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COVID-19 Update for Virginia<\/strong><\/p>\n November 22, 2021<\/p>\n Dear Colleague:<\/p>\n Thank you for your continued partnership in responding to the COVID-19 pandemic.\u00a0 Please visit the Virginia Department of Health (VDH) website<\/a> for current clinical and public health guidance, epidemiologic data, and other information.\u00a0 Updates on the following topics are included in this correspondence:<\/p>\n FDA and CDC Expand Eligibility for COVID-19 Booster Dose to All Adults<\/strong><\/p>\n On November 19, the U.S. Food and Drug Administration (FDA) authorized<\/a> and the Centers for Disease Control and Prevention (CDC) recommended<\/a> expanding the eligibility for a COVID-19 booster shot to everyone aged 18 years or older.\u00a0 A single booster dose is now recommended for any adult who completed a Pfizer-BioNTech or Moderna vaccine series at least six months ago.\u00a0 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.\u00a0 FDA amended the Pfizer-BioNTech<\/a>, Moderna<\/a>, and Johnson & Johnson<\/a> fact sheets for healthcare providers and for recipients and caregivers to reflect these changes.<\/p>\n CDC distinguishes their recommendations between those populations that should<\/strong> get a COVID-19 vaccine booster and those that may<\/strong> get a COVID-19 vaccine booster.\u00a0 COVID-19 vaccines cannot be administered without CDC recommendations so the intent of this distinction is to emphasize those at higher risk.\u00a0 CDC expanded their recommendation for who should<\/strong> 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.\u00a0 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\u201364 years with certain underlying medical conditions.\u00a0 CDC also updated their recommendation for who may <\/strong>get a booster following completion of an mRNA primary series to 1) all adults 18\u201349 years of age based on their individual risks and benefits.\u00a0 Previously, CDC recommended that these people who completed an mRNA primary series may<\/strong> get a booster dose: 1) people 18\u201349 years old with underlying medical conditions and 2) people 18\u201349 years old whose living or work conditions placed them at high risk.\u00a0 CDC\u2019s revised Clinical Considerations for the Use of COVID-19 Vaccines Currently Approved or Authorized in the United States<\/a> reflects these changes.<\/p>\n 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<\/a>.\u00a0 If they have difficulty with this, they can call 877-VAX-IN-VA (877-829-4682).\u00a0 Please also encourage your patients to enroll in CDC\u2019s v-safe after vaccination health checker<\/a>\u2120 and complete the personalized health check-ins after COVID-19 vaccination.<\/p>\n 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.<\/strong>\u00a0 Two recent publications in CDC\u2019s Morbidity and Mortality Weekly Report <\/a>and a preprint<\/a> article highlight that pregnant or recently pregnant people are at increased risk for severe COVID-19, including ICU admission, ventilator use, and death.\u00a0 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.\u00a0 Please also encourage anyone aged 6 months or older, including pregnant people, to get the separate flu vaccine<\/strong>, which can be safely coadministered with the COVID-19 vaccine.<\/p>\n 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<\/strong><\/p>\n On November 17, CDC updated their Clinical Considerations for the Use of COVID-19 Vaccines Currently Approved or Authorized in the United States<\/a> 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.\u00a0 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.\u00a0 This ensures that eligible people can get an additional primary dose if immunocompromised or booster dose of Pfizer-BioNTech COVID-19 vaccine.\u00a0 EUI fact sheets are available for healthcare providers<\/a> and for recipients\/caregivers<\/a>.<\/p>\n Vaccine Administration Errors with Pediatric COVID-19 Vaccine <\/strong><\/p>\n Reports of misadministration of COVID-19 vaccine, especially in pediatric populations, have been recently reported in Virginia.\u00a0 These have specifically involved giving the wrong vaccine formulation to children aged 5\u201311 years.\u00a0 As a reminder, Pfizer-BioNTech\u2019s 10 \u00b5g dose formulation (orange cap) that is authorized for use in children aged 5\u201311 years for primary vaccination is not interchangeable<\/strong> with the Pfizer-BioNTech\u2019s 30 \u00b5g dose formulation (purple cap and label with purple border) that is authorized or approved for those aged 12 years and older.\u00a0 If a patient aged 5\u201311 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:<\/p>\n Appendix A in CDC\u2019s Clinical Considerations for the Use of COVID-19 Vaccines Currently Approved or Authorized in the United States<\/a> summarizes common vaccine administration errors and how to address them.\u00a0 Healthcare providers should report any <\/strong>vaccine administration error to the Vaccine Adverse Event Reporting System (<\/a>VAERS<\/a>)<\/a>, notify the recipient, and take corrective action immediately to prevent it from happening again.\u00a0 VDH encourages healthcare providers to also refer to CDC\u2019s patient safety checklist<\/a> to support safe COVID-19 vaccine administration.<\/p>\n VDH Releases New Monoclonal Antibodies Locator Tool and Provides Additional Updates<\/strong><\/p>\n VDH recently released a Monoclonal Antibodies Locator Tool<\/a> that can be used by healthcare providers and the public to locate healthcare facilities that can provide monoclonal antibodies (mAbs) to eligible patients. \u00a0For more information about becoming an outpatient provider of COVID-19 mAb therapy, please complete the instructions on this form<\/a>.\u00a0\u00a0 More information about mAbs is available at VDH\u2019s COVID-19 Outpatient Monoclonal Antibody Therapy Resource Center<\/a>.\u00a0 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.<\/strong><\/p>\n Two new therapeutic agents are currently under review by the FDA for Emergency Use Authorization (EUA).\u00a0 Molnupiravir (Merck & Co., Inc.) is an oral antiviral drug studied for the outpatient treatment of high-risk<\/a> patients with mild to moderate COVID-19.\u00a0 On November 30, FDA\u2019s Antimicrobial Drugs Advisory Committee<\/a> will meet to discuss this agent.\u00a0 The second drug is AstraZeneca\u2019s monoclonal antibody \u201cAZD7442.\u201d\u00a0 The product is a combination of two mAbs, tixagevimab and cilgavimab, and an EUA is being sought for COVID-19 pre-exposure prophylaxis.\u00a0 VDH will send updates to providers when more information becomes available.<\/p>\n Thank you again for your continued partnership as we respond to the COVID-19 pandemic.\u00a0 I hope you have a safe and happy holiday season.<\/p>\n Sincerely,<\/p>\n M. Norman Oliver, MD, MA<\/p>\n State Health Commissioner<\/p>\n","protected":false},"excerpt":{"rendered":" COVID-19 Update for Virginia November 22, 2021 Dear Colleague: Thank you for your continued partnership in responding to the COVID-19 pandemic.\u00a0 Please visit the Virginia Department of Health (VDH) website for current clinical and public health guidance, epidemiologic data, and other information.\u00a0 Updates on the following topics are included in this correspondence: FDA and CDC […]<\/p>\n","protected":false},"author":78,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_lmt_disableupdate":"","_lmt_disable":"","footnotes":""},"tags":[],"class_list":["post-997","page","type-page","status-publish","hentry"],"yoast_head":"\n\n
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