In a recent announcement, Pfizer-BioNTech revealed that their low-dose COVID-19 vaccine trial for children aged 2 to 5 has not produced the desired immune response. This disappointing news means that parents who have been eagerly awaiting a vaccine for their little ones will likely face further delays.
In the trial, children aged 6 months to 5 years received a dose that is one-tenth of what adults receive. While the vaccine generated an adequate immune response in the younger cohort, those aged 2 to 5 did not show a significant reaction. Rather than increasing the dose for this age group, Pfizer will now explore administering a three-shot regimen instead of the original two, a change that has been approved by the FDA. The company intends to seek FDA authorization for this three-dose schedule for all children in the first half of 2022, similar to the approach now used for adults.
“The objective is to evaluate the potential benefits of adding a third dose,” stated Lena Johnson, a Pfizer representative. “We are currently studying doses of 3 micrograms.”
The fact that older participants did not achieve a strong immune response from the first two doses does not signify a total failure of the trial. It simply means the trial will be extended by two months to allow for the administration of the additional shot. Should the immune response still not meet the necessary threshold, they may need to initiate a new trial to adjust the dose or modify the vaccination schedule for this age group.
Dr. Mark Henson, a vaccine specialist at the Children’s Health Institute, noted that while the two-dose regimen may not prevent COVID-19, it could still mitigate the severity of the illness. “The main goal of this vaccine is to avoid serious health complications,” he remarked.
In a future study, Pfizer plans to investigate a three-dose series for children aged 5-12, maintaining the same dose size of 10 micrograms, which is one-third of the adult dosage of 30 micrograms.
On a positive note, Pfizer confirmed that “no safety concerns were identified” during any phase of the ongoing trial.
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In summary, Pfizer’s trial for a COVID vaccine in children aged 2-5 has produced disappointing results, prompting a shift to a three-dose approach. While this setback raises concerns for parents, safety remains a priority, and further studies are planned for older children.