What is Immunoprevention?
Immunoprevention is the use of antibodies from patients that have recovered from a virus to prevent severe disease or even infection in the first place for other people that have been exposed to it.
Evolution has provided a mechanism to protect newborns of every vertebrate species – antibodies. These are passed from mothers, who have survived many infections, to newborns either via the placenta or milk. Louis Pasteur was the first to use antibodies to prevent a fatal disease – rabies. Beginning in the 19th century, antibodies were used to prevent tetanus and diphtheria. In 1960, antibodies were found to be carried on immunoglobulin G (IgG) molecule. This resulted in the production of concentrated IgG antibodies as a byproduct of blood donations.
For several decades, this product, hyper-immune gamma globulin (IGG) prevented disease for which there were no vaccines. Just before the Salk vaccine came on the market, IGG was successfully used to prevent polio in trials involving hundreds of thousands of children. IGG has been licensed in the United States to prevent hepatitis A and B in travelers with special uses in persons exposed to rabies, chickenpox, measles, tetanus, respiratory syncytial virus or cytomegalovirus.
Millions of Americans have survived COVID 19 infections and now circulate antibodies. Can’t we use their antibodies to prevent infection? We can. COVID 19 antibodies have been shown to protect animals from infection and disease. Specialized protective monoclonal antibodies (MAb) also are obtained from disease survivors and be cloned and produced on an industrial scale. Several of these therapeutics for COVID 19 have been developed in record time, completed successful Phase 3 trials, been granted Emergency Use Authorizations and are now in nationwide distribution. The use of IGG or MAb to protect vulnerable persons and essential workers is an essential way to lessen the terrible burden of COVID 19.
Who Needs Immunoprevention?
Ultimately, we all need it! But most of us can wait for the vaccines. Along with acquiring and recovering from an infection naturally this is the best form of long term immunoprotection from COVID-19. There are two key groups that need immunoprotection with antibodies right now.
1. Vulnerable Population Groups
One of the very tricky things about COVID-19 is how dramatically different the severity of disease can be for different types of people. Since the demand for antibody-based therapeutics will far outstrip the supply – until and if we invest and focus on scaling production – it is critical to distinguish between the risk of infection and the risk of severe disease or death, and prioritize distribution accordingly until supply can be increased.
Anyone can get infected, but there is more than a thousand-fold difference in the risk of death between the oldest and youngest. For old people, COVID-19 is more dangerous than the annual influenza.
People with Pre-existing Conditions
There is also a huge increase in risk for severe disease or death from COVID-19 for people with pre-existing conditions and diseases. This spans a broad range – asthma, diabetes, obesity, heart disease, cancer and so on. All in all, this comprises 1/3 or more of the population. But risk does vary by specific criteria, so each person should consult with their physician.
2. Frontline Workers
Then there is the group of people whose work requires entails a much higher risk of exposure and infection to the virus. This starts with healthcare workers, of course, but in the broader view encompasses anyone that whose work involves social proximity. They can and should take stringent precautions to wear masks and other PPE, but they cannot avoid the increased risks.
Within this group, we will first need to prioritize immunoprotection as well, focusing on those who are also vulnerable – there just is not enough supply. But as rapidly as possible, we need to give them protection with either antibodies or vaccines.
What About Children?
For children, the COVID-19 mortality risk is less than for the annual influenza. Besides the very large data and experience we have globally, we can also look at Sweden as a case study. They are the only major western country that did not close schools during the height of the pandemic, and kept day-care and schools open for children ages 1 to 15. During this time, symptomatic children were told to stay home, or sent home if they came to school, but there were no masks used or physical distancing at school. Among its 1.8 million children in this age range, there were exactly zero deaths from COVID-19 during this time-period, and only a handful of hospitalizations.
The problem with children, however, is that they live in families and communities. So, they become vectors for spreading the virus to people that are vulnerable. That’s why Sweden has also had 4 – 5 times the rate of infections and deaths in the adult population versus many neighboring countries in Europe and is near the top of the charts globally in those measures.
But there simply will not be enough supply of antibodies for some time. So we need to focus not on giving antibodies to “children” – but rather to those children that are vulnerable because of other pre-existing conditions and illnesses. And we need to continue to maintain practices that minimize infection and community spread among and through children until all vulnerable adults can be protected.
What Is Being Done to Develop Them?
The use of antibodies for prevention of infection, mitigation of disease in those recently exposed and containment of epidemics is a concept supported by most experts in the field, and used by millions of international travelers every year.
It is no surprise, therefore, that many parallel efforts began almost immediately upon the discovery and isolation of the Covid-19 virus to develop antibody-based drugs and treatments. First to market was the use of convalescent plasma, which has shown therapeutic effectiveness but has been limited to the treatment of those already severely ill. This misses the most important opportunity: widespread prevention and containment of the epidemic. Achieving that requires approaches that are more scalable to produce and easier to administer: monoclonal antibodies and hyper-immune globulin. Multiple parallel efforts – by companies such as Eli Lilly, Regeneron, AstraZeneca and Emergent BioSolutions in partnership with the NIH and funding from the Federal Government – have been underway since the early in 2020 to achieve exactly this.
Is It Available Now?
Yes. Advanced production of these medicines was supported by Federal funding and expedited regulatory approvals through “Operation Warp Speed”, whose mandate includes the prophylactic and preventive use case that we are seeking to execute. There are now at least 3 different medicines that have demonstrated efficacy in these trials, two of which have been granted Emergency Use Authorizations and are in nationwide distribution.
Learn More About the Leading Antibody-Based Drugs
There are no guarantees in life or medicine: the degree of protection gained may not confer complete sterilizing immunity for those that receive it. But over 100 years of history, and the successful data from early stage trials of both these drugs and vaccines for Covid-19 tells us that they should impede viral spread to pulmonary stage and progression to severe disease for those that are otherwise vulnerable – where vaccines may not be as effective as hoped. That would be an enormous step forward. In August, the NIH launched clinical trials of monoclonal antibodies to prevent COVID-19, and others are underway.
The question is: should we wait for these trials to conclude, and then ramp up production? Given the costs in lives, treasure and suffering we face every day, we say emphatically no! Efficacy far beyond any other treatments has already been demonstrated, and the final checkpoints to establish safety well under way. We must take action now to shorten the timeline and ramp up production based on the data that has already demonstrated that these drugs are far more effective than any other existing options, and are unlikely to surface any major safety issues.
What Can I Do to Help My Community and Family?
Unfortunately, while Operation Warp Speed has made substantial investments in production of these medicines, these were underfunded and lacked focus commensurate to the benefit they can provide as a bridging and complementary solution to vaccines. Therefore, in the short term, supply will be very limited until well into Q1. 2021. If you would like to help us in our effort engage with the government and these companies to change that:
Until then, there will be a process of distribution & rationing through the states. That process is still being sorted out, but here are some initial tips.