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Clinical trials of vaccines are going well, but we are still looking at December and roll-out over the course of 2021 as a best case scenario. And the history of vaccine development tells us that proving safety and efficacy – critical to avoiding a catastrophic mistake – could take far longer. Vaccines are also often less effective and pose higher risks to the elderly and people with pre-existing conditions – who are most vulnerable groups for severe illness or death from Covid-19.
With rising infection rates, and our economy crippled, we need an interim strategy to safely open up our schools — protecting students and teachers — and businesses — protecting all workers — until a vaccine is proven safe and can be distributed nationwide. Every day we can’t safely re-open America, we lose lives and jobs, and see increasing negative impacts on our children’s education, sports and cultural activities and psychological well being.
Herd immunity for Covid-19 – or anything close to it – has not been reached in any countries to date. Usually 70% to 90% of a population is needed to achieve “herd immunity”. Given that Covid-19 is highly contagious, experts believe that for America to achieve it would require at least 70% of the population to have been infected or vaccinated.
To date, the over 8 million cases of Covid-19 still only represents only slightly more than 2% of the US population! Of course, most observers expect that the actual rate of infection is much higher – perhaps as much as 5% to 10% of the population. And no matter what, most people are going to remain cautious and avoid infection using common sense practices. So getting to herd immunity via ‘natural spread’ could take years – and tens or hundreds of thousands of more deaths – before we achieved even the low end of 70%. America cannot stay closed for that long, nor bear that level of needless suffering.
The tricky thing about COVID-19 is how different the outcomes can be. So many of us have seen neighbors, kids and celebrities all do just fine.
Unfortunately, you cannot extrapolate from these data points. Age and underlying health conditions are hugely important factors influencing disease severity.
- A study of more than 1.3 million COVID-19 cases in the United States, published June 15 in the journal Morbidity and Mortality Weekly Report, found that rates of hospitalizations were six times higher and rates of death were 12 times higher among COVID-19 patients with underlying conditions, compared with patients without underlying conditions. The most commonly reported underlying conditions were heart disease, diabetes and chronic lung disease.
- About 8 out of 10 deaths associated with COVID-19 in the U.S. have occurred in adults ages 65 and older, according to the U.S. Centers for Disease Control and Prevention (CDC). The risk of dying from the infection, and the likelihood of requiring hospitalization or intensive medical care, increases significantly with age. For instance, adults ages 65-84 make up an estimated 4-11% of COVID-19 deaths in the U.S, while adults ages 85 and above make up 10-27%.
- These trends tend to overlap because so many elderly people have the exact chronic medical conditions that can exacerbate the symptoms of COVID-19, according to the CDC. The ability of the immune system to fight off pathogens also declines with age, leaving elderly people vulnerable to severe viral infections.
While it is true that people who are most vulnerable to severe disease of death from COVID-19 tend to have pre-existing conditions, it is most definitely the virus that is causing the resulting illness or deaths. Most importantly, one of these conditions is simply age!
There is a lot of confusion, however, because people read about all the other complications people get by the time they are hospitalized. It can be boiled down to simple concept: with COVID-19, it is not usually “the virus” that kills you, but rather a cascading set of reactions and complications caused by your body’s response and effort to destroy to the virus. There is no doubt that the virus attacks many different parts of your body, and is the direct cause of disease. But the proximal, direct cause of life threatening illness or death range across the now infamous “cytokine storms” that destroy victim’s lungs, and this and other systemic reactions that cause kidney failure, liver damage and even brain damage. Sometimes, this can be the side effects from the treatment itself – including in particular ventilators, which have multiple high risk factors.
This varies according to the specific drugs and their approaches. The first wave of antibody therapeutics that will be arriving from Regeneron and Eli Lilly are all administered via IV (intravenous solutions). These will require a clinical setting and take about 15 to 30 minutes to be administered.
Historically, antibody-based drugs (such as Gamma Globulin) intended for prevention and protection of recently exposed people are usually administered like a shot.
Simply put, the economy cannot fully recover until the virus is brought under control and people can be assured they are safe to return to the everyday activities that put them into social proximity with others.
We are now engaged in a national dialogue about the need to re-open the economy, versus the stark realities that Covid-19 and its kin are likely here to stay. The risk of new outbreaks and deaths will be directly related to easing of restrictions under current circumstances. But this does not have to be the case.
Immunoprevention with antibody-based drugs can achieve all critical objectives that are needed until a safe and effective vaccine is widely available:
- save lives and reduce severity of disease from infections;
- protect healthcare and other front line workers;
- provide a safety net for the resumption of economic activity protection for people whose work requires travel and social proximity; and
- quickly containing local outbreaks.
The difference is that, because of our long experience and history with this approach, it is much faster to develop and demonstrate both safety and efficacy. With focus, resources and a sense of urgency, these drugs can be available within a few months. That is far ahead of any timeline that is safe for a vaccine.
There is no doubt that – just like a vaccine – the greatest benefit comes from mass application of vaccine until what is called “Herd Immunity” is achieved. That’s the ultimate goal, and the sooner we get there, the sooner normal economic life, cultural and sports activities can be fully restored.
But until the, antibodies can be applied with levels of priority and benefit that can be achieved on a societal level as people get this treatment.
- Level 1: Health. Focus first on the elderly and those with pre-existing conditions, and the ‘front line workers’ in healthcare and assisted living that care for them.
Benefit: Prevent deaths and serious disease.
- Level 2: Work. Focus on people whose jobs and small businesses require social proximity – logistics, travel, hospitality, restaurants, sports, entertainment, education, etc.
Benefit: Protect against infections and enable work to resume safely.
- Level 3: Life. Address the rest of the population that wish to resume their participation in normal economic, sports and cultural activities.
Each level that is achieved will have direct, measurable benefits and positive impact on saving lives, reducing illnesses and deaths, and progressively restoring the economy and life.
And, of course, the very first level of benefit is to you and your family! As soon as you make the decision and are able to get immunoprevention with antibody-based drugs, you gain for a period of time at least a reduction in severity of disease, and at best prevention of infection.
We can’t speak to that now, and of course each company involved in developing and producing these drugs makes its own decisions. However, given the large amounts of Federal funding (for example, Regeneron’s REGN-COV2 will be fully funded) behind these efforts, as well as the clear benefit to insurers of preventing hospitalizations, we expect that all participants will be fully covered.
Immunoprevention.org will also seek to raise funds to help cover any costs not covered by the Federal Government.
While that is important to public health officials and the overall public health response, that really is not an individual concern. What matters is your immunity or enhanced immune response – and that is in your control.
The great thing about getting the antibodies is that you will be in charge of your immunity by ensuring that you have an enhanced immune response. This is in your control.
This means that if someone you don’t know forgoes wearing a mask and they have COVID-19, you won’t catch it (even though they still can).
After treatment, typically it is 3 – 4 months before you would need your next boost. We all expect, of course, that vaccines will be available at scale in the 2nd quarter of 2021. But if not, we you can continue to get ‘boosters’ of immunoprevention.
It’s also important to realize that vaccines may not be as effective for the vulnerable populations – such as the elderly and those with pre-existing conditions. In this case, antibody-based drugs can be a valuable supplement to vaccines to boost immune response.
Actually, this is expected consistent with other Coronaviruses. Here’s one article on a recent study:
Masks and social distancing have worked in America – where they have been applied and followed rigorously. What has not worked is having half the population ignore these basic best practices of infection control.
The new breed of antibody-based drugs that are being developed are based on the same principles as convalescent plasma and immunoglobulin that have been used successfully and safely for immunoprevention and therapy to save lives and contain epidemics for over 100 years in the United States against diseases such as Smallpox, Rubella, Measles, Polio – and the Spanish Flu epidemic of 1918 – 20.
After WW II commercial gamma globulin was widely available affording short term protection against measles, paralytic poliomyelitis, hepatitis A, and hepatitis B (7–11). In the 1950s, a large scale blinded efficacy trial found that gamma globulin given to 100,000 children successfully blunted poliomyelitis attack rates (9).
Convalescent plasma has been primarily used as a stop gap treatment in late stage Covid-19. Based on all that we’ve seen and learned about the virus’ pathogenesis, it should not be a surprise that its effectiveness has been limited.
If you think of the virus like a fire, where antibodies – and immune response generally – works best is when the fire is small. Antibodies are given to “put out the fire”, and the same principles prevail. The bigger the fire and longer it has been going, the harder it is to put out the fire with an all-purpose agent – water(antibodies). So if you wait until late stage, severe illness – when the whole house is on fire – antibodies are not going to help nearly as much.
Respiratory infections are particularly difficult because the infections are really on the surface of the body – lung tissue. This means the blood can’t bring enough antibodies to be effective.
On top of that, a lot of studies and data have concluded that what is causing the very severe disease and death in most cases with Covid-19 is the immune response itself – those ‘cytokine storms.’ Why this varies so much is a mystery, but it seems clear that the bad outcomes are closely associated with this reaction. So, adding more antibodies is not going to help address this. The treatments that are having the most success in severe, late stage illness have been drugs that reduce the body’s over-active immune response.
The data that is most relevant to antibodies for the prevention use case are the vaccine trials. The consistent positive results of those together with the Phase 2 antibody trials indicate that immune response is both strong and effective in putting that fire out when it first starts.
The main reason that antibody-based drugs are going to be available much sooner than vaccines is because they are inherently safe.
- These drugs do not use weakened viruses, or parts of viruses – which creates risks that need to be tested at scale and over time to be fully understood and avoided.
- Instead, they are bolstering the immune system directly with antibodies that have already been successful in fighting the virus in other people.
- They are based on the same principles as convalescent plasma and immunoglobulin that have been used successfully and safely for immunoprevention and therapy for over 100 years.
More importantly, nothing is going to happen until Phase 3 trials are completed and there is definitive data to show both efficacy & safety.
Both harness your immune system to prevent infection and disease, but they are different.
Vaccines work by using either a weakened virus or parts of the virus to give you a ‘mild’ infection that provokes an immune response. This then causes your body to produce antibodies which fight the virus when you are actually exposed.
Antibody-based drugs work by using the antibodies from people that have already had the virus – or synthetic derivatives of them. So you get the immune response without any exposure to the virus, or parts of it, avoiding the inherent risks that come with that.
We can’t speak to that now. However, given the large amounts of Federal funding (for example, Regeneron’s REGN-COV2 will be fully funded) behind these efforts, as well as the clear benefit to insurers of preventing hospitalizations, we expect that all participants will be fully covered. Immunoprevention.org will also seek to raise funds to help cover any costs not covered.
Immunoprevention.org is building a model for each community to pursue if it schooses – providing not just the template and proof of the model, but also the digital infrastructure that can be used by local chapters / organizers across the country.
We also believe that the model & infrastructure for collective coordination & action combined with activism & messaging powered in a distributed, Internet model can have a permanent positive role in both:
- preparedness and response to future break-out epidemics like Covid-19 or return of Covid-19 itself (it is quite possible it will be like the Flu in terms of mutations & ongoing circulation seasonally); and
- other infectious diseases that have chronic circulation and flair-ups.
Immunoprevention.org also sees ongoing activism & messaging around vaccinations as part of its mission. This is about immunoprevention in all its forms and tools, and providing a non-governmental, bottom up platform for citizens to counteract the ‘anti-vaxxer’ misinformation and ideology.