Pfizer-BioNTech has made a welcome announcement saying it has submitted data on its clinical trials of their vaccine for 6 month old – 4 year old children. Parents and childcare providers will be delighted to know that finally, the children in their care may be eligible for a vaccine sometime this year.
With the Omicron variant proving more transmissible and infectious to younger children with pediatric cases at over 10 million now, this initiative from Pfizer-BioNTech gives families and childcare providers hope that they will be able to adequately protect their children.

Who will be eligible for the vaccine?

Pfizer-BioNTech has submitted clinical trial data to show its vaccine efficacy for 6-month old babies up to 4-year old children.

What do initial data suggest about the vaccine efficacy?

Last December, Pfizer-BioNTech announced that the lower dose vaccine which was given at a 2-dose interval gave 6-month-old to 2 year-olds a strong immune response. However, the effect on 2-4 year olds weren’t as good.

What is Pfizer-BioNTech doing to raise efficacy for 2-4 year olds?

Based on the results of the 2-dose interval, Pfizer announced they would test how adding a 3rd dose affects the vaccine efficacy on 2-4 year olds. The data for the clinical trial of the 3rd dose will be submitted and applied for a separate application for extension of the emergency use authorization (EUA).

What is the vaccine schedule for young children?

Young children 6-month old to 4 years of age will be given a total of 3 doses.
The second dose of vaccine will be given 3 weeks after the first vaccination.
The third and final dose will be given 2 months after the second dose.

Will it be different for immuno-compromised children?

Pfizer-BioNTech has indicated that immunocompromised children aged 5 years and up are advised to get a third dose of the vaccine at least 28 days after the second dose.

Who were tested in these clinical trials for COVID-19 vaccines on young children?

The clinical trials for the Pfizer-BioNTech vaccine for 6-month-old to 4-year-olds were held at 90 clinical trial sites in the United States, Finland, Poland, and Spain. The initial sample size was 4,500 children with ages 6-month old to 12 years.
Following revisions in the clinical trial, the sample size grew to 8,300 children.

When will the vaccine be administered to young children?

The Food and Drug Administration (FDA) has set up a meeting on February 15 to discuss Pfizer-BioNTech’s submission to revise their EUA for use to include the 6-month old to 4-year olds. If approved, the vaccine rollout for young children can be expected to start as early as March.