U.S. Food and Drug Administration provides updated summary regarding vaccines and OTC COVID-19 tests

April 13, 2022

On April 7, the FDA authorized an extension for the shelf life of the refrigerated Janssen COVID-19 Vaccine, allowing the product to be stored at 2-8 degrees Celsius for 11 months, according to a news release.

The vaccine was previously authorized to be stored for up to nine months. This extension was granted following a thorough review of data submitted by Janssen. This extension applies to all refrigerated vials of Janssen COVID-19 Vaccine that have been held in accordance with the manufacturer’s storage conditions. A copy of the concurrence letter is posted on FDA’s website.

Also, on April 7, the FDA authorized two over-the-counter (OTC) at-home COVID-19 antigen tests. The validation data was gathered through the FDA’s collaboration with the National Institutes of Health (NIH) and the Independent Test Assessment Program (ITAP). The emergency use authorizations (EUA) issued to Osang LLC was for their OHC COVID-19 Antigen Self-Test and Xiamen Boson Biotech Co., Ltd for their Rapid SARS-CoV-2 Antigen Test Card. These are examples of the FDA’s ongoing commitment to increase the availability of appropriately accurate and reliable at-home COVID-19 diagnostic tests for all Americans.

    The tests are:

  • OTC at-home COVID-19 antigen diagnostic tests that show results in 15 minutes.
  • Intended for use as a serial test for people with or without symptoms, meaning the test is done two times over three days, with at least 24 hours and no more than 48 hours between tests.

    Can be used for people:

  •  Age 14 years or older with a self-collected nasal swab sample.
  •  Age 2 years or older when an adult collects the nasal swab sample.

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