The World Health Organization (WHO) has issued an updated Emergency Use Listing (EUL) for the Johnson & Johnson COVID-19 vaccine, recommending the vaccine for use in boosted regimens in persons aged 18 years and older. The updated EUL recommends the Johnson & Johnson COVID-19 vaccine be used both as a homologous booster (same vaccine) after a single-dose primary vaccination and as a heterologous booster (‘mix-and-match’ vaccines) following a primary mRNA vaccine regimen. The WHO has also recommended to extend the shelf-life of thawed vaccine stored at 2 to 8 degrees Celsius (36 to 46 degrees Fahrenheit) to 11 months within the vaccine’s maximum 24-month shelf-life when stored at -25 to -15 degrees Celsius.
“WHO’s updated recommendations, taken together, underscore the continued importance and ease-of-deployment of the Johnson & Johnson COVID-19 vaccine, including in resource-limited settings,” said Penny Heaton, M.D., Global Therapeutic Area Head, Vaccines, Janssen Research & Development, LLC. “As the effort to vaccinate the world against COVID-19 continues, including through booster campaigns, our vaccine is a flexible option that has demonstrated proven efficacy and durability of protection, both through a single-dose primary vaccination and through boosted regimens for added protection.”
With WHO’s updated guidance, in a homologous regimen the Company’s vaccine may be administered for both primary vaccination of a single dose and as a booster shot as soon as two months later. In a heterologous regimen, the Johnson & Johnson COVID-19 vaccine may be administered as a booster following the completion of primary vaccination with an approved mRNA COVID-19 vaccine, at the same dosing interval as that authorized for a booster dose of the vaccine used for primary vaccination.
The WHO’s decision to update the EUL follows a December 2021 interim recommendation for use by the Strategic Advisory Group of Experts on Immunization (SAGE) for the WHO supporting the use of the Johnson & Johnson COVID-19 vaccine as a booster shot in persons aged 18 years and older.
The Johnson & Johnson COVID-19 vaccine booster has also received Emergency Use Authorization from the U.S. Food and Drug Administration and a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).
As the COVID-19 pandemic continues to evolve, including the recent surge in the Omicron BA.2 subvariant, the Company continues to closely monitor, assess and share results relating to the durability and efficacy of the Johnson & Johnson COVID-19 vaccine.
The WHO recommendation to extend the shelf-life of the Johnson & Johnson vaccine to 11 months at 2 to 8 degrees C (36 to 46 degrees F) is based on data from ongoing stability assessment studies, and follows an identical extension recently approved by the European Medicines Agency. The extended shelf-life of the Johnson & Johnson COVID-19 vaccine may help drive greater uptake and absorption in countries around the world, especially in limited-resource settings. Having a vaccine with long shelf-life at standard refrigeration is a clear logistical advantage for adequate planning and vaccine rollouts on the ground and can help support the WHO’s goals for vaccination coverage across countries. There is no change to the maximum shelf-life of 24 months when the vaccine is stored frozen at -25 to -15 degrees C (-13 to -5 degrees F).
The Company will continue to conduct stability studies for the Johnson & Johnson COVID-19 vaccine and is working with regulators to update product labeling to ensure that all countries have the latest guidance in this regard.
About the Johnson & Johnson COVID-19 Vaccine
The Johnson & Johnson COVID-19 vaccine was developed to provide protection with a single dose and be easily stored and distributed with standard refrigeration globally, including in resource-limited, rural or remote settings. Its profile and extended shelf-life offers countries greater flexibility in implementing immunization programs that best meet the needs of their populations. The vaccine is being made available globally through COVAX, the African Vaccine Acquisition Trust (AVAT) and other supply agreements with governments, and access to the vaccine for some of the world’s most vulnerable people has been enabled through the COVAX Humanitarian Buffer.