Johnson & Johnson Single-Shot COVID-19 Vaccinations to Resume in the U.S. for All Adults Aged 18 and Older Following CDC and FDA Decision.

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April 24, 2021

Johnson & Johnson Single-Shot COVID-19 Vaccinations to Resume in the U.S. for All Adults Aged 18 and Older Following CDC and FDA Decision.

Johnson & Johnson

NEW BRUNSWICK, N.J., April 23, 2021 — Johnson & Johnson has announced that vaccinations with the Company’s COVID-19 single-shot vaccine would resume for all adults aged 18 years and older in the U.S. under Emergency Use Authorization (EUA). It follows a decision from the United States Centers for Disease Control (CDC) and Food and Drug Administration (FDA).

The decision was based on a recommendation from the U.S. CDC Advisory Committee on Immunization Practices (ACIP). ACIP had followed a rigorous evaluation of data relating to an infrequent adverse event involving blood clots combined with low platelet counts (thrombosis with thrombocytopenia) observed within approximately one to two weeks following vaccination.

“As the global pandemic continues to devastate communities around the world, we believe a single-shot, easily transportable COVID-19 vaccine with demonstrated protection against multiple variants can help protect the health and safety of people everywhere. We will collaborate with health authorities around the world to educate healthcare professionals and the public to ensure this infrequent event can be identified early and treated effectively,” said Paul Stoffels, Chief Scientific Officer of Johnson & Johnson.

Johnson & Johnson has updated the EUA Fact Sheets for Healthcare Providers Administering Vaccine (Vaccination Providers) and Recipients and Caregivers for the Company’s COVID-19 vaccine.

The Company said it continues to work with other healthcare authorities and regulators worldwide to ensure that the product labels for the Company’s COVID-19 vaccine include this information. On April 20, the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) also issued a recommendation, confirming the overall benefit-risk profile of the Company’s COVID-19 vaccine remains positive.

The Johnson & Johnson COVID-19 Vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, received EUA from the FDA on February 27, 2021, to prevent COVID-19 in individuals 18 years of age and older.

This decision was based in part on the totality of scientific evidence, including data from the Phase 3 ENSEMBLE study. The study had demonstrated that the vaccine was 66.1 percent effective in preventing moderate to severe/acute disease and 85 percent effective in preventing severe/critical illness across all regions studied, 28 days post-vaccination.

The terms of the EUA allow the use of the vaccine while more data are gathered. The Company plans to file for a Biologics License Application (BLA) with the FDA later in 2021.

On April 21, 2021, Johnson & Johnson announced primary data from the Phase 3 ENSEMBLE clinical trial in the New England Journal of Medicine. The preliminary analysis of the Company’s single-dose COVID-19 vaccine follows the topline efficacy and safety data announced in January, showing the trial met all primary and critical secondary endpoints and prevented COVID-19 related hospitalization across all study participants 28 days after vaccination. The data also show the vaccine to be consistently effective against symptomatic infection, including in South Africa and Brazil, where there was a high prevalence of rapidly emerging SARS-CoV-2 variants.

IMPORTANT SAFETY INFORMATION

WHAT SHOULD YOU MENTION TO YOUR VACCINATION PROVIDER BEFORE YOU GET THE JANSSEN COVID-19 VACCINE?

Tell the vaccination provider about all of your medical conditions, including if you: