On August 12, 2021, the FDA amended the emergency use authorizations (EUAs) for both the Pfizer and Moderna COVID-19 Vaccine to allow for the use of an additional dose in certain immunocompromised individuals, specifically, solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise and those in close contact of the immunocompromised.
TO NOTE: the term booster is to be utilized when the first immune response was adequate and has waned. With immunocompromised individuals, their response may not have been adequate so technically, these patients are receiving an additional primary dose.
The following guidelines serve to provide information to UPN member pharmacies for enhanced patient care during the COVID-19 pandemic.
Both the Pfizer and Moderna COVID-19 vaccinations have amended EAUs (emergency use authorizations) by the FDA allowing for an additional (third) dose.
The third dose should be given no sooner than 28 days and be of the same manufacturer as the first 2 doses.
If the mRNA COVID-19 vaccine product given for the first 2 doses is not available, the other may be administered.
A patient should not receive more than 3 doses of any COVID-19 immunization.
This recommendation stands for patients 18 years of age or older for Moderna, and 12 years of age or older for Pfizer, and ONLY for patients who have undergone solid organ transplantation (or have been diagnosed with a condition that is considered to have the same level of immunocompromise).
Pharmacies should document the reason a patient meets any current criteria for an extra dose (patient attestation or clinical documentation of their diagnosis).
Pfizer - Booster is 0003A
Moderna - Booster is 0013A
All COVID-19 vaccine claims require an SCC (Submission Clarification Code) in NCPDP field 420-DK:
02 - initial dose of a two-dose vaccine
06 - second dose of a two-dose vaccine
06 - single dose vaccine
07 - additional dose of either a single-dose or a two-dose vaccine
Antibody testing is NOT recommended to assess immunity after vaccination per the FDA, however, some patients will be requesting this test and pharmacies should be prepared to meet this demand.
Antibody tests can be performed in the pharmacy with a CLIA certificate of waiver with products such as the EZ Test Cup.
Antigen testing should continue, with pharmacies potentially seeing a spike in testing with school entering session for Fall of 2022 and Delta Variant spikes.
Appropriate PPE should be ordered and stocked for potential spikes in immunizations and testing due to the above reasons.
Ensure proper PPE is on hand for testing and immunizations.
Determine how best to document the patient's immunocompromised status.
Verification from their PCP?
What are the specific criteria to be considered immunocompromised?
Pharmacies may want to begin considering launching or re-launching their scheduling program.
Many physician offices have begun advance scheduling for patients that received early doses of the vaccine. Currently, looking to schedule patients 8 months after their 2nd shot is a greatly anticipated timeframe (look at September/October 2021 timeframe to begin).
Look to have documentation from the patient when they received their second dose.
Advanced scheduling will help prep for workflow and revenue predictions.