In the past I have spoken favorably of Moderna being the superior COVID vaccine and have taken both doses and a booster dose of the Moderna vaccine. This fall and winter season I will not be taking Moderna's new bivalent booster COVID vaccine dose.

It has nothing to do with the vaccine itself which I believe remains superior to alternatives in its protectiveness (exception for young males for whom there is a heart inflammation risk on second dose) but because of the clearly politicized FDA decision making that led to ...

the approval by the FDA on Sept 20th of 10 million doses of the new Moderna bivalent booster dose from a suspect Catalent mfg site which has not yet been formally approved by the FDA to perform commercial manufacturing of the bivalent dose. washingtonpost.com/health/2022/09…

The FDA cites Moderna's quality control data in approving these vaccines despite the site not yet having passed its recently concluded FDA inspection, a month long inspection carried out from Aug 1 to Sept 1. fda.gov/emergency-prep…

Of course Moderna wants those batches of doses approved, they don't want to lose market share to Pfizer and of course the Biden admin wants the FDA to approve those batches as well because they don't want a shortage of the new more effective bivalent booster doses.

The WaPo report does not seem to understand or comment on the unprecedented nature of this regulatory action. This would literally never happen in any other FDA inspection in any other context.

A site which was going through a pre-approval inspection before being authorized by the FDA for commercial scale manufacture of a vaccine product and had a very damaging set of inspection observations issued by the on-site FDA inspectors (Form 483) and for which ...

... no final inspection report has been issued is still allowed to supply 10 million doses it had previously manufactured at risk before the final FDA authorization decision on the facility purely on the basis of ...

... representations made by its customer on the integrity and quality of those doses. If customers are allowed to make those calls despite the obvious conflict of interest then what the hell is the FDA for?

This would NEVER ever be allowed by the FDA in the inspection and regulation of any other product, especially an injectable product. Most of the healthcare reporting I have seen on this issue seems clueless about the literally unprecedented nature of this regulatory FDA action

Now getting back to the inspection at the end of the inspection by FDA inspectors they issue a Form 483 with their preliminary observations. These are normally not public but people can file Freedom of Information or FOI Act requests to the FDA to release them.

In select cases FDA will pre-emptively make them public on their website. The Form 483 for the Catalent facility in Indiana that had requested approval to make the bivalent Moderna booster has been made public by the FDA fda.gov/about-fda/offi…

You can search on Catalent and click in the 483 link for the filing which was made public on Sept 20th which suggests pre-emptive action by FDA in response to their approval of the Catalent doses.

This form 483 is absolutely horrible, it is 19 pages long and has 12 very serious observations which is a bad 483 form for an inspection. fda.gov/media/161643/d…

The FDA inspection happened during the entire month of August and appears to cover a full GMP (Good Manufacturing Practices) inspection of the facility for all injectable products not just limited to the COVID bivalent dose manufacturing

For an injectable product reports of impurities in the vial visible to the naked eye is as bad as it gets. The Form 483 notes that Catalent did not thoroughly investigate reports of such impurities even in batches that were commercially released

also it did not always document findings of investigations and follow-up in wake of customer complaints about product quality (most of which are visible impurities)

The facility lacked proper controls in monitoring manufacturing processes that might result in variability of the drug product and equipment being used was in some cases not meeting acceptance criteria for its intended use (which can also cause defects)

They literally were not detecting obvious foreign matter impurities like *HAIR* during visual inspection of drug product vials.

Furthermore the site was not following procedures designed to prevent microbiological contamination of drug products that were supposed to be sterile (like vaccines for example)

Routine checking of equipment was not done and procedures used to manufacture sterile drug products via an aseptic manufacturing process (a more stringent form of making a sterile product that requires more controls at each step) were not adequately validated.

There are also a couple of other observations related to record keeping and data integrity (read in layman's term potential for fraud in quality records).

Any other manufacturing site receiving such a horrendous 483 Form would be prepared to receive a final EIR (Establishment Inspection Report) which would basically result in a Warning Letter, a very serious regulatory action that could result in total or partial shutdown of ...

... the facilty till the FDA was convinced enough changes had been made to operations at the facility to resolve the observations it found. Normally sites received warning letters take 2-3 years or more to emerge from this status.

Yet the FDA has announced it will allow 10 million doses from such a plant be injected into the bodies of healthy individuals just so the Biden admin doesn't have another public health failure on its hands after the Baby formula shortage disaster.

There is something very curious about how the FDA has gone about this decision. There is no press release on its main media website or tweets by its two main social media accounts. The WaPo story was dropped presumably to a sympathetic reporter ...

... you actually need to be involved in the industry to understand where to look for the underlying FDA memos and letters which I linked above.

I am hoping this historic unprecedented politicized action of the FDA will be exposed in the mainstream media.

@Vivek Ramaswamy you have been a Biotech CEO you will immediately understand how serious and unprecedented this regulatory action is. Please use your public bully pulpit to highlight this issue in the media.

@John Carreyrou you are the star WSJ healthcare investigative reporter you should dig into the details of this story this is a major scandal.

@The New York Times you should put your healthcare regulatory beat reporter Christina Jewett @Christina Jewett in digging into this episode. As a reporter covering the FDA she will realize how norm breaking this decision is.