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FDA's COVID-19 Vaccine Guidance Shows 'Substantial' Obligations For Developers: Analyst

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FDA's COVID-19 Vaccine Guidance Shows 'Substantial' Obligations For Developers: Analyst

Despite political pressure to expedite coronavirus vaccine programs, the FDA has opted to err on the side of caution.

What Happened: In guidance released Tuesday on according emergency use authorization for coronavirus vaccines, the FDA revealed criteria and considerations for issuing emergency use authorization; key logistics recommendations for vaccine sponsors seeking emergency authorization; the information and data that should be included in such a request; considerations for continuing clinical trials following emergency authorization; and the considerations for an FDA panel reviewing them.

For coronavirus vaccine manufacturing, the FDA is seeking a minimum of three process performance qualification lots per manufacturing facility to support the consistency of vaccine quality.

A 50% efficacy bar, with a greater than 30% lower bound of confidence interval, will be applied to the emergency use authorization assessment of efficacy, and at least five severe COVID-19 cases are required in the placebo group to demonstrate vaccine efficacy against serious coronavirus, according to the guidelines.

For safety data, the FDA guideline calls for a high proportion of enrolled subjects, numbering well over 3,000 vaccine recipients.

The FDA also requires that a full chemistry, manufacturing and control protocol should be made available ahead of an emergency use authorization submission.

Patient and physician information brochures and a proposed label should be made available at the time of submission, the regulatory agency said.

The guidelines also indicate that the same set of regulatory requirements will be applied to all vaccine candidates irrespective of technology.

All vaccine candidates will have to be reviewed by an Adcom to assess whether safety and effectiveness data for a particular vaccine candidate supports emergency use authorization.

Related Link: Attention Biotech Investors: Mark Your Calendar For October PDUFA Dates

Why It's Important: The expedited timeframe pursued by vaccine developers is seen as a deterrent to vaccine adoption due to safety fears. 

"The summary of these documents is that the obligations on manufacturers seeking an EUA are substantial, and include extensive documentation about clinical trials, manufacturing processes, facilities, analytical methods and controls, expected label, physician and patient information documents, and post-EUA clinical trial plans and post approval safety surveillance plans," SVB Leerink analyst Geoffrey Porges said in a note. 

The requirements suggest that emergency use authorization could take longer than many investors are expecting, the analyst said. 

The FDA seems to be suggesting that emergency use and biologics license application decision will be data- and science-driven, and not influenced by other factors such as political or economic pressure, he said. 

What's Next: The FDA's Vaccines and Related Biological Products Advisory Committee is scheduled to meet Oct. 22 to discuss the development, authorization and/or licensure of vaccines to prevent COVID-19. 

Related Link: The Week Ahead In Biotech: Avenue's FDA Decision, Alkermes Adcom Meeting, Aziyo Biologics IPO

 

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