Emergent Ruined 60 Million J&J Vaccine Doses
The (almost) worst-case scenario in the mix-up of Johnson & Johnson and AstraZeneca’s Covid-19 vaccine at the Baltimore, Maryland, plant of CDMO Emergent BioSolutions apparently has occurred. After an extensive FDA probe at the site, it was determined that around 60 million J&J doses will have to be discarded, the newspaper New York Times reported.
Only 15 million doses are believed to have been directly affected by the mix-up at the facility. However, the FDA said it fears that many other doses may have been cross-contaminated. The health agency is allowing 10 million Johnson & Johnson doses to be shipped from Baltimore under an emergency authorization procedure, but these will carry a warning label saying it cannot guarantee that Emergent’s output was GMP-compliant.
Part of the shipment from the US site is earmarked for the EU. It is unclear, however, how much of the contingent will actually be distributed. Although the European Medicines Agency (EMA) initially said it did not believe Europe’s designated supply was contaminated, authorities in member states may not release vaccine batches containing the active substance made at around the same time that the mix-up occurred.
The European Commission has already announced that it will not exercise its option to order an additional 100 million Johnson & Johnson doses. The US, too, has said it has enough Covid vaccine supply with Pfizer/BioNTech and Moderna and doesn’t need J&J or AstraZeneca.
All of the J&J doses doses administered in the US up to now were made by a CDMO partner in the Netherlands. According to the Times, at least 170 million doses of vaccine (100 million J&J and 70 million AZ) were “left in limbo” after the discovery of the Baltimore incident in April. The FDA temporarily closed the Emergent plant shortly afterward.
Recent hints that the US facility was due to reopen imminently now appear to have been premature. The FDA said it "continues to work through issues" at the site. As J&J doses were in danger of expiring as demand for them waned amid dual concerns of blood clots and contamination, the health agency has now approved a longer shelf life and temporarily halted new shipments, giving US states more time to work through the backlog.
EMA approves Moderna plant in France
In other Covid vaccine news, the European Medicines Authority (EMA) has approved the plant at Monts, France, where Swedish CDMO Recipharm will produce US biotech Moderna’s mRNA-based vaccine. The facility will have capacity to turn out 1 to 2 million finished doses per month.
The green light flanks the approval of two US sites producing APIs and finished product intermediates for the Moderna shot by EMA’s committee for human medicines (CHMP). All three plants will produce for the EU.
