After the FDA updated the Emergency Use Authorization for the mRNA COVID-19 bivalent vaccines, the CDC issued new, simplified recommendations yesterday and effective now.  Their complete guidance can be found here. The CDC is working to update the Interim COVID-19 Clinical Considerations and this will be updated as soon as possible.  We will add them and a link to the WV BOP FAQ section as soon as they are available.  See below for a summary of the new guidelines.  WHAT THIS MEANS:  Monovalent mRNA vaccines are no longer authorized for use.

• CDC’s new recommendations allow an additional updated (bivalent) vaccine dose for adults ages 65 years and older and additional doses for people who are immunocompromised. This allows more flexibility for healthcare providers to administer additional doses to immunocompromised patients as needed.

WHAT THIS MEANS:

• Individuals ages 65 years and older who have NOT received a bivalent mRNA dose, are eligible for one bivalent mRNA dose and then at least 4 months later may receive an OPTIONAL additional bivalent mRNA dose
• Individuals ages 65 years and older who have received a bivalent mRNA dose, may receive an OPTIONAL additional bivalent mRNA dose at least 4 months after their first bivalent mRNA dose
• Immunocompromised individuals ages 6 years and older who already received a bivalent mRNA dose, may receive an optional additional bivalent mRNA dose at least 2 months after the last bivalent dose and then health care providers can determine the need for additional bivalent mRNA doses as needed at least 2 months apart based on the level of immunocompromise for conditions such as stem cell transplant, CAR-T therapy, B-cell depletion, and others.  The immunocompromised patient determination remains a self-attestation and does not require additional documentation.

• Monovalent (original) COVID-19 mRNA COVID-19 vaccines will no longer be recommended for use in the United States.

• CDC recommends that everyone ages 6 years and older receive an updated (bivalent) mRNA COVID-19 vaccine, regardless of whether they previously completed their (monovalent) primary series.

WHAT THIS MEANS: Completion of a primary monovalent series is no longer necessary to be eligible for the bivalent mRNA dose.  Because data shows that enough people either were vaccinated or have had the virus and the bivalent mRNA vaccine are able to induce an immune response when given as either a primary or booster dose, the FDA removed the authorizations for the monovalent mRNA vaccines.  There are no changes to the Novavax or Janssen COVID-19 vaccines. Thus, regardless of whether an individual completed a monovalent mRNA primary series, the individuals ages 6 years and older are recommended to receive one updated (bivalent) mRNA COVID-19 vaccine dose.

• Individuals ages 6 years and older who have already received an updated mRNA bivalent vaccine do not need to take any action unless they are 65 years or older or immunocompromised.

• For young children, multiple doses continue to be recommended and will vary by age, vaccine, and which vaccines were previously received.  Details for these recommendations will be available ASAP.  Below is the link for the EUA for both the Moderna and Pfizer Bivalent mRNA products.