Officials are telling AstraZeneca to cut ties with Emergent entirely, a senior health official said.
U.S. health officials are helping AstraZeneca find a new manufacturing partner for millions of its coronavirus shots after the contractor Emergent BioSolutions mixed up ingredients for two Covid-19 vaccines it's simultaneously producing, a senior health official told POLITICO.
The Biden administration already told Johnson & Johnson to directly take over vaccine manufacturing at Emergent’s Maryland plant after reports that the manufacturer had contaminated 15 million Johnson & Johnson doses with ingredients for AstraZeneca’s shot.
But now, officials are telling AstraZeneca to cut ties with Emergent entirely, worried about the prospect for more mishaps that could erode public confidence in Covid vaccines, the official said. They added that the administration has identified two potential partners for AstraZeneca to work with on future production.
Emergent announced late Sunday that the administration's health agency has put $23 million towards new manufacturing equipment at the Bayview, Maryland facility that manufactured the contaminated doses. "In addition, Emergent expects to align with the U.S. government and AstraZeneca on a mutually agreed ramp down of manufacturing for AstraZeneca’s COVID-19 vaccine bulk drug substance," the company said in a statement.
AstraZeneca confirmed in a statement that it is relocating its manufacturing and "will work with the U.S. Government to identify an alternative location for domestic drug substance production."
The company has already produced roughly 90 million doses that are ready or almost ready for U.S. use, the official said. AstraZeneca has not yet filed for emergency authorization that would allow the doses to be administered in the United States but has said it could do so by mid-April. Meanwhile, its vaccines are already being used in dozens of other countries.
It is possible that supply for those countries could be disrupted by the switch-out of Emergent’s facilities. While the company was using Emergent for U.S. doses, it relied on another Baltimore drug plant run by Catalent to produce vaccines for Europe, Japan and an international purchasing consortium known as the COVAX Facility, the official said. It's unclear if the Catalent plant could take on the added work.
AstraZeneca signed a deal with the Trump administration last summer to supply 300 million doses of vaccine. If it gains U.S. authorization, it would become the fourth vaccine maker contributing to American stockpiles. Officials say they expect to hit goals of vaccinating most Americans this summer without AstraZeneca’s doses, but the company's shots could still be important for booster doses to be used against emerging variants of the virus.
Source: Politics, Policy, Political News Top Stories https://www.politico.com/news/2021/04/05/astrazeneca-vaccine-producer-479035