CDC: Johnson & Johnson vaccine shortage imminent

The news of the impending shortage comes as quality control failures at Emergent BioSolutions, a little-known company vital to the vaccine supply chain, forced J&J to discard 15 million doses of the vaccine. J&J said that it was forced to discard the doses because a large batch of the vaccine, developed at Emergent’s Baltimore factory, failed to meet quality standards.

On Friday, the CDC warned that states are projected to only receive 700,000 doses of the vaccine—a sharp decline from 4.9 million the week before, the Wall Street Journal reports. The figure is an 80% plunge from previously expected numbers, according to state officials and CDC data.

“The expected sharp decrease will complicate states officials’ mass vaccination plans at a time when they are counting on a greater supply of doses to help immunize the growing number of people becoming eligible,” reports the WSJ.

The extent of the quality control failures at Emergent cannot be overstated. While it was initially reported that only 15 million doses had been spoiled, the company was also understood to have produced in excess of 100 million that had not been impacted by the company’s problems.

However, the scope of the company’s issues with quality control go well beyond the already-spoiled doses. The FDA has yet to authorize further production of vaccine doses from Emergent. The Baltimore Sun reports:

“The site of the ruined doses, the Emergent BioSolutions plant near the Johns Hopkins Bayview Medical Center, does not yet have approval from the U.S. Food and Drug Administration to distribute its product, and officials have said all the Johnson & Johnson vaccine distributed in Maryland is made in Europe.

But an official with the U.S. Department of Health and Human Services told The Baltimore Sun Thursday that Johnson & Johnson expects to provide ‘a relatively low level of weekly dose delivery’ until the East Baltimore plant gets federal authorization to distribute.”

The shortfall is expected to cause a 33% drop in availability of vaccine doses compared to the previous week – bad news for states preparing to expand its availability to younger demographics.

Despite the problems with Emergent, J&J is prepared to produce its own supply of the vaccine in its Netherlands-based plant and hopes to meet US targets by the summer deadline, saids a spokesman to theNew York Post.