FDA Inspects Moderna Main COVID-19 Vax Manufacturing Facility—Finds Numerous Quality Breaches—Issues 483 Warning Letter, Yet Not Disclosed Publicly

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FDA Inspects Moderna Main COVID-19 Vax Manufacturing Facility—Finds Numerous Quality Breaches—Issues 483 Warning Letter, Yet Not Disclosed Publicly  Moderna vaccine
mRNA

A recent Reuters-sponsored Freedom of Information Act (FOIA) request turned up information about Moderna production problems. Specifically, the Food and Drug Administration (FDA) in an inspection discovered serious quality control lapses at the mRNA biotech company’s main production site, including issues associated with the manufacturing of the COVID-19 vaccine known as mRNA-1273 or Spikevax. Interestingly, the inspection occurred back in September, yet to date, the FDA still has not shared the warning letter publicly. See the databaseCould this finding in any way tie into DNA fragments found in samples?

Apparently, the FDA inspection was conducted between Sept. 11-21 at the Norwood, Massachusetts production site, used to manufacture both the Spikevax COVID-19 vaccine plus the investigational mRNA cancer regimen currently under development, part of a partnership with Merck, reports Patrick Wingrove.

But Moderna shared that this particular FDA inspection was routine, ensuring that any observations were not implications for product quality or safety concerns.

They said all products released by the company were tested and met product specifications and international regulatory requirements.

What did the FDA find in the inspection?

According to the Reuters entry, the FDA inspectors cited five distinct observations including the company’s failure to verify cleaning tests concerning production equipment used to make the COVID-19 vaccine.

Additionally, the regulatory agency, according to Reuters found that Moderna lacked the appropriate quality control (policies, procedures, processes and systems) at the Norwood site to offer assurance that expired materials would not be used to make vaccines, nor that airborne contaminants did not make it into any products.

According to the report by Patrick Wingrove, the FDA report found 2,000 expired items in the company’s warehouse, plus cold storage not contained in a separate or defined location from other materials. 

Another indicator of slipping quality were materials put to use beyond the appropriate expiration date.

No disclosure as to risk to the public

Not known at this point is whether the batches under scrutiny made their way to the public. The agency declined to comment to Reuters.  Why did Reuters have to issue a FOIA? Why hasn’t the FDA shared the 483 letters with the public as typically done?  

Moderna in a statement said: “Upon receipt of the FDA’s findings, Moderna immediately and comprehensively updated the specific procedures identified and is confident that the actions taken will be satisfactory to regulators.”

No Evidence of Harm, But No Evidence of Not Harm Either

Reuters reported no evidence that the quality lapses leading to the FDA observations (writer up in Form 483 letter) led to any consumer harm associated with the COVID-19 mRNA vaccines. On the other hand, they didn’t provide evidence that they have not caused problems.

Favoring a Moderna interpretation is the fact that at least thus far, there have been no FDA-issued recalls of Moderna vaccines.

Expert Commentary

Wingrove spoke with Steven Lynn, a former head of the FDA’s Office of Manufacturing and Product Quality who is now a regulatory compliance consultant. He reported that the use of the drug substance in question represented a serious matter but again, it hasn’t been disclosed by the regulatory if any of the output made its way to the market.

“At face value, it appears multiple controls designed to prevent contamination were deficient,” said Lynn.

Japanese Problems

The Reuters piece reminded the reader of problems with Moderna’s quality in Japan in 2021. In that Asian nation, regulators suspended the use of 1.63 million doses of the mRNA vaccine after contaminates were found in some vials produced by a Spanish contract manufacturer called Rovi.

TrialSite has reported on anomalies with Moderna involving its communications around their key vaccine. See TrialSite’s Moderna–Questions Regarding the Company’s Next Generation mRNA Vaccine.” This media has also questioned the true value, at least in the short to intermediate run, of the company’s pipeline. Other potential issues may present soon, concerning the dependence on one commercial product (the vaccine). The government primed the pump of demand during the pandemic. But COVID-19 national emergency status is over.

In financial disclosures as recently as 2020, the company acknowledged it had no commercial manufacturing experience, and in many ways, like Pfizer, was building the airplane while flying.

Not surprisingly, Moderna went on the record: the COVID-19 vaccines are safe and effective. Yet given the enormous cash infusion into the company thanks to the COVID-19 mandates and government support why have the quality conditions become lax enough for several observations? This finding and the lack of transparency could be indicative of more challenges ahead.