As of mid-November 2020, ten COVID-19 vaccine candidates were in the clinical trials phase of the staged, deliberate, and careful vaccine development process followed in the United States. Even though COVID-19 vaccines are new, the technology they are based on has been studied for decades.
In November 2020, two manufacturers applied to the Food and Drug Administration (FDA) to obtain Emergency Use Authorizations (EUA) for their COVID-19 vaccines, and one has since received an EUA. The candidates must show evidence of effectiveness, that its benefits outweigh any risks, and that no alternative medication or treatment exists. Vaccine products approved under an EUA are administered under strict guidelines for educating and screening patients, reporting use and adverse reactions to the Centers for Disease Control and Prevention (CDC), and submitting manufacturing lot samples to the FDA on a regular basis. A vaccine approved under an EUA cannot be mandated.
The next step for a vaccine candidate is approval by the CDC’s Advisory Committee on Immunization Practices (ACIP). The ACIP’s COVID vaccine work group analyzes data from the vaccine development process and clinical trials. If approved, a recommendation is published in the Mortality and Morbidity Weekly Review (MMWR) with specifics regarding age ranges and/or medical conditions for intended vaccine recipients. A Vaccine Information Statement (VIS) is created to inform the recipient about the disease the vaccine is formulated to prevent, contraindications and precautions for use, and reactions identified during clinical trial. Each Vaccine Information Statement includes contact information for the Vaccine Adverse Events Reporting System (VAERS) and the Vaccine Injury Compensation Program (VICP). A current VIS must be offered before any each vaccine and each dose of a vaccine series.
Washington State’s DOH predicts that there will eventually be enough COVID-19 vaccine for everyone who wants them, but availability and access dates remain uncertain. Plans for distribution include priority phases identifying occupational, medical, and socio-economic considerations that will be worked through as vaccines are approved and shipped. Please note:
- All school staff would fall under Phase 2 (phase one is heavily allocated to long-term care and front line healthcare workers).
- It remains to be determined if COVID-19 vaccine will be recommended for children.
As with other vaccines that protect school communities, you are encouraged to get the vaccine when it is available, and if you have questions, reach out to the health district or your healthcare provider. For more information, go to:
Snohomish Health District’s COVID-19 Information Page
Snohomish County’s distribution plan overview
Snohomish County Interim Plan