White House Official: Emergent’s Bayview Facility Could Be Authorized This Month

Emergent BioSolutions’ beleaguered Baltimore, Md., facility, which Johnson & Johnson has taken over to exclusively produce its vaccine, may be cleared to start shipping out J&J doses before the month is over, according to the White House’s COVID-19 response leader.

Jeff Zients, the coordinator of the Biden administration’s coronavirus task force, said Friday that J&J anticipates delivering up to 8 million doses per week to states and the government later in April after the Bayview, Baltimore, facility receives FDA authorization. But Zients was unable to say if J&J will receive the required clearance for shipping doses from the Emergent site this month.

“Those conversations, that process is between the FDA and the company, and I don’t know, or I won’t speculate, on how long that will take,” he said. “J&J is working with the FDA to get the Baltimore facility authorized. What the company has told us is once they have authorization, that they will be able to have a weekly cadence of up to 8 million doses per week by the end of the month.”

This statement, while unclear, suggests that the drugmaker does believe the FDA will give the green light on the 112,000 square-foot drug substance manufacturing plant before the end of April. J&J declined to comment on the situation.

Previously, the Emergent facility had been producing both J&J’s one-dose shot and AstraZeneca (AZ)’s two-dose vaccine. But following an alarming and high-profile mix-up that resulted in 15 million ruined doses of J&J’s vaccine intended for Europe, it has shifted gears to solely produce J&J’s inoculation.

AZ is currently working with the U.S. government to find another facility to use for vaccine manufacturing, while J&J has brought in its own senior leadership team to handle all components of production and manufacturing at the Emergent site (DID, April 6). Zients noted that the facility will also be supported by expertise provided by Merck.

Until the Emergent facility is cleared, however, the drugmaker expects “a relatively low level of weekly dose delivery,” Zients noted. According to data from the Centers for Disease Control and Prevention (CDC), states will see a mere 700,000 doses this week, a sharp decline from the nearly 5 million shots that were delivered the week before.

Deliveries of the U.S.’ other two authorized COVID-19 vaccines, Pfizer/BioNTech and Moderna’s, are on track, Zients said, with both companies slated to deliver 200 million vaccine doses each by the end of May.

In other J&J vaccine news, a vaccination site in Colorado was temporarily shut down last week after some patients experienced adverse reactions. Centura Health, the healthcare company running the inoculations, said that two individuals were sent to the hospital “out of an abundance of caution.” It noted that the 11 patients who had adverse reactions represented a small fraction of the more than 1,700 patients given shots that day. Inoculations at the site were scheduled to resume Sunday, Centura said.

In Europe, the European Medicines Agency (EMA) announced that it has begun investigating the J&J vaccine after four serious cases of unusual blood clots were reported post-vaccination. One of the cases occurred in a clinical trial while the other three were seen in U.S. patients, the regulator said, noting that one resulted in death.

“These reports point to a safety signal, but it is currently not clear whether there is a causal association between vaccination with [the J&J] COVID-19 vaccine and these conditions,” the agency said. The EMA’s safety committee “is investigating these cases and will decide whether regulatory action may be necessary, which usually consists of an update to the product information.”

The European Commission authorized the J&J vaccine on March 11, but Europe has not yet begun rolling out J&J vaccines. The EU expects to begin using them “in the next few weeks,” the agency said. — James Miessler