COVID-19 is a novel coronavirus, and the big unique challenge is not only is it a novel pathogen in humans, but many of the technologies being pursued for treatment are relatively novel as well. No RNA and DNA vaccines have yet been approved by the FDA, so while vaccine developers are moving as quickly as possible, the process still must be very thorough. A lot of information is being published online through research studies, drugs and vaccines across stages of development, business events and clinical trials and everyone has their eye on the proverbial finish line.
On an enlightening and diverse panel discussion hosted by FiercePharma and sponsored by Signals Analytics yesterday, multiple health experts, including our very own, Dr. Shlomi Madar, VP Healthcare Solutions, gave their perspectives on the status of the ongoing clinical trials, the process for getting a vaccine into the hands of the general public and potential roadblocks that can arise.
Things are looking good but there are obvious safety concerns, especially considering the widespread global use of any successful vaccine. There are 50 different vaccines under investigation representing 10 different approaches; this is on top of companies generating and testing materials that make vaccines more effective. Given the diversity of the testing, there is hope that one of the trials will lead to a successful outcome, however Phase II results will have to be convincing in order for the approval process to be completed in record time.
There is a high level of coordination between big pharma, small biotechs, research labs, and government institutions. Public-private partnerships like these have been a proven method of success in the past and especially for pandemic vaccines because the market is not assured.
The best-case timing is to be able to immunize healthcare workers by fall and general population later. Usually to get to the stage we are at takes about 6-12 months; panelists marveled that we are on pace to get to a phase 1 trial in a world record 66 days. In the meantime, it was noted that companies like Johnson & Johnson are not waiting for the process to conclude, scaling up the manufacturing capacity of their coronavirus vaccine to be able to supply one billion doses for broad distribution, which will be available on a not-for-profit basis for emergency use.
Potential roadblocks have to do with vaccine-induced enhancements (a phenomenon in which certain vaccines may lead to increased susceptibility of infections), a concern of the FDA based on SARS, and if declining number of cases in certain jurisdictions will inhibit the ability to test the efficacy of the vaccine which has already happened in China.
The discussion ended with an emphasis on the volume of information that will continue to be generated and there will be many learnings that the community should take out of this experience to apply to the next pandemic, which all agreed is highly likely to happen again.
At yesterday’s event, Dr. Madar shared some of the latest insights gleaned from the COVID-19 Playbook:
Synthetic mRNA, which we have seen in the Moderna trial, has gone to clinic in record time. So far, FDA has yet to approve an mRNA vaccine so this is definitely going to be a trend that will have an impact on the Vaccine market beyond the current pandemic.
Virus like particles, led by companies such as Medicago, has seen a vaccine candidate in under a month and if successful, will have to ability to scale up without much delay.
Another synthetic solution is DNA vaccines, such as the vaccine candidate INO-4800 from Inovio. The company mentioned it expects to start clinical trials in the U.S. with 30 participants in April (also plans to conduct trials in China and South Korea).
Signals Analytics has created an off-the-shelf COVID-19 Playbook, a specialized front-end user interface of its advanced analytics platform, which leverages COVID-19 specific taxonomies to extract context and actionable insights that address many important business questions such as: what are the leading and emerging targets being analyzed for COVID-19, which are the leading and emerging drugs and vaccines that are being researched and tested, which drugs are being repurposed to treat COVID-19, and which entities are leading and emerging for COVID-19 testing and treatment.
The COVID-19 Playbook is being offered at no-cost to heads of research, development, and innovation as well as leaders responsible for growth, business development, mergers and acquisitions, looking for ways to speed up the vaccine and drug discovery process as our way of doing our part in the race to a vaccine.
For more information on the COVID-19 Playbook, click here.
To unlock free access to the COVID-19 Playbook, click here.