On August 12, 2021, the United States Food and Drug Administration (“FDA”) authorized a COVID-19 vaccine booster for immunocompromised individuals. Because booster vaccines were not previously authorized under the FDA’s emergency use authorization, the FDA’s announcement today was a necessary step to begin administering booster vaccines. This is the first time an additional dose of the COVID-19 vaccine has been authorized in the United States.

The CDC estimates that about 2.7% of adults in the United States are immunocompromised. Those individuals are more likely to experience severe illness from COVID-19 and have a higher risk of transmitting the virus to others. The CDC also found that immunocompromised adults are more likely to have a breakthrough infection. Because immunocompromised individuals are still vulnerable to COVID-19 following vaccination, the FDA believes that amending the emergency use authorization is necessary.

This announcement from the FDA comes a little over one week after the World Health Organization (“WHO”) urged a moratorium on COVID-19 booster shots. It is unclear whether WHO Director-General Tedros Adhanom Ghebreyesus’s urge of such a moratorium would encompass booster shots for the immunocompromised. To read more about that announcement from the WHO, please see our prior update here.

Norton Rose Fulbright lawyers will continue to provide relevant updates for healthcare providers on the Health Law Pulse during the COVID-19 public health crisis.