Johnson & Johnson COVID-19 Vaccine Booster Shot Authorized for Emergency Use by U.S. FDA

Johnson & Johnson announced the U.S. FDA has issued Emergency Use Authorization (EUA) for a booster dose of the Johnson & Johnson COVID-19 vaccine for adults aged 18 and older at least two months following primary vaccination with single-shot Johnson & Johnson COVID-19 vaccine; and for eligible individuals who received a different authorized or approved COVID-19 vaccine. The Johnson & Johnson booster shot will be the same formulation and dosage as the primary shot.

The EUA follows a unanimous recommendation from the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) based on data provided by the Company, including efficacy, safety and immunogenicity data from its clinical trials and real-world evidence data. When administered as a primary or booster dose, following initial vaccination with the Company’s COVID-19 single-shot vaccine, it provided protection against symptomatic disease and was generally well-tolerated, highlighting the favorable benefit-risk profile of a booster dose in light of the ongoing pandemic.

“We welcome the FDA’s decision to authorize emergency use of our COVID-19 vaccine as a booster,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson. “Our data support a schedule that provides benefit to individuals based on their risks associated with COVID-19, whether administered as a single dose for an efficient response to the pandemic, or as a booster dose after at least two months – to protect against symptomatic COVID-19. We also welcome the FDA’s decision to include a heterologous boosting option as part of this authorization. The ability to boost immune responses regardless of the primary vaccine regimen an individual has received provides more flexibility in protecting those already immunized, and is very beneficial to global public health as we look to curb this pandemic.”

“Today’s authorization by the FDA is yet another positive step toward the goal of curbing the COVID-19 pandemic,” said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, Johnson & Johnson. “It is now even clearer that Johnson & Johnson’s vaccine booster can play an important role in maintaining protection against COVID-19. We look forward to sharing our robust safety, efficacy and immunogenicity data in support of a booster dose with other regulatory bodies and advisory groups around the world to address the continued threat of COVID-19.”

A single booster dose of the Johnson & Johnson COVID-19 vaccine may also be administered as a heterologous booster dose following completion of primary vaccination with another authorized or approved COVID-19 vaccine. The eligible population(s) and dosing interval for the heterologous booster dose are the same as those authorized for a booster dose of the vaccine used for primary vaccination.

The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) will provide a potential recommendation on October 21.

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.

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.