Johnson and Johnson have taken over the production of their vaccine at an emergency biosolution facility in Baltimore, which previously prepared J&J and AstraZeneca doses.
President Joe Biden’s administration has agreed to abandon the Baltimore Covid-19 vaccine plant in the United States, and is working with AstraZeneca plc to find new manufacturing capacity in the United States that will focus exclusively on creating doses for Johnson and Johnson.
This discussion is the latest development in the wake of the Emergency Biosolution Inc. error – where the vaccine components of the two companies were mixed – resulting in the loss of 15 million doses of the drug in a batch.
J&J announced Saturday that it has undertaken the task of developing its vaccine at the Emergency General Service, which is preparing JJ and AstraZeneca doses. The Department of Health and Human Services worked with AstraZeneca to shift production from the plant.
The AstraZeneca vaccine has not yet been approved for use in the United States. The United States has lent প্রথম 42.2 million in its first dose to Canada and Mexico, clearing the use of the vaccine.
“The move was made to ensure that Johnson and Johnson are the only drugs being manufactured at the site,” White House Press Secretary Jane Sosaki said in a briefing Monday. “We are working with AstraZeneca to immediately identify other benefits to the domestic production of AstraGeneca drug substances and various alternatives to continue them.”
The single-dose vaccine for J and J has been approved in the United States, “so the importance of Johnson & Johnson production continues to grow,” Sosaki said.
The Baltimore plant was not approved for the production of J and J vaccines, meaning that none of the doses administered and distributed in the United States were affected by manufacturing or defects. The United States still has enough to meet its goal of delivering the vaccine to all U.S. adults by the end of May, Pasaki said.
“We weren’t betting on vaccinating the American people,” he said.
J&J said in a statement on Saturday that it was “adding dedicated leaders to operations and quality and significantly increasing the number of production, quality and technical operations staff to work with already specialized agency specialists.”
At a briefing Monday, White House Covid adviser Andy Slavitt stressed the importance of the plant as well as the arrival of people, as the plant now produces only one vaccine drug component instead of two. HHS supports both initiatives, he said.
Slavit said the removal of AstraZeneca from the site “would eliminate the possibility of any cross-contamination.” “HHS made a decision in full cooperation with Johnson and Johnson and Astrageneca and so Astrageneca also agreed that it was the right path.”
He said the decision “has absolutely nothing to do with faith or belief in one way or another” as to whether the AstraZeneca vaccine would eventually be approved in the United States. The AstraZeneca vaccine “will begin the Food and Drug Administration approval process as soon as the application is submitted,” Slavitt said.
AstraZeneca has faced growing concern in the UK and Europe over its vaccine, which is the backbone of the UK’s successful inclusion campaign. Many countries around the world rely on AstraZeneca to run their immunization programs and are reconsidering some.
The UK weekend confirmed that seven people had died of rare blood clots after receiving the AstraZeneca vaccine, and Australia is also investigating a case of clotting and raising questions about the safety of the widely used vaccine. More than 16 million doses have been administered in the UK and regulators there have insisted the shot is safe.