US regulators have revoked emergency authorization for Johnson & Johnson’s Covid-19 vaccine after the company’s Janssen unit requested its withdrawal. The decision comes as Janssen informed the Food and Drug Administration that shots bought by the government had expired and there was no demand for the product in the US.
The FDA released a statement last week, saying that “FDA has determined that it is appropriate to protect the public health or safety to revoke this authorization.” Furthermore, the company “does not intend to update the strain composition of this vaccine to address emerging variants.”
Johnson & Johnson’s single-dose vaccine had faced problems early on following manufacturing hiccups. Cases of a rare and potentially deadly clotting disorder also slowed its roll out in early 2021. Demand for the vaccine has remained subdued compared to more popular shots from Moderna Inc. and the partnership of Pfizer Inc. and BioNTech SE.
However, according to Joshua Sharfstein, dean for public health practice and community engagement at Johns Hopkins Bloomberg School of Public Health, the decision shouldn’t affect people who’ve already received Janssen’s shot as part of their Covid vaccine regimen. “Since the reason for the withdrawal does not have to do with the effectiveness of the vaccine, I would not expect it to change whether the vaccine counts for someone’s protection,” he said.
In summary, the FDA's decision to revoke emergency authorization for the J&J vaccine came after the company's Janssen unit requested its withdrawal due to expiration and declining demand. While J&J's vaccine faced early manufacturing problems and concerns over clotting disorder, people who have already received the shot as part of their vaccination regimen should remain protected, according to a public health expert.