FDA Fast Track for New Vaccine During COVID-19 Pandemic

Introduction

The  world has never faced a crisis like COVID-19 (SARS-CoV-2), a pandemic health  emergency.  As of May 7, 2020,  there are over 3.6 million cases (70,581+ new)  and over 251,446 deaths of COVID-19  worldwide. (1) In order to develop  effective vaccine against  COVID-19, the US Food and Drug Administration (FDA) has initiated new procedures  to expedite the development of potentially safe and effective life-saving  treatments, called the Coronavirus Treatment Acceleration Program  (CTAP).

Department  of Health and Human Services (DHHS) Secretary Azar indicated in an address that  the FDA is announcing a new, comprehensive public-private approach to bring  coronavirus treatments to the market as fast as possible. As part of this new  program, the FDA is cutting red tape, redeploying staff, and working day and  night to review requests from companies, scientists and doctors who are working  toward therapies.

Under  the CTAP, staff from the FDA’s Center for Drug Evaluation and Research and the  Center for Biologics Evaluation and Research will provide regulatory advice for  the development of novel vaccines against the COVID-19 pedantic, guidance and  technical assistance as quickly as possible. As part of this work, the FDA is  triaging requests from developers and scientists seeking to develop new drug and  biologic therapies, getting the relevant FDA staff in touch with them and  providing rapid, interactive input to get studies underway quickly.  (2)

Advantages  of the FDA Fast Track Process

According  to the FDA, speeding the availability of drugs that treat serious diseases are  in everyone's interest, especially when the drugs are the first available  treatment or if the drug has advantages over existing treatments.

Fast-tracking  allows manufacturers early and quicker access to valuable time-saving resources  to advance a drug product to market as quickly and safely as possible.  Because  of the resources required to do this, the FDA does not grant Fast Track status  lightly.  

The  designation is designed to aid in the development and expedite the review of  drugs which show promise in treating a serious or life-threatening disease and  address an unmet medical need. A Serious Condition label is based on whether the  drug will affect such factors as survival, day-to-day functioning, or the  likelihood that the disease, if left untreated, will progress from a less severe  condition to a more serious one.  For a drug to address an unmet medical need,  the drug may be developed as a treatment or preventative measure for a disease  which lacks an existing therapy. The type of information necessary to  demonstrate an unmet medical need classification varies with the stage of drug  development. In early development stages, nonclinical data, mechanistic  rationale, or pharmacologic data will suffice.  Later in the development stages,  clinical data is strongly suggested. If there are already existing therapies, a  fast track eligible drug must show some advantage over available treatment.   These could include:

• Showing  superior effectiveness

• Avoiding  serious side effects of an available treatment

• Improving  the diagnosis of a serious disease where early diagnosis results in an improved  outcome

• Decreasing  a clinically significant toxicity of an available treatment

• Addressing  an expected public health need.

If  these requirements can be met sufficiently, the FDA will approve Fast Track  status.  Fast Track designation opens up a manufacturer and their drug product  to some or all of the following:

• More  frequent meetings with the FDA to discuss the drug's development plan and ensure  collection of appropriate data needed to support drug approval

• More  frequent written correspondence from FDA about such things as the design of the  proposed clinical trials

• Accelerated  Approval or priority review if the requisite criteria are met. Accelerated  approval is meant for drugs that demonstrate an effect on a surrogate, or  intermediate endpoint reasonably likely to predict clinical benefit. Priority  review shortens the FDA review process for a new drug from ten months to six  months and is appropriate for drugs that demonstrate significant improvements in  both safety and effectiveness of an existing therapy. A fast track application  is automatically considered for both of these designations.

• Rolling  Review, which means that medical supplies manufacturers can submit completed sections of its New  Drug Application (NDA) for review by FDA, rather than waiting until every  section of the application is completed before the entire application can be  reviewed. NDA review usually does not begin until the drug company has submitted  the entire application to the FDA

Once  a drug receives Fast Track designation, early and frequent communication between  the FDA and a drug company is encouraged throughout the entire drug development  and review process. The frequency of communication assures that questions and  issues are resolved quickly, often leading to earlier drug approval and access  by patients.

Novel  Vaccines Which Could Be Fast-Tracked by FDA For The COVID-19  Pandemic

As  of April 2020,  the global COVID-19 vaccine R&D landscape is made up of 115 vaccine  candidates, with 78 confirmed active and 37 unconfirmed. 73 of the confirmed  active projects are currently at exploratory or preclinical stages. (3) The most  advanced candidates have recently moved into clinical development, including  mRNA-1273 from Moderna, Ad5-nCoV from CanSino Biologicals, INO-4800 from Inovio,  and LV-SMENP-DC and pathogen-specific aAPC from Shenzhen Geno-Immune Medical  Institute (4, Table 1).  Among the confirmed active vaccine candidates, 72% are  being developed by private/industry developers, with the remaining 28% of  projects being led by academic, public sector and other non-profit  organizations. Although a number of large multinational vaccine developers have  engaged in COVID-19 vaccine development, many of the lead developers are small  and/or inexperienced in large-scale vaccine manufacture.  This increases the  need for collaboration and access to resources.

(Source:  Thanh Le et al., 2020 Nature Reviews)

Conclusion

While  the US FDA has initiated ground breaking changes in regulation to allow for the  fast-tracking of promising vaccines to treat COVID-19, much work is still left  to be done. With large pharma companies having the resources and ability to push  forward into Phase I testing, which will look more favorable to FDA Fast Track  status. Along the way, smaller corporations, universities and/or non-profits  might struggle to see quick acceptance. To successfully combat this pandemic  with the ability to target the right drug with the minimal potential side  effects is a task ever present in the minds of the FDA regulators. Cooperation  and an aggressive go-to-market strategy combined with FDA Fast Track benefits  will lead to a quicker rollout of a vaccine(s) ready for mass production.  

References

1. WHO：https://covid19.who.int

2. FDA： www.fda.gov Office  of the (November 3, 2018). "Fast Track".

3. https://www.europeanpharmaceuticalreview.com/news/116125/fda-and-ema-offer-updates-on-covid-19-treatments-and-vaccines-in-development/.  2020, 1 April.

4. Nature  Reviews: Drug Discovery. 2020, April 9th.

About the Author:

Lin Zhang, M.D., senior director of a health care industry company in the United States. With the experience in clinical medicine, biotechnology, health industry and other fields, he is responsible for the research and development of plant medicine, functional food and health products. He was a clinician and worked for the National Cancer Institute, FDA and the National Cancer Center of Japan for many years.