The US Food and Drug Administration is expected to post its independent review.
A child-sized dose of the Pfizer BioNTech COVID-19 vaccine appears to be safe and about 91% effective in preventing symptomatic infection in children ages 5 to 11, according to study details released Friday.
The news comes as the nation considers opening up vaccinations to that age group, with shots starting in early November if regulators give the green light.
US Food and Drug Administration (FDA) was expected To post its independent review of the company’s safety and effectiveness data later in the day.
In addition, agency advisers will publicly debate the evidence next week.
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Should the group eventually authorize the shots, the US Centers for Disease Control and Prevention (CDC) will make the final decision on who should receive them.
In September, there was a Pfizer/BioNTech booster dose authorized for emergency use FDA approved for persons 65 years of age and older, persons 18 to 64 years of age at high risk of severe COVID-19, and persons 18 to 64 years of age with persistent institutional or occupational exposure .
On Wednesday, a booster dose was also authorized by the FDA for emergency use for eligible individuals who have completed primary vaccination with a different authorized COVID-19 vaccine.
While full-strength Pfizer shots are already authorized for anyone 12 or older, pediatricians and many parents are eagerly looking to prevent the growing infection from the highly transmissible delta variant for young children and send children to school. Waiting for security to help keep you in.
More than 25,000 pediatricians and primary care providers have already signed up to bring the shots to smaller arms.
The Biden administration has purchased enough kid-sized supplements for the nation’s nearly 28 million 5- to 11-year-olds. If the vaccine is approved, millions of doses will be shipped immediately.
A Pfizer study tracked 2,268 children in that age group who received two shots over three weeks in addition to a placebo or low-dose vaccine. Each dose was one-third of the amount given to both teens and adults.
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The researchers calculated that the low-dose vaccine was about 91% effective, based on 16 COVID-19 cases in children who were given the placebo shot versus three cases among vaccinated children. No serious illness was reported in any of the children, but the vaccinated children had more mild symptoms than their non-vaccinated counterparts.
Additionally, young children who were given low-dose shots had as strong levels of antibodies fighting the coronavirus as teens and young adults who received regular-strength vaccinations.
Earlier this week, the CDC reported that the Pfizer vaccination was 93% effective in preventing hospitalizations among 12- to 18-year-olds, despite increasing delta mutants.
Pfizer’s study of young children found that the low-dose shots proved safe, with similar or less temporary side effects such as sore throat, fever, or pain that teens experience. However, studies are not sufficient to detect any extremely rare side effects.
According to CDC data, while children have a lower risk of serious illness or death than older people, COVID-19 has killed more than 630 Americans aged 18 and younger.
The American Academy of Pediatrics says: About 6.2 million children have been infected with the coronavirus, including more than 1.1 million in the past six weeks.
Moderna, Inc. is also studying its COVID-19 shots in elementary school-age youth.
approximately 190 million Americans fully vaccinated, of whom 66.9% are over or equal to 12 years and 68.7% who are over or equal to 18 years.
More than 733,000 people have died of coronavirus in the US Johns Hopkins Coronavirus Resource Center.