Roughly 15 months after the first COVID-19 vaccine was administered in the U.S., vaccine manufacturers Pfizer and Moderna have submitted requests to the United States Food and Drug Administration (FDA) for approval of a second booster – a fourth dose overall – for certain population groups.
The vaccine manufacturers suggest a fourth dose may be necessary to help prevent serious disease among individuals with compromised immune systems or those older than 65, especially as additional COVID-19 variants continue to emerge.
Who does the authorization request cover?
Pfizer’s request is focused on those 65 and older while Moderna’s broader request includes anyone 18 or older, which the manufacturer says will provide healthcare providers broader discretion to decide who should be eligible for an additional vaccine dose. Moderna recommended those older than 65 and anyone at higher risk for severe disease should be prioritized. According to the CDC, there are more than 217 million fully vaccinated Americans. Of these, 194 million are older than 18 and 49 million are older than 65.
Who is currently eligible for a fourth dose?
Currently, the only individuals approved for a fourth vaccine dose are those with weakened immune systems, including people who have had organ or stem cell transplants, are undergoing chemotherapy treatment for cancer, have advanced or untreated HIV infection, or are on immune-suppressing drugs.
When will a decision be made, and what does this mean for vaccine supply?
While there is no timeline for the FDA to issue a ruling on the requests, if approved, it would mean millions of additional doses would need to be manufactured and stored to meet demand.
The CDC has provided guidance relating to long- and short-term storage of the Pfizer and Moderna vaccines, both of which recommend purpose-built freezer and refrigeration storage units that utilize a detachable temperature probe that best reflects vaccine temperature (e.g. a buffered probe or ballast) as well as a digital data logger (DDL) for accurate temperature monitoring.
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