The deficiencies were flagged in a Sept. 11-21 FDA inspection at Moderna’s facility in Norwood, Massachusetts, according to documents received via Reuters through a Freedom of Information Act request.
The FDA’s report stated that Moderna had released eight batches of the active ingredient used in Spikevax, its COVID-19 vaccine, using equipment that had failed the company’s own cleaning verification protocols.
In addition to Spikevax, Moderna uses its Norwood facility to manufacture the experimental vaccines it is developing lately.
Additionally, the regulator found that Moderna’s Norwood site did not have the proper safeguards to prevent airborne contamination from getting into its products, nor did the company have adequate measures to ensure that expired materials were not used in manufacturing, Reuters reported.
On Form 438, FDA inspectors discovered more than 2,000 expired pieces that were separated from other fabrics. The report also notes that some fabrics were worn beyond their expiration date.
Despite the quality issues, Reuters reported that there was no evidence that any of the affected batches were released, or that the discrepancies resulted in harm to patients who had won Spikevax or clinical trial participants who had won one of its experimental vaccines. The FDA has not issued any booster doses of the Moderna vaccine.
BioSpace has reached out to Moderna for comment and will publish this article accordingly.
The Reuters report comes as Moderna faced a sharp drop in its profits in the third quarter of 2023, basically due to a sharp drop in demand for its COVID-19 vaccine. The company’s net product sales fell 44% year-over-year. Basically due to a decrease in sales volume, which might not be fully compensated by a higher average advertising value for Spikevax.
Also during the third quarter, Moderna sustained a cost of $1.3 billion for inventory write-downs related to “excess and obsolete COVID-19 products.”
To buck the trend, Moderna will leverage its mRNA platform to produce vaccines against other diseases, including cancer. Last week, the company announced that its investigational shot V940/mRNA-4157, developed in collaboration with Merck, in combination with a Merck vaccine. The successful PD-1 inhibitor, Keytruda (pembrolizumab), reduced the threat of death or recurrence by 49% at 3 years compared to Keytruda alone in patients with high-risk melanoma after complete resection.
Moderna and Merkc are also assessing the investigational vaccine in non-small cell lung cancer and plan to expand into other tumor types.
Tristan Manalac is an independent scientist based in Metro Manila, Philippines. He can be reached at tristan@tristanmanalac. com or tristan. manalac@biospace. com.
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