02/02/22 Health Advisory: FDA Provides Full Approval For Spikevax

Requested Actions

Be aware, U.S. Food and Drug Administration (FDA) granted full authorization to Moderna COVID-19 vaccine for people 18 years or older. Evidence shows the vaccine is safe and effective and manufactured with high quality. The vaccine will now be called Spikevax but has the same formulation as emergency use authorization (EUA) Moderna COVID-19 vaccine.
- Strongly recommend patients get vaccinated.
Be aware of the confusion between terminology and guidance for third dose vs booster dose for immunocompromised persons.
- Encourage moderately to severely immunocompromised patients to get a:
  - Third dose of their primary series COVID-19 vaccine 28 days after their second dose.
  - Booster dose 5 months after their third dose.
- Encourage patients who got Johnson & Johnson COVID-19 vaccine to get a booster dose 2 months after their first dose.
Tell patients how to access, use and interpret at-home antigen test kits. Many people are going to local emergency departments seeking COVID-19 testing, increasing the burden on our hospital system. Coordinate with your lab to collect and submit your own specimens or direct patients to the COVID-19 testing sites in Whatcom County.
Tell patients with mild to moderate illness how to care for themselves at home and when to go to the emergency department.

Additional Information

Vaccine recommendation changes press release, CDC.
Sotrovimab EUA.
Sotrovimab EUA frequently asked questions (FAQs), Food and Drug Administration (FDA).
Sotrovimab fact sheet for healthcare providers.
Sotrovimab fact sheet for patients, parents and caregivers.
Isolation and quarantine guidance for healthcare workers, CDC.
Isolation and quarantine guidance for the general public, CDC.
Find more resources on other therapeutics in the COVID-19 monoclonal antibody therapeutics communication toolkit.

COVID-19 Vaccine

Booster dose updates, FDA.

EUA and FDA-approved vaccine information:

COVID-19 vaccine locator, Washington State Department of Health, DOH.
COVID-19 vaccine provider toolkit and resources, DOH.
COVID-19 vaccination for providers, Centers for Disease Control and Prevention, 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, DOH.
Antigen test guidance, CDC.

COVID-19 Test Processing

Labs report varying amounts of time to process COVID-19 tests. To support faster turnaround, we encourage providers to use in-state labs. The table below shows COVID-19 test processing times for in-state private labs.

LAB	TIME TO PROCESS TEST	TESTS PROCESSED DAILY
FidaLab	24 to 30 hours	5,000
Kaiser	24 hours	700 to 800
LabCorp	24 to 48 hours	Unknown
Northwest Pathology	48 to 72 hours	20,000
Quest	24 to 48 hours	700
UW Virology	24 to 48 hours	10,000 to 11,000
Atlas Genomic	24 to 48 hours	10,000

COVID-19 Therapeutics

Department of Health and Human Services (HHS) allocates monoclonal antibody and oral antiviral supplies to each state. DOH distributes doses to enrolled providers. Providers must enroll in Healthcare Partner Ordering Portal (HPoP) to manage COVID-19 therapeutics. Email mcm@doh.wa.gov to register for HPoP training, held Tuesdays at 9 a.m.
Once enrolled, to request a supply of monoclonal antibodies or therapeutics, complete a smart sheet.
Supplies of all therapies are current limited. Safeway, Haggen and independent pharmacies may have oral antivirals. Hospital-associated systems and infusion centers may have monoclonal antibodies. All therapies must be dispensed by prescription. Prescriptions for oral antivirals should include the appropriate dates of use to ensure initiation within a 5-day window. Oral therapies from Safeway are intended to be delivered to patients’ homes. Patients with questions about accessing their medication should call the pharmacy.
You can find:
- Available doses in your area with HHS’ COVID-19 therapeutics locator.
- More information and resources on DOH’s therapeutics for providers page.