FDA Extends Johnson & Johnson COVID-19 Vaccine Shelf Life
Killian Meara, assistant editor for ContagionLive, joined the MJH Life Sciences team in November 2020. He graduated from William Paterson University with a degree in liberal studies, and concentrations in history and psychology. He enjoys film, reading, and pretending he is a good cook. Follow him on Twitter @krmeara or email him at [email protected]
The extension changes the shelf life from 3 months to 4.5 months.
On Thursday, Johnson and Johnson announced that the United States Food and Drug Administration (FDA) has authorized an extension on the shelf life of their COVID-19 vaccine, which was developed by their company Janssen Pharmaceuticals.
The decision is aimed at easing concerns about does that will soon expire, and is based on data from ongoing stability assessment studies.
The studies have demonstrated that the single-shot adenovirus is stable for 4.5 months when refrigerated at temperatures of 36 – 46 degrees Fahrenheit (2 – 8 degrees Celsius).
The FDA granted the extension, going from the previously approved 3 months to 4.5 months.
States have been voicing concerns over stockpiles of the Janssen vaccine that are not being used and are soon set to expire id they are not administered.
For example, Governor Mike DeWine of Ohio on Monday issued an urgent warning that about 200,000 doses of the vaccine will expire by June 23 if they do not get used.
The granted shelf-life extension will allow more time for the doses to get used, taking away at least some concerns about expiration dates for now.
“We continue to work with the U.S. government and health authorities to support the use of our vaccine,” Johnson and Johnson said. “[It] plays an important role in combatting the pandemic, including among those who wish to be fully vaccinated with one shot.”