- People in the United States will soon have access to three coronavirus vaccines.
- The FDA has authorized the Johnson & Johnson COVID-19 vaccine for emergency use.
- The decision comes one day after a key advisory group voted to give emergency authorization for the single-dose vaccine.
The Food and Drug Administration (FDA) has authorized the use of the single-dose COVID-19 vaccine made by Johnson & Johnson (J&J).
This emergency use authorization (EUA) was given one day after an advisory group recommended that the FDA allow Johnson & Johnson’s coronavirus vaccine to be given people 18 and older.
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The vote came after the panel of independent scientific experts, infectious disease doctors, and statisticians spent much of the day reviewing data from Johnson & Johnson phase 3 clinical trial.
The single-dose vaccine is made by J&J’s vaccine division, Janssen Pharmaceuticals. It’s also “fridge stable,” which means it can be shipped and stored at standard refrigerator temperatures.
“This is going to allow for easier delivery to different sites in the country and enable a greater proportion of the country to be vaccinated,” said Dr. Jarod Fox, an infectious disease physician at Orlando Health, who was not part of the advisory committee.
Both the Pfizer-BioNTech and Moderna-NIAID coronavirus vaccines need to be stored in ultracold freezers until being thawed prior to use.
An analysis of the J&J data by FDA scientists found that this vaccine offers strong protection against severe COVID-19, although it showed a lower overall effectiveness.
The scientists also identified “no specific safety concerns” that would prevent the vaccine from receiving emergency authorization.
The FDA doesn’t need to follow the recommendation of the advisory group, but it usually does.
This new EUA will give people in the United States access to a third coronavirus vaccine, although the J&J vaccine is expected to have limited availability in the beginning.
Source: healthline