Vaccines alone are not the answer: The US is overlooking Covid’s main culprit — the threat that vaccines do not address.

As of December 2020, the U.S. government’s Operation Warp Speed (OWS) spent $12.4 billion to bring vaccines to market to prevent Covid-19 illnesses. This does not include the cost of delivering and injecting the vaccines or the money spent by numerous companies not supported by OWS.

Now the country is facing the emergence of variants that are thought to be more deadly and contagious, and the new vaccine may prove less effective against them. More than 500,000 Americans have succumbed to Covid due to an out of control inflammatory response to the infection.

So why isn’t the government focusing on conquering Covid’s main culprit — inflammation — to prevent people from becoming seriously ill and dying? The very same inflammation that is likely the cause of the lingering symptoms experienced by “long haulers” — people who suffer long-term symptoms after surviving their acute Covid infection?

Vaccines alone are not the answer.

No one questions the need for vaccines to reduce the devastating impact of this pandemic. While vaccines are intended to prevent an individual from succumbing to an illness, they are merely one part of the solution. Vaccines don’t prevent disease, vaccination does and regrettably, people’s unwillingness to be vaccinated may delay efforts to reduce the levels of infection to a point where Covid becomes rare. Vaccines are also specific to the microbial threat targeted, not the future ones that emerge.

Viral and bacterial mutations may render vaccines ineffective over time, and Covid-19 variants are already spreading with potential to escape current vaccines. So, while we have invested heavily in one approach, we have shortchanged two other approaches that are needed in spite of our miraculous generation of effective vaccines in less than a year.

Antiviral treatments provide many benefits.

What are these other approaches? The next best-known approach is antiviral drugs that directly tackle the virus, including convalescent plasma and monoclonal antibodies targeted to this specific virus. Antiviral products have been used for many years to address influenza, HIV and other viruses. Some of these already known compounds and newly developed SARS-COV-2-targeted molecules were rushed into studies and in some cases showed some benefit. But the focus has been more on vaccines, and antiviral drugs are not being commonly used.

Why? Mixed results in many studies have left the antiviral approach with a reputation of being mostly ineffective. These antivirals were developed specifically for other viral threats and are likely not optimal. Combinations are more effective but are subject to the emerging mutated variants. Should this approach have been supported more aggressively at an earlier point to address the expected delay in achieving herd immunity with vaccines? Of course.

Novel anti-inflammatory treatments can close the gap.

Last, and I propose of most importance, is the scarcity of investment that is needed to address inflammation. Many do not realize that the severe outcomes that kill Covid patients generally occur after the viral load is reduced. These deaths are caused by the body’s own reaction to the infection…an out-of-control inflammatory response. Not only does this cause a much higher mortality rate in hospitalized patients than influenza, the very same excess inflammation is likely the cause of the long-term morbidity experienced by “long haulers” — people who suffer long-term symptoms after surviving their acute Covid infection.

The corticosteroid, dexamethasone, an anti-inflammatory agent, has been clearly shown to reduce mortality in patients, confirming the importance of quelling this inappropriate inflammatory response. But this class of compounds and other currently approved anti-inflammatory agents are immunosuppressive, lowering the body’s ability to fight threats, and putting patients at risk for secondary infections and other side effects, as noted in an article in the New England Journal of Medicine.

Better anti-inflammatory agents suited for use in patients at high risk of secondary infections and often with already compromised immune systems must be addressed. Investment to make this possible is sorely lacking. The importance of fixing this gap is that addressing the host-response, with its over-exuberant inflammation, is an approach that does not just address Covid-19. Success in this third approach could also help address future pandemic threats. This is the only approach that promises to address disease not specific to a known microbial threat, including new variants and the next pandemic.

Such a drug would also be helpful for many diseases with excess inflammation that are currently underserved, including severe bacterial pneumonias, severe influenza and chronic inflammatory conditions such as lupus, rheumatoid arthritis, as well as some neurologic diseases which are currently treated with immunosuppressive drugs such as corticosteroids.

The cumulative financial cost of the Covid-19 pandemic is estimated at more than $16 trillion, or roughly 90% of annual GDP of the United States, according to the JAMA network. Increasing the investment centered on vaccines from more than $12.4 billion investment today to $25 billion, would allow the other approaches to be fully developed into effective therapies. This would ensure that we have all the possible tools to fight this pandemic, the next pandemic and the many diseases driven by excess inflammation.

The proposed doubling is a paltry amount compared to the societal cost we have already incurred with a fiscally conservative approach to innovation. We should have done this before SARS-COV-2 emerged, but the next best time to do this is now.

By Susan L. Levinson, PhD., co-founder and CEO of BioAegis Therapeutics Inc. BioAegis is currently conducting a Phase 2 clinical trial of its gelsolin treatment in severe Covid-19 patients.

CEO, BioAegis Therapeutics Inc. — A clinical stage private company focused on developing therapies for infectious, inflammatory and degenerative diseases.