COVID-19 Update for Virginia
October 28, 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 Expands Eligibility for COVID-19 Booster Doses for Certain Recipients of Moderna and Johnson & Johnson COVID-19 Vaccines and Allows for Heterologous Booster Doses
- Update on Pfizer COVID-19 Vaccines for Children Aged 5 to 11 Years
- VDH Webinar on Understanding COVID-19 Vaccine: What the Evidence Tells Us
- VDH Statement on the Use of Ivermectin for the Prevention or Treatment of COVID-19
CDC Expands Eligibility for COVID-19 Booster Doses for Certain Recipients of Moderna and Johnson & Johnson COVID-19 Vaccines and Allows for Heterologous Booster Doses
On October 21, the Centers for Disease Control and Prevention’s (CDC) Director Dr. Rochelle Walensky endorsed the recommendations of the Advisory Committee on Immunization Practices (ACIP) to expand eligibility for COVID-19 booster shots. Booster doses are now available to certain recipients of the Moderna and Johnson & Johnson (J&J)/Janssen primary series, and heterologous (or “mix and match”) booster doses are allowed. Booster doses of Pfizer vaccine were already authorized for certain recipients of the Pfizer primary series. On October 20, the U.S. Food and Drug Administration (FDA) amended emergency use authorizations (EUAs) for Pfizer, Moderna, and J&J vaccines. Updated FDA fact sheets for healthcare providers (Pfizer, Moderna, J&J) and recipients and caregivers (Pfizer, Moderna, J&J) are also available.
A booster shot of COVID-19 vaccine is recommended at least six months after the completion of an mRNA vaccine primary series (Moderna or Pfizer) for certain populations. These people should receive a booster:
- People aged 65 years and older
- People aged ≥ 18 years who live in long-term care settings
- People aged 50 to 64 years with an underlying medical condition
In addition, these people may also benefit from a booster based on their individual benefits and risks:
- People aged 18 to 49 years with an underlying medical condition
- People aged 18 to 64 years who work or live in high-risk settings
Moderna sent a letter to vaccine providers to alert them of prescribing information for booster doses. Importantly, the booster dose of Moderna COVID-19 vaccine is 50 micrograms (µg) in 0.25 mL, which is half the dose of the primary series vaccine. Although the dose sizes for the booster and primary series are different, the product used for both purposes is the same. The dose for the Pfizer booster is the same as the primary series vaccine (0.3 mL).
Additionally, all individuals aged ≥ 18 years who received a J&J primary series should receive a single COVID-19 vaccine booster dose at least two months after the J&J primary dose. The dose and the product for the J&J booster is the same as the initial dose (0.5 mL).
CDC recommendations now allow for heterologous (or “mix and match”) booster doses. Individuals who are eligible to receive a COVID-19 booster dose may choose which vaccine product they would like to receive as a booster and discuss which product is most appropriate for them with their healthcare provider. If a heterologous booster dose is administered, the interval between the primary series and the booster dose should be based on the vaccine that was used in the primary series. The booster dose size and volume are the same regardless of whether the patient is receiving a homologous (same as primary series) or heterologous (different from primary series) booster.
An individual risk benefit assessment can be used to help determine which booster dose is most appropriate for a particular patient, including the risks of the different available vaccines. The potential risks of an mRNA booster dose include the rare risk of myocarditis or pericarditis. The risk of these conditions is highest among males aged ≤ 30 years based on data from mRNA primary vaccine series. Additionally, the potential risk of the J&J vaccine include the rare conditions of Guillain-Barré Syndrome (GBS) and thrombosis with thrombocytopenia (TTS). Based on data after receipt of the J&J primary dose, the risk of GBS is highest among males aged 50 to 64 years, and the risk of TTS is highest among females aged 18 to 49 years. Vaccine providers should ensure women aged 18 to 49 years are aware of the increased risk for TTS and of the availability of mRNA vaccines. Individuals who had TTS following their initial J&J vaccine should not receive a J&J booster dose. More guidance is available in CDC’s Interim Clinical Considerations for Use of COVID-19 Vaccines.
Moderately and severely immunocompromised people who are aged ≥ 18 years and received a two-dose mRNA vaccine and an additional primary mRNA dose may receive a COVID-19 booster dose (i.e., Pfizer, Moderna, or J&J) at least six months after their additional primary dose. Immunocompromised individuals who are aged ≥ 18 years and received the J&J vaccine at least two months ago should receive a booster dose of COVID-19 vaccine. If these individuals receive a Moderna booster dose, they should receive the 50 µg in 0.25 mL booster dose (half dose).
As a reminder, COVID-19 booster doses may be given at the same time, or anytime before or after other vaccines, including the flu shot. This is especially important now that we are in the flu season. Help keep your patients from falling behind on their recommended vaccines by coadministering them with COVID-19 booster doses or primary series. People seeking a booster dose should be permitted to self-attest to their eligibility.
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). Please also encourage your patients to enroll in CDC’s 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.
Update on Pfizer COVID-19 Vaccines for Children Aged 5 to 11 Years
On October 26, FDA’s Vaccines and Related Biological Products Advisory Committee recommended the extension of Pfizer’s COVID-19 vaccine EUA for children aged 5 to 11 years. There are still multiple steps that must occur at the federal level before providers can begin administering vaccines to this population. Next, the FDA must decide whether to formally amend the EUA. If amended, CDC’s ACIP will meet and vote on recommendations for Pfizer vaccine for 5 to 11 year olds, and finally the CDC Director will determine official CDC recommendations.
There are some important differences between Pfizer’s vaccine for children aged 5 to 11 years and the vaccine for people aged 12 years and older. The dose size for Pfizer vaccine for 5 to 11 year olds is 10 micrograms (mcg) / 0.2 mL, which is a third of the dose size for Pfizer recipients aged 12 years or older. Although the active ingredients in the Pfizer COVID-19 vaccine for 5 to 11 year olds are the same as those in the vaccine authorized for people aged 12 years and older, the product configurations and vials are different. Vaccine providers will be required to use the Pfizer product for 5 to 11 year olds if vaccination is authorized and recommended for this age group.
If FDA amends the Pfizer EUA, available supplies of the vaccine for 5 to 11 year olds will be prepositioned with vaccine providers; however, providers are not able to begin administering these vaccines until the CDC Director provides official recommendations. Initial supplies may be very limited. VDH expects that over the next few months all children in Virginia will have access to the vaccine, but there may not be enough for everyone to get them in the first few weeks.
VDH Webinar on Understanding COVID-19 Vaccine: What the Evidence Tells Us
VDH will host a Webinar on Understanding COVID-19 Vaccine: What the Evidence Tells Us on November 3 from 6:00 pm to 7:00 pm. This is a free event that has been approved for Continuing Medical Education (CME) credit / Continuing Education (CE) credit for physicians, nurses, and pharmacists. This webinar is open to all healthcare professionals and all healthcare staff. Information to access the webinar and descriptions of the panelists are available here. Please share this with members of your professional organizations.
VDH Statement on the Use of Ivermectin for the Prevention or Treatment of COVID-19
VDH strongly discourages the ordering, prescribing, or dispensing of ivermectin to prevent or treat COVID-19 outside of a clinical trial. Ivermectin is approved by FDA for human use to treat infections caused by internal and external parasites. It is not approved to prevent or treat COVID-19, or any other viral infection. Ivermectin is also available to treat certain veterinary conditions; medications formulated or intended for use in animals should not be used by humans.
In addition, we urge physicians, other prescribers, and pharmacists—trusted healthcare professionals in their communities—to warn patients against the use of ivermectin outside of FDA-approved indications and guidance, whether intended for use in humans or animals, as well as purchasing ivermectin from online stores. Veterinary forms of this medication are highly concentrated for large animals and pose a significant toxicity risk for humans. Use of ivermectin for the prevention and treatment of COVID-19 has been demonstrated to be harmful to patients.
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