Johnson & Johnson has resumed production of its vaccine at an Emergent BioSolutions plant in Baltimore, which previously manufactured J&J and AstraZeneca doses.
President Joe Biden’s administration is working with AstraZeneca Plc to find new manufacturing capacity in the United States after the company agreed to abandon a Baltimore Covid-19 vaccine plant that will focus exclusively on manufacturing doses for Johnson & Johnson.
The talks are the latest development after an error in the facility of Emerging BioSolutions Inc. – in which the two companies’ vaccine ingredients were mixed together – led to the spoilage of a 15 million dose batch of the drug. .
J&J announced on Saturday that it had resumed production of its vaccine at the Emergent plant, which manufactured doses of J&J and AstraZeneca. The Department of Health and Human Services worked with AstraZeneca to move production from the plant.
AstraZeneca’s vaccine has not been licensed in the United States, but the government has ordered 300 million of its vaccines, some of which have already been manufactured. The United States loaned 4.2 million of its first doses to Canada and Mexico, which cleared the vaccine for use.
The manufacturing decision was made “to ensure that Johnson & Johnson is the only drug produced at this site, as the issue was cross-contamination of AstraZeneca and Johnson & Johnson,” the press secretary said. from the White House, Jen Psaki, at a briefing Monday. “We are working with AstraZeneca to immediately identify additional facilities to continue their domestic manufacture of the drug substance AstraZeneca and several options.”
J & J’s single-dose vaccine has been cleared in the United States, “hence the importance of Johnson & Johnson’s production which continues to be ramped up,” Psaki said.
Intact timeline
The Baltimore plant has not been licensed for the production of the J&J vaccine, which means that none of the doses administered and distributed in the United States so far have been manufactured there or affected by the error. The United States still has enough doses to meet its goal of providing vaccines to all American adults by the end of May, Psaki said.
“We don’t bet on these to vaccinate the American public,” she said.
J&J said in a statement on Saturday that it is “adding dedicated operations and quality leaders, and dramatically increasing the number of manufacturing, quality and technical operations staff to work with the company’s specialists already at. Emergent.
In a briefing Monday, White House Covid adviser Andy Slavitt stressed the importance of this influx of people, as well as the factory now producing only one drug substance of the vaccine instead of two. . HHS supports both actions, he said.
Moving AstraZeneca from the facility “will eliminate the potential for any cross-contamination,” Slavitt said. “It was a decision that HHS made with Johnson & Johnson and AstraZeneca in full collaboration, and so AstraZeneca also agreed that it was on the right track.”
The decision “says absolutely nothing about our belief one way or another” as to whether AstraZeneca’s vaccine will ultimately be authorized in the United States, he said. Slavitt said the AstraZeneca vaccine will go through the Food and Drug Administration authorization process “as soon as an application is submitted.”
AstraZeneca has faced growing concerns in the UK and Europe over its vaccine, which is the backbone of the UK’s successful inoculation campaign. Many countries around the world relied on AstraZeneca to conduct their immunization programs and some are reconsidering their decision.
Over the weekend, the UK confirmed that seven people had died of rare blood clots after receiving the AstraZeneca vaccine and Australia was also investigating a case of coagulation, raising questions about the safety of the vaccine largely used. Over 18 million doses have been administered in the UK and the regulator insists the vaccine is safe.
