FDA Authorizes Additional COVID-19 Vaccine Dose for Immunocompromised People

• The FDA authorized the emergency use of a third dose of mRNA vaccines for certain people with severely weakened immune systems.
• It’s unclear whether immunocompromised people who received the J&J vaccine would be able to get a second dose of an mRNA vaccine.
• Vaccination also indirectly protects people who are immunocompromised by reducing the spread of the virus in the community.

People with severely weakened immune systems can now get a third dose of an mRNA COVID-19 vaccine.

The Food and Drug Administration (FDA) on Thursday authorized the emergency use of a third dose of the Pfizer-BioNTech or Moderna-NIAID COVID-19 vaccines for certain people with severely weakened immune systems.

This follows growing evidence that some immunocompromised people may not generate a robust immune response from the normal two-dose regimen of these mRNA vaccines.

The agency updated the emergency use authorization (EUA) for both vaccines, along with the fact sheets for healthcare professionals and recipients and caregivers.

This allows “solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise” to receive a third dose of an mRNA vaccine at least 28 days following their second dose.

The update applies to people 12 years and older for Pfizer-BioNTech and 18 years and older for Moderna-NIAID — the age range for which the vaccines are currently authorized.

The change does not apply to the one-dose Johnson & Johnson vaccine, which has been used far less in the United States than the mRNA vaccines.

It’s unclear whether immunocompromised people who received the J&J vaccine would be able to get a second dose of an mRNA vaccine.

“The country has entered yet another wave of the COVID-19 pandemic, and the FDA is especially cognizant that immunocompromised people are particularly at risk for severe disease,” acting FDA Commissioner Dr. Janet Woodcock said in a statement released on Thursday.

“After a thorough review of the available data, the FDA determined that this small, vulnerable group may benefit from a third dose of the Pfizer-BioNTech or Moderna vaccines,” she said.

The vaccine advisory panel of the Centers for Disease Control and Prevention met today and recommended that immunocompromised people get a third dose of either the Pfizer-BioNTech or Moderna-NIAID vaccine.

The CDC endorsed the committee’s decision later on Friday.