The U.S. Food and Drug Administration (FDA) on Friday approved a single dose of Pfizer’s COVID-19 vaccine for children over 5 years of age.
The FDA’s decision comes several days after its advisory committee voted 17-0, with one abstention, in favor of recommending the vaccine for children. The committee concluded that the benefits of vaccination outweigh its risks.
As reported by the Wall Street Journal, the move paves the way for one of the last remaining groups, children ages 5 to 11, to be vaccinated against COVID-19. The vaccination process will likely begin in a few days.
The Centers for Disease Control and Prevention (CDC) must also provide a go-ahead approval for the vaccine, something that is expected to happen next week.
According to the FDA, the Pfizer-BioNTech vaccine proved as effective and safe for 5-year-olds as it was for people between the ages of 16 and 25.
“Immune responses in children aged 5 to 11 years were comparable to those in people aged 16 to 25 years,” reads the official announcement released by the FDA. “In addition, the vaccine was found to have 90.7% efficacy in preventing COVID-19 in children aged 5 to 11 years.”
Their data also indicate that the safety of the vaccine was studied in approximately 3,100 children aged 5 to 11 years who received the dose and that no serious side effects have been detected in the study, which is still ongoing.
The vaccine for children in that age range will be administered as a two-dose primary series, 3 weeks apart, but is a lower dose (10 micrograms) than that used for persons 12 years of age and older (30 micrograms).
Although children are the age group least affected by the new coronavirus, health authorities consider it necessary to include them in the vaccination plan.
According to CDC data, approximately 8,300 cases of COVID-19 in children aged 5 to 11 years resulted in hospitalization. As of October 17, 691 COVID-19 deaths had been reported in persons under 18 years of age, with 146 deaths in the 5- to 11-year-old age group.
An FDA abstention due to lack of evidence
When the FDA advisory committee voted to approve the decision to vaccinate 5-year-olds, one of its members decided to abstain because of a lack of data regarding the safety and efficacy of the vaccine in infants.
Michael Kurilla, M.D., an infectious disease and pathology expert who heads a division within the National Institutes of Health (NIH), was the only committee member who did not support the recommendation.
As reported by The Epoch Times, Kurilla objected to the ambiguous and unspecific wording of the committee’s proposal, which opened up the possibility that any child between the ages of 5 and 11 could receive the Pfizer vaccine.
Kurilla was also concerned that the longest follow-up in the clinical trial involving the age group was only three months. In addition, he noted that the data show that children experience severe cases of COVID-19 much less frequently than adults.
The specialist also argued that a large proportion of children in that age group have already had the disease, so they have some degree of immunity.
In this regard, the FDA indicated that the efficacy data to support vaccination in children up to 5 years of age are based on a randomized, placebo-controlled study, which is still ongoing and which has enrolled approximately 4,700 children in the determined range. The study is being conducted in the United States, Finland, Poland and Spain.
As Kurilla states, the study has followed a total of 1,444 vaccine recipients for at least 2 months after the second dose.