The panel of outside vaccine experts voted 21-0 with one abstention in favor of the vaccine for those 18 and older after discussing whether the shot’s benefits outweigh risks, including rare occurrences of heart inflammation that may be associated with the vaccine.
If the FDA follows the recommendation and authorizes the shot, it will be the fourth COVID vaccine available for use in adults in the United States. The FDA has approved previous COVID shots within days of panel votes, with distribution quickly following.
Novavax Chief Commercial Officer John Trizzino says he hopes to have the product available in the U.S. by the end of June.
Novavax’s shot, which is already available in over 40 countries, is a more traditional type of vaccine employing technology that has been used for decades to combat diseases like influenza.
Before shots can be administered, the FDA must authorize the vaccine and the Centers for Disease Control and Prevention needs to green light its use.
U.S. Department of Health and Human Services said in a statement on Monday that it is coordinating with Novavax “to receive a limited quantity of vaccine and will make that vaccine available to the American public” once those steps are complete. A CDC panel may consider the Novavax shots late next week.
Novavax filed for U.S. authorization in late January, almost a year behind its original plan, following development and manufacturing problems.