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By Amanda Sealy | CNN
In a highly anticipated announcement, Pfizer said connected Monday a Phase 2/3 proceedings showed its Covid-19 vaccine was harmless and generated a “robust” antibody effect successful children ages 5 to 11.
These are the archetypal specified results released for this property radical for a US Covid-19 vaccine, and the information has not yet been peer-reviewed oregon published. Pfizer said it plans to taxable to the US Food and Drug Administration for exigency usage authorization soon.
The proceedings included 2,268 participants ages 5 to 11 and utilized a two-dose regimen of the vaccine administered 21 days apart. This trials utilized a 10-microgram dose — smaller than the 30-microgram dose that has been utilized for those 12 and older.
“The 10 microgram dose was cautiously selected arsenic the preferred dose for safety, tolerability and immunogenicity successful children 5 to 11 years of age,” Pfizer said in a quality release.
Participants’ immune responses were measured by looking astatine neutralizing antibody levels successful their humor and comparing those levels to a power radical of 16- to 25-year-olds who were fixed a two-dose regimen with the larger 30-microgram dose. Pfizer said the levels compared good with older radical who received the larger dose, demonstrating a “strong immune effect successful this cohort of children 1 period aft the 2nd dose.”
“Further, the COVID-19 vaccine was good tolerated, with broadside effects mostly comparable to those observed successful participants 16 to 25 years of age,” the institution said.
A Pfizer spokesperson besides confirmed that were nary instances of myocarditis, a benignant of bosom inflammation that has been linked with mRNA vaccines.
Pfizer said these information volition beryllium included successful a “near-term submission” for EUA and the companies volition proceed to accumulate the information needed to record for FDA support for radical ages 5 to 11.
The Pfizer/BioNTech vaccine is presently approved for radical property 16 and older, and authorized for usage successful radical ages 12 to 15.
Pfizer said it is expecting proceedings information for children arsenic young arsenic 6 months “as soon arsenic the 4th fourth of this year.”
“Since July, pediatric cases of COVID-19 person risen by astir 240 percent successful the U.S. — underscoring the nationalist wellness request for vaccination. These proceedings results supply a beardown instauration for seeking authorization of our vaccine for children 5 to 11 years old, and we program to taxable them to the FDA and different regulators with urgency,” Albert Bourla, president and main enforcement serviceman of Pfizer, said successful the statement.
Acting FDA Commissioner Dr. Janet Woodcock and Dr. Peter Marks, manager of FDA’s Center for Biologics Research and Evaluation, said successful a connection this period that the bureau would reappraisal information for a vaccine for younger children “as rapidly arsenic possible, apt successful a substance of weeks alternatively than months,” erstwhile it was submitted for authorization.
“However, the agency’s quality to reappraisal these submissions rapidly volition beryllium successful portion connected the prime and timeliness of the submissions by manufacturers,” they wrote.
Calls for a Covid-19 vaccine for younger children person grown louder successful caller months arsenic cases surged among children.
Coronavirus infections person risen “exponentially” among children crossed the United States, and present relationship for astir 29% of each cases reported nationwide, the American Academy of Pediatrics reported past week.
Still, US wellness officials person emphasized that children are not conscionable tiny adults, and adjacent those approaching property 12 should not beryllium fixed the larger vaccine dose disposable for older people.
“We don’t privation children to person adverse effects. Granted, we privation them to beryllium capable to get vaccinated arsenic rapidly arsenic possible, but let’s bash it right,” FDA’s Marks said successful a fireside chat hosted by the ResearchAmerica Alliance past week.
“There is simply a quality present due to the fact that they’re not conscionable getting the same-old, same-old dose arsenic a 12 and up idiosyncratic will. They person to get a reduced dose. And that’s wherefore it’s not a bully thought for doctors to instrumentality things successful their ain hands astatine this point.”
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