A restart of manufacturing could lead to the release of millions of doses of Johnson & Johnson’s single-dose Covid-19 vaccine as well as the AstraZeneca shot. Emergent’s facility had been making vaccines for both, but it was closed by the FDA after workers mixed ingredients for the two products. Subsequently released results of a previous plant inspection by the drugs regulator revealed sanitary issues and other irregularities.

By order of the US government, control of the facility was handed to J&J just prior to the shutdown, and AstraZeneca told to find another partner. Though there have been no reports that it has inked any agreements, the drugmaker is now running tests to get clearance for its cache of vaccines made by Emergent, estimated at around 60 million doses of the single-shot vaccine.

Emergent CEO Robert Kramer told a virtual committee meeting of the US House of Representatives his company has turned out enough drug substance to yield more than 100 million doses of the J&J product. The CDMO’s management has blamed some of the plant’s problems on having to produce the two different vaccines simultaneously in large quantities, a situation it called “unprecedented.”

The US government had paid Emergent $271 million in monthly reservation fees to be prepared to manufacture vaccines, but partially stopped payment after learning of the contamination, according to a memo from the Democratic staff of the House Select Subcommittee on the Coronavirus Crisis cited by WSJ.

J&J meanwhile said it is “working around the clock” to kick-start manufacturing of its vaccine on a global scale and continues to work with the CDMO to secure Emergency Use Authorization in the US for the drug substance produced at Bayview “as quickly as possible.”

A spokesperson for Emergent told US trade journal Fierce Pharma last week that the company had sent the FDA a "comprehensive quality enhancement plan” on Apr. 30 and has continued to work with J&J on readying the plant for resumption of production.

A timetable for the rollout of the doses made in Maryland has not yet been revealed. All of the vaccines distributed during the early phase of the J&J launch came from a contract partner in the Netherlands. Observers said the additional doses of both manufacturers will be needed if US president Joe Biden is to fulfill a promise made last month to export Covid shots to poorer nations.

Some 80 million doses are due to exported from the US during the summer, though Washington has yet to announce where they will go. Both the UK and Mexico meanwhile have approved the J&J shot for emergency purposes but won’t be recipients of the shipments. Johnson & Johnson has pledged to supply 200 million doses to the World Health Organization’s COVAX program for distribution to lower- and middle-income countries.

Author: Dede Williams, Freelance Journalist