As part of our ongoing look at how American companies are stepping up to confront the virus, we have news from Novavax brought to you by JiNan Glasgow George.
By securing a US federal grant of $1.6 billion for the development of 100 million doses of COVID-19 vaccine, Novavax has joined the ranks of top COVID-19 vaccine producers in America. This recent deal marks the $4 billion investment milestone for vaccine development through public-private partnerships, also known as “Operation Warp Speed.” Moderna is another well-known American vaccine manufacturer that has secured over $500 million in federal grants. Notably, Magic Number’s Patent Radian® data covering the Pandemics/Epidemics technology sector shows Novavax & Moderna as the top two patent owners in this space. This data confirms the significant investment in research & development and patent assets by both companies – a hallmark of successful pharmaceutical and biotechnology commercial success..
CureVac AG, a German biopharmaceutical company, rounds out the top 3 patent owners in this list; CureVac has secured funding of $338 million from the federal government of Germany. CureVac and Moderna are pioneers in the mRNA vaccine market, while Novavax has introduced a novel approach of combining a proprietary adjuvant with a recombinant nanoparticle vaccine. The US government’s Operation Warp Speed investing a major share of its resources in Novavax may be a good bet, since the company has realized success in its Phase 1 trials and appears to have a solid foundation of patent assets. There is momentum here, and great expectation that Novavax will be producing an effective and safe vaccine by the end of 2020.
You can learn more about US patent assets owned by Novavax, Moderna, and Curevac for the last 2.5 years. Here Magic Number’s Pandemic Patent Forecast®.
JiNan Glasgow George Contributor American BioDefense Institute CEO Magic Number
The past four months have taught us how unprepared we were for a novel threat like COVID-19. ABI exists to collaborate with researchers, policymakers, and industry experts to ensure we never find ourselves this unprepared again.
Our Congressional Climate report is designed to give an overview of the current policy landscape. While we have begun to see discussion in Congress around developing more rapid responses, such as the recent work by Congressman Gosar of Arizona, there is much work yet to be done. We are calling for a fourprong model approach to health during pandemics going forward.
Specifically: 1. Self-care
Natural resistance to infection through physical barriers and the innate immune response is the first line of defense for all people. These systems prevent infection by most disease-causing organisms when you are exposed to small amounts of contagion. Clinical study has demonstrated that the function of each individual’s innate infection resistance can be improved by following some simple principles.
2. Rapid ‘Preventive Firebreak’ Response:Protection for New Bio Threats & Conditions
There is a large gap between self-care and vaccination that novel threats, such as the COVID-19 pandemic, can exploit to wreak havoc with lives and economies. A safe, effective, and rapid means of responding to these outbreaks is by creating passive immunity firebreaks that can be developed and deployed quickly to intercept and suppress infectious disease threats. This type of intervention is already well established in nature in the form of breastfeeding. A mother transfers her immune system to her child through her milk to help protect the child during the time when the child does not yet have an effective immune system of their own. A mother transfers her immune system to her child through her milk to help protect the child during the time when the child does not yet have an effective immune system of their own. By ‘borrowing’ the ‘mother’s immune system, the child is able to avoid more infections than it would experience without the benefit of passive immunity. If this could be replicated by utilizing antibodies in a way that can be scaled, it could produce a rapid response to established or emerging infectious disease threats alike—hence providing large-scale, inexpensive protection within 2-3 months of a novel threat.
3. Rescue response: Treatments for New Bio Threats & Conditions
When someone becomes seriously ill, a curative treatment to improve the prognosis of the disease is important. Antibodies are the primary means of intervening in an active case of infection because they facilitate the reduction of virus levels and speed up the recovery. Other examples of rescue medication can also be found in the form of steroids or other small molecule formulations. All of these are important options for a patient that is already critically ill and requires a means of improving their prognosis. While the utility of improving the prognosis of a critically ill patient is undeniable, the direct and indirect costs of illness, as well as the cost of the rescue medication, are very high. Thus, making avoiding illness in the first place, a far more desirable path to retaining health.
4. Development of Vaccines Fostering Natural and Herd Immunity
The long-standing utility of vaccines in public health cannot be overstated. Although many vaccines are of varying effectiveness and can be difficult to produce, the benefits far outweigh the costs. By reducing the number, length, and severity of cases an infectious disease creates, it reduces the impact on the overall community significantly. Long-term use of vaccines in conjunction with passive immunity firebreak treatments offers the most comprehensive protection for both individuals and communities. There are significant challenges still ahead. While we as a civilization have been fortunate to avoid a serious pandemic for decades, the COVID-19 pandemic has proven that this is a luxury we can no longer afford. Going forward, we have to accept that the next pandemic is inevitable, just as this one was – it is only a question of when it is going to occur and how severe it is going to be. The sacrifices made during this pandemic make it our duty to create a system that will be able to respond effectively in the future and protect what we have been unable to protect today.
Ravi Starzl PhD Executive Director American BioDefense Institute
Immunization is a process of fortifying an individual’s immune system against an agent, typically disease-causing pathogen or a toxin. When the immune system is exposed to foreign molecules, this will trigger an immune response. Because of immunological memory, our immune system is also able to develop the ability to respond quickly to any subsequent encounter with the same agent, which is a function of the adaptive immune system – a subsystem which responds within 4-7 days to a previously encountered foreign molecule. The concept of exposing the body to a foreign agent in a controlled manner to artificially activate the immune system and impart the ability of a quick response to a subsequent encounter due to immunological memory is called active immunization.
Active immunization gives the body the ability to produce antibodies to counter the pathogen or a toxin on its own. The most common technique of active immunization is vaccination, a process of introducing a microorganism or a virus in a weakened, live or killed state, or proteins or toxins from that microorganism, triggering the body’s adaptive immunity. This allows the body to quickly respond to a next encounter with the same pathogen or toxin. Inoculation refers to a method where the body is exposed to a milder form of a disease to induce immunity. It originated as a method of preventing smallpox, where dried smallpox macules were used to induce a generally milder form of the disease, which still induced full immunity to the disease. Compared to vaccination, it is inferior due to significantly higher risk – vaccination does not cause disease, even in its milder form, while inoculation does.
Passive immunization is a process of introducing antibodies into the body directly, rather than imparting on the body the ability to produce them. This still imparts immunity, however, because this immunity is not caused by the body’s immune system, it will only last as long as the introduced antibodies as present in the organism. This is called transient immunity. Antibodies have been used for the prevention and treatment of various diseases for centuries (Keller, 2000). Immunization by the administration of antibodies is a very efficient way of obtaining immediate, short-lived protection against infection or the disease-causing effects of toxins from microbial pathogens or other sources.
Due to its rapid action, passive immunization is often used to treat diseases caused by infection or toxin exposure. In bacterial diseases, antibodies neutralize toxins, facilitate opsonization, and, with complement, promote bacteriolysis. In viral diseases, antibodies block viral entry into uninfected cells, promote antibody-directed cell-mediated cytotoxicity by natural killer cells, and neutralize virus alone or with the participation of a complement. Prior to the discovery of antibiotics, antibodies were the only available treatment for a significant number of infectious diseases. They can be administered as:
human or animal plasma or serum
pooled human immunoglobulin for intravenous (IVIG) or intramuscular (IG) use
high-titer human IVIG or IG from immunized or convalescing donors
monoclonal antibodies (MAb).
Passive immunization occurs widely in nature to protect offspring against disease at birth and during lactation in mammals, through the transfer of immunoglobulins from mother to its offspring. This can be dated back hundreds of millions of years, to the primitive species of fish. In humans, the half-life of immunoglobulins (IgG) is about 3 weeks, making the maternal antibodies active in children 2-3 months old (Shahid, 2002). In birds (IgY) and fish (IgM), immunoglobulins have a shorter half-life of only a few days (Hedegaard, 2016). Passive immunization is not a real alternative to vaccination, as it does not confer long-term immunity. However, vaccines are not a viable option for immuno-compromised people, whose immune system is too weak to respond to an infection with its antibodies. Passive immunization provides immunity regardless of the body’s own response to infection, making it a viable option for these cases, too.
Due to the long-lasting immunization effects, vaccination is considered the superior method of imparting immunity. There are currently 27 diseases for which vaccines are available (World Health Organization, 2011). However, vaccination is only available for known diseases or known strains of viruses, and developing a new vaccine is a long and expensive process (Struck, 1996). As a consequence, many infectious diseases that have emerged over the past few decades have seen little or no vaccine development, due to a relatively small number of infections and perceived lack of commercial market for such products (Hixenbaugh, 2020). Long development and testing processes make vaccines eminently unsuitable as a rapid response tool for emerging diseases.
Even when a disease represents a mutated form of a known pathogen, there is no guarantee that the vaccine for the original pathogen would be fully effective, and in most cases, it is not (like with different influenza strains). This is particularly pertinent in today’s globalized world, where epidemics have a greater potential to spread worldwide than ever before. Therefore, while vaccines represent our best defense against infectious diseases, there is still a need for a “firebreak” – a set of measures designed to delay the spread of a disease long enough to allow for vaccine development. This report is meant to offer an introduction to the concept and strategy of passive immunity as a mechanism of rapid pandemic response and a broad overview of the current state of technology.
The American BioDefense Institute is working with Congressional stakeholders to formulate solutions to reopen the American economy with built-in biodefense and biosecurity measures meant to minimize the prolonged impact of the COVID 19 pandemic. Our program includes a multi-layered biodefense and bio-hygiene strategy that can be used to eliminate or drastically reduce the introduction and proliferation of future pandemics globally.
This initiative is not exclusive to scientific safety measures and includes:
Collaborating with researchers to develop a new class of antivirals focused on developing preventive solutions for pandemics to provide rapid response to the current and future crisis.
First responder advisory
National, State, and localized economic reboot strategy
Bleeding edge infection tracing and disinfecting technology
BioSecurity and BioDefense virtual events for scientific researchers
Federal agency communication of pandemic focused intelligence sharing
Grassroots information socialization strategy
Minority and low-income community outreach program
ABI has a unified constituency of more than 15,000,000 grassroots enthusiasts to socialize our Reopen America campaign for a more expedient and enunciated effort for maximum impact. We are able to triple the distance in a fraction of the time for efforts in matters of biodefense. We’ve taken our process global via the addition of more than 50 Washington DC based embassies who will take our tools, tactics and procedures to their nations to reopen their economies in a bio-secure manner.
Find out more about American BioDefense Institute’s “Reopen America” campaign Here
The high degree of national vulnerability to infectious respiratory disease observed during the COVID-19 pandemic brings into focus the need for rapid identification of similar emerging biothreats, to both enable early containment and development of countermeasures. The H1N1 influenza virus represents just such a threat – it is a known killer with a deadly history that possesses the ability to evolve serotypes that are both highly infectious and for which there is no established herd immunity. The possibility of a widespread H1N1 outbreak during the COVID-19 pandemic would compound the strain on regional medical systems, as there is no cross-protection between COVID-19 and H1N1 influenza immunity.
H1N1 is an influenza A subtype whose strains had been responsible for several known major flu epidemics, including the deadliest known flu pandemic in 1918-19. Different strains of the H1N1 virus are endemic to humans, pigs, and birds.
There have been three pandemics of influenza in the 20th century and one in the 21st century (Kilbourne, 2006). The H1N1 virus caused a significant and best-known pandemic in 1918-19 and the most recent one in 2009-10. In addition, there were three other notable epidemics in the 20th century that were not considered pandemics: (i) a pseudo pandemic in 1947 (that was not considered pandemic due to low death rates), (ii) 1977 epidemic that was pandemic in children, (iii) an abortive epidemic of swine flu in 1976 in Fort Dix, NJ. All of these were caused by strains of the H1N1 virus.
An antigenic variation of H1N1 caused the 1947 epidemic. One remarkable feature of this epidemic was the complete failure of the H1N1 vaccine with the 1943 H1N1 strain due to the antigenic drift of the 1947 virus. Millions of U.S. military personnel that were vaccinated were found to have no protection against the new strain of the H1N1 virus. Luckily, the epidemic caused relatively few deaths and is, therefore, considered to be a pseudo pandemic.
The 1976 outbreak of H1N1 was confined to Fort Dix, NJ, although it triggered a mass vaccination program that planned to vaccinate 43 million Americans. The vaccination was suspended after repeated reports of Guillain-Barré syndrome affecting vaccinated individuals in around a dozen states and seven times the higher reported incidence of swine flu in vaccinated individuals. There were indications that reporting bias was to blame for at least part of these cases, as there were no specific tests for Guillain-Barré syndrome, and the doctors were aware of the reported link between the vaccination and the syndrome. In any case, the vaccination program was not reinstated, and the virus did not spread. This outbreak became a cautionary tale about overreacting to the danger of an epidemic by initiating a pre-emptive vaccination program with a hastily developed and tested vaccine.
In 1977, there was an outbreak of the 1947 H1N1 virus in the Soviet Union, which spread worldwide. Because the older population was already exposed to the strain in 1947-1957, the epidemic primarily affected the population under 25. Since both haemagglutinin (HA) and neuraminidase (NA) antigens were very similar to the 1947 strain, this lack of antigenic drift led to speculations that this strain of H1N1 virus escaped from a laboratory somewhere in the USSR.
The latest 2009-10 pandemic caused around 500,000 cases and 18,500 deaths, although it has been speculated that these numbers are significantly higher: CDC estimated around 284,000 (Roos,2012). For comparison, reported deaths from influenza worldwide are 200,000-500,000 annually. Unlike most influenza viruses, this strain of the H1N1 virus did not affect disproportionately people over 60 years old.
Amendment to Rules Committee Print for H.R. 6395 offered by Congressman Gosar of Arizona
On behalf of the American BioDefense Institute, we commend Rep. Paul Gosar of Arizona on proposing an amendment to the H.R.6395 – William M. (Mac) Thornberry National Defense Authorization Act for Fiscal Year 2021. We submit this statement for the record to urge the Congress to include this amendment into the final bill to provide useful rapid pandemic response capabilities.
This amendment would add the Pandemic Prevention Platform to H.R.6395,obliging the Secretary of Defense to establish a program “to implement and advance thedevelopment of rapid and cost-effective medical countermeasures to pandemics.” The objective is to ensure that our nation has the capability to respond to any pandemic within 60 days of identifying a virus or other pathogen and make every effort to reduce this time frame to 28 days. This would provide unprecedented capabilities to contain and suppress anypandemic before it spreads.
This initiative addresses a bipartisan issue. The development of rapid pandemic response tools is a vital national security issue and a public health issue. CongressmanGosar has rightly recognized that pandemic prevention is a vital issue that has not been appropriately recognized until now. Given the current COVID-19 pandemic and its broader economic and social consequences, it is necessary to take action to prevent any future pandemic from having a similar effect.
One of the vital provisions of the amendment is the challenge to the American ingenuity to reduce the time frame of the rapid pandemic response from 60 days to 28 days. In the first 60 days of apandemic, every day is crucial, and being able to deploy pandemic countermeasures as early as possible is vital in saving lives. This amendment recognizes the importance of this and also recognizes that American companies and research institutions are capable of developing cutting-edge pandemic response tools with the U.S. government’s support.
The development ofrapid pandemic response tools holds the promise of effectively countering any future emerging infectious disease at its source. By preventing its spread worldwide and containing it and eradicating it if it reaches the U.S. These tools can be used both as a therapy for the infected patients and as a passive immunization method to prevent further infections and spread of the disease.
The American BioDefense Institute urges the Congress to accept this amendment to the H.R.6395 – William M. (Mac) Thornberry National Defense Authorization Act for Fiscal Year 2021. And ensure that the U.S. healthcare system is equipped to deal with any future pandemic effectively and that the American people are given the pandemic protection they deserve. The ongoing COVID-19 pandemic has shown that this is a vital issue of both national security and public health, and a necessary measure to protect the U.S. economy and the American way of life.