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Vaccine for kids under 5 delayed
P zer extending trials so FDA can review more data on a third dose
By John Woolfolk jwoolfolk@bayareanewsgroup.com
Parents hoping to vaccinate their preschoolers and toddlers against COVID-19 will have to wait months after the Food and Drug Administration and Pfizer said Friday they are extending trials of the proposed reduced-dose for children 6 months through 4 years old to review more data.
The announcement marks a reversal from just 10 days ago when they announced that the FDA on
Feb. 15 would consider authorizing two doses of the vaccine for the 23 million American kids in that age group while awaiting more data on the e ectiveness of a third dose.
“Given the recent omicron surge and the increase in hospitalizations among the youngest children that are at the highest levels of the pandemic, we thought it was our obligation to act with urgency,” said Dr. Peter Marks, director of the FDA’s center for biologics evaluation. “Our goal was to understand if two doses would provide sufficient protection to move forward. At this time, we believe additional information regarding the ongoing evaluation of a third dose is needed.”
Pfizer said in a statement Friday that “cases continue to ac -