The FDA recommended that COVID-19 vaccine manufacturers update their COVID-19 Vaccines with an Omicron BA.4/5 spike protein component to create a bivalent booster vaccine.

“As we move into the fall and winter, it is critical that we have safe and effective vaccine boosters that can provide protection against circulating and emerging variants to prevent the most severe consequences of COVID-19,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.

So far, vaccine manufacturers have only gathered data from clinical trials with modified vaccines containing an Omicron BA.1 component. No studies have been conducted yet on modified vaccines containing an Omicron BA.4/5 component.