A plan to fast-track approval of the Pfizer-BioNTech COVID vaccine for kids under 5 has failed, leaving parents and caregivers of young children in limbo once again. Initially, the U.S. Food and Drug Administration (FDA) planned to meet February 15 to decide if children under 5 could finally start receiving their long awaited initial doses of Pfizer’s COVID vaccine. Now, the meeting has been postponed and many caregivers are anxiously wondering what happens next. Here’s everything we know about what’s causing the delay and when a COVID shot for young kids can finally be expected to get approval.<\/p>
Kids younger than 5 are the only remaining age group in the U.S. who doesn’t have access to a COVID vaccine. During initial trials by vaccine maker Pfizer-BioNTech, the standard two-shot COVID vaccine<\/a> failed to produce an adequate immune response in this younger group; however, the makers believe a three-shot vaccine will provide the necessary protection. Given the hope that a third dose will be effective and the exponential rise in pediatric COVID cases during the month of January, Pfizer-BioNTech submitted their available data as part of a plan to fast-track vaccine approval<\/a> using rolling submissions. First, the FDA would approve the two-shot vaccines, and then data and authorization for a third shot would hopefully follow.<\/p> Last week, the FDA put a hold on this plan, postponing their planned meeting until more data on a third shot can be reviewed. In a statement<\/a>, the FDA said it believes “additional information regarding the ongoing evaluation of a third dose should be considered.”<\/p>