It's the end of the line for J&J's COVID shot in the US, CDC says

While Johnson & Johnson's adenovirus vaccine against COVID-19 never caught on like the mRNA shots from Pfizer and Moderna did, the prophylactic once carried high hopes. But now, the shot’s fate is officially sealed in the U.S.

J&J's COVID-19 vaccine is “no longer available in the U.S.,” the Centers for Disease Control and Prevention (CDC) said Monday. The last remaining doses in the U.S. stockpile expired May 7, 2023, with the CDC now giving instructions to “[d]ispose of any remaining Janssen COVID-19 vaccine in accordance with local, state and federal regulations.”

For U.S. adults who received J&J’s shot—either at one or two doses—a follow-up bivalent mRNA dose, either from Moderna or Pfizer and BioNTech, is recommended “at least 2 months after completion of the previous dose,” the CDC said.

J&J, for its part, said via email that it’s “working closely with U.S. regulators to determine the best path forward."

“Our focus remains on ensuring our vaccine is available to people most in need globally,” a company spokesperson explained.

In the time since J&J’s vaccine scored an emergency nod in the U.S.—the third COVID shot to do so behind Pfizer’s and Moderna’s—some 31.5 million doses have been delivered, with around 19 million of those administered to patients, according to CDC data. Unlike the more popular mRNA shots, J&J’s only required a single dose for patients to complete their primary vaccine series.

Still, J&J’s glory days in the U.S. were short-lived. The month after the vaccine snagged its emergency use authorization, the FDA recommended “a pause in the use of this vaccine out of an abundance of caution,” after six recipients—all women between 18 and 48—were diagnosed with rare blood clots.

About a week later, U.S. vaccine advisers agreed vaccinations should resume, albeit with a warning label noting the blood clot risk.

By May of the following year, however, the FDA had officially restricted use over the rare-but-serious side effect concern. More specifically, the regulator said the shot could continue to be used by those 18 and older who could not access other vaccines. Also excluded from the restrictions were those who “[elected] to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine.”

After the halt to the rollout, J&J struggled to restore public confidence in its vaccine. By January of this year, it was reported that the company was scaling back production over low demand.

The move came just a few months after J&J liquidated vaccine production contracts with the likes of Catalent and Sanofi. Further, a deal with Merck & Co. that failed to pan out ultimately ended in arbitration.

J&J's shot has failed to live up to sales expectations, too. The drugmaker originally expected $3 billion to $3.5 billion in 2022 sales but dropped that guidance last spring after a weak first-quarter performance. Ultimately, the shot pulled down $2.18 billion in worldwide sales last year.