Paxlovid Emergency Use Authorization (EUA): The Food and Drug Administration (FDA) and the Washington State Department of Health (DOH) are alerting providers to changes to the EUA for Paxlovid, most recently updated July 6, 2022.
- State-licensed pharmacists are now authorized Paxlovid prescribers.
- New drug interactions and a viral RNA rebound study were added to the EUA and Paxlovid Patient Eligibility Screening Checklist Tool for Prescribers.
- Adverse reactions during post-authorization use of Paxlovid have been identified, including immune system disorders, hypersensitivity reactions, gastrointestinal disorders, abdominal pain, nausea, and general malaise. The DOH advises that “because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.”
- In addition, Pfizer has updated the contraindications related to drug interactions with use of Paxlovid.
Evusheld dosing and shelf life: On June 29, the FDA revised the recommended adult and pediatric Evusheld doses to repeated dosing every six months, with doses of tixagevimab and cilgavimab if ongoing protection is needed. The FDA also extended the authorized shelf life from 18 months to 24 months for specific lots of Evusheld, as long as the batches are unopened and in compliance with storage requirements. The relevant lot numbers and extended expiration dates are listed in “Table 1” online here.
DOH resources for Washington providers: The DOH announced that Health Partner Ordering Portal (HPOP) users should access the portal on its supported browsers: Chrome, Firefox, Edge and Safari. Internet Explorer is not supported.
The DOH also shared an updated compilation of compiled a list of COVID Health Care Mitigation Strategies for providers, created in partnership with the Department of Social and Health Services (DSHS).
Finally, the DOH would like providers to be aware of the remaining 2022 federal holiday schedule for therapeutics distribution. For holidays occurring on Mondays, threshold determination/notification will be paused for the holiday, and resume on Tuesday. Deliveries will be paused on the day of the holiday, and resume the following day, except for Indigenous People’s Day. Upcoming 2022 federal holidays include:
- Labor Day on Monday, Sept. 5
- Indigenous People’s Day on Monday, Oct. 11
- Christmas Day on Tuesday, Dec. 26
Additional resources, guidance and previous updates are available on WSHA’s 2022 COVID-19 Therapeutics webpage. For questions related to therapeutics or these resources, please reach out to the Washington State Department of Health Medical Countermeasure Team at email@example.com or WSHA Senior Director Tina Seery at firstname.lastname@example.org.