COVID-19 Vaccines

Three vaccines are now available to prevent COVID-19 disease in the United States:

• Pfizer-BioNTech COVID-19 Vaccine
• Moderna COVID-19 Vaccine
• Johnson & Johnson’s Janssen COVID-19 Vaccine

The pediatric dose of the Pfizer vaccine is one third the dose available to people 12 and older. It is a 2-dose series, administered at least 3 weeks apart. It will arrive in a 10-dose vial with an orange cap and an orange border on the label and must be diluted before use. 

See interim clinical considerations for use of mRNA COVID-19 vaccines (Pfizer-BioNTech and Moderna) currently authorized in the US from the CDC for administration, patient counseling, and other details.

On August 23, the FDA granted full authorization for Pfizer-BioNTech COVID-19 vaccine for people 16 years or older. Pfizer-BioNTech will now be referred to as Comirnaty.

Vaccine Clinics This Week

Third dose of Pfizer/Moderna for immunocompromised individuals

On August 12, the U.S. Food and Drug Administration (FDA) amended its emergency use authorizations (EUAs) for Pfizer and Moderna COVID-19 vaccines to allow an additional (third) dose for certain immunocompromised people including those who have:

• Been receiving active cancer treatment for tumors or cancers of the blood
• Received an organ transplant and are taking medicine to suppress the immune system
• Received a stem cell transplant within the last 2 years or are taking medicine to suppress the immune system
• Moderate or severe primary immunodeficiency (such as DiGeorge syndrome, Wiskott-Aldrich syndrome)
• Advanced or untreated HIV infection
• Active treatment with high-dose corticosteroids or other drugs that may suppress immune response

Call and recall patients determined to be immunocompromised who received Pfizer or Moderna vaccine and offer an additional (third) dose of COVID-19 vaccine. Offer the same vaccine product (i.e., Pfizer or Moderna) the person originally received.

The primary series for Johnson & Johnson/Janssen (J&J) COVID-19 vaccine remains one dose; however, people who received a J&J dose should get a booster dose two months after.

People who received an additional primary shot (third dose) may also receive a booster dose five months after that shot.

Encouraging Vaccination and Talking with Patients

On July 27, the Centers for Disease Control and Prevention (CDC) issued a health advisory declaring an urgent need to increase the percentage of the population fully vaccinated against COVID-19. Promote the COVID-19 vaccines and vaccinate everyone 12 years or older, including those who are pregnant, lactating or who may become pregnant.

For information about the role of healthcare providers in encouraging vaccination and tips on how to have conversations with patients, the following resources may be helpful to you:

• How Health Care Providers Can Promote COVID-19 Vaccination
• Fostering COVID-19 Vaccine Confidence in Russian- and Ukrainian-Speaking Communities
• Vaccine Confidence Discussion Guide
• Confronting Health Misinformation: The U.S. Surgeon General’s Advisory on Building a Health Information Environment
• Pediatric Provider Discussion Guide: Building Parental/Guardian Confidence in COVID-19 Vaccination

Vaccine timing and completion

• Restarting the series: Currently, there is no recommendation to restart either the Pfizer or Moderna vaccine series due to time between the first and second doses. While we know the second dose is most effective given 21 or 28 days after the first dose, there is no need to restart the series if the second dose is given later than that. If a patient comes in overdue for their second dose, you only need to administer the second dose to complete the series.

• Updated standing orders: The Centers for Disease Control and Prevention (CDC) will be revising standing orders for the Johnson & Johnson vaccine to include additional screening for Guillain-Barré syndrome recommended during their July 8, 2021, update to the Emergency Use Authorization Fact Sheets.
  • Updated provider EUA fact sheet
  • Updated patient EUA fact sheet

This follows the previous revisions informing people of the increased risk of thrombosis with thrombocytopenia syndrome (TTS). Following a thorough safety review weighing the benefits and risks, the Advisory Committee on Immunization Practices (ACIP) voted to recommend the ongoing use of Johnson & Johnson vaccine under a revised emergency use authorization (EUA). ACIP recommended the Food and Drug Administration (FDA) include a warning statement and Johnson & Johnson include an information sheet at vaccination informing people about the increased risk of thrombosis with thrombocytopenia syndrome (TTS).

Discard any Johnson & Johnson EUA Fact Sheets you have on hand and use the new fact sheets.

If a patient is concerned about the increased risk associated with J&J vaccine, offer Moderna or Pfizer vaccine.

Vaccine costs

Following the issuance of an emergency order from the Washington State Office of the Insurance Commissioner, healthcare providers can now bill insurance for vaccine consults with patients, even if the patient does not get vaccinated at that visit.

Patients should not pay out-of-pocket costs to get COVID-19 vaccine. Enrolled providers must give the vaccine regardless of a patient’s ability to pay. Providers may bill a patient’s health plan or program. Providers may not bill the patient for the balance. For details, see CDC’s information on filing claims for reimbursement.

Pfizer and Johnson & Johnson Vaccine Storage Updates

The FDA updated its Pfizer-BioNTech COVID-19 vaccine storage guidelines. The vaccine may be kept at standard frozen temperatures, including:

• Storing undiluted (purple cap) Pfizer vaccine vials at -25°C to -15°C for up to 2 weeks.
• Transport undiluted (purple cap) Pfizer vaccine vials at -25°C to -15°C.
• Thaw and store undiluted (purple cap) Pfizer vaccine vials in the refrigerator (2°C to 8°C) for up to 1 month.
• Thaw and store diluted (gray cap) Pfizer vaccine vials in the refrigerator (2°C to 8°C) for up to 10 weeks.

View the updated fact sheet.

The pediatric formulation can be stored for 6 months in an ultra-low temperature freezer (-90 deg C to -60 deg C) and 10 weeks in the refrigerator (2 deg C to 8 deg C).

The FDA has extended the shelf life of Johnson & Johnson (Janssen) (J&J) COVID-19 vaccine from 4½ months to 6 months when the vaccine has been refrigerated at temperatures of 36° to 46° Fahrenheit (2° to 8° Celsius). Visit the J&J lot expiry checker to determine the updated expiration of your vaccine.

The FDA has also extended the shelf life of Pfizer-BioNTech COVID-19 vaccine an additional 3 months on vials dated after July 2021 as long as authorized storage conditions (-90°C to -60°C or ‑130°F to -76°F) have been maintained. Frozen vials stored at -25°C to -15°C and refrigerated vials (2°C to 8°C) are not eligible for extension. Visit CDC’s Pfizer-BioNTech COVID-19 vaccine page for additional information.

Enrollment is Still Open

Helpful Resources for Offices Administering Vaccine

·       Pre-vaccination checklist for COVID-19 vaccines:

English, Spanish, Chinese, Korean, Russian, Vietnamese, Tagalog

.        V-Safe Infographic:

English, Spanish, Chinese, Korean, Russian, Vietnamese, Tagalog

·       Moderna EUA fact sheet for recipients and caregivers

·       Pfizer EUA fact sheet for recipients and caregivers

·       Johnson & Johnson EUA Fact sheet for recipients and caregivers

Additional Information for Providers

Centers for Disease Control and Prevention’s (CDC’s) COVID-19 Vaccine Training Module offers a general overview of immunization best practices for healthcare providers.

The DOH COVID-19 vaccine provider toolkit has many helpful resources.

Keep your patients informed.

Learn more about COVID-19 vaccine planning, development and safety standards from DOH and CDC.