Johnson & Johnson COVID-19 Cleared For Use Following Investigation Into Blood Clotting

Johnson & Johnson JNJ got a reprieve after the Food and Drug Administration and the Centers for Disease Control revoked their earlier recommendation to pause the use of its COVID-19 vaccine.

What Happened: The pause regarding the use of J&J's COVID-19 vaccine should be lifted and the use of it should resume, the FDA said in a statement. The decision followed a thorough safety review, including two meetings of CDC's Advisory Committee on Immunization Practices.

The FDA, along with the CDC, recommended the pause on April 13 after reports of six cases of severe blood clots.

The agencies examined data to assess the risk of thrombosis, involving the large blood vessels in the brain, or cerebral venous sinuses, along with thrombocytopenia, or low blood platelet counts. They also conducted extensive outreach to providers and clinicians to ensure they were made aware of the potential for these adverse events and can properly manage and recognize these events.

Related Link: FDA, CDC Officials Discuss Johnson & Johnson Vaccine: A 'Pause Recommendation', Resolution Timeline And Advisory

The FDA and CDC have confidence that this vaccine is safe and effective in preventing COVID-19 and have determined that the available data show that the vaccine's known and potential benefits outweigh its known and potential risks in individuals 18 years of age and older, the agencies said.

"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.

The company also said it has updated the emergency use authorization fact sheets to healthcare providers, recipients and caregivers to include information about the diagnosis and treatment of thrombosis with thrombocytopenia.

Issuing an updating on the adverse events, the FDA and CDC said 15 cases of thrombosis with thrombocytopenia have been reported thus far, including the original six reported cases. All of these cases occurred in women between the ages of 18 and 59, with the onset of symptoms coming between 6 and 15 days after vaccination.

Why It's Important: As the world is continuing to battle with the pandemic, the news comes as a welcome development. J&J's vaccine is a single-shot, easily transportable COVID-19 vaccine with demonstrated protection against multiple variants.

For J&J, this removes an overhang, ensuring the time, manpower and dollars the healthcare giant has invested in its vaccine program does not go down the drain.

The agencies' quick response to the adverse events and the follow-up work in the run-up to the resolution could instill public confidence regarding the efficacy and safety of the vaccines.

J&J shares ended 0.21% higher at $165.52 Friday.

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Image by torstensimon from Pixabay.