When will the Pfizer COVID-19 vaccine be available for keiki under age five?

Many are awaiting the authorization of the Pfizer-BioNTech COVID-19 vaccine for keiki under the age of five. On February 1, Pfizer submitted a request to the U.S. Food and Drug Administration(FDA) for an emergency use authorization (EUA) for their two-dose COVID-19 vaccine for keiki aged six months and up. A vaccine being available to children six months and older can bring relief for parents who have been concerned about their child getting COVID-19. Many parents of school-aged children say their child has experienced some disruption in their schooling during January 2022. We recognize the stress on parents managing quarantines and isolations, worrying about school closures, and in most cases struggling with unpaid family and medical leave. With new variants emerging and the unpredictable surges in cases, the vaccine will provide more protection for keiki.

What steps must be taken before the vaccine becomes available? The first step is for the vaccine to receive an emergency use authorization (EUA). An EUA allows the use of medical products during a public health emergency as long as the benefits are expected to outweigh the risks based on the data that is currently available. The FDA reviews manufacturing information to ensure quality and consistency, and the data presented to ensure the efficacy and safety of the product.

Submitting an EUA is not an easy or quick process. A company must first conduct clinical trials that consist of multiple phases in order to compile safety and efficacy data. After submitting an EUA request, the FDA will evaluate the data. While the evaluation is ongoing, the FDA’s Vaccines and Related Biological Products Advisory Committee, holds a public meeting. External scientific and public health experts from throughout the country with no conflicts of interest, discuss the data submitted. The advisory meeting for Pfizer’s EUA for keiki six months and up will take place virtually on February 15 from 3:30 a.m. – 12 p.m. To join the meeting or watch the recording, visit https://youtu.be/nGRNfZ8ZHN8. Interested persons may present data, information, or views, orally or in writing to the committee before Thursday, February 10. To learn how to do so, click here.

Following the meeting, the FDA weighs the advisory panel vote and makes a final decision on the EUA. After the EUA is issued, the Centers for Disease Control and Prevention (CDC) reviews if the vaccine should be recommended for all children in this age group or only certain subgroups of children. The CDC’s Advisory Committee on Immunization Practices (ACIP) will vote on the implementation of the vaccine and the official recommendation is signed off by the CDC’s director, Dr. Rochelle Walensky. After the CDC’s recommendation, the Hawai‘i Department of Health (DOH) will issue guidance to local pediatricians and pharmacies. Once the Pfizer vaccine is available for keiki under age five, you can visit hawaiicovid19.com to find a vaccination site.