Healthcare Advisory: FDA Provides Full Approval For Spikevax

Note: This advisory is for healthcare professionals. To read public health advisories, visit kitsappublichealth.org/news/categories/advisories

COVID-19 Updates for Providers

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.

  • 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. Direct patients to the many COVID-19 testing sites available.

• Tell patients with mild to moderate illness how to care for themselves at home and when to go to the emergency department.

COVID-19 vaccine

• Booster dose updates, FDA.

• EUA and FDA-approved vaccine information:

  • Comirnaty/Pfizer-BioNTech.

  • Spikevax/Moderna.

  • Johnson & Johnson.

• 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	24–30 hours	5,000
Kaiser	24 hours	700–800
LabCorp	24–48 hours	Unknown
Northwest Pathology	48–72 hours	20,000
Quest	24–48 hours	700
UW Virology	24–48 hours	10,000–11,000
Atlas Genomic	24–48 hours	10,000

COVID-19 Therapies

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 and independent pharmacies may have oral antivirals. Hospital-associated systems may have monoclonal antibodies. All therapies must be dispensed by prescription. 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.

COVID-19 prevention patient education

Share with patients:

• What to do if you test positive for COVID-19.

• What to do if you were exposed to someone with COVID-19.

Immediately report COVID-19

Contacting the Health Department

Additional resources

• 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.