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"Existing, widely-available vaccines have the potential to protect the world against COVID-19, as well as to prevent or mitigate pandemics caused by other viruses. We should not just be reactive, we should be proactive. We should be ready for both this pandemic and the next ones."
— Jaykumar Menon, Chair and Co-Founder, Open Source Pharma Foundation

OSPF

Scientists
Open Source Pharma Foundation

This project is supported by scientists of the Open Source Pharma Foundation, a non-profit based in Bangalore, India, with centers in New York and Paris. Using open source principles, the organization seeks to develop affordable medicines in areas of great health need. In the Harvard trial, OSPF will be a “collaborator”. In the Government of India trial, it will be a “secondary sponsor”. OSPF’s role includes providing scientific support for and helping draft the protocol for both trials, providing a study monitor for the India trial, advocacy, and helping to bring both the trials into being. Our team has a deep experience in infectious disease and clinical trials. While India has been heavily affected by COVID-19, OSPF scientists and researchers are determined to support this collaborative effort with Harvard and the Government of India to develop affordable vaccines to fight the pandemic.

The principal investigators and primary sponsors of the trials are not OSPF but Harvard and the Government of India.     

For more information, please visit: www.ospfound.org/meet-our-team.html

Summary

We need to protect humanity against pandemics—including the current COVID-19 pandemic.

Existing, widely-available vaccines have the potential to protect the world against COVID-19, as well as to prevent or mitigate pandemics caused by other viruses. We should not just be reactive, we should be proactive. We should be ready for both this pandemic and the next ones. 

While the scientific case for exploring the efficacy of certain existing live attenuated vaccines is strong, the commercial potential is low, as these vaccines are already widely available, cost as little as pennies per dose, and are off-patent. The private sector thus has little incentive to invest.  As a result, there is a major market failure, in which the minute level of R&D funding is simply incommensurate with the enormous scale of the public health opportunity.

Our goal is to conduct Phase 3 clinical trials exploring the efficacy of certain existing vaccines against COVID-19. This would also lay the groundwork for protecting against future pandemics, as these vaccines have the potential to provide a broad umbrella of protection. If the trials are successful and find efficacy, the vaccines, which are already being taken by hundreds of millions of people at a low cost, could reach the population very quickly. 

The initial repurposed candidate vaccines are BCG (tuberculosis), MMR (measles/mumps/rubella) and OPV (oral polio vaccine).

Why is this important?

Existing, widely-available, off-patent vaccines have a number of potential advantages over the possible new vaccine candidates currently under development:

  • Speed:  Repurposed vaccines are radically faster to develop.
  • Cost: They are 100-1000 times less costly to develop.
  • Safety:  Repurposed vaccines have well-established histories of safety, stretching over decades.
  • Manufacturing:  Large scale manufacturing is already in place.
  • Certainty: Vaccine development is difficult.  The proprietary novel vaccine candidates under development are still just candidates; there is no guarantee that a new vaccine will arrive in short order, or that it will be fully effective.
  • Combination: Repurposed existing vaccines may be used in combination with new vaccines, should they arrive.  They can be complementary, with different and valuable scientific effects.
  • Acceptability:  Repurposed vaccines that are already widely utilized and familiar will possibly be better accepted by the public, given their long histories of use.
  • Affordability:  Prices can be as low as pennies per dose.
  • Open IP:  Off-patent repurposed vaccines have open intellectual property (IP), enabling multiple producers to participate in the market.
  • Ethical Use of Public Funds:  Rather than using public funds to subsidize the development of proprietary products over which private corporations would hold a monopoly—and for which they may charge a prohibitive price, with taxpayers paying fore and aft—public funds can be directed toward public/open intellectual property and affordable treatments. This presents a better deal for the public.
  • Future Pandemics:  The repurposed vaccines that we are developing have already been shown in many studies to create a broad type of protection, an umbrella that protects against any types of germs.  They do this by boosting the overall immune system. As such, they may help prevent the next pandemic. They could be an armamentarium for humanity, a safeguard for all humankind.

There is significant potential that lies in repurposing existing vaccines for global pandemics like COVID-19. It is one that cannot be ignored. If successful, such vaccines would be rapidly released, cost only a few cents per dose, avail of existing manufacturing capacity in the hundreds of millions of doses, and have intellectual property that is the “common heritage of all humankind.”

Who will benefit?

Anyone and everyone affected by the pandemic, as well as future pandemics, would benefit. As COVID-19 is impacting lives in myriad ways across the world, developing an effective vaccine to fight the virus would improve the wellbeing of all. It is also important to emphasize that this vaccine would be produced and distributed at a low cost, making it accessible and far-reaching to all communities affected by the pandemic around the world, not limited by affordability. The vaccines would be open IP – “the common property of all humankind.”  

Budget

This project will provide support for pre-trial preparation including: literature searches; evidence analysis; protocol drafting and refining; forming collaborations between the multiple parties involved in the trials; and interaction between the various collaborators. If we exceed our $50,000 initial goal, then Open Source Pharma Foundation (OSPF) will put the money raised toward pre-trial planning, to defray a small portion of the costs of a trial, and to help any ensuing vaccine get to patients. These items could include but are not limited to: a) enabling patient enrollment for several patients; b) specific immunological or other lab studies, c) processing of samples, d) coordination between the various parties collaborating on the trial e) deploying a study monitor, and f) advocacy. The actual budget for the phase 3 clinical trials will of course be far more than $50k. The funds collected will come to OSPF, and will go to support OSPF’s activities in relation to these trials. 

Updates

Open Source Pharma Foundation Receives Honorable Mention for the FastCompany World Changing Ideas Awards 2020

OSPF was recently featured in Fast Company magazine in an article about the potential of open source to prepare us for the current and future pandemics (https://www.fastcompany.com/90498448/how-open-source-medicine-could-prepare-us-for-the-next-pandemic). OSPF also received honourable mention for the FastCompany World Changing Ideas Awards 2020 for its work harnessing the power of data, machine learning, or artificial intelligence to understand the world and empower change. Open source initiatives in the pharma realm are becoming more and more recognized for their potential impact on global health concerns. An open source vaccine effort for pandemics would certainly harness great support and interest.

Letter to Congress, signed by our OSPF team and other scientists

A Letter to Congress has been signed by our OSPF team as well as other scientists to encourage funding in the next COVID-19 relief package: 

“We write to encourage you to provide funding in the next COVID-19 relief package to test the efficacy of low-cost, existing vaccines against the virus.

Existing, widely-available vaccines have the potential to protect against COVID-19, as well as prevent or mitigate future pandemics caused by other viruses.

...

In brief, repurposed existing, widely available, off-patent vaccines could be near the front of the global pandemic vaccine race, as they are at Phase 3, and also have huge advantages in manufacturing, acceptability, and affordability."

New England Journal of Medicine: Trained Innate Immunity, Epigenetics, and Covid-19

“Exposure to selected vaccines, such as bacille Calmette–Guérin (BCG) or microbial components, can increase the baseline tone of innate immunity and trigger pathogen-agnostic antimicrobial resistance (known as trained innate immunity). Such training is directly relevant to resistance against infectious diseases, including Covid-19.”

https://www.nejm.org/doi/full/10.1056/NEJMcibr2011679

Science Magazine: Can existing live vaccines prevent COVID-19?

“[A]n increasing body of evidence suggests that live attenuated vaccines can also induce broader protection against unrelated pathogens likely by inducing interferon and other innate immunity mechanisms that are yet to be identified. The stimulation of innate immunity by live attenuated vaccines in general, and oral poliovirus vaccine (OPV) in particular, could provide temporary protection against coronavirus disease 2019 (COVID-19).”

https://science.sciencemag.org/content/368/6496/1187.full

Proceedings of National Academy of Sciences: BCG vaccine protection from severe coronavirus disease 2019 (COVID-19)

"[S]everal significant associations between BCG vaccination and reduced COVID-19 deaths were observed. This study highlights the need for mechanistic studies behind the effect of BCG vaccination on COVID-19, and for clinical evaluation of the effectiveness of BCG vaccination to protect from severe COVID-19”

https://www.pnas.org/content/117/30/17720

American Society for Microbiology:  MMR Vaccine Could Protect Against the Worst Symptoms of COVID-19

“Live attenuated vaccines seemingly have some nonspecific benefits as well as immunity to the target pathogen. A clinical trial with MMR in high-risk populations may provide a low-risk-high-reward preventive measure in saving lives during the COVID-19 pandemic,” 

https://asm.org/Press-Releases/2020/MMR-Vaccine-Could-Protect-Against-the-Worst-Sympto

CNN: How a 100-year-old vaccine for tuberculosis could help fight the novel coronavirus

"Tuberculosis and Covid-19 infection are two very different diseases -- TB is caused by a type of bacteria while Covid-19 is caused by a virus, for starters. But the BCG vaccine might help people build immune responses to things other than TB, causing "off-target effects," according to Dr. Denise Faustman, director of immunobiology at Massachusetts General Hospital and associate professor of medicine at Harvard Medical School."

https://www.cnn.com/2020/04/09/health/tuberculosis-bcg-vaccine-coronavirus/index.html