12/22/21 Health Advisory: Paxlovid granted EUA and Testing before gathering

| December 23, 2021

COVID-19 Updates for Providers

Requested actions

  • Be aware, Food and Drug Administration (FDA) granted emergency use authorization (EUA) to the first oral antiviral treatment for COVID-19, Pfizer’s Paxlovid. The EUA comes after research showed Paxlovid was nearly 90% effective at preventing hospitalization and death in people 12 years or older at high risk of severe outcomes within 5 days of symptom onset.
    • Be aware, Paxlovid supplies will be significantly limited initially. Priority is given to providers located in or prioritizing treatment to populations with greater disease burden and higher social vulnerability.
    • Be aware, Department of Health and Human Services (HHS) will allocate Paxlovid and monoclonal antibodies to each state. Washington State Department of Health (DOH) will distribute doses to enrolled providers.
      • Enroll to become a provider in the Healthcare Partner Ordering Portal (HPoP) to manage COVID‑19 Email mcm@doh.wa.gov to register for HPoP training, held Tuesdays at 9 a.m.
  • Be aware that Omicron is predicted to have markedly reduced susceptibility to some anti-SARS-CoV-2 mAb products, including bamlanivimab plus etesevimab and casirivimab plus imdevimab (Regen-CoV). Sotrovimab appears to retain activity against this variant, although supplies are limited.
  • Recommend patients perform COVID-19 self-tests (also called home tests or over-the-counter tests) before indoor holiday gatherings and encourage their guests to do the same. Along with vaccination, masking and physical distancing, self-tests reduce the chance of spreading SARS-CoV-2, the virus that causes COVID-19. Self-tests also help protect unvaccinated children, older individuals, those who are immunocompromised and people at risk of severe disease.
    • Refer patients to local testing sites. Prepare patients that turnaround times for test results may be long when demand is high.
    • Teach patients how to use and interpret self-tests. Teach patients what to do if they test positive or negative. Encourage patients who test negative to test again 24 hours later.
    • Encourage all patients with COVID-19-like symptoms and recent exposure to stay home and away from others. If they must be around others, they need to wear a mask and maintain physical distance.
    • Encourage all patients to wear well-fitted, high quality masks and improve indoor ventilation.
    • Encourage all patients 5 years or older to get fully vaccinated against COVID-19.
    • Encourage all patients 16 years or older to get a booster dose of COVID-19 vaccine at the recommended interval.
    • Share our blog post on testing before gathering with patients looking for additional guidance.

 Background

As Omicron cases surge in our region—and communities gather for the holidays—we welcome news of additional tools to combat COVID-19 and reduce the burden on our healthcare systems. We are working with DOH and local healthcare partners to establish equitable access and distribution as these therapeutics become available.

Paxlovid and ritonavir prescribing information is contained in their EUAs:

  • Before prescribing, clinicians should carefully review drug interaction.
  • Paxlovid is provided as 2 pink 150 mg tablets co-packaged with 1 white 100 mg tablet of ritonavir. People already taking ritonavir for another condition should be counseled to not take the white tablet with their dose. These medications should be taken as a single dose at the same time every day.
  • This combination therapy has not been studied during pregnancy or lactation but the EUA does allow for use in this population with proper informed consent.
  • Paxlovid should not be used by people with severe liver and/or renal disease. People with moderate reductions in renal function may require dose modifications.

Paxlovid and ritonavir supplies will be significantly limited initially. We await guidance from DOH on how many doses will be allocated to Washington and where they will be sent.

Additional information

COVID-19 therapeutics

HHS allocates monoclonal antibody and oral antiviral supplies to each state. DOH distributes doses to enrolled providers. Providers must enroll in HPoP to manage COVID-19 therapeutics. Email mcm@doh.wa.gov to register for HPoP training, held Tuesdays at 9 a.m.

Find more resources in the COVID-19 monoclonal antibody therapeutics communication toolkit.

COVID-19 vaccine

COVID-19 testing

COVID-19 prevention patient education

Share the following materials with patients.

Immediately report COVID-19

We ask that you notify us of cases in the following people:

    • Healthcare workers (e.g., EMS, medical, nursing, any healthcare facility employee).
    • Public safety workers (e.g., law enforcement, firefighter).
    • Live or work in a long-term care facility, senior living center, permanent supportive housing or similar congregate setting (e.g., shelter, correctional facility) housing people at high risk for severe outcomes.
    • Anyone who dies with COVID-19.
    • Anyone with suspected MIS-C.
  • For all cases, report the person’s race, ethnicity and preferred language.
  • Fax the COVID-19 Report Form to 360-778-6103.
  • You can leave us a non-urgent confidential report on our 24-hour Communicable Disease Report Line, 360-778-6150.

Additional resources

Contacting the Health Department

360-778-6100     Main Call Line – available M-F 8:30am to 4:30pm

360-715-2588     Afterhours Answering Service – available after 4:30pm and weekends

360-778-6150     Communicable Disease Report Line – 24 hours a day 7 days a week

360-778-6103     Confidential Communicable Disease Fax – 24 hours a day 7 days a week