Johnson & Johnson COVID-19 Vaccine Gets OK from Key FDA Panel

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If authorized, the Johnson & Johnson COVID-19 vaccine would be the third vaccine available in the United States. Niels Wenstedt/BSR Agency/Getty Images
  • People in the United States may soon have access to three coronavirus vaccines.
  • A key advisory group voted Feb. 26 to give emergency authorization for the single-dose coronavirus vaccine developed by Johnson & Johnson.
  • The FDA is likely to give authorization to the vaccine in the coming days.

An advisory group recommended Friday, Feb. 26, that the Food and Drug Administration (FDA) issue emergency authorization of Johnson & Johnson’s coronavirus vaccine for people 18 and older.

The Vaccines and Related Biological Products Advisory Committee voted unanimously 22-0 in favor of the emergency use authorization (EUA).

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 (J&J) 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.

If the EUA is approved, it would 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