The U.S. Food and Drug Administration (FDA) has amended the emergency use authorizations (EUAs) for an additional COVID-19 mRNA vaccine dose (Pfizer and Moderna) for certain immunocompromised individuals. Those with primary immunodeficiencies are not specifically listed in the FDA announcement but may be covered as individuals diagnosed with conditions that are considered to have an equivalent level of immunocompromise to those with solid organ transplant recipients.
In addition, the Centers for Disease Control (CDC) Advisory Committee on Immunization Practices (ACIP) met earlier today and recommended a third COVID-19 dose for those who are moderate to severely immunocompromised. Their recommendation included those with moderate and severe primary immunodeficiency.
According to the CDC ACIP:
attempts should be made to match the additional dose type to the one used in the original set of shots someone receives. But if that is not feasible, the committee said an additional dose with the other vaccine is permitted. According to the recommendations, the additional dose should be administered at least 28 days after completion of the primary vaccine series.
- The CDC ACIP is advisory and does not issue formal CDC guidances or FDA authorizations. The committee’s recommendations, however, are used to inform formal directives issued by these agencies.
- No guidance has been shared regarding additional doses for those who may have received a Johnson & Johnson COVID-19 vaccine. IDF will be following agency actions regarding this issue and will keep the community informed on any new developments.
Our recommendation is to consult with your physician for guidance regarding your need for an additional dose and, if needed, the best way to access a third shot. For additional treatment questions, please see IDF’s statement on August 6 that addresses treatments and protections to COVID-19.