FDA extends J&J Covid vaccine shelf life to 11 months, grants EUA to two OTC tests

The FDA last week extended the storage time of the Johnson & Johnson vaccine and gave emergency use approval to two home tests for COVID-19.

Following a thorough review of data submitted by Janssen, the Food and Drug Administration (FDA) authorized last week an extension for the shelf life of the refrigerated Johnson & Johnson COVID-19 vaccine from 9 months to 11 months, when stored at the recommended 2-8 degrees Celsius (about 36-46 degrees Fahrenheit).

The extension applies to “all batches that have been released to the US market” and “have been held in accordance with the manufacturer’s storage conditions,” FDA said.

In collaboration with the National Institutes of Health (NIH) and the Independent Test Assessment Program (ITAP), FDA has also issued emergency use authorizations (EUA) for two over the counter (OTC) at-home COVID-19 antigen tests – Osang LLC’s OHC COVID-19 Antigen Self-Test and Xiamen Boson Biotech Co., Ltd’s Rapid SARS-CoV-2 Antigen Test Card.

Both tests show results in 15 minutes and can be used for people aged 14 years or older with a self-collected nasal swab sample or age 2 years or older “when an adult collects the nasal swab sample,” FDA said.

They are 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,” FDA said.

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