FDA asks J&J to discard millions of COVID-19 vaccine doses

[toast]

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The U.S. Food & Drug Administration on Friday said Johnson & Johnson (JNJ.N) must throw away millions of doses of its COVID-19 vaccine that were manufactured at a problem-plagued Baltimore factory but also cleared millions for use.

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The agency said it was not yet ready to authorize Emergent BioSolutions Inc's (EBS.N) plant for manufacturing the J&J vaccine. Production of J&J's vaccine at the Baltimore site was halted by U.S. authorities in April and J&J was put in charge of manufacturing at the plant.

reuters

Emergent BioSolutions Inc. has a big quality management issue:

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An FDA report cites multiple failures in an Emergent BioSolutions plant tapped to produce vaccines for Johnson & Johnson and AstraZeneca.

Emergent BioSolutions recently paused production of the vaccine during the FDA inspection and had quarantined doses it had in reserve. The FDA will subject those vaccines to further testing before clearing the way for their distribution, explained two head FDA officials, Peter Marks and Janet Woodcock, in a statement.

Pharmaceutical Processing World

 

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FDA Continues Important Steps to Ensure Quality, Safety and Effectiveness of Authorized COVID-19 Vaccines

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During an inspection of Emergent BioSolutions that ended Tuesday, the FDA cited a number of observations concerning whether the facility’s processes met our requirements and standards. These observations are outlined in our inspection closeout report, also known as a “FDA Form 483.”

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FDA

Here the Emergent BioSolutions FDA audit report (PDF), which is pretty devasting.

EDIT: I`ve read in another article (lost the link, sorry) that the JJ vaccines were contaminated with raw materials which were intended for the AstraZeneca vaccine. That seems likely as the FDA report on page 12/Observation 9 state "Equipment and/or utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strengh, quality or purity of the drug substance".

I would bet that Emergent BioSolutions Inc. is history very soon.

Edited June 11, 2021 by toast

[Dark_Grey]

J&J has had the worst rollout of all the vaccine manufacturers. First the blood clots, then the recall and now this.

[+Desertrat56]

13 minutes ago, Dark_Grey said:

J&J has had the worst rollout of all the vaccine manufacturers. First the blood clots, then the recall and now this.

The thing is, there were reports of people getting blood clots after getting the pfizer vaccine as well, same demographic, women between the ages of 25 & 40, with no verification what actually caused the blood clots.   It was in the news about a month before the hoopla about the J&J vaccine.   And there were a lot of Astra Zeneca vaccines sitting in warehouses all over the U.S. for a months before they got shipped over seas since the U.S. FDA would not approve them.  The way things work in the U.S. (even the FDA) revolves around money.   Someone paid someone off and so the J&J gets a bad rap, one facility has problems so the J&J gets another bad rap.   

[+and-then]

QC issues are nearly inescapable in such settings but overall, medical facilities, including labs that manufacture such products, have rigorous policies and procedures designed to avoid situations like this.  I didn't read the PDF but I will.  It's unfortunate that this occurred and I have to wonder if the total immunization from liability didn't play a part in some corner-cutting and sloppiness.  Thankfully, at least no one died from the lapse.

[toast]

1 hour ago, Desertrat56 said:

Someone paid someone off and so the J&J gets a bad rap, one facility has problems so the J&J gets another bad rap.   

No, its not that simple. The product responsibility remains at the client, in this case JJ, no matter who is the manufacturer of the drugs. Its a general resonsibility of pharma companies to select manufacturers who meet the specifications and requirements in compliance to FDA rules. And, the manufacturers must have FDA approval anyway because if not, they are not certified to produce drugs.

Emergent BioSolutions is (still) FDA certified, means, the company`s quality management system and procedures were in compliance to FDA rules at least at the first certification run. It is a lot of hard work to get FDA approval but its more, and ongoing, hard work to keep that status alive. I know what I`m talking about because I´m in the quality business for 20+ years meanwhile, related to the field of the pharma -and biotechnology industry. All of my clients are FDA approved and have to undergo regular FDA audits and I have never heard something that the FDA ladies and guys are some kind of unfair. Of course, they are very strictly but not unfair. If you fulfil the specifications, you will win. If not, you are in trouble. Simple deal, isnt it?