October 26, 2021
FOR IMMEDIATE RELEASE
Media Contact: Melissa Gordon, Vaccinate Virginia,
Statement from Virginia State Vaccination Liaison Dr. Danny Avula on FDA Advisory Panel’s Recommendation of Pfizer-BioNTech Vaccine for 5-11-Year-Old Children
(Richmond, Va.) – Today, the U.S. Food and Drug Administration (FDA) received the recommendation of its independent advisory panel, the Vaccine and Related Biological Products Advisory Committee (VRBPAC), to expand the Emergency Use Authorization (EUA) of the Pfizer-BioNTech C0VID-19 vaccine to include children from the ages of 5 through 11 years.
The VRBPAC recommendation and FDA’s coming action on that recommendation are only the first two review steps the vaccine must undergo before it can be administered to children. The next step is for the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) to meet November 2 to discuss the administration of the vaccine to this age group, followed by the final decision by CDC Director Dr. Rochelle Walensky. Only when this process is complete would children ages 5 to 11 years be eligible for vaccination.
The following statement is from Virginia’s state vaccination liaison Dr. Danny Avula, MD, MPH.
“The Virginia Department of Health (VDH) is tremendously excited about this first step by the FDA’s advisory committee to recommend expanding the Emergency Use Authorization for the Pfizer-BioNTech vaccine for use in 5-11-year-old children. It’s a milestone on the road toward emerging from the pandemic, returning to a more normal life, and most importantly being able to provide this protection to more Virginians.
“VDH has been planning for several months for the eventual rollout of this vaccine to young children, working with a wide range of healthcare partners to get these vulnerable children vaccinated as quickly as possible, utilizing channels ranging from pediatricians, family practices, and pharmacies to Community Vaccination Centers and local health departments. We await action by the FDA and then the CDC’s final decision, hopefully by next week. There’s light at the end of this pandemic tunnel sooner rather than later.”
Everyone 12 or older is eligible to be vaccinated. To find free vaccines at a Community Vaccination Center or another location near you, visit vaccinate.virginia.gov or call 877-VAX-IN-VA (877-829-4682, TTY users call 7-1-1). Assistance is available in English, Spanish, and more than 100 other languages. At Community Vaccination Centers, appointments are strongly encouraged to ensure you get the vaccine you want and to avoid extended wait times. Walk-ins are still welcome.
Media Memo: Backgrounder
To: Accredited members of the Virginia media
From: Melissa Gordon, VDH Vaccine PIO
Date: October 26, 2021
Subject: Vaccine supply and logistics details for ages 5-11
The Virginia Department of Health (VDH) received a number of media inquiries on the upcoming 5-11 vaccine approval and distribution. The purpose of this media memo is to give the accredited media background information on the 5-11 vaccine federal approval process; how it differs from the 12+ doses; federal allocation; and the logistics of the roll out.
On October 26, the U.S. Food and Drug Administration (FDA) received the recommendation of its independent advisory panel, the Vaccine and Related Biological Products Advisory Committee (VRBPAC), to expand the Emergency Use Authorization (EUA) of the Pfizer-BioNTech C0VID-19 vaccine to include children from the ages of 5 through 11 years. The CDC Advisory Committee on Immunization Practices (ACIP) plans additional meetings on November 2 on this topic as well. If the FDA issues an Emergency Use Authorization (EUA), and the CDC’s ACIP votes whether to recommend use, and the CDC Director makes a final recommendation, Virginia will begin providing the Pfizer-BioNTech vaccine to children 5-11 years old.
Based on the data that Pfizer-BioNTech submitted to the FDA on September 18, 2021:
- The dose is one-third of the Pfizer-BioNTech dose administered to people 12 years and older.
- The study included 2,268 participants who were 5-11 years old.
- Side effects were similar to those seen in people 12 years and older.
- Immune response was similar to those seen in people 12 years and older.
In the coming weeks, assuming FDA authorization and CDC recommendation, COVID-19 vaccine for children ages 5-11 years old will be available to the public in Virginia. The Pfizer-BioNTech vaccine is currently available, FDA authorized, and CDC recommended for those ages 12 years and older. The Pfizer-BioNTech vaccine could become available for everyone 5 and older as soon as November.
Virginia has been planning for the expansion of vaccine availability. There are many options for children to receive the COVID-19 vaccine – this includes pediatric offices, family practice offices, Community Vaccination Centers (CVCs), retail pharmacies, school-based clinics, and mobile vaccine units. Appointments are recommended. Once vaccines are available, parents can check in with their child’s provider or can find locations for their child to receive their vaccine by visiting www.vaccinate.virginia.gov or by calling (877) VAX-IN-VA (877-829-4682, TTY users call 7-1-1).
Logistics Mission/Philosophy/Organizational Process
VDH is working to ensure doses are distributed to local health districts based on need and health equity concerns. Local health districts make decisions about local allocation based on the needs of their communities, and these strategies may be different from one locality to the next. Upon receiving more information, VDH will contact providers with updated guidance.
VDH expects that over the next few months, all children in Virginia will have access to the vaccine, but allocation from the federal government may be less than demand in the first few weeks as the doses will be on a rolling basis and not all at once. Virginia’s initial allocation of 252,000 is broken into three ordering waves. The waves consist of 3 consecutive 48 hours starting 10/22 and ending 10/26. Weekly allocation is expected thereafter. There will also be an allocation to the Federal Retail Pharmacy Partnership (FFRP) that is roughly 50% of Virginia’s allocation amount. The initial state ordering process took place from October 22-26, 2021. The first delivery will begin sometime during the week of November 1, 2021.
CDC stated that the weekly allocations in the future will be steady amounts of a smaller quantity than what’s allocated during this initial allocation. The initial allocation shipments will be sent in intervals of 300 doses (300, 600, 900, etc.). The following allocations will be shipped in intervals of 100 doses. These smaller shipments ensure that doses are distributed to localities and providers that need smaller quantities. VDH will incorporate the Small Shipment Redistribution Program (SSRP) to distribute smaller quantities of the vaccine than what is available through direct federal shipments. Redistribution helps move smaller quantities of doses to providers who are in need.
Since the beginning of the vaccination campaign in mid December 2020, 5,324,523 Virginians or 62.4 percent of the total population has become fully vaccinated with either one shot of the Johnson & Johnson/Janssen vaccine or two doses or either Pfizer-BioNTech or Moderna. As of October 24, 5,921,619 Virginians or 69.4 percent of the state’s residents have received at least one dose of a vaccine. Of the adult population of Virginia, 18 years and older, 74.2 percent has been fully vaccinated, while 82.3 percent have received at least one dose of vaccine. Since the approval of third doses for immunocompromised individuals began in August 2021 and the approval of booster doses for Pfizer-BioNTech recipients in late September, 373,171 persons have received an additional dose or booster.
In the initial vaccination rollout, VDH focussed its attention on high-risk individuals — healthcare providers and staff and residents of long-term care facilities. In late January, eligibility began opening up additional people: the elderly ages 65 and older, persons 18-64 years with certain underlying conditions, persons in settings that make them more at risk of being infected, persons working in mission-critical jobs and, ultimately, the general public by late May. Virginia reached President Biden’s goal of having 70 percent of the population vaccinated with at least one dose by mid-June, two weeks before the president’s goal of July 4 for the nation as a whole.
Media Call To Action
VDH will issue press releases when the 5-11 vaccine officially receives federal approval and immediately before the roll out. Multiple subject matter experts will be available at that time for interviews and written statements.