AstraZeneca In Talks to Switch Factories for Vaccine Production for U.S. Government

The vaccine maker has been seeking a new manufacturing partner since U.S. authorities decided that Emergent BioSolutions could not produce its coronavirus vaccine.

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Ejected from a troubled plant, AstraZeneca is in talks about producing vaccine for U.S. government at another site.

Nurses prepared doses of the AstraZeneca coronavirus vaccine in Taipei, Taiwan, on Wednesday.Credit…Ann Wang/Reuters

June 2, 2021, 3:02 p.m. ET

WASHINGTON — The British-Swedish company AstraZeneca is negotiating with the federal government to shift production of its coronavirus vaccine from a troubled plant near Baltimore to a factory owned by the pharmaceutical company Catalent, according to people familiar with the government’s plans.

Catalent 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 federal 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 government are also likely to be exported because the United States has not yet authorized the AstraZeneca vaccine for domestic distribution and has enough of other vaccines to meet demand.

“We can confirm we are working with Catalent but have not disclosed specific details on supply,” said Holly Campbell, a spokeswoman for AstraZeneca. A spokesman for Catalent, which is based in New Jersey, declined to comment.

AstraZeneca has been searching for a new manufacturing partner since the federal authorities decided that Emergent, which has received hundreds of millions of dollars from the federal government to manufacture vaccines, was not capable of producing the AstraZeneca and Johnson & Johnson’s vaccines simultaneously. The decision came after Emergent workers accidentally contaminated a batch of Johnson & Johnson’s vaccine, ruining 15 million doses.

That episode has led to cascading problems for Emergent, Johnson & Johnson and AstraZeneca. Federal regulators asked Emergent to halt all production at its plant while they inspected it. Inspectors returned on Wednesday for 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 been distributed in the United States, the Biden administration had been counting on tens of millions of AstraZeneca doses 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 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 country awash in other vaccines, AstraZeneca doses seem mainly bound for export. Federal officials say some might still be useful as booster shots, should those be needed and should AstraZeneca’s vaccine be cleared for distribution in the United States.

Some experts say they worry that producing more AstraZeneca vaccine in the United States will use up valuable materials that might be better directed overseas or to make other vaccines.

One federal official, speaking on the condition of anonymity to discuss continuing talks, said the government was renegotiating AstraZeneca’s contract, at least partly to shift production to Catalent from Emergent. The official estimated that Catalent could produce about 25 million to 35 million doses of AstraZeneca’s vaccine a month on its new line — a rate similar to that 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 in the United States. Without an obvious or immediate need in this country, AstraZeneca officials are leaning against pursuing authorization here, according to people familiar with their thinking. The company could still pursue licensure, a lengthier and more complicated process.

The AstraZeneca vaccine appears to be linked to a very rare but sometimes fatal blood clotting disorder, similar to the side effects that led to a pause in administering the Johnson & Johnson’s vaccine in the United States. Many European countries temporarily stopped using the AstraZeneca vaccine this year after a small number of clotting episodes, 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 last month that 10 million of those doses could be released to other countries soon, with the rest to be shared in months, pending an F.D.A. review.

Mr. Biden later expanded his pledge, promising to send 20 million doses of other coronavirus vaccine overseas. Samantha Power, the administrator of the United States Agency for International Development, told lawmakers last week that three-fourths of the excess supply in the United States was likely to go to Covax, an international vaccine-sharing initiative, with the rest distributed through bilateral agreements.

Secretary of State Antony J. Blinken said this week that the administration would announce an overseas distribution plan within two weeks.

Rebecca Robbins and Benjamin Mueller contributed reporting.

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