- An advisory panel to the Centers for Disease Control and Prevention voted unanimously during a Friday meeting to allow some immunocompromised people to receive a third dose of the Pfizer or Moderna vaccines. The meeting came after the Food and Drug Administration's Thursday evening announcement expanding the emergency use authorization of the two vaccines to allow for a third dose for the approximately 7 million Americans with weakened immune systems.
- Following the vote from the Advisory Committee on Immunization Practices, or ACIP, CDC Director Rochelle Walensky endorsed the recommendation, meaning providers could begin administering third doses to eligible individuals as soon as this weekend, if not early next week, according to the CDC's Immunization Safety Office.
- The Johnson & Johnson vaccine was not included in updated authorization due to "insufficient data," leaving questions about if and when immunocompromised people who received this one-shot vaccine will need the antibody boost from a booster.
Booster shots of the COVID-19 vaccines have been controversial for months. While industry executives have called them inevitable, the FDA and CDC initially wanted to wait for more evidence they were needed. With the FDA's action for immunocompromised people, and this latest ACIP meeting, it's apparent that regulators now see value in another vaccine dose — at least for some people.
Despite reports that over 1 million people have opted to get a third dose of a messenger RNA, or mRNA, vaccine without soliciting approval, ACIP member Kathleen Dooling said immunocompromised patients will self-attest to receive their booster shot.
"We are not recommending that either prescriptions or a physician sign-off be necessary for individuals to receive an additional dose of mRNA if they're immunocompromised," Dooling, medical officer for the Division of Viral Diseases at the National Center for Immunization and Respiratory Diseases and the CDC, said.
In a presentation to the ACIP panel, the CDC recommended individuals receive the same mRNA vaccine as their initial inoculation, but said it would be permissible to use the alternate candidate in the case the one they received first is not available. The additional doses will continue to be without cost to the patient and available through pharmacies or providers.
While the FDA only specified organ transplant recipients as an example of who should receive the third dose right now, the CDC laid out a more thorough list of which groups would be classified as moderate to severely immunocompromised. This includes, but is not limited to, organ transplant recipients, people who are undergoing or have recently undergone treatment for cancer, people with HIV and people with chronic medical conditions such as asplenia and chronic renal disease.
Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, stressed the third dose only appeared to be "moderately effective in increasing antibody titers." Marks encouraged those who receive it to remain physically distanced from others, and to ensure their close contacts are also vaccinated.
But despite this warning, the panel agreed in an 11-0 vote that the additional dose has clear benefits for the 2.7% of the U.S. population living with suppressed immune systems. They are at higher risk to become severely ill from COVID-19, more likely to transmit the virus to household contacts and their antibody levels after two doses are lower than non-immunocompromised people.
The timing of the FDA's amendment and subsequent ACIP vote comes as the delta variant spreads across the country and accounts for over 90% of new cases. Immunocompromised people are especially vulnerable to its heightened contagiousness.
"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 Janet Woodcock said in the FDA's statement on Thursday.
Non-immunocompromised and otherwise healthy people do not need to receive a third dose right now, as both Pfizer and Moderna are testing booster shots for the general population.