Problems At Factory In Baltimore, USA Choose To Continue Johnson & Johnson Vaccine Production
JAKARTA - United States health authorities have decided to make a production facility in Baltimore, Maryland, United States of America to fully produce the Johnson & Johnson vaccine. Meanwhile, the AstraZeneca vaccine, which was previously produced there, was stopped and 'left' from the production facility.
Johnson & Johnson says it will take full responsibility for the Emergent BioSolutions facility in Baltimore. The target is that Johnson & Johnson is able to provide 100 million doses to the United States Government by the end of May 2021.
The Department of Health & Human Services facilitated the move, health officials said in an email, asking not to be named because of the sensitivity of the matter.
Meanwhile, AstraZeneca, whose vaccine has not yet been approved in the United States, said it would work with President Joe Biden's administration to find alternative sites for producing its vaccine. There has been no comment from the White House on this matter.
Meanwhile, according to The New York Times, this change came in response to recent revelations that Emergent, a manufacturing partner for AstraZeneca and Johnson & Johnson, accidentally mixed the ingredients of two different vaccines, forcing regulators to delay authorizing the pathway of factory production.
Federal officials fear that the mix-up will erode public confidence in vaccines, just as President Joe Biden made an aggressive push to have enough vaccine doses to cover every American adult by the end of May.
At the same time, there are deep concerns about the safety of the AstraZeneca vaccine, amid health concerns that have prompted some European countries to limit their use.
The mix of ingredients and Saturday's move by the government represents a significant setback and a public relations disaster for Emergent, a Maryland biotech company that has built a lucrative business working closely with the federal government, primarily selling its anthrax vaccine to Strategic National Inventory.
An Emergent spokesman declined to comment, except to say that the company will continue making AstraZeneca doses until it receives contract modifications from the federal government.
Experts in vaccine manufacturing say that in the past, the Food and Drug Administration (FDA) had rules to prevent such accidents by not allowing facilities to manufacture two live viral vector vaccines, because they could potentially be mixed and contaminated.
Unlike Johnson & Johnson, AstraZeneca does not yet have FDA authorization for its vaccine. With three official federal vaccines (the other two made by Pfizer-BioNTech and Moderna), it's unclear whether the AstraZeneca vaccine, which has a history of troubling regulators, could even be issued in time to meet US needs.
However, one of the federal officials said the Department of Health and Human Services was discussing cooperation with AstraZeneca to adapt its vaccine to fight a new variant of the coronavirus.
To note, the Emergent Baltimore facility is one of two built with taxpayer support and is federally designated the 'Center for Innovation in Advanced Development and Manufacturing'.
Last June, the government paid Emergent $628 million to reserve space there as part of Operation Warp Speed, the Donald Trump administration's fast-track initiative to develop a coronavirus vaccine.
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Johnson & Johnson and AstraZeneca have both signed with Emergent to use the space. The vaccines of these two companies are called live viral vector vaccines, meaning they use a different, harmless, modified version of the virus as a vector, or carrier, to convey instructions to the immune system. The Johnson & Johnson vaccine is a single dose, while the AstraZeneca vaccine consists of two doses.