FDA's Priority Review Voucher for COVID-19 Vaccine

 To spur drug development in the under-developed area, FDA relies on various policies and programs to incentify the biotech and pharmaceutical companies. The most famous one is the orphan drug development. In the last 10 years or so, a program called 'priority review voucher' become popular. If the biotech and pharmaceutical companies develop a drug in certain underdeveloped areas, once the drug is approved (not emergency user authorization), FDA will issue the marketing authorization holder a priority review voucher. The priority review voucher can be redeemed for future NDA/BLA applications to shorten the review time by four months. The priority review voucher can be a commodity to be sold or transferred to another company for monetary gain. 

• FDA's Priority Review Voucher Programs

• RAPS: Regulatory Explainer: Everything You Need to Know About FDA’s Priority Review Vouchers
• Endpoints: Priority review voucher updates: Who's won PRVs, who's bought them, and how much they're selling for

FDA currently has three priority review voucher programs and each has its own guidance to industries:

• Tropical Disease Priority Review Voucher Program and its guidance
• Rare Pediatric Disease Priority Review Vouchers
• Material Threat Medical Countermeasure Priority Review Vouchers 

To qualify for a PRV for tropical disease, a sponsor’s application must be for a drug or biological product for the prevention or treatment of a “tropical disease,” where a list of tropical diseases are listed by FDA and additional tropical diseases may be added by FDA. For example, Ebola was not in the original list but was added in 2019.

To qualify for a PRV for rare pediatric disease, a sponsor's application must be for a drug or biological product for the prevention or treatment of a "rare pediatric disease," where the rare pediatric disease is defined as:

The 21st Century CuresAct (Cures Act) Section 565A of the FD&C Act was designed to encourage development of new drug and biological medical countermeasures (MCMs), by offering additional incentives for obtaining FDA approval of certain MCMs. While there are existing incentive programs to encourage the development and study of drugs and biologics that may also be applicable to MCMs, section 565A of the FD&C Act provides an incentive specifically for development of certain MCMs, which may be used alone or in some cases in combination with other incentive programs. Other FDA incentive programs include: orphan-drug designation and the associated benefits under the Orphan Drug Act for rare disease drugs; programs to encourage study of drugs used in pediatric populations; various programs to facilitate and expedite development and review of new drugs to address unmet medical needs in the treatment of serious or life-threatening conditions; and programs for certain tropical disease products and antibacterial products. 

Last week (Jan 31, 2022), Moderna obtained the final approval (not emergency user authorization) for its Covid-19. After the approval, a brand drug name or proprietary name - SPIKEVAX - is approved. In the approval letter, FDA granted Moderna a material threat medical countermeasure priority review voucher (PRV).

Endpoints had an article "Exclusive: The curious case of the BioNTech priority review voucher" indicating that for Pfizer/BioNTech's Covid-19 vaccine (brand name Comirnaty) approval, the priority review voucher was not included at the time of the BLA approval. After the approval, BioNTech (as the market authorization holder) received a MCM priority review voucher even though the company did not announce it publicly. 

A priority review voucher can be worth hundreds of millions if transferred. however, the monetary awards from the MCM priority review voucher are trivial compared to the sales of the Covid-19 vaccines - PRV is just a nice-to-have incentive.