AstraZeneca In Talks to Switch Factories for Vaccine Production for U.S. Government
The vaccine maker has been seeking a new manufacturing partner ever since U.S. authorities decided that Emergent BioSolutions could not produce its coronavirus vaccine.,
Ejected from a troubled plant, AstraZeneca is in talks to produce vaccine for U.S. government at a different factory.
WASHINGTON — The British-Swedish company AstraZeneca is negotiating with the federal government to shift production of its coronavirus vaccine from a troubled Baltimore plant to another factory owned by the pharmaceutical firm Catalent, according to people familiar with the government’s plans.
Catalent, headquartered in New Jersey, already produces AstraZeneca’s vaccine for export at a factory in Harmans, Md., south of Baltimore. It is now in discussions to retrofit a production line there to make the vaccine for the U.S. government, taking over for Emergent BioSolutions, which was forced to stop manufacturing AstraZeneca’s vaccine more than six weeks ago after a major production mishap.
While it is unclear when the new line could begin operating, any extra doses that Catalent produces for the federal government would also likely be exported because the United States has not yet authorized the vaccine for distribution here and has more than enough supply of other vaccines to meet demand.
Holly Campbell, head of corporate communications in the U.S. for AstraZeneca, said, “We can confirm we are working with Catalent but have not disclosed specific details on supply.” A spokesman for Catalent declined to comment.
AstraZeneca has been searching for a new manufacturing partner ever since federal authorities decided that Emergent, a firm that has received hundreds of millions of dollars to manufacture vaccines, was not capable of manufacturing AstraZeneca and Johnson & Johnson’s vaccines simultaneously. The decision came in April, after Emergent workers accidentally contaminated a batch of Johnson & Johnson’s vaccine, ruining 15 million doses.
That incident has led to cascading problems for Emergent, Johnson & Johnson and AstraZeneca. Federal regulators asked Emergent to halt all production at its plant while they inspect it. Inspectors are returning Wednesday for yet another on-site review, according to people familiar with the process.
Regulators are also insisting that Johnson & Johnson and AstraZeneca provide extensive proof that batches of their vaccines produced by Emergent meet regulatory standards before allowing them to be released either for domestic use or for export. While no doses of any vaccine produced by Emergent have yet been distributed in the United States, the Biden administration had been counting on tens of millions of AstraZeneca doses from Emergent’s plant to fulfill its promise to help other countries in need.
The federal decision to strip Emergent of the responsibility to manufacture AstraZeneca’s vaccine reduced the risks and complexity of the factory’s operations. But it left AstraZeneca temporarily unable to produce its vaccine for the U.S. government.
Last May, the Trump administration pledged up to $1.2 billion to AstraZeneca to finance the development and manufacturing of its vaccine, and to supply the United States with 300 million doses if it proved effective. With the nation now awash in other vaccines, AstraZeneca doses seem mainly bound for export, although some supply might still be useful for booster shots, should those be needed and AstraZeneca’s vaccine be cleared for distribution here.
Some experts say they worry that producing more of AstraZeneca’s vaccine in the United States at this point will use up valuable raw materials that might be better directed overseas or to make other vaccines.
One federal official, speaking on condition of anonymity to discuss ongoing discussions, said the government is now renegotiating AstraZeneca’s contract, at least partly in order to shift production from Emergent to Catalent. That official estimated that Catalent could produce roughly 25 million to 35 million doses a month of AstraZeneca’s vaccine on its new line — similar to the output that was expected from Emergent.
Unlike Johnson & Johnson, Pfizer and Moderna, AstraZeneca has not sought authorization from the Food and Drug Administration to distribute its vaccine for emergency use here. Without an obvious or immediate need for the vaccine in the U.S., company officials are leaning against doing so according to people familiar with their thinking. AstraZeneca could still pursue licensure, a lengthier and more complicated process.
The AstraZeneca shot appears to be linked to a very rare, but sometimes fatal, blood clotting disorder, similar to the side effects that earlier led to a temporary pause on use of Johnson & Johnson’s vaccine in the United States. Many European countries temporarily stopped using the AstraZeneca vaccine earlier this year after a small number of clotting incidents, but they have largely restarted, in some cases with restrictions on what age groups should receive it. The vaccine is being used in 173 countries.
President Biden in late April committed to sharing 60 million doses of AstraZeneca’s vaccine. Jeffrey D. Zients, the White House’s Covid-19 response coordinator, said a month ago that 10 million of those doses could be released to other countries soon, with the rest ready to be shared within months, pending an F.D.A. review.
Mr. Biden later expanded his pledge, promising to also send 20 million doses of Covid-19 vaccines developed by other companies overseas. Samantha Power, who heads the federal Agency for International Development, told lawmakers last week that three-fourths of American excess supply would likely go to Covax, an international vaccine-sharing initiative, and the rest would be distributed through bilateral agreements.
Secretary of State Antony J. Blinken said this week that the administration will announce a plan to distribute vaccines overseas within two weeks.
Rebecca Robbins and Benjamin Mueller contributed reporting.