Setting Unprecedented Records in Vaccine Development During the Pandemic

The Complexities and Challenges of Bringing a Vaccine to Market

Posted: June 30, 2020

API Manufacturing and Pharmaceutical Manufacturing

Since coronavirus first began to sideline the world, scientists around the globe have been feverishly working to develop a vaccine. Today, eight vaccine candidates have entered clinical trials. And, already, Boston-based Moderna’s coronavirus vaccine is showing great promise in clinical trials and is on a fast track to move to wider human trials soon.

Government officials and health experts say that we won’t truly be able to return to normal until a vaccine is available and as a result, people everywhere are demanding speedier development of a vaccine.  The truth of the matter is that there are only so many shortcuts that can be taken when developing a vaccine. The fact that promising vaccines are already in clinical trials within weeks of the outbreak is nothing less than herculean, especially when you consider that a typical vaccine can take up to 10 years to become commercialized. In fact, less than a generation ago, more than a half-million people died from AIDS and it took seven years to come up with treatments and a vaccine has yet to be developed. 

TECH TRANSFER

While here at Seqens, we’re strictly a chemical company and microbiology falls a bit out of our wheelhouse, we understand the process of bringing a new drug entity to market, and we regularly work with regulatory agencies and sponsors to reach the goal of drug commercialization.

The Vaccine Development Process

As with all new chemical entities, the development of a vaccine is a long, costly and complex process. Scientists can take years to study a virus and secure funding to develop a vaccine. It can be difficult to secure funding since it’s a risky investment, in which financial rewards are not realized for many years – if at all.

According to the CDC, “there are six stages of vaccine development: exploratory, pre-clinical, clinical development, regulatory review and approval, manufacturing and quality control.”

In the exploratory stage, research is conducted to identify antigens that can attack a disease.  During the pre-clinical stage, researchers use cell-culture systems or animal testing to find out if the vaccine will create immunity. If pre-clinical trials are successful, the sponsor submits an application to the FDA for an Investigational New Drug (IND). This would show the findings and provide the strategy for how the drug will be tested and manufactured.  Once approved, the vaccine would have to complete three phases of human testing (involving thousands of people).

Once a vaccine completes all clinical trials (usually over several years), the developer submits a Biologics License Application to the FDA; and once approved, manufacturing begins.  Yet, manufacturing isn’t the last stage in the process. The pharma firm must track to see if the vaccine is performing as expected. 

Fast-Tracking COVID-19 Vaccines

As we’re seeing with the scientists working on COVID-19 vaccines today, the complex and long process of vaccine development is expected to be drastically reduced to 12-to-18 months, with testing being done on animals and humans at the same time.  

This accelerated timetable just may be reached thanks to the sheer number of scientists working together and separately to find a cure. It’s also being made possible because of the technology, which has changed the landscape for treating disease.  From gene editing, DNA manipulation, AI, computer science and other innovations, the ability to speed up what may have been manual or impossible tasks are now made possible. 

It’s also important to consider that it took years to decode the human genome, yet now we’re decoding the genome of the virus and finding antibodies in a matter of days

Easing of FDA Restrictions

The warp-speed race to a vaccine, however, is also made possible because of the easing of regulatory controls.  The FDA has traditionally been very conservative when it comes to making it possible to commercialize drugs and vaccines. It has always focused on increasing regulations and requirements, instead of conducting more inspections (since inspections are resource and time intensive). 

If anything, the coronavirus pandemic has forced the FDA to rethink how it operates. It has fast-tracked requirements for Moderna and other vaccine and test kit developers. It has been working directly with federal health partners, academics and pharma firms to advance treatments to combat COVID-19. It also launched the Coronavirus Treatment Acceleration Program to help get treatments to patients as soon as possible, while simultaneously  determining their effectiveness and if the benefits outweigh the risks. A silver lining to the current crisis just may be that the FDA comes to realize how unreasonable restrictions and regulatory controls don’t always make for safer products, but can restrict access to patients who desperately need them.

It’s truly amazing to see just how far we have come when it comes to scientific discovery, vaccine therapies and treatments. While we’ve seen far too many deaths because of the pandemic, if it occurred even 25 years earlier that number would have been doubled, at a minimum.  Thanks to bright minds, scientific and technology advancements and public/private partnerships working in lockstep with each other we’re setting new standards in how quickly vaccines and medical treatments can be brought to the front lines.

About the Author

Ed Price CEO of PCI Synthesis
Ed is President & CEO of SEQENS North America (formerly PCI Synthesis). He serves as a co-chair of the New England CRO/CMO Council and sits on the Industrial Advisory Board for the Department of Chemical Engineering at UMass, Amherst. Ed is also a long standing member of the American Chemical Society and advises the Bulk Pharmaceutical Task Force of the Society of Chemical Manufacturer’s and Affiliates (SOCMA)...

Do you have questions? Talk to Ed.