Pfizer Seeks Approval for COVID-19 Vaccine for Kids Aged 5 to 11
The number of COVID-19 cases and hospitalizations in the United States are rising by the day amid the rise of the more infectious Delta variant.
The 7-day average of new COVID-19 cases in all populations in the United States was almost 131,000. Just a few months ago, the average number was just over 11,000 according to the Centers for Disease Control and Prevention (CDC). This surge in cases we are seeing across the county has also strained hospitals and healthcare professionals.
Currently, Americans eligible for vaccination are 12+ years old. Trials for younger children are in progress and just last week Pfizer/BioNTech announced that a Phase 2 of 3 trial showed their two-dose vaccine was safe and generated a great antibody response in children aged 5 to 11. As cases rise, hospitalization rates increase, and the number of children that are hospitalized with COVID-19 is also on the rise, this vaccine data from the trials couldn’t come at a better time.
The US Food and Drug Administration (FDA) could soon authorize the Pfizer/BioNTech COVID-19 vaccine for children. An authorization would offer hope in the midst of a critical time in the pandemic for kids, who accounted for a quarter of all cases reported earlier this month. Dr. James Hildreth, who is a vaccine adviser to the FDA, shared, “It is conceivable that by Halloween, we could see shots going into arms, but it’s going to take a number of weeks for that process to work its way through.”
The trial showed that not only are the vaccines effective in the younger age range, but they can also be administered at a lower dosage. The adult dose of the Pfizer-BioNTech vaccine is 30 micrograms, while the companies propose a 10 microgram dose in children ages 5 to 11. As in adults, the vaccine would be given to children in two shots, delivered at least three weeks apart. The companies are also studying their vaccine in children ages 2 to 5, and 6 months to age 2, but those trials are not yet complete. Younger children are being tested on a 3 microgram dose.
So what happens now?
For the adult version of the vaccine, the FDA took about a month to review the data. Given the rapidly growing number of infections, the FDA is under pressure to move at least as quickly to authorize the vaccine for younger children. As for Moderna and Johnson & Johnson, they are also studying their vaccines in children but have not yet completed their research on the same age groups.
