COVID-19 Update for Virginia
September 30, 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. Updates on the following topics are included in this correspondence:
- CDC Recommends a Booster Dose of Pfizer-BioNTech Vaccine Following a Primary Series for Certain Populations
- COVID-19 Vaccination and Pregnancy
- Vaccination for Children Aged 5 to 11 Years
- Update on Monoclonal Antibody Treatment for COVID-19 Distribution
CDC Recommends a Booster Dose of Pfizer-BioNTech Vaccine Following a Primary Series for Certain Populations
On September 23, the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) recommended certain populations at high risk for severe COVID-19 illness receive a booster shot of Pfizer’s COVID-19 vaccine at least six months after the completion of their Pfizer vaccine primary series. The CDC Director adopted ACIP’s recommendations and also recommended a booster dose for workers in high-risk occupational and institutional settings. The Pfizer booster dose is the same formula and volume (0.3 mL) as the primary series.
CDC recommends the following people should receive a booster shot of Pfizer’s COVID-19 vaccine at least six months after their Pfizer primary series:
- People 65 years and older
- Residents aged 18 years and older in long-term care settings
- People aged 50–64 years with underlying medical conditions
The following people may receive a booster shot of Pfizer’s COVID-19 vaccine at least six months after their Pfizer primary series, based on individual benefits and risks:
- People aged 18–49 years with underlying medical conditions
- People aged 18-64 years who are at increased risk for COVID-19 exposure and transmission because of occupational or institutional setting
CDC revised its Clinical Considerations for COVID-19 Vaccination, which provides information about assessing individual risks and benefits and occupations (e.g., healthcare workers, teachers) or institutional settings (e.g., correctional and detention facilities) where an increased risk for transmission or exposure exists. Providers may begin administering Pfizer boosters to patients who self attest that they are eligible. VDH also updated its Vaccination FAQs for the public and healthcare providers.
The CDC Director’s decision follows the U.S. Food and Drug Administration’s (FDA) amendment to the Emergency Use Authorization (EUA) on September 22, 2021, to allow a booster dose of Pfizer’s COVID-19 vaccine for certain populations. FDA updated its fact sheets for healthcare providers administering vaccine and for recipients and caregivers for the Pfizer-BioNTech vaccine.
The potential benefits of a Pfizer booster dose include increased protection against severe disease and infection. The strongest evidence for waning of protection against severe disease has been seen among adults 65 years and older, while protection against severe illness, hospitalization, and death remain high for younger individuals. Waning of vaccine effectiveness against infection has been noted in all age groups, including residents of long-term care facilities, healthcare and other frontline essential workers.
A booster dose is not yet recommended for those who received the Moderna and Johnson & Johnson/Janssen (J&J) vaccines for their primary series. People who got these vaccines will likely need a booster dose in the future. CDC and FDA are reviewing data to determine recommendations for booster doses for this population over the next few months.
Because immunity decreases gradually, Pfizer booster doses are recommended no sooner than six months after completing the two-dose primary series and may be given at intervals greater than six months. The real urgency is still to vaccinate people who remain unvaccinated.
If your patients are uncertain of which vaccines they received in the past, they can look up their COVID-19 vaccination record at www.vaccinate.virginia.gov. If they have difficulty looking up their record, they can contact 877-VAX-IN-VA (877-823-4628). Providers should also encourage their patients to enroll in the v-safe after vaccination health checker℠ and complete health check-ins after COVID-19 vaccination. V-safe is a smartphone-based tool that uses text messaging and web surveys to provide personalized health check-ins after COVID-19 vaccination.
COVID-19 Vaccination and Pregnancy
On September 29, CDC issued a Health Alert Network (HAN) Health Advisory urging action to increase COVID-19 vaccination among people who are pregnant, recently pregnant (including those who are lactating), who are trying to become pregnant now, or who may become pregnant in the future. Pregnant and recently pregnant people are at increased risk for severe disease (including hospitalization and death) and pregnancy complications related to COVID-19. Despite these risks, only 31% of pregnant people were fully vaccinated before or during pregnancy as of September 18, 2021. A strong recommendation from a healthcare provider is an important factor in the decision to get vaccinated.
Vaccination for Children Aged 5 to 11 Years
On September 28, Pfizer and BioNTech submitted initial data from the Phase 2/3 clinical trial of their COVID-19 vaccine in children aged 5 to 11 years to the FDA. Pfizer and BioNTech state that they anticipate submitting a request to amend the vaccine EUA in the coming weeks. The initial data submission follows an announcement from the company on September 20 that the Phase 2/3 trial showed a safe and effective vaccine response in children aged 5 to 11 years using a two-dose regimen of 10 µg (micrograms) administered 21 days apart.
Update on Monoclonal Antibody Treatment for COVID-19 Distribution
On September 13, the U.S. Department of Health and Human Services (HHS) added an allocation process for the distribution of the monoclonal antibody (mAb) therapies, REGEN-COV and Bamlanivimab/Etesevimab. Each state now receives a weekly allotment based on its number of COVID-19 cases and mAb usage. States are required to then allocate the mAbs to providers (administration sites) and place their orders with AmerisourceBergen (the distributor) for shipment to the administration site. VDH emailed current administration sites to inform them of the new process. Please email firstname.lastname@example.org if you have questions or would like to become a mAB provider site.
Of note, on September 16, Bam/Ete received FDA Emergency Use Authorization (EUA) for the product to be used for postexposure prophylaxis (PEP) against COVID-19. Please see the updated Bam/Ete package insert. With this new EUA, both Bam/Ete and REGEN-COV now have an indication for COVID-19 PEP.
Thank you for all your continued efforts to protect Virginians from COVID-19. If you have questions about COVID-19, please contact your local health department.
M. Norman Oliver, MD, MA
State Health Commissioner