Child-sized doses of Pfizer’s COVID-19 vaccine appear safe and nearly 91% effective in preventing symptomatic infections in 5-11 year olds, according to the study details released on Friday, as the US is considering getting vaccinations for that age group to open.
The shooting could begin in early November – with the first children in line fully protected until Christmas – when regulators give the go-ahead.
Details on Pfizer’s study were posted online. The Food and Drug Administration was expected to release its independent review of the company’s safety and efficacy data later in the day.
FDA advisors will publicly debate the evidence next week. When the agency finally approves the shots, the Centers for Disease Control and Prevention will make the final decision on who to receive them.
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Pfizer full-strength syringes are approved for anyone 12 years and older, but pediatricians and many parents are eagerly awaiting protection for younger children in order to curb rising infections from the extra-contagious Delta variant and keep the children in school.
More than 25,000 paediatricians and general practitioners have already signed up to receive the syringes in little arms.
The Biden government has bought enough child-sized doses – in special orange-capped vials to distinguish them from the adult vaccine – for the country’s roughly 28 million 5-11 year olds. When the vaccine is approved, millions of doses along with child-sized needles will be shipped across the country in an instant.
A Pfizer study tracked 2,268 children in this age group who received two vaccinations three weeks apart with either a placebo or the low-dose vaccine. Each dose was one third of the amount given to adolescents and adults.
The researchers calculated that the low-dose vaccine was nearly 91% effective, based on 16 cases of COVID-19 in adolescents given sham vaccinations, compared to three cases in vaccinated children. No serious illness was reported in any of the adolescents, but those who were vaccinated had much milder symptoms than their unvaccinated ones.
In addition, young children who received the low-dose vaccinations developed just as strong antibodies to the coronavirus as adolescents and young adults who were vaccinated regularly.
This is important information when you consider that the hospital admissions of mostly unvaccinated children have reached record highs in the past month.
The CDC reported earlier this week that Pfizer vaccinations were 93% effective in preventing hospitalization in 12-18 year olds, even as the delta mutant increased between June and September.
Pfizer’s study of younger children found that the low-dose syringes were shown to be safe, with similar or less temporary side effects such as aching arms, fever, or pain that teenagers experience.
The study is not big enough to find extremely rare side effects, such as the heart inflammation that occasionally occurs after the second dose, especially in young men.
While children are at lower risk of serious illness or death than the elderly, COVID-19 has killed more than 630 Americans under the age of 18, according to the CDC. Almost 6.2 million children contracted the coronavirus, more than 1.1 million in the last six weeks when the delta mutant gained weight, says the American Academy of Pediatrics.
Moderna is also investigating its COVID-19 recordings in elementary school age teenagers. Pfizer and Moderna also study younger children, up to 6 months. Results are expected later in the year.
The Associated Press Health and Science Department is supported by the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.
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Reference: time.com
