Sunday, October 17, 2021

Johnson & Johnson sees ‘very viable path forward’ for its COVID-19 vaccine despite safety, manufacturing setbacks

It’s going to be a big week for Johnson & Johnson’s COVID-19 vaccine, which has hit pitfall after pitfall since its launch.

European officials offered renewed backing for the shot Tuesday—with a warning about its risks—and a key Centers for Disease Control and Prevention committee is set to meet Friday to review the latest data. By Saturday, depending on that committee’s vote, the vaccine could have a clear road ahead in the U.S.

Meanwhile, the company is trying to recover from a manufacturing snafu at its U.S. partner Emergent BioSolutions. But whatever happens right now, J&J execs say they are confident the company can get its launch back up to speed.

After an FDA emergency use authorization in late February, J&J’s COVID-19 vaccine pulled in $100 million in first-quarter sales, the drugmaker said Tuesday. For now, though, the vaccine launch remains on pause as U.S. health officials investigate rare blood clots in a small number of recipients.

CFO Joe Wolk told analysts Tuesday the company is “cautiously hopeful that there is a very viable path forward” for the vaccine. 

Execs aren’t sure whether U.S. regulators will endorse the vaccine with a new warning about rare clotting risks, or whether certain populations will be discouraged from getting it. But with “clear diagnostic and therapeutic guidance” on how to identify and treat the rare blood clots, J&J is confident it can “restore the confidence in our vaccine,” chief scientific offer Paul Stoffels said. 

Just after J&J’s first-quarter earnings call ended, the European Medicines Agency’s safety committee said that a warning about rare blood clots should be added to the shot’s product information. The vaccine’s overall risk-benefit profile remains favorable, EMA said.  

The CDC’s advisory committee on vaccines is set to take up the issue Friday, and NIAID chief Anthony Fauci said over the weekend he expects the shot to return before too long.

RELATED: Johnson & Johnson’s COVID shot could return by late this week with some extra safety warnings: Fauci

But J&J’s vaccine hasn’t only run into safety setbacks. On the manufacturing front, J&J’s manufacturing partner Emergent ruined a large batch of material containing millions of doses weeks ago. J&J recently took over at the company’s Baltimore site, but this week, Emergent disclosed that the FDA has clamped down on any new manufacturing there while it inspects the facility.

It’s “premature to speculate” about any takeaways from the inspection, J&J vice chairman Joaquin Duato told analysts on Tuesday. J&J will work with Emergent and the FDA to “close the inspection this week,” he said, and will address any of the agency’s findings afterward. The exec didn’t say whether J&J has another plan lined up to manufacture vaccine doses if that site doesn’t pan out. 

The company still plans to ship 200 million doses to Europe and 100 million to the U.S. this year, chief scientific officer Stoffels noted on the call. 

There were some questions the execs didn’t answer, including one about when the company would try to collect a profit from its vaccine. Right now, the company is focused on delivering its shot around the world, Duato said.  

RELATED: FDA orders shutdown at Emergent’s troubled plant 2 weeks after handing J&J the keys

“Once this pandemic is over, there will be time” to discuss options to the company’s current not-for-profit model, he said. 

And asked whether the company still expects to produce 1 billion doses of the shot this year—its stated goal—Wolk said J&J wants to be “respectful” of the regulatory process that’s playing out. J&J’s current manufacturing setup “should put us in a position to meet of all of our contractual commitments as they stand today,” Wolk said.

The COVID-19 vaccine was a tiny piece of J&J’s overall business during the first quarter. The company posted overall sales of $22.32 billion, a 7.9% increase. Pharma sales grew nearly 10% versus the same period last year, while medical device sales jumped nearly 11%.

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