J&J COVID-19 Vaccine Shelf Life Extended

New Jersey-based Johnson & Johnson issued a statement on June 10, 2021, regarding the U.S. Food and Drug Administration (FDA) authorization for extending the shelf life for the Johnson & Johnson COVID-19 Janssen vaccine from 3 months to 4.5 months.

'The FDA's decision is based on data from ongoing stability assessment studies, which have demonstrated that the vaccine is stable at 4.5 months when refrigerated at temperatures of 36 – 46 degrees Fahrenheit (2 – 8 degrees Celsius).

'A single-shot vaccine that provides protection and prevents hospitalization and death is an important tool in the global fight against COVID-19. Evidence from our Phase 3 ENSEMBLE study demonstrates the efficacy of our single-shot COVID-19 vaccine, including against viral variants that are highly prevalent. Regardless of race and ethnicity, age, geographic location, and comorbidities, these results remain consistent.'

'We continue to work with the U.S. government and health authorities to support the use of our vaccine, which plays an important role in combatting the pandemic, including among those who wish to be fully vaccinated with one shot,' concluded Johnson & Johnson's comments.

Vaccine providers should visit www.vaxcheck.jnj to confirm the latest expiration dates of this vaccine, including those currently available for administration throughout the USA.

The Janssen COVID-19 vaccine is authorized for use under an Emergency Use Authorization in the USA for active immunization to prevent COVID-19 caused by the SARS-CoV-2 coronavirus in individuals 18 years of age and older.

Janssen COVID-19 (Ad26.COV2.S) single-shot vaccine leverages Janssen's AdVac and PER.C6® technologies. Janssen’s AdVac® vectors are based on a specific type of adenovirus, which has been genetically modified so that it can no longer replicate in humans and cause disease.