hurdle remains: On Tuesday, advisers to the Centers for Disease Control and Prevention volition marque much elaborate recommendations connected which youngsters should get vaccinated, with a last determination by the agency’s manager expected soon afterwards.

“Vaccinating younger children against COVID-19 volition bring america person to returning to a consciousness of normalcy,” Dr. Janet Woodcock, the acting FDA commissioner, said successful a statement. “Our broad and rigorous valuation of the information pertaining to the vaccine’s information and effectiveness should assistance guarantee parents and guardians that this vaccine meets our precocious standards.”

A fewer countries person begun utilizing different COVID-19 vaccines successful children nether 12, including China, which conscionable began vaccinations for 3-year-olds. But galore that usage the vaccine made by Pfizer and its spouse BioNTech are watching the U.S. decision, and European regulators conscionable began considering the companies’ kid-size doses.

With FDA’s action, Pfizer plans to statesman shipping millions of vials of the pediatric vaccine — successful orangish caps to debar mix-ups with the purple-capped doses for everyone other — to doctors’ offices, pharmacies and different vaccination sites. Once the CDC issues its ruling, eligible kids volition get 2 shots, 3 weeks apart.

While children are astatine little hazard of terrible unwellness oregon decease from COVID-19 than older people, 5- to 11-year-olds inactive person been earnestly affected — including implicit 8,300 hospitalizations, astir a 3rd requiring intensive care, and astir 100 deaths since the commencement of the coronavirus pandemic, according to the FDA.

And with the extra-contagious delta variant circulating, the authorities has counted much than 2,000 coronavirus-related schoolhouse closings conscionable since the commencement of the schoolhouse year, affecting much than a cardinal children.

“With this vaccine kids tin spell backmost to thing that’s amended than being locked astatine location connected distant schooling, not being capable to spot their friends,” said Dr. Kawsar Talaat of Johns Hopkins University. “The vaccine volition support them and besides support our communities.”

Earlier this week, FDA’s autarkic technological advisers voted that the pediatric vaccine’s promised benefits outweigh immoderate risks. But respective panelists said not each youngsters volition request to beryllium vaccinated, and that they preferred the shots beryllium targeted to those astatine higher hazard from the virus.

Nearly 70% of 5- to 11-year-olds hospitalized for COVID-19 successful the U.S. person different superior aesculapian conditions, including asthma and obesity, according to national tracking. Additionally, much than two-thirds of youngsters hospitalized are Black oregon Hispanic, mirroring long-standing disparities successful the disease’s impact.

The question of however broadly Pfizer’s vaccine should beryllium utilized volition beryllium a cardinal information for the CDC and its advisers, who acceptable ceremonial recommendations for pediatricians and different aesculapian professionals.

A Pfizer survey of 2,268 schoolchildren recovered the vaccine was astir 91% effectual astatine preventing symptomatic COVID-19 infections, based connected 16 cases of COVID-19 among kids fixed dummy shots compared to conscionable 3 who got vaccinated.

The kid dosage besides proved safe, with akin oregon less impermanent reactions — specified arsenic sore arms, fever oregon achiness — that teens experience.

But the survey wasn’t ample capable to observe immoderate highly uncommon broadside effects, specified arsenic the bosom inflammation that occasionally occurs aft the 2nd full-strength dose, mostly successful young men and teen boys. It’s unclear if younger children getting a smaller dose besides volition look that uncommon risk.

Some parents are expected to vaccinate their children up of household vacation gatherings and the wintertime acold season.

But a caller Kaiser Family Foundation survey suggests astir parents won’t unreserved to get the shots. About 25% of parents polled earlier this period said they would get their children vaccinated “right away.” But the remaining bulk of parents were astir divided betwixt those who said they volition to hold to spot however the vaccine performs and those who said they “definitely” won’t person their children vaccinated.

The likewise made Moderna vaccine besides is being studied successful young children, and some Pfizer and Moderna besides are investigating shots for babies and preschoolers.

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The Associated Press Health and Science Department receives enactment from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely liable for each content.