J&J COVID-19 Vaccine Ships Again in the USA

New Brunswick, NJ - based Johnson & Johnson (J&J) announced that vaccinations with the Company’s (Janssen) COVID-19 single-shot vaccine would resume for all adults aged 18 years and older in the USA following a decision from the CDC and FDA late on April 23, 2021.

This decision to rescind an eleven-day 'Pause' was based on a recommendation from the CDC's Advisory Committee on Immunization Practices (ACIP), which followed a rigorous evaluation of data relating to a very rare adverse event involving blood clots in combination with low platelet counts (thrombosis with thrombocytopenia) observed within approximately one to two weeks following vaccination.

The experimental J&J COVID-19 Vaccine, developed by the Janssen Pharmaceutical Companies of J&J, received emergency authorization from the FDA on February 27, 2021, to prevent COVID-19 in individuals 18 years of age and older. The FDA has not approved this vaccine.

“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 very rare event can be identified early and treated effectively,” said Paul Stoffels, Chief Scientific Officer of J&J, in a press statement.

J&J has updated the Fact Sheets for Healthcare Providers Administering Vaccine and Recipients and Caregivers for the Company’s COVID-19 vaccine to include information about the diagnosis and treatment of thrombosis with thrombocytopenia.

The CDC, FDA, and American Society of Hematology have made information about the proper recognition and management of this medical condition and the unique treatment required for this type of blood clot. The health authorities advise that people who have received our COVID-19 vaccine and develop a severe headache, chest pain, swelling in the leg, abdominal pain, tiny blood spots under the skin, or excessive bruising within two weeks after vaccination should immediately contact their health care provider.

The Pharmaceutical Companies of Johnson & Johnson focuses 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.