Health Advisory: Paxlovid Granted EUA and Testing Before Gathering

Actions Requested

• 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.
• 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.

For questions, please contact our Communicable Disease staff at 360-728-2235.

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

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.

Kitsap COVID Case and Vaccine Trends

Average cases over the past 7 days have been increasing. Kitsap is now experiencing “high” transmission (100+ cases per 100,000 population) with an average of 112.4 cases per 100,000 population.

New COVID-19 hospitalizations were at 19 for the week ending 12/18/2021.

To date, we have had 262 Kitsap resident COVID-associated deaths.

The rate of infection among unvaccinated individuals was 2.4 times higher than among fully vaccinated. In the past 30 days, unvaccinated people age 12-59 were 5.6 times more likely and adults age 60 and older were 2.6 times more likely to be hospitalized for COVID-19 than those fully vaccinated.

As of December 21, 2021, 76.6% of Kitsap residents age 5 and older had initiated vaccination, 69.9% were fully vaccinated. Vaccination initiation rates are lowest in adults age 19-34 (66%), residents of Bremerton (66%) and Central Kitsap (68%), Black/African American (49%), and males (67%). So far, 26% of Kitsap children age 5-11 have initiated vaccination.

The chart below provides trend over time of vaccine doses administered to Kitsap County residents. On the right, light blue indicates the number of additional/booster doses administered.

Additional Information

• FDA frequently asked questions (FAQs) on the EUA for Paxlovid for treatment of COVID-19.
• Paxlovid EUA.
• Paxlovid fact sheet for healthcare providers.
• Paxlovid fact sheet for patients, parents and caregivers.
• Pre-exposure prophylaxis (PrEP) for COVID-19:
  • To request an initial supply of Evusheld monoclonal antibody for PrEP, complete a smart sheet.
  • Read more about Evusheld monoclonal antibody for PrEP.
• Other therapeutics:
  • Find more resources in the COVID-19 monoclonal antibody therapeutics communication toolkit.

COVID-19 Vaccine

• Booster dose updates, FDA.
• EUA fact sheets for recipients and caregivers:
  • Pfizer-BioNTech.
  • Moderna.
  • J&J.
• COVID-19 vaccine locator, DOH.
• COVID-19 vaccine provider toolkit and resources, DOH.
• COVID-19 vaccination for providers, CDC.
• Clinical considerations for COVID-19 vaccination and guidance for managing anaphylaxis, CDC.
• COVID-19 vaccine quick reference guide for healthcare professionals, CDC.
• COVID-19 vaccine training module on best practices for providers, CDC.

COVID-19 Testing

• K–12 test requirements to return to school.
• Antigen test guidance, CDC.

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.

• To request an initial supply of Evusheld monoclonal antibody for PrEP, complete a smart sheet.
• Read more about Evusheld monoclonal antibody for PrEP.

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

COVID-19 Prevention Patient Education

Share the following materials with patients.

• What to do if you have COVID-19.
• What to do if you may have been exposed to COVID-19.
• What to do if you have COVID-19 symptoms and have not been tested or exposed.

Immediately report COVID-19

Contact Kitsap Public Health by calling (360) 728-2235 or faxing our confidential fax (360) 813-1168.

Additional resources

• Our COVID-19 page for healthcare providers.
• Our COVID-19 data dashboard.
• Washington COVID-19 risk assessment dashboard.
• CDC guidance for healthcare providers and facilities.
• DOH COVID-19 data dashboard.
• DOH COVID-19 page.
• CDC COVID-19 page.
• SARS-CoV-2 sequencing and variants in Washington.

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