CDC Panel Supports Third Dose of Pfizer, Moderna Vaccines for the Immunocompromised

An advisory panel assembled by the Centers for Disease Control and Prevention (CDC) voted unanimously on Friday to endorse the FDA’s expanded Emergency Use Authorizations allowing a third dose of the Pfizer/BioNTech and Moderna COVID-19 vaccines for certain immunocompromised individuals.

The panel was also asked to discuss clinical recommendations for the immunocompromised individuals covered in the FDA’s expanded authorization, which includes solid organ transplant recipients or “those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.” Immunocompromised adults account for 2.7 percent of the U.S. population, or seven million people, according to CDC estimates.

The CDC is now recommending that moderately to severely immunocompromised people receive an additional dose, including people who have:

• Been receiving active cancer treatment for tumors or cancers of the blood;
• Received an organ transplant and are taking medicine to suppress the immune system;
• Received a stem cell transplant within the last 2 years or are taking medicine to suppress the immune system;
• Moderate or severe primary immunodeficiency;
• Advanced or untreated HIV infection; or
• Active treatment with high-dose corticosteroids or other drugs that may suppress your immune response.

But much of the panel’s discussion at the meeting focused on whether there would be equal access to the third vaccine dose among the immunocompromised population and whether there would be confusion about the benefit of an added dose.

“My only concern about adding a third dose for the immunocompromised is the impression that our immunocompromised population will then be safe,” said Helen Talbot, an infectious disease specialist at Vanderbilt University.

“I think the reality is they’ll be safer but still at incredibly high risk for severe disease,” she said.

The panel’s chair, Grace Lee, a pediatric infectious diseases specialist at Stanford University, noted that the CDC has been working with pharmacies and jurisdictions to prepare for the FDA’s authorization of a third dose of the mRNA vaccines.

Lee said she hoped they would be “rapidly implemented” and noted that the CDC was preparing updated clinical guidance for doctors and hospitals for immediate release.

The panel was not asked to consider recommending an additional dose of the adenovirus-based Johnson & Johnson (J&J) vaccine for immunocompromised individuals, but members said they did not find data to support an extra dose of the J&J vaccine.

However, Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research said during the meeting that his agency was working on a near-term solution for immunocompromised individuals who received the J&J vaccine.

Pfizer has recently been touting a third dose for all vaccine recipients to protect against the Delta variant, which now account for most COVID-19 infections in the U.S. But the drugmaker has yet to provide phase 3 data showing that an additional dose would offer greater protection. ― Jason Scott