Covid-19 vaccines made in the US by AstraZeneca will take weeks to ship to hard-hit countries instead of days because of problems at a factory owned by one of the company’s suppliers.
The Biden administration announced on Monday it would share up to 60m doses of AstraZeneca’s vaccine with other countries in an effort to stem further surges in other parts of the world. Officials did not specify where the doses would be sent but demand is likely to be high in India, which is suffering a catastrophic wave of infections.
US officials said the initial batch of 10m doses would be ready to be shipped “within weeks” after the country’s drugs regulator performed a range of quality control checks.
But people briefed on the plans said the process would have been far shorter had it not been for manufacturing problems at the Baltimore plant owned by Emergent BioSolutions, where a mix-up of vaccine ingredients last month ruined doses of the AstraZeneca and Johnson & Johnson shots.
“This could have taken a few days, but all of these doses came from the Emergent plant,” said a person briefed on the administration’s strategy. “That’s why this is going to take so long.”
Jen Psaki, White House press secretary, said: “Before any AstraZeneca doses are shipped from the United States, the [Food and Drug Administration] will confirm any such doses meet the expectations for product quality. This is being done in the context of the FDA’s ongoing review of all doses made at the plant where these AstraZeneca doses were produced.”
The FDA and Emergent declined to comment. AstraZeneca did not respond to a request to comment.
The White House said its new measures would include the export of millions of doses of the AstraZeneca vaccine that have been stockpiled in anticipation of US regulatory approval.
Some experts have urged the White House to export extra doses to India, where infections have reached global records and health services are overwhelmed.
If the administration decides to do so, however, officials said it would be weeks before the doses were ready because of extra checks being conducted by the FDA.
“We expect there to be approximately 10m doses that could be ready if and when the FDA gives its concurrence, which could happen in the coming weeks,” Psaki said, adding: “This is not immediate.”
Quality control checks for Covid-19 vaccines usually only take a matter of days and are performed throughout the manufacturing operations, according to people involved in the process. The contract signed between Pfizer and the US government stipulated that the company must run checks for purity and safety for the vaccine it developed with BioNTech and submit them to the regulator 48 hours before distributing them.
People briefed on the export plans said the FDA was running a much more extensive set of quality control checks on AstraZeneca doses that were made at Emergent’s Baltimore plant. They said the FDA was expected to release further details about the additional checks in the coming days.
The plant had made doses for both AstraZeneca and Johnson & Johnson, but has been taken over by the latter company after millions of doses were reportedly ruined by the mix up of ingredients.
The FDA last week released a report listing a string of manufacturing problems at the site, including unclean buildings and poor controls to prevent cross-contamination.
“For the vaccines already manufactured, the products will undergo additional testing and will be thoroughly evaluated to ensure their quality before any potential distribution. We will not allow the release of any product until we feel confident that it meets our expectations for quality,” the report said.