Pfizer COVID-19 vaccine has FDA approval for those 5 and older; more steps before available in Oregon
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KLAMATH FALLS, Ore. – Last week the FDA gave emergency use authorization for the Pfizer-BioNTech vaccine to be used for those age five to 11. There are several steps left before the vaccine will be available to children in Oregon.
The process to approve and initiate pediatric COVID-19 vaccines has many steps. Each step serves a critical role to ensure that these vaccines are used safely and effectively, from the beginning of the manufacturing process to the very last step when an administering provider makes a recommendation to a patient, draws up and administers a dose.
These are the steps necessary prior to allowing COVID-19 vaccine administration in Oregon to the new group of pediatric patients anticipated to be covered in final recommendations. The timeline dates may change, and it’s important to remember all steps must be completed before immunization.
November 1: Pediatric vaccine will begin arriving in Oregon. Pediatric Pfizer will arrive at some locations before it is authorized for use. For authorization, it must go through several stages of review by multiple government bodies. Pediatric Pfizer doses will not be administered until the state has notified providers that it is time.
November 2 and 3: 1) The CDC’s Advisory Committee on Immunization Practices (ACIP) meets and makes recommendations to the CDC for use of COVID vaccines for children ages 5 through 11 years. 2) CDC makes formal recommendations, signed by the CDC director. 3) The Western States Scientific Safety Review Committee meets to consider CDC recommendations. 4) The Oregon Immunization Program (OIP) will send a listserv notice with links to updated DRAFT vaccine administration protocols to give providers an opportunity to review before final publication.
November 4: Oregon Governor Brown announces final authority for Oregon vaccinating providers and partners.
November 5: Earliest possible date for vaccinations to begin.
FDA key points for parents and caregivers:
Effectiveness: Immune responses of children 5 through 11 years of age were comparable to those of individuals 16 through 25 years of age. In addition, the vaccine was found to be 90.7% effective in preventing COVID-19 in children 5 through 11.
Safety: The vaccine’s safety was studied in approximately 3,100 children age 5 through 11 who received the vaccine and no serious side effects have been detected in the ongoing study.
The Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age is administered as a two-dose primary series, 3 weeks apart, but is a lower dose (10 micrograms) than that used for individuals 12 years of age and older (30 micrograms).
In the U.S., COVID-19 cases in children 5 through 11 years of age make up 39% of cases in individuals younger than 18 years of age. According to the CDC, approximately 8,300 COVID-19 cases in children 5 through 11 years of age resulted in hospitalization. As of Oct. 17, 691 deaths from COVID-19 have been reported in the U.S. in individuals less than 18 years of age, with 146 deaths in the 5 through 11 years age group.
Families should direct questions to their primary care providers, pediatricians and/or pharmacists.