COVID-19 Update for Virginia
November 22, 2021
Dear Colleague:
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:
- FDA and CDC Expand Eligibility for COVID-19 Booster Doses to All Adults
- CDC Updates Vaccine Guidance People Who Received COVID-19 Vaccine Outside the U.S. and People Who Received COVID-19 Vaccine as Part of a Clinical Trial
- Vaccine Administration Errors with Pediatric COVID-19 Vaccine
- VDH Releases New Monoclonal Antibody Locator Tool and Provides Additional Updates
FDA and CDC Expand Eligibility for COVID-19 Booster Dose to All Adults
On November 19, the U.S. Food and Drug Administration (FDA) authorized and the Centers for Disease Control and Prevention (CDC) recommended expanding the eligibility for a COVID-19 booster shot to everyone aged 18 years or older. A single booster dose is now recommended for any adult who completed a Pfizer-BioNTech or Moderna vaccine series at least six months ago. The earlier recommendation of a single booster dose for those adults who received a Johnson & Johnson/Janssen vaccine at least two months ago still applies. FDA amended the Pfizer-BioNTech, Moderna, and Johnson & Johnson fact sheets for healthcare providers and for recipients and caregivers to reflect these changes.
CDC distinguishes their recommendations between those populations that should get a COVID-19 vaccine booster and those that may get a COVID-19 vaccine booster. COVID-19 vaccines cannot be administered without CDC recommendations so the intent of this distinction is to emphasize those at higher risk. CDC expanded their recommendation for who should get a COVID-19 booster dose following completion of an mRNA primary series to 1) people aged 50 years or older and 2) people aged 18 years or older who reside in a long-term care facility. Previously, CDC recommended that these people who completed an mRNA primary series should get a booster dose: 1) people aged 65 years and older, 2) people aged 18 years and older who live in a long-term care setting, and 3) people aged 50–64 years with certain underlying medical conditions. CDC also updated their recommendation for who may get a booster following completion of an mRNA primary series to 1) all adults 18–49 years of age based on their individual risks and benefits. Previously, CDC recommended that these people who completed an mRNA primary series may get a booster dose: 1) people 18–49 years old with underlying medical conditions and 2) people 18–49 years old whose living or work conditions placed them at high risk. CDC’s revised Clinical Considerations for the Use of COVID-19 Vaccines Currently Approved or Authorized in the United States reflects these changes.
If your patients are uncertain of which vaccines they previously received, they can look up their COVID-19 vaccination record at www.vaccinate.virginia.gov. If they have difficulty with this, they can call 877-VAX-IN-VA (877-829-4682). Please also encourage your patients to enroll in CDC’s v-safe after vaccination health checker℠ and complete the personalized health check-ins after COVID-19 vaccination.
With the rising cases and upcoming colder weather and holidays, please urge your eligible patients to get vaccinated against COVID-19 or get their booster dose now. Two recent publications in CDC’s Morbidity and Mortality Weekly Report and a preprint article highlight that pregnant or recently pregnant people are at increased risk for severe COVID-19, including ICU admission, ventilator use, and death. People with COVID-19 during pregnancy are also at increased risk for preterm birth and stillbirth and might be more likely to experience other pregnancy complications. Please also encourage anyone aged 6 months or older, including pregnant people, to get the separate flu vaccine, which can be safely coadministered with the COVID-19 vaccine.
CDC Updates Vaccine Guidance for People Who Received COVID-19 Vaccine Outside the U.S. and People Who Received COVID-19 Vaccine as Part of a Clinical Trial
On November 17, CDC updated their Clinical Considerations for the Use of COVID-19 Vaccines Currently Approved or Authorized in the United States with new information and Emergency Use Instructions (EUI) for people who were vaccinated outside the U.S. and people who received COVID-19 vaccine as part of a clinical trial. The updates allow the FDA-approved Pfizer-BioNTech COVID-19 vaccine to be given as an additional primary dose for those moderately or severely immunocompromised or a booster dose to certain people who completed a vaccine primary series with certain COVID-19 vaccines that are not authorized or approved by the FDA. This ensures that eligible people can get an additional primary dose if immunocompromised or booster dose of Pfizer-BioNTech COVID-19 vaccine. EUI fact sheets are available for healthcare providers and for recipients/caregivers.
Vaccine Administration Errors with Pediatric COVID-19 Vaccine
Reports of misadministration of COVID-19 vaccine, especially in pediatric populations, have been recently reported in Virginia. These have specifically involved giving the wrong vaccine formulation to children aged 5–11 years. As a reminder, Pfizer-BioNTech’s 10 µg dose formulation (orange cap) that is authorized for use in children aged 5–11 years for primary vaccination is not interchangeable with the Pfizer-BioNTech’s 30 µg dose formulation (purple cap and label with purple border) that is authorized or approved for those aged 12 years and older. If a patient aged 5–11 years is inadvertently given the adolescent/adult formulation, then the next steps depend on the volume administered and when it was administered in the series:
- If 0.1 ml was administered, then, in general, do not repeat the dose. However, based on clinical judgement (e.g., child received 2 doses of incorrect formulation), a repeat dose of Pfizer-BioNTech COVID-19 Vaccine 5–11 years formulation (orange cap) may be administered at an interval of 21 days after the dose given in error.
- If >0.1 ml was administered, resulting in a higher-than-authorized dose, then do not repeat the dose.
- If the dose given in error is the first dose, administer the second Pfizer-BioNTech COVID-19 Vaccine 5–11 years formulation (orange cap) dose 21 days later.
Appendix A in CDC’s Clinical Considerations for the Use of COVID-19 Vaccines Currently Approved or Authorized in the United States summarizes common vaccine administration errors and how to address them. Healthcare providers should report any vaccine administration error to the Vaccine Adverse Event Reporting System (VAERS), notify the recipient, and take corrective action immediately to prevent it from happening again. VDH encourages healthcare providers to also refer to CDC’s patient safety checklist to support safe COVID-19 vaccine administration.
VDH Releases New Monoclonal Antibodies Locator Tool and Provides Additional Updates
VDH recently released a Monoclonal Antibodies Locator Tool that can be used by healthcare providers and the public to locate healthcare facilities that can provide monoclonal antibodies (mAbs) to eligible patients. For more information about becoming an outpatient provider of COVID-19 mAb therapy, please complete the instructions on this form. More information about mAbs is available at VDH’s COVID-19 Outpatient Monoclonal Antibody Therapy Resource Center. While mAb therapy is an important therapeutic tool for treating eligible patients infected with or exposed to SARS-CoV-2, it is not a substitute for vaccination.
Two new therapeutic agents are currently under review by the FDA for Emergency Use Authorization (EUA). Molnupiravir (Merck & Co., Inc.) is an oral antiviral drug studied for the outpatient treatment of high-risk patients with mild to moderate COVID-19. On November 30, FDA’s Antimicrobial Drugs Advisory Committee will meet to discuss this agent. The second drug is AstraZeneca’s monoclonal antibody “AZD7442.” The product is a combination of two mAbs, tixagevimab and cilgavimab, and an EUA is being sought for COVID-19 pre-exposure prophylaxis. VDH will send updates to providers when more information becomes available.
Thank you again for your continued partnership as we respond to the COVID-19 pandemic. I hope you have a safe and happy holiday season.
Sincerely,
M. Norman Oliver, MD, MA
State Health Commissioner