The following is a press release from the ACR released within half an hour of this post:
The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices today recommended that rheumatology patients being actively treated with high-dose corticosteroids, alkylating agents, antimetabolites, tumor-necrosis factor (TNF) blockers, and other biologic agents that are immunosuppressive or immunomodulatory receive a third dose of the Pfizer-BioNTech or Moderna mRNA COVID-19 vaccines.
The approval came one day after the FDA announced it would be revising the current emergency use authorizations (EUA) for the two mRNA vaccines to permit a third dosage in certain immunocompromised patients. The recommendation applies for ages 12 and older for individuals receiving the Pfizer-BioNTech vaccine and18 and older for patients receiving the Moderna vaccine. The new EUA is specifically for the two mRNA vaccines and does not extend to recipients of the Johnson & Johnson vaccine currently.
“This will be enormously important for our immunocompromised patients, and we are thankful to the FDA and CDC for hearing our concerns, recognizing the needs of this population and moving forward,” stated ACR President Dr. David Karp. “We look forward to working with the agencies as they communicate this new recommendation.”
The additional dose of mRNA COVID-19 vaccine should be administered at least 28 days after completion of the primary vaccine series, and patients and providers should stick to the same brand for the third dose, if possible. No determination was made on the safety of receiving one of the mRNA vaccines if a patient initially received the Johnson & Johnson shot.
All immunocompromised patients, including those who receive an additional mRNA dose should continue to follow prevention measures, including:
- Wearing a mask
- Staying 6 feet apart from those they don’t live with
- Avoiding crowds and poorly ventilated indoor spaces until advised otherwise by their healthcare provider
- Close contacts of immunocompromised people should be strongly encouraged to be vaccinated against COVID-19.
These preventative measures remain critical due to real-world data that shows immunocompromised individuals are more likely to have a lower response to the initial vaccine dosage and are more likely to experience breakthrough infections. According to the CDC, 40-44 percent of hospitalized breakthrough cases are immunocompromised patients.
In a recent randomized trial of a third dose of Moderna vaccine in transplant recipients, 33 – 50 percent of those who had no detectable antibody response to an initial mRNA vaccine series developed one with a third dose, and the proportion of the group who are seropositive increased to 68 percent with the third dose. No serious adverse events were reported, and the symptoms reported were consistent with previous doses, with mostly mild or moderate symptoms reported.
The CDC noted that the effectiveness and accuracy of antibody testing are still being evaluated. Patients who are moderately to severely immunocompromised should discuss a third dose with their providers.
“Not all medications that our patients take have been shown to have significant effects on responses to vaccination. Patients should ask their provider if they are likely to see a beneficial effect from additional vaccination,” Dr. Karp said. “Luckily, we have not seen any safety signals in patients with autoimmune and rheumatic diseases from the COVID-19 vaccines, so there should be no concern for the third dose.”
The ACR’s COVID-19 Vaccine Clinical Guidance Task force is meeting Monday, Aug. 16 to discuss potential changes to the ACR’s clinical guidance and expect to share recommendations shortly after.
For more on this, you can also check out the recent town hall webinar from ACR now uploaded to YouTube.