COVID-19 Update for Virginia
November 5, 2021
Thank you for your continued partnership in responding to the COVID-19 pandemic. Please visit the Virginia Department of Health (VDH) website for current clinical and public health guidance, epidemiologic data, and other information. The following topic is included in this correspondence: Pfizer-BioNTech COVID-19 Vaccine Authorized and Recommended for 5–11 Year Olds.
On October 29, 2021, the U.S. Food and Drug Administration (FDA) expanded the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to include children 5–11 years of age. The FDA determined that the known and potential benefits of this vaccine in individuals 5 years of age and older outweigh the known and potential risks. The available safety data support the EUA in this age group. The vaccine’s safety was studied in about 3,100 children aged 5–11 years who received the vaccine, and no serious side effects were detected. Based on the clinical trial data, commonly reported side effects included injection site pain (sore arm), redness and swelling, fatigue, headache, muscle and/or joint pain, chills, fever, swollen lymph nodes, nausea and decreased appetite. Side effects were more common after the second dose and were mild to moderate in severity; these typically resolved within one to two days.
FDA also authorized a new formulation of the Pfizer-BioNTech vaccine for individuals aged 12 years and older, which uses a different buffer (Tris buffer), to improve stability and storage conditions. Tris buffer is in other FDA-approved vaccines and other biologics, including those for use in children. FDA provided updated or new fact sheets for healthcare providers and recipients to align with these recent authorizations.
On November 2, the Centers for Disease Control and Prevention (CDC) recommended the Pfizer-BioNTech COVID-19 Vaccine for children 5–11 years of age. CDC’s Advisory Committee on Immunization Practices (ACIP) unanimously voted to recommend this vaccine based on the safety, immunogenicity, and efficacy of the vaccine. The vaccine is nearly 91% effective at preventing COVID-19 in children ages 5–11 years. CDC updated its Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United States to incorporate vaccinating this population.
The Pfizer-BioNTech vaccine for children 5–11 years of age should be administered as a two-dose primary series, 3 weeks (21 days) apart. If necessary, the second dose may be administered up to 6 weeks (42 days) after the first dose. The new pediatric formulation for 5–11 year olds comes in vials with orange caps and allows for the delivery of a lower dose (10 micrograms) than the vaccine for people aged 12 years and older (30 micrograms). The Pfizer-BioNTech vaccine for people aged 12 years and older is supplied in vials with purple or gray caps and should not be used for individuals 5–11 years of age. As a reminder, CDC also recommends that COVID-19 vaccines be administered without regard to timing of other vaccines. This includes simultaneous administration of COVID-19 and other vaccines (e.g., flu vaccine).
In Virginia, COVID-19 vaccination of these younger children aged 5–11 years began on November 3, 2021. Virginia will have enough supply of the Pfizer-BioNTech vaccine for all Virginians in this age group. Options for children to receive the free vaccine include pediatrician and family practice offices, retail pharmacies, federally qualified health centers (FQHCs), free clinics, and Community Vaccination Centers (CVCs). Walk-ins may be available at some CVCs and appointments may be required at other locations. Because of the nature of vaccinating children, VDH anticipates that appointments with a primary care provider may be preferred by parents, and these appointments may be limited initially in certain areas. Please direct parents to vaccinate.virginia.gov, which is being updated this week to include vaccination locations for 5–11 year olds, or the VDH hotline at 877-VAX-IN-VA (877-829-4682) to find available vaccination locations. VDH encourages all parents whose children are vaccinated against COVID-19 to enroll in v-safe so they can provide health check-ins after vaccination and receive reminders about the second dose. Patients, caregivers, and vaccine providers are asked to report adverse events after vaccination to the Vaccine Adverse Event Reporting System (VAERS), even if it is not clear that the vaccine caused the adverse event.
VDH’s COVID-19 Vaccination Response website is the best source of Virginia-specific information. Resources include extensive FAQs about vaccination, a COVID-19 Vaccine Dosage and Scheduling Table, information about how to get a copy of your immunization record, and other vaccine clinic information.
Thank you again for your continued partnership as we respond to the COVID-19 pandemic.
M. Norman Oliver, M.D., M.A.
State Health Commissioner