Lauren Loor is the Statewide Program Manager for Healthy Eating + Active Living (HEAL) Initiative.…
The Process of Vaccine Authorization in the U.S.
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.
Public health officials, community based organizations, and parents cannot do this alone. Laulima, meaning many hands or cooperation, is a value that holds an important message for us today. Laulima is needed to make keiki vaccinations accessible in Hawai‘i.
Our Community Engagement for Health Equity in COVID-19 Prevention and Mitigation Project grantis accepting applications from community-based organizations that provide COVID-19 testing, vaccination, and education. To qualify, you must be a community-based organization in Hawaiʻi that is currently providing COVID-19 outreach work to Native Hawaiian, Pacific Islander, Filipino, and other higher risk communities in Hawai‘i. For more information, visit www.hiphi.org/covid19-grant-opportunity. Applications are being accepted until Friday, February 11, 2022, at 5:00 p.m. Funds are provided through DOH on behalf of the CDC. If you have any questions, please contact Dr. May Rose Dela Cruz at email@example.com.
If you know an organization who may benefit from this grant, please share the information above. We cannot do this work alone. Thank you for your doing your part in staying informed, spreading accurate information, and looking out for the health of your community.