I am writing to provide you brief updates on COVID-19, monkeypox, and parechovirus.
EVUSHELD Dosing Schedule Change
- On June 29, the U.S. Food and Drug Administration (FDA) revised the EVUSHELD Emergency Use Authorization (EUA) to recommend repeat dosing (300 mg tixagevimab/300 mg cilgavimab) every 6 months for patients needing ongoing pre-exposure prophylaxis against COVID-19.
Paxlovid – Pharmacist Prescriptive Authority
- On July 6, FDA revised the EUA for Paxlovid (nirmatrelvir and ritonavir) to authorize state-licensed pharmacists to prescribe Paxlovid to eligible patients, with certain limitations to ensure appropriate patient assessment and prescribing of Paxlovid.
- Pharmacists are only able to prescribe Paxlovid if the following conditions are met:
- Health records less than 12 months old are available to assess renal and hepatic function AND a comprehensive medication list (including over-the-counter and prescription medications) is available to assess drug-drug interactions.
- If a drug-drug interaction must be resolved with modification of another medication or the patient is not eligible for Paxlovid per the EUA, the patient must be referred to their primary care or other healthcare provider.
CDC Recommends Novavax COVID-19 Vaccine for Individuals Aged 18 Years and Older
- On July 13, the FDA granted an EUA for the Novavax vaccine in adults, 18 years and older.
- After a meeting of the Advisory Committee on Immunization Practices (ACIP) to discuss the vaccines, on July 19, the Centers for Disease Control and Prevention (CDC) recommended that the vaccine be used as a two-dose primary series.
- Additional guidance is available in CDC’s Interim Clinical Considerations.
- Novavax is not yet available for ordering but is anticipated to begin in August. Virginia’s complete allocation is 20,800 doses with no additional doses expected at this time. Vaccines will be made available for pharmacies, healthcare provider offices and health departments to order; however, due to the limited supply not all locations may carry the vaccines.
- In the current outbreak in non-endemic countries, monkeypox virus is spreading mostly through close, intimate contact with someone who has monkeypox. To date, many cases have been reported in gay, bisexual and other men who have sex with men. As explained in this recent publication, Monkeypox: Avoiding the Mistakes of Past Infectious Disease Epidemics, the epidemiology of an emerging condition may change over time, and it is important to avoid stigmatizing a particular population.
- Testing for monkeypox is now available at multiple commercial laboratories (Labcorp, Quest Diagnostics, Aegis Sciences, and Sonic Healthcare). Testing at Mayo Clinic Laboratories is expected to become available soon. VDH encourages providers to utilize commercial laboratories for testing.
- Public health testing at the Division of Consolidated Laboratory Services (DCLS) continues to be available; providers should consult their local health department (LHD).
- VDH urges providers to report all suspected cases immediately to their LHD, even if testing is conducted through a commercial laboratory.
- Vaccine for postexposure prophylaxis (PEP) is available for known close contacts of individuals with monkeypox.
- As more vaccine becomes available from the federal government, LHDs will soon expand vaccine availability to people with certain exposure risk factors, with priority given to areas with confirmed cases. Please check the VDH website regularly for the most current information.
- For the most current information and resources, including information about treatment, please visit VDH’s Monkeypox Information for Healthcare Professionals and CDC’s Information For Healthcare Professionals websites.
CDC Health Alert Network: Recent Reports of Human Parechovirus (PeV) in the U.S.
- On July 12, CDC released a health advisory to alert clinicians and public health staff that PeV is circulating in the U.S. Since May 2022, CDC has received reports from multiple states that the virus is infecting neonates and children.
- No cases have been reported in Virginia at this time.
- Parechoviruses can cause a variety of illnesses, ranging from asymptomatic infection to severe illness and death. Neonates and infants are at the highest risk of severe disease.
- Clinicians are encouraged to include PeV in the differential diagnoses of infants presenting with fever, sepsis-like syndrome, or neurologic illness (seizures, meningitis) without another known cause.
- Testing for PeV is available at commercial clinical laboratories, and hospitals may use multiplex meningitis and encephalitis panels for CSF testing that include PeV. DCLS does not currently test for PeV but can facilitate specimen shipment to CDC. Providers should consult with their LHD for assistance if considering CDC testing.
Colin M. Greene, MD, MPH
State Health Commissioner