Johnson & Johnson's COVID-19 vaccine has taken a back seat to mRNA programs from Pfizer and Moderna in many developed nations, but it's still in high demand around the world. That's why news the company recently paused production came as a surprise to some people, including J&J's top customers.
Late last year, Johnson & Johnson halted production of its COVID-19 vaccine from its facility in the Dutch city of Leiden, The New York Times reports, citing people close to the matter. Thanks to vaccine stockpiles, it’s unclear whether the pause has affected vaccine supplies, the NYT notes.
The pause is only temporary, with J&J gearing up to resume production in Leiden of its COVID shot in March, according to the NYT. Doses made there next month will likely roll out around May or June, following plant tests and inspections, the newspaper said.
In the meantime, the factory is making an experimental vaccine against respiratory syncytial virus, a person close to the matter told the NYT.
“Our manufacturing sites produce multiple products as we have an obligation to supply life changing medicines to patients around the world,” a J&J spokesperson told Fierce Pharma over email. “We manage our production planning accordingly and are currently supplying from our extensive global network based on the demand for our vaccine and the needs of our patients and customers.
“We currently have millions of doses of our COVID-19 vaccine in inventory,” he added.
Still, over the next few months, the production pause in Leiden could whittle down supplies of J&J’s vaccine by a few hundred million doses, one of the NYT's sources said. While other factories have been enlisted to help make the shot, they’re either not up and running yet or they haven’t received regulatory approval to ship out product.
Meanwhile, the J&J pause came as a surprise to the African Union and the COVAX consortium, the NYT reports. Officials at those groups reportedly learned of the pause from NYT reporters rather than J&J itself.
Aside from Leiden, J&J and partners are gearing up for COVID vaccine production at Emergent BioSolutions’ Baltimore plant, where J&J took over production last year after a widely publicized cross-contamination snafu. Production restarted there in August, but the FDA has yet to give the plant its stamp of approval, instead reviewing individual batches of vaccine before they’re shipped for bottling, the NYT points out.
J&J is also counting on a Merck plant in North Carolina and a Biological E. facility in India to chip in on COVID-19 vaccine production, but those plants aren’t expected to crank out usable vaccine substance until late spring, the NYT says, highlighting the importance of the Leiden plant.
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“[W]e expanded the capacity of our facility in Leiden in 2021, and the site continues to play a role in our vaccine manufacturing in 2022,” J&J’s spokesperson told Fierce Pharma. “Our network is working day-and-night to help fight the global pandemic, and Johnson & Johnson continues to provide all of our fill and finish sites, including Aspen, with drug substance to produce our COVID-19 vaccine,” he continued.
But the pause shouldn’t come as a total shock: All along, J&J had told U.S. officials that it planned to pull the Leiden plant out of its pandemic manufacturing rotation, current and former U.S. officials told the NYT. Nevertheless, the Leiden decision raised concerns among J&J executives that the company wouldn’t be able to meet its vaccine commitments to the developing world, the publication reports.
In Western countries, J&J’s vaccine has been largely overshadowed by the mRNA offerings from Pfizer and Moderna. Still, the single-dose shot has remained an important product in low- and middle-income countries.
The news also comes as J&J has fallen short on its vaccine supply pledges, the NYT points out. Back in March 2021, the company predicted it could deliver 1 billion doses of its COVID shot in 2021, but instead released some 400 million doses, a person familiar with J&J’s vaccine production told the NYT. J&J has also lagged on deliveries to Gavi, the Vaccine Alliance along with the Coalition for Epidemic Preparedness and the World Health Organization’s COVAX facility.
The African Union, for its part, has received doses on or ahead of schedule, the NYT notes.
“In 2021, approximately 70% of our global vaccine supply was made available to low- and middle-income countries through our advance purchase agreements and country donations,” Johnson & Johnson’s spokesperson added in his email. He said the company is focused on making its shot available where needed, and it continues to fulfill its contractual obligations with COVAX and the African Union.
Johnson & Johnson’s vaccine hasn’t been the cash cow that Moderna’s and Pfizer’s have. Last year, J&J’s shot generated roughly $2.4 billion in sales. Pfizer’s BioNTech-partnered mRNA shot Comirnaty, by comparison, ginned up nearly $37 billion.