On 17 December 2021, Pfizer stated that trials for its pediatric COVID-19 vaccine for children ages 2 to 5 show that it did not provide the expected immunity. Therefore, it is adding a third dose to the clinical trial, and it will probably mean a significant delay in getting Emergency Use Authorization (EUA) for the COVID-19 vaccine for that age group.
Pfizer, after its independent Data and Safety Monitoring Board examined the data, decided to add the third dose for all children and babes, ages 6 months to 5 years, that were included in the clinical trial. Apparently, the data showed that the two pediatric-sized doses of the Pfizer COVID-19 vaccine were not producing the expected immunity in the 2- to 5-year-old group. Although they did not have the data for babies up to two years old, they decided to add the booster to them.
The Pfizer pediatric vaccine includes a 3 microgram (µg) dose as opposed to the 10 µg dose for individuals 5-12 years old, and a 30 µg dose for those older than 12-years-old. Pfizer said that the third 3 µg dose will be given at least two months after the second dose in the two-dose series that was included in the original clinical trial protocol.
The independent Data and Safety Monitoring Board, which can see clinical trial data without giving details to the company or investigators, also indicated that there were “no safety concerns were identified and the 3 microgram dose demonstrated a favorable safety profile in children 6 months to under 5 years of age.” This should assure anyone that a third dose will not bring up any safety issues.
The decision to evaluate a third dose of 3 micrograms for children 6 months to under 5 years of age reflects the companies’ commitment to carefully select the right dose to maximize the risk-benefit profile. 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.
Pfizer is also planning to test third doses in older children, who do not yet have authorization for booster doses of vaccine. Kids ages 5 to 11 and 12 to 15 will get full-dose third shots in the trials.
It’s clear that Pfizer is taking extreme care with its lower-dose pediatric COVID-19 vaccine. They want to make certain that they are providing effective doses without any serious safety signals.
One final point — whenever someone makes a claim that companies somehow cheat during vaccine clinical trials, nothing could be further from the truth. Companies, such as Pfizer, institute a number of protocols and independent advisors to make certain that these clinical trials provide unbiased and quality data that support the safety and effectiveness of these vaccines.