April 4, 2022 - 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.”
Boosting Recommendation
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.
Shelf-Life Extension
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.
Johnson & Johnson is committed to ensuring equitable global access to COVID-19 vaccines, and recently completed a landmark agreement to enable the first COVID-19 vaccine to be manufactured and made available by an African company for people living in Africa, with the goal of increasing COVID-19 vaccination rates across the continent.
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About the Janssen Pharmaceutical Companies of Johnson & Johnson
At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology and Pulmonary Hypertension.
Learn more at www.janssen.com. Follow us at @JanssenUS and @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies of Johnson & Johnson.
About Johnson & Johnson
At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s largest and most broadly-based healthcare company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. We are blending our heart, science and ingenuity to profoundly change the trajectory of health for humanity. Learn more at www.jnj.com. Follow us at @JNJNews.
Cautions Concerning Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding the development, manufacture and distribution of the Johnson & Johnson COVID-19 vaccine. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Pharmaceuticals, Inc., the Janssen Pharmaceutical Companies, and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: the potential that the expected benefits and opportunities of the agreement may not be realized or may take longer to realize than expected; challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended January 2, 2022, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Report on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of Janssen Pharmaceuticals, Inc., the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.