đź’ĄBreaking News Fridayđź’Ą
TL:DR: A slight delay to Pfizer’s vaccine trial for <5 year olds:
The trial is adding a 3rd dose to boost immune response, and now expects submission of data “in the first half of 2022.”
The vaccine news the past 12 months has mostly been WAY better than expected.
Today the news was disappointing for parents of young children who had been hoping approval of a vaccine for <5s might be imminent.
âť“Why the delay?
The Pfizer trial for children aged 6 months-5 years uses two 3 µg doses given 3 weeks apart. This compares to a 10 µg dose for ages 5-11 and 30 µg for ages 12 and up.
Adjusting the dose for small kids is a balancing act between finding the right dose to induce a proper immune response while minimizing potential side effects.
Routine analysis of the trial data found that the two doses did not induce as high of an immune response in 2–5-year-olds compared to the benchmark of immune response in 16–25-year-olds (which are known to be protective against infection from the large vaccine trials).
For ages 6-24 months, the immune response WAS comparable (or more precisely “non-inferior”) to the 16–25-year-olds, so the dosage was likely not far off for those a bit older. No safety concerns were identified from the 3 µg dose.
Pfizer will now evaluate a third dose of the 3 µg dose at least two months after the second dose to boost immunity.
➡️ Pfizer reports that if the three-dose study is successful, they expect to submit for Emergency Use Authorization (EUA) for children 6 months to 5 years of age in the first half of 2022.
➡️ Pfizer also plans to evaluate a third dose of the 10 µg formulation in children 5 to under 12 years of age (BOOSTERS!).
➡️ Finally, the company has also started a low dose study of a third dose of 10 µg or 30 µg in approximately 600 adolescents aged 12- to 17, to assess safety and immunogenicity (MORE BOOSTERS!).
The news, even about life-saving vaccines, can’t *always* be good. The vaccine timelines played out MUCH more quickly than original estimates, for which we are grateful.
But our hearts go out to the parents of little ones who were anxiously awaiting this news, especially with the Omicron waves on the horizon. Hang in there. xoxo
Love,
Those Nerdy Girls
Links:
“Pfizer plans to test a third dose of its COVID vaccine on infants and young children”
