Posted on 04/04/2021 9:25:46 PM PDT by SeekAndFind
The United States has put Johnson and Johnson in charge of a plant that ruined 15 million doses of its COVID-19 vaccine and has stopped British drugmaker AstraZeneca Plc from using the facility, a senior health official said on Saturday.
J&J said it was “assuming full responsibility” of the Emergent BioSolutions facility in Baltimore, reiterating that it will deliver 100 million doses to the government by the end of May.
In a separate statement late Sunday, Emergent said it expects to align with the U.S. government and AstraZeneca to ramp down manufacturing for AstraZeneca’s COVID-19 vaccine at its Baltimore plant.
The Department of Health and Human Services has also increased Emergent’s order by $23 million for expansion of production specific to J&J’s vaccine doses, Emergent added.
“The $23 million will be used for the purchase of biologics manufacturing equipment specific to Johnson & Johnson’s COVID-19 vaccine for the potential expansion of manufacturing of that bulk drug substance into a third suite of Emergent’s Baltimore Bayview facility,” the company said.
The Department of Health and Human Services facilitated the move, the health official said in an email, asking not to be named due to the sensitivity of the matter.
AstraZeneca, whose vaccine has not been approved in the United States, said it will work with President Joe Biden’s administration to find an alternative site to produce its vaccine.
(Excerpt) Read more at reuters.com ...
How will the cocktail of the various COVID-19 vaccinations by donors affect our nation’s blood supply?
Hmm that is a VERY good question.
It was probably done so that a “whipping boy” example of the Trump administration’s “reckless disregard of safety standards” or somesuch can be used for the next four years.
Just wait. These people are soooooo predictable.
How can the federal government take control of a private facility with out due process and fair compensation to the owners?
And more importantly, why do citizens of this great nation allow it to take place? If they can do it for this facility they can and will do it for your place of work, your business or your home.
It’s quasi-govn’t. It’s not Astrazeneca’s building and it was built with taxpayer money and they are using taxpayer funds to make the vaccine. J&J and Astro were contracted by the gov to make their vaccines there and now they are finding separate facilities for each so there are no more screw ups, Astro agreed to this
The ingredient mix-up, and Saturday’s move by the administration, is a significant setback and public relations debacle for Emergent, a Maryland biotech company that has built a profitable business by teaming up with the federal government, primarily by selling its anthrax vaccines to the Strategic National Stockpile.
A spokesman for Emergent declined to comment, except to say that the company would continue making AstraZeneca doses until it received a contract modification from the federal government.
Experts in vaccine manufacturing said that in the past, the Food and Drug Administration had a rule to prevent such mishaps by not allowing a facility to make two live viral vector vaccines, because of the potential for mix-ups and contamination.
Unlike Johnson & Johnson, AstraZeneca does not yet have emergency F.D.A. authorization for its vaccine. With three federally authorized vaccines (the other two are by Pfizer-BioNTech and Moderna), it is unclear whether the AstraZeneca vaccine, which has had a troubled history with regulators, could even be cleared in time to meet U.S. needs.
However, one of the federal officials said the Health and Human Services Department was discussing working with AstraZeneca to adapt its vaccine to combat new coronavirus variants.
None of the Johnson & Johnson doses made by Emergent have been released by the F.D.A. for distribution. The agency’s acting commissioner, Dr. Janet Woodcock, said in a statement that the agency “takes its responsibility for helping to ensure the quality of manufacturing of vaccines and other medical products for use during this pandemic very seriously.”
But she made clear that the ultimate responsibility rested with Johnson & Johnson. “It is important to note that even when companies use contract manufacturing organizations, it is ultimately the responsibility of the company that holds the emergency use authorization to ensure that the quality standards of the F.D.A. are met.”
Emergent’s Baltimore facility is one of two facilities that were built with taxpayer support and are federally designated as “Centers 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 Trump administration’s fast-track initiative to develop coronavirus vaccines.
Johnson & Johnson and AstraZeneca both contracted with Emergent to use the space.
https://www.nytimes.com/live/2021/04/03/world/covid-vaccine-coronavirus-cases
More information as to why the U.S. Government granted immunity from lawsuits to these “vaccine” manufacturers. Nothing like denying rights to citizens and then poisoning them.
Once the gubmint was funneling all that money into these pharmaceutical firms (and provided legal protection for them), they became gubmint agencies.
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