Pfizer says its lower-dose COVID-19 shot may not provide enough protection for 2-to-5 year-olds, setting back the timeline for when babies and toddlers in the US might be eligible for the vaccines.
On Friday, December 17, 2021, the company released a statement saying that, while its COVID-19 vaccine looks safe for young children, according to early indications the lowest dose, 3-microgram (3 µg) shot may not be enough vaccine to provide good protection for 2-to-5-year-olds (though early indications suggest the low-dose probably is enough for 6-month- to 2-year-olds.)
The 3 µg dose is a third of what 5- to 11-year-olds receive (at 10 µg), and 10% of what everyone aged 12 years old and above gets (30 µg).
But instead of trying a higher dosage for toddlers, Pfizer says it’s going to seek FDA authorization to give 6-month- to 5-year-olds a third, tiny 3 µg shot to bolster their immune response.
“The study will now include evaluating a third dose of 3 µg [micrograms] at least two months after the second dose of the two-dose series, to provide high levels of protection in this young age group,” the statement read.
The potential change in regimen seems to set back the pharmaceutical company’s timeline for filing with regulatory agencies like the US Food and Drug Administration.
“If the three-dose study is successful, Pfizer and BioNTech expect to submit data to regulators to support an Emergency Use Authorization (EUA) for children 6 months to under 5 years of age in the first half of 2022,” the company said.
Earlier this fall, Dr. Anthony Fauci, head of the National Institutes of Health infectious diseases branch, told Insider that Pfizer’s 2-shot course would “likely” be available to babies, toddlers and their parents “in the first quarter of 2022.”