Here’s Why the Review of COVID-19 Pfizer Vaccine For Children Under 5 Has Been Delayed

Good Morning America

Currently, children under the age of 5 are the only group of people in the United States who are not eligible to get vaccinated for Covid-19. The FDA was hoping to change that this month by fast tracking the Pfizer vaccine for this age group and reviewing the data to grant emergency use authorization. Now, Pfizer has done an about face and removed their request for emergency use authorization for the under 5 vaccine.

Pfizer’s plan is for the vaccine for the 2-4 age group to require 3 doses before these children are considered fully vaccinated. Each dose of the vaccine is only 3 micrograms which is significantly less than the 10 microgram dose for ages 5+.

Pfizer was asking the FDA to authorize the first two doses of the vaccine in February since they’re still waiting for data from the third dose of the vaccine in the clinical trials. Now, they have changed their mind.

Watch the video below to learn more about why Pfizer decided to delay their request for emergency use authorization for the Covid vaccine for ages 2-4.

Dr. Scott Gottlieb, who is the former head of the FDA and currently on the Pfizer board, told CNBC that there were a “low number of cases overall in the clinical trial.” He explained that since very few kids in this age group are getting symptomatic Covid-19, “One case in one direction or another can tip the perception of the vaccine’s overall effectiveness.”

Pfizer plans to wait until after they have the data from the third dose to submit the data to the FDA for an emergency use authorization request.

Gottlieb believes that once the vaccine has been authorized by the FDA, only about 15% or 20% of parents will rush out to vaccinate their children. He knows that for this percentage of parents, the vaccine is “very important.”

Gottlieb does not believe that the vaccine should be mandated for the 2-4 age group. Instead, he thinks the FDA will choose to simply recommend the vaccine and say something like children “could get vaccinated to reduce their risk.”

Since the beginning of the pandemic, 400 children under the age of 5 have died from Covid-19. While that is significantly less than in other age groups, it is significant as compared to the flu, which has only caused the deaths of 5 children in the past 2 years.