Johnson & Johnson stopped production of its single-shot COVID-19 vaccine at the only plant making usable doses late last year, according to a report Tuesday.
The stoppage at the plant in the Netherlands is temporary — with production of the vaccine expected to resume sometime in March, the New York Times reported, citing sources close to the matter.
While it’s unclear if the shutdown that began late last year has had an impact on vaccine availability, it could slash Johnson & Johnson’s supply by a few hundred million doses, one source told the newspaper.
Other facilities have been tasked to produce the J&J vaccine, but they either still await regulatory approval or weren’t yet manufacturing it, the Times reported.
Johnson & Johnson had already fallen behind on deliveries of its one-shot COVID-19 vaccine to poorer countries. The facility in the Dutch city of Leiden has instead shifted its efforts to produce an experimental vaccine to treat an unrelated virus, according to the report.
The plant has since been manufacturing a vaccine against respiratory syncytial virus – or RSV – to be used in a clinical trial in older adults in wealthy countries, a source close to the matter told the Times.
The vaccine is not expected to be available for several years even if it’s proven effective. RSV, which causes mild, cold-like symptoms, kills an estimated 14,000 older Americans each year. Johnson & Johnson is one of several companies trying to develop the first vaccine against it.
Johnson & Johnson’s COVID-19 vaccine has been linked to a rare but dangerous blood-clot disorder and some studies found it performs worse than its Pfizer and Moderna counterparts.
Still, poorer countries rely on Johnson & Johnson’s version since it doesn’t require ultra-cold storage. The Leiden plant had the capacity to produce more than 50 million doses per month, the Times reported.
Once restarted, doses made at the plant won’t be shipped until May or June, according to the report.
Johnson & Johnson hired a contractor to start producing its vaccine at a Baltimore plant capable of producing a billion doses per year, but regulators shut it down last April.
It then restarted in August, but regulators haven’t yet found it can operate in compliance with manufacturing standards, officials told the Times.
The Food and Drug Administration is now insisting on reviewing individual batches of the vaccine before shipment and regulators haven’t approved any made since the factory reopened, a spokesman for the contractor said.
But plans are underway for J&J to start production of its vaccine at two other facilities in late spring, including one in India and another in North Carolina.
A J&J spokesman told the Times the company was “working day and night” to fight the COVID-19 pandemic – with millions of doses stockpiled away in inventory.
The company said last summer it planned to deliver one billion doses of the one-shot treatment in 2021, but fell far short with roughly 400 million doses, one source close to the matter told the Times.