Halfway through the pandemic's second year, vaccine rollouts have hit their stride in some countries. Still, manufacturing problems can take an immediate toll on production and delivery timelines. Now, two COVID-19 vaccines—one authorized and the other not—are grappling with delays overseas.
Moderna and Novavax are facing separate struggles to supply their COVID-19 shots outside the U.S., according to media reports and company representatives. For one, a South Korean shipment of Moderna’s authorized mRNA vaccine will now arrive in August instead of late July, thanks to issues with two of the biotech’s European manufacturing partners, Reuters reports.
The company’s “ex-U.S. manufacturing partners are facing delays due to manufacturing laboratory issues that occurred in the past days, slowing down the release to markets outside of the U.S.,” a Moderna spokesperson said over email. The company isn’t reserving safety stock—a decision aimed at speeding deliveries overall—so Moderna doesn’t have supplies on hand “to smooth these types of shortfalls or delays,” he added.
Now, though, production is “back on track,” and Moderna expects only a “short-term adjustment” in the upcoming 2 to 4 weeks, the spokesperson said.
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Moving south, 51 million doses of Novavax’s protein-based vaccine, which has yet to win an authorization in any country, are now expected to land in Australia next year, rather than the second half of 2021 as planned, The Guardian reports.
Novavax previously flagged problems securing raw materials such as 2,000-liter bioreactor bags, depth filters and growth media, a company spokesperson told Fierce Pharma. Those shortages haven't been exclusive to Novavax, and they've "generally been resolved," she said this week.
Australia's drug regulator accepted Novavax's shot for provisional determination in January, kicking off a rolling review process, the company said. Novavax aims to have final submissions in the third quarter and start shipping doses to Australia in the fourth, provided its shot is authorized.
Meanwhile, in Korea, officials ordered 40 million Moderna doses and say the delay is linked to the biotech's Swiss manufacturing partner Lonza and an undisclosed Spanish company that does bottling work for the shot. The delays could affect countries who rely on those links in Moderna's supply chain, Korea’s vaccine procurement head Jung Eun-young said at a news conference, as quoted by Reuters.
Moderna’s spokesperson said the company is in close contact with governments and working with its manufacturing partners to minimize the shortfall across all affected nations. He did not say where delays were expected.
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Delays and delivery cuts have hit practically every COVID-19 vaccine player, oftentimes more than once. In April, Moderna scaled back deliveries to several countries including Canada and the U.K., which it blamed on a deficit of “human and material resources” in its European supply chain.
Novavax, for its part, has flagged difficulties securing certain supplies needed to make its shot, and it recently pushed back its U.S. regulatory filing on separate production issues.
Editor's note: This story was updated to clarify that Novavax has applied to Australia's TGA for authorization of its vaccine.