+- MacResource (https://forums.macresource.com)
+-- Forum: My Category (https://forums.macresource.com/forumdisplay.php?fid=1)
+--- Forum: 'Friendly' Political Ranting (https://forums.macresource.com/forumdisplay.php?fid=6)
+--- Thread: don't touch this dirty Johnson?!....inspection of J&J vaccine facility reveals violations..... (/showthread.php?tid=255212)
don't touch this dirty Johnson?!....inspection of J&J vaccine facility reveals violations..... - NewtonMP2100 - 04-22-2021
.....contamination, etc......resulting in more batches being discarded.....
FDA inspectors find "brown residue" and other violations in plant making Johnson & Johnson vaccine
....The Baltimore factory contracted to make Johnson & Johnson's COVID-19 vaccine was dirty, didn't follow proper manufacturing procedures and had poorly trained staff, resulting in contamination of material that was going to be put in the shots, U.S. regulators said Wednesday.
The Food and Drug Administration released a statement and a 13-page report detailing findings from its recent inspection of the now-idle Emergent BioSciences factory.
Agency inspectors said a batch of bulk drug substance for J&J's single-shot vaccine was contaminated with material used to make COVID-19 vaccines for another Emergent client, AstraZeneca. That batch, reportedly enough to make about 15 million J&J vaccine doses, had to be thrown out.
Other problems cited in the inspection report were peeling paint, black and brown residue on floors and walls in the factory, inadequate cleaning and employees not following procedures to prevent contamination.
Nothing made at the factory for J&J has been distributed, the FDA noted. The nearly 8 million doses of J&J vaccine given in the U.S. came from Europe.
Both Emergent and Johnson & Johnson said Wednesday that they are working to fix the problems as quickly as possible.
Production halted
After quality problems surfaced late last month, J&J took control of the factory. The Biden administration now is working to move AstraZeneca vaccine manufacturing to another factory. AstraZeneca's vaccine is not yet authorized in the U.S.
The Baltimore factory halted all production late last week at the request of the FDA. The agency hasn't given emergency approval to the factory, which is needed before any vaccine material made there can be distributed.
As part of our regulatory processes for reviewing all manufacturing facilities, FDA recently completed an inspection of Emergent BioSolutions, a proposed manufacturing facility for the Johnson & Johnson #COVID19 Vaccine. https://t.co/Jhu4SEn1mk pic.twitter.com/1Rf77Oocp1
— U.S. FDA (@US_FDA) April 21, 2021
All the bulk vaccine substance Emergent has made, plus early batches made there and then put in vials and packaged by other J&J contractors, are being stored and will undergo additional testing by the FDA, the agency said.
"We are doing everything we can to ensure that the COVID-19 vaccines that are given to the people of this nation have met the agency's high standards for quality, safety and effectiveness," the FDA said.
At the moment, use of the J&J vaccine is on hold in the U.S. as government health officials investigate its possible connection to very rare blood clots. Their decision on whether to allow the vaccine to be given could come Friday. The factory inspection is unrelated to the ongoing evaluation.
On Tuesday, the European Medicines Agency's safety committee said its review found the blood clots are a very rare side effect but that the J&J vaccine's benefits outweigh that risk.
Emergent, a little-known drug manufacturing contractor, was granted a major role in the Trump administration's response to the coronavirus. The company has been repeatedly cited by the FDA for problems ranging from poorly trained employees to cracked vials and mold around one of its facilities, according to records obtained by The Associated Press.
Potential for contamination
FDA inspectors started checking the Emergent factory in Baltimore on April 12 and finished their investigation on Tuesday.
The inspectors reviewed security camera footage that showed employees carrying unsealed bags of medical waste in the factory, with the bags touching materials ready to be used to make vaccine batches. The footage also showed employees moving between manufacturing areas for the two vaccines without documenting whether they changed protective gowns and showered in between, as required.
The inspection report noted that Emergent didn't sufficiently investigate the contamination of the later-discarded J&J batch and didn't appear to have done any extra cleaning after the contamination was discovered.
"There is no assurance that other batches have not been subject to cross-contamination," the report stated.
It also noted that the factory had inadequate procedures for assuring that the vaccine substance met all quality and purity requirements.
It's unclear how long it will take the companies to resolve all the problems at the factory, known as Bayview.
J&J has pledged to provide 100 million doses for the U.S. by the end of May and 1 billion doses globally by the end of the year.
"Right now, we can't speculate on any potential impact this could have on the timing of our vaccine deliveries," J&J said in a statement.
you......disgust me.......?!
Re: don't touch this disgusting Johnson?!....inspection of J&J vaccine facility reveals violations..... - neophyte - 04-22-2021
I think that building should be repurposed, maybe for recycling paper or plastics.
Re: don't touch this disgusting Johnson?!....inspection of J&J vaccine facility reveals violations..... - S. Pupp - 04-22-2021
No wonder there are so many government regulations.
Even with them, administrators find ways to cost cut to the extreme, with no care whatsoever as to the consequences to others.
Re: don't touch this disgusting Johnson?!....inspection of J&J vaccine facility reveals violations..... - Pam - 04-22-2021
Why was this facility chosen in the first place?
Re: don't touch this disgusting Johnson?!....inspection of J&J vaccine facility reveals violations..... - Sarcany - 04-22-2021
Pam wrote:
Why was this facility chosen in the first place?
Trump donors and cozy with one of his appointees.
https://www.cnbc.com/2021/04/20/congressional-investigation-launched-into-emergent-biosolutions-federal-vaccine-contracts-.html
Top House Democrats are investigating whether Emergent Biosolutions, which recently botched 15 million doses of Covid vaccine, won the federal contract to make the shots based on its cozy relationship with a top former Trump administration official...
"Specifically, we are investigating reports that Emergent received multi-million-dollar contracts to manufacture coronavirus vaccines despite a long, documented history of inadequately trained staff and quality control issues," the lawmakers wrote.
The committees are specifically looking at the role Dr. Robert Kadlec, a former consultant to Emergent and Trump's assistant secretary for preparedness and response, played in helping the company win the contract. They asked the company to turn over a slew of documents, including all of its federal contracts since 2015, all communication with Kadlec as well as information on audits and inspections of its facilities, drug pricing and executive compensation, among other things.
They are also the primary mfr for the Novavax COVID vaccine and for Novavax's candidate flu vaccine. I think I'm gonna skip those if they get approved for the US market.
Re: don't touch this dirty Johnson?!....inspection of J&J vaccine facility reveals violations..... - GGD - 04-22-2021
Meanwhile, what's happening with that deal with Merck to produce the J&J vaccine.
https://forums.macresource.com/read.php?2,2608115
"Is something fishy about the Merck / Johnson & Johnson deal?"
GGD wrote:
I'm having a little trouble visualizing how Merck is going to be able to help out so quickly. Especially since Biden says that we'll have enough supply for all adults by the end of May.
Here's part of Merck's press release about the agreement.
https://www.merck.com/news/merck-to-help-produce-johnson-barda-to-provide-merck-with-funding-to-expand-mercks-manufacturing-capacity-for-covid-19-vaccines-and-medicines/
Merck to Help Produce Johnson & Johnson’s COVID-19 Vaccine; BARDA to Provide Merck With Funding to Expand Merck’s Manufacturing Capacity for COVID-19 Vaccines and Medicines
March 2, 2021 4:30 pm EST
KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today it has entered into multiple agreements to support efforts to expand manufacturing capacity and supply of SARS-CoV-2/COVID-19 medicines and vaccines. The Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS), will provide Merck with funding of up to $268.8 million to adapt and make available a number of existing manufacturing facilities for the production of SARS-CoV-2/COVID-19 vaccines and medicines. Merck has also entered into agreements with Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, to support the manufacturing and supply of Johnson & Johnson’s SARS-CoV-2/COVID-19 vaccine. Merck will use its facilities in the United States to produce drug substance, formulate and fill vials of Johnson & Johnson’s vaccine.
“We are steadfast in our commitment to contribute to the global response to the pandemic as part of the remarkable efforts of the entire medical and scientific community,” said Mike Nally, executive vice president, Human Health at Merck. “This funding from BARDA will allow us to accelerate our efforts to scale up our manufacturing capacity to enable timely delivery of much needed medicines and vaccines for the pandemic.”
Under the terms of the BARDA agreement, Merck will adapt and make available some of the company’s existing manufacturing sites to accelerate manufacturing efforts for SARS-CoV-2/COVID-19 vaccines and medicines. This funding is in addition to Merck’s continued investment in its global vaccines manufacturing network as part of its planned capital investments of more than $20 billion from 2020 through the end of 2024.
...
There's 90 days from the time of the announcement to the end of May when the vaccine supply is supposed to be available. There's $268.8 million of work to be done to start the process. Realistically, how quickly can Merck ramp up production of J&J's vaccine and start adding to the end of May vaccine supply?
Re: don't touch this dirty Johnson?!....inspection of J&J vaccine facility reveals violations..... - sekker - 04-22-2021
Nothing new here, even with the Trump-era mess calculated into the story.
We as a country/world have largely decided vaccines are not a priority. We have not spent a lot of capacity, prior to COVID not been willing to actually use technologies over 40 years in testing, nor willing to pay the companies to care.
Honestly, the value to someone with a good vaccine for COVID 19 is likely worth thousands of dollars or more even to a healthy person, especially if it gives you the freedom to travel. But what are we willing to offer? A hundred dollars a dose? Something like that.