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Pfizer said Tuesday it is advancing late-stage clinical trials of its COVID vaccine, in lower doses, on children ages 5 to 11 years old and expects to apply for approval early this fall.
Pfizer’s vaccine is already being administered to children 12 and up, who receive the same 30 microgram dose as adults.
Moderna said it also expects its COVID vaccine will be available for kids as young as 5 by early fall. CEO Stéphane Bancel said Monday he thinks the data will become available sometime in September, CBS Boston reported.
Earlier this month, Moderna applied to the U.S. Food and Drug Administration (FDA) for full approval of its COVID vaccine for adults 18 and older, which is being administered now under Emergency Use Authorization. The company said it plans to seek expanded emergency use approval in the U.S. for the vaccine for ages 12 and up early this month.
Pfizer plans trials on children as young as 6 months
The Pfizer study on children 5 to 11 will enroll up to 4,500 children at more than 90 clinical sites in the U.S., Finland, Poland and Spain, the company said.
Based on safety, efficacy and tolerability data from the 144 children included in Pfizer’s phase 1 trial, the company will use 10 micrograms of each vaccine dose for kids between the ages of 5 and 11 in phase 2/3 trials, and 3 micrograms of each dose for those 5 and younger.
In the coming weeks, late-stage trials will start for 2- to 4-year-olds, as well as those as young as 6 months, Gruber said.
“We take a deliberate and careful approach to help us understand the safety and how well the vaccine can be tolerated in younger children,” Dr. Bill Gruber, senior vice president of clinical research and development at Pfizer, said in a statement.
Another Pfizer spokesperson said the company expects data from 5- to 11-year-olds in September and would likely ask regulators for Emergency Use Authorization (EUA) later that month. Data for children 2 to 5 years old could arrive soon after that, Reuters reported.
Pfizer expects to have data from the 6-month to 2-year-old age group in October or November.
On May 10, the U.S. Food and Drug Administration (FDA) expanded the EUA for Pfizer’s COVID vaccine to include children aged 12–15 years, and Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices recommended it for this age group on May 12.
Kids at low risk for COVID, raising questions about need for vaccine
As The Defender reported earlier this month, some physicians and scientists oppose vaccinating children against COVID — including a group of 40 doctors who told UK drug regulators vaccinating kids is “irresponsible, unethical and unnecessary.”
In an open letter addressed to the Medicines and Healthcare Products Regulatory Agency, the group said no one under 18 should be vaccinated for COVID because evidence shows the virus poses almost no risk to healthy children.
The authors of the letter said the risk of death from COVID in healthy children is 1 in 1.25 million. COVID vaccines, however, are linked to strokes due to cerebral venous thromboses in people under 40 — a finding that “led to the suspension of the Oxford-AstraZeneca children’s trial,” the authors said.
According to the CDC, COVID adolescent hospitalization rates in the 12-17 age group was 2.1 per 100,000 in early January 2021, and 1.3 per 100,000 in April. Of 204 hospitalizations assessed by the CDC from March 1, 2020 to April 24, 2021, no deaths occurred.
According to CDC data, the death rate among adolescents ages 0 to 17 who get COVID and are subsequently hospitalized is 0.7%, with many experiencing either mild or no symptoms at all. The COVID death rate in all adolescent age categories is less than 0.1%, according to the CDC.
As The Defender reported, two papers published May 19 in the journal of Hospital Pediatrics found pediatric hospitalizations for COVID were overcounted by at least 40%, carrying potential implications for nationwide figures used to justify vaccinating children.