(Bloomberg) — U.S. regulators have revoked the emergency authorization for Johnson and Johnson’s Covid-19 vaccine after the company’s Janssen unit requested its withdrawal.
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Janssen informed the Food and Drug Administration that the government-bought vaccines had expired and there was no demand for the product in the United States, according to a regulatory statement released last week.
“The FDA has determined that it is appropriate to protect public health or safety to revoke this authorization,” the statement said. The company “has no intention of updating the strain composition of this vaccine to address emerging variants.”
J&J’s single-dose vaccine faced setbacks early on after manufacturing issues and cases of a rare and life-threatening bleeding disorder delayed its launch to early 2021. Since then, demand has remained subdued compared with the most popular vaccines from Moderna Inc. and the partnership of Pfizer Inc. and BioNTech SE.
The decision should not affect people who received Janssen’s vaccine as part of their covid vaccination regimen, according to Joshua Sharfstein, dean of the public health and community engagement practice at the Johns Hopkins Bloomberg School of Public Health. .
“Since the reason for the recall has nothing to do with the effectiveness of the vaccine, I don’t think it changes the fact that the vaccine counts for someone’s protection,” he said.
Translated by Paulina Munita.
Nota Original:FDA Revokes Authorization of J&J’s Unpopular Covid Vaccine
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2023-06-05 16:50:15
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