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Additional dose (3rd dose) of COVID mRNA vaccines now recommended for moderate to severely immunocompromised individuals

Additional doses are NOT yet recommended for non-moderate or severely immunocompromised people, or for those who received the Johnson & Johnson COVID-19 vaccine.

Clinical guidance from CDC: https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html

The CDC’s expert advisory committee voted on August 13 to recommend a third dose of mRNA COVID-19 vaccines (specifically those made by Pfizer and Moderna) for certain immunocompromised people. The vote came after the FDA expanded its emergency use authorization for the vaccines to allow for a third dose for certain immunocompromised people at least 28 days after finishing the initial two-dose series. 

The recommendation does not currently include additional doses of the Johnson & Johnson (J&J) vaccine or additional doses for non-immunocompromised people.

Those with weakened immune systems may not develop adequate immunity following vaccination. They are also more likely to get seriously ill with COVID-19 and may spread the virus to others in their home. And, recent research suggests that immunocompromised persons may be a contributing factor to the emergence of variants. Adding a dose to the series for immunocompromised people could help better protect those most vulnerable to COVID-19 and slow the emergence of variants.   

Those who currently qualify for the third dose include people 12 years and older (Pfizer/BioNTech vaccine)/18 years and older (Moderna vaccine) with medical conditions or who are receiving treatments that are associated with moderate to severe immune suppression, such as*: 

  • Active treatment for solid tumor and hematologic malignancies 
  • Receipt of solid-organ transplant and taking immunosuppressive therapy 
  • Receipt of CAR-T-cell or hematopoietic stem cell transplant (within 2 years of transplantation or taking immunosuppression therapy) 
  • Moderate or severe primary immunodeficiency (e.g., DiGeorge, Wiskott-Aldrich syndromes) 
  • Advanced or untreated HIV infection 
  • Active treatment with high-dose corticosteroids (i.e., ≥ 20mg prednisone or equivalent per day), alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutic agents classified as severely immunosuppressive, TNF blockers, and other biologic agents that are immunosuppressive or immunomodulatory) 

Factors to consider in assessing the general level of immune competence in a patient include disease severity, duration, clinical stability, complications, comorbidities, and any potentially immune-suppressing treatment.

If you’re considered to be moderately or severely immunocompromised and you’ve been vaccinated with the two-dose series of the Pfizer or Moderna vaccine, you should get a third dose of whichever mRNA vaccine you originally received. 

Providers should consider obtaining a documented attestation from patients that their medical history aligns with the conditions that fall within the CDC description of being moderately to severely immunocompromised.

The dose for these additional doses is the same as the previous 2 doses (0.3ml for Pfizer/BioNTech/0.5ml for Moderna). 

Which vaccine should individuals receive:  The additional mRNA COVID-19 vaccine dose should be the same vaccine product as the initial 2-dose mRNA COVID-19 primary vaccine series (Pfizer-BioNTech or Moderna). If the mRNA COVID-19 vaccine product given for the first two doses is not available, the other mRNA COVID-19 vaccine product may be administered. A person should not receive more than three mRNA COVID-19 vaccine doses.

Timing of Additional Vaccine:  Until additional data are available, the additional dose of an mRNA COVID-19 vaccine should be administered at least 28 days after completion of the initial 2-dose mRNA COVID-19 vaccine series, based on expert opinion.

Fully vaccinated people with healthy immune systems do not need another dose of COVID vaccine at this time. If you aren’t sure whether you qualify for a third dose, please talk to your health care provider.    

In addition to a third dose of mRNA COVID-19 vaccines, immunocompromised people should continue to take precautions such as wearing masks, avoiding crowds, and keeping their physical distance from people they don’t live with. Likewise, everyone around immunocompromised people should get vaccinated against COVID-19 to protect their loved ones.  

Background regarding difference between additional doses and boosters

  • Additional dose after an initial primary vaccine series: an additional dose of vaccine administered when the immune response following a primary vaccine series is likely to be insufficient. An additional mRNA COVID-19 vaccine dose is recommended for moderately to severely immunocompromised people after an initial 2-dose primary mRNA vaccine series.
  • Booster dose: an additional dose of vaccine administered when the initial sufficient immune response to a primary vaccine series is likely to have waned over time. The need for and timing of a COVID-19 booster dose have not been established. No booster doses are recommended at this time. This guidance may be updated as more information becomes available.

Fully Vaccinated  Means:  For public health purposes, immunocompromised people who have completed a primary vaccine series (i.e., 2-dose mRNA vaccine series [Pfizer-BioNTech and Moderna] or single dose of the Janssen vaccine) are considered fully vaccinated ≥2 weeks after completion of the series. However, an additional dose of an mRNA COVID-19 vaccine after an initial 2-dose primary mRNA COVID-19 vaccine series should be considered for people with moderate to severe immune compromise due to a medical condition or receipt of immunosuppressive medications or treatments.

Whenever possible, mRNA COVID-19 vaccination doses (including the primary series and an additional dose) should be completed at least two weeks before initiation or resumption of immunosuppressive therapies, but timing of COVID-19 vaccination should take into consideration current or planned immunosuppressive therapies and optimization of both the patient’s medical condition and response to vaccine.

The utility of serologic testing or cellular immune testing to assess immune response to vaccination and guide clinical care (e.g., as part of need assessment for an additional dose) has not been established. Serologic testing or cellular immune testing outside of the context of research studies is not recommended at this time.

Reinforcement of the need for prevention measures among immunocompromised people

People who are immunocompromised (including people who receive an additional mRNA COVID-19 vaccine dose after an initial 2-dose primary mRNA COVID-19 vaccine series) should be counseled about the potential for a reduced immune response to COVID-19 vaccines and the need to continue to follow current prevention measures (including wearing a maskstaying 6 feet apart from others they don’t live with, and avoiding crowds and poorly ventilated indoor spaces) to protect themselves against COVID-19 until advised otherwise by their healthcare professional. Close contacts of immunocompromised people should also be strongly encouraged to be vaccinated against COVID-19 to protect these people.

The presentations considered by the ACIP in adopting its recommendations can be found here.

An FAQ developed by APhA can be found here.

Source: CDC-ACIP, FDA, APhA, Vaccinate Your Family

Posted: August 16, 2021