While pre-license inspections of manufacturing sites are typically done following the acceptance of a BLA filing, due to the public health emergency of COVID-19, the FDA is instead requiring a quality control unit to be established by each manufacturer with detailed report submissions about their manufacturing processes.
Since 2009, the U.S. Food and Drug Administration (FDA) has performed close to 30,000 drug manufacturing inspections to make sure production standards of medications being dispensed to U.S. citizens are up to snuff. Typically, inspections are required before new drugs are approved to ensure high-quality products.
However, the closely-watched COVID-19 vaccine developers won’t have that same requirement.
Last Thursday, the FDA held a virtual meeting with their Vaccines and Related Biological Product Advisory Committee to discuss measures being taken to ensure the vaccines approved for COVID-19 are safe, effective and deserving of public trust. The full 8 hour and 50-minute meeting can be viewed on the FDA’s YouTube channel, but if you don’t have a third of your day to devote watching, here’s a recap of what they said on the matter of inspections in the briefing document released.
While pre-license inspections of manufacturing sites are typically done following the acceptance of a Biologics License Application (BLA) filing, due to the public health emergency of COVID-19, the FDA is instead requiring a quality control unit to be established by each manufacturer with detailed report submissions about their manufacturing processes. The FDA will determine the need for on-site inspections based on their own assessment. So, the bottom line is that facilities producing the vaccines might be inspected... or not.
Current frontrunner in the race for a coronavirus vaccine is Pfizer, with Moderna just behind. Pfizer has already started manufacturing hundreds of thousands of their candidate, a two-dose vaccine. They’re utilizing their facility in Puurs, Belgium, which, according to an FDA database, was last inspected in 2017. It passed with an NAI, meaning no action indicated, no objectionable conditions or practices were found.
Moderna has yet to gain FDA clearance of a product, so the database shows the company’s facilities have never been inspected by the agency. However, they’ve partnered with Lonza to help boost manufacturing capacity. Lonza’s New Hampshire site has been inspected several times.
Both Pfizer and Moderna are using mRNA technology for their vaccines. Due to this, NIH official and advisory committee member Luigi Notarangelo said that pre-EUA inspections are warranted and would “provide some additional trust into the process.”
More trust is certainly needed before even the most effective COVID-19 vaccine produced has a chance at having an impact on the coronavirus pandemic. A recent survey by Axios Ipsos shows only 30% of Americans would be willing to take a first-generation vaccine as soon as it’s available. Of the remaining 70%, 65% said they would likely get it after it’s proven safe and effective, with 34% saying they likely won’t get it at all.
To combat public fears, transparency and openness are crucial, Claire Hannan, executive director of the Association of Immunization Managers, testified during the public comment period.
“Holding open online meetings allows the public to see for themselves how the process works is key,” she said.
Pfizer is anticipating approval for their vaccine in November while Moderna hopes to be ready in December.
