AZ’s Vaccine Production Unlikely to be Slowed by Emergent’s Facility Mishap, U.S. Official Says

The U.S. government has stepped in to address a serious manufacturing error at Emergent BioSolutions’ Baltimore, Md., facility that wasted 15 million Johnson & Johnson (J&J) vaccine doses. However, putting J&J in charge of the site and barring production of AstraZeneca (AZ)’s vaccine there isn’t likely to halt AZ’s production schedule, a White House official said Monday.

Action was taken over the weekend after a serious mix-up at Emergent’s Bayview facility contaminated the equivalent of 15 million J&J vaccine doses with AZ product, a batch intended for Europe that did not go out for distribution (DID, April 5).

The feds’ move, facilitated by the Biden administration through HHS, according to a senior health official, puts J&J in sole control of the plant, allowing the company to direct all of the facility’s resources toward making its vaccine. The 112,000 square-foot drug substance manufacturing site will now be dedicated to manufacturing the one-dose J&J shot after previously devoting capacity to manufacture AZ’s vaccine as well.

At the administration’s behest and “in full cooperation,” AZ is currently working with the government to find other facilities it can use to continue domestic drug substance manufacturing for its vaccine, and several options are currently being considered. The high-profile incident may appear to be another thorn in the side for the beleaguered drugmaker, but the White House’s senior adviser for the COVID-19 response, Andy Slavitt, said Monday that the company doesn’t believe its vaccine production schedule will be impacted by its move from the Emergent plant.

The British-Swedish company has seen plenty of production delays in Europe, where officials have grown frustrated by continual delays to supply commitments that AZ says have been caused by export restrictions and production problems. It has still not filed for the FDA’s Emergency Use Authorization (EUA) for its vaccine that would arm the U.S. with a fourth weapon against the coronavirus, though it could submit its request this month.

With J&J now in charge of the Bayview facility, the company will establish a new senior leadership team that will manage all aspects of production and manufacturing at the site, with the company taking on full responsibility for the plant’s operations. The new hires will work alongside the company specialists already assigned to the plant, J&J said.

The government has also given Emergent an additional $23 million, under HHS’ Biomedical Advanced Research and Development Authority (BARDA), to buy biologics manufacturing equipment that will be used to expand bulk drug substance manufacturing into a third suite at the site, the company announced.

“Emergent continues to own the facility and perform its contracts consistent with its obligations to all of its customers and in compliance with the regulatory standards promulgated by the FDA and all other applicable regulatory authorities,” the firm said. “Emergent’s top priority continues to be the strengthening of the supply chain for J&J’s vitally needed COVID-19 vaccine.”

Still, an FDA inspection conducted in April 2020 reportedly revealed issues at the plant that involved insufficient employee training, unsecured records and a deficient method for preventing contaminations or mix-ups.

It’s not clear how many doses will ultimately be produced at the facility now that it will be fully steered by J&J, but the company said it’s on track to deliver approximately 100 million doses to the government by the end of May. Around 24 million doses are expected this month after an anticipated slow start by J&J following FDA emergency authorization in

However, the facility is still awaiting clearance from the FDA, and due to this, no vaccines made there have yet been used in inoculation efforts, the senior health official noted. And the official did not provide a potential timeline for authorization. J&J said it “continues to work closely” with the government on obtaining authorization for the Bayview facility.

The Biden administration has not been shy in involving itself in COVID-19 vaccine production, including for the J&J vaccine, helping to broker a deal between the company and rival pharma giant Merck last month that will help J&J to increase production (DID, March 3).

The president has previously said he would not hold back from invoking the Defense Production Act if he deemed it necessary to bolster COVID-19 vaccine production (DID, Jan. 19). — James Miessler