Invivyd Chairman Marc Elia: The bureaucracy is killing people with Long COVID

Listen to Marc Elia discuss this op-ed on our podcast:

In 2024, someone in the United States died from COVID-19 approximately every 11 minutes. And those are just the deaths of which we are aware. I am angry about the significant sickness in America, and you should be, too. People are dying; hospitalization remains a crushing burden on our healthcare system; and the prevalence of Long COVID, a disabling disease threatening both health and lifespan, continues to rise.

Despite this, the Biden administration failed to prioritize innovative solutions that could alleviate or prevent the worsening of this crisis. Instead, they relied on short-acting, marginally-effective COVID-19 vaccines while restricting the development and availability of new medicines that could dramatically change health outcomes for millions.

How do I know all this? Because in addition to suffering from Long COVID, I have worked for years to bring alternative COVID-19 preventatives and treatments to market. As chairman of the board at Invivyd, Inc., a biotechnology company focused on cutting-edge COVID-19 medicines called monoclonal antibodies (mAbs), I’ve seen firsthand how politics, bureaucracy, and indifference to our collective well-being obstruct innovation.

Before the pandemic, I was fortunate to lead an active and healthy lifestyle. I was a 45-year-old endurance athlete, thriving in both body and spirit. I understood the gravity of the pandemic from the start — my background in science and drug development ensured that. I masked, stayed home, got vaccinated, and followed all public health guidelines. For a while, these measures worked. However, as any parent with children in school knows, the virus’ reach is endless.

In late 2021, I contracted a “mild” case of COVID-19. I believed I was recovering after a week, but the virus had other plans. My “mild” case escalated to life-threatening blood clots that put me in the hospital. I survived, but my life has been irrevocably changed.

For the past few years, I’ve endured the debilitating effects of Long COVID. My symptoms — autonomic dysfunction, intrusive tinnitus, exercise intolerance, and severe sleep disturbances —  have significantly impacted my ability to live as I once did. Each day brings fear of reinfection, knowing that another encounter with the virus could prove more debilitating or catastrophic.

Monoclonal antibodies can be highly effective medicines and indeed played a major role early in the pandemic for both prevention and treatment of COVID-19. In essence, mAbs are medicines that are similar to the natural human antibodies that form the backbone of our immune response. In the pharmaceutical industry, we can make them much more potent and resistant to evolution.

While I am proud of our efforts to develop mAbs for immunocompromised individuals to protect them from COVID-19, I — like millions of others — am not eligible to receive the antibodies Invivyd makes, so I remain at risk. Why? Government choice: the Food and Drug Administration (FDA)’s decision whether to rapidly authorize novel medicines for COVID-19 hinges on whether it determines “adequate, approved, and available” options already exist. The FDA has deemed current vaccine options for people like me (who do not have an expressly compromised immune system) to be “adequate.”

Let’s take a look at how they define adequacy. The latest vaccine efficacy data from the Centers for Disease Control and Prevention (CDC) show that current COVID-19 booster shots provide a 50% reduction in risk of hospitalization or urgent care visit for only 60 days before the benefit wanes. For immunocompromised individuals, that 60-day risk reduction drops to 36%.

In the view of the FDA, a vaccine that gives someone like me a 60-day long, 50% reduction in risk of hospitalization compared to doing nothing is “adequate.” That blocks the rapid path for new options for many of us. Of course, by contrast, for immunocompromised people, the 36% risk reduction over the same timeframe constitutes an “emergency” and companies like Invivyd can rapidly bring new options. I guess the meaning of “adequate” is in the eye of the beholder. A 14% difference in risk reduction determines who has a choice of medicines? Give me a break.

I see very little overall adequacy when I consider a world in which most of us will now repeatedly get sick, hoping for the best and fearing the worst. Moreover, I’d like the opportunity to decide how adequate the status quo is for myself, rather than outsourcing that decision to disconnected bureaucrats. I imagine many other Americans would agree.

I see very little overall adequacy when I consider a world in which most of us will now repeatedly get sick, hoping for the best and fearing the worst.

Other choices have been made on our behalf. For example, in exchange for a rapid pathway to market, the FDA asks sponsors like Invivyd for very high doses of COVID-19 mAb. Why? The FDA’s great concern is clinical uncertainty – how well do new mAbs work with a virus that evolves quickly? When the FDA doesn’t know, they tell us to simply use more. The consequence? Unnecessary impacts to dose and therefore cost and method of administration.

So, the relatively fewer people who are eligible and want to access a COVID-19 mAb need to jump through hoops, while others are forced to settle for no incremental protection at all. Of course, there is excellent research in top scientific journals that shows very low doses of COVID-19 mAbs generate strong protection, but because the FDA isn’t quite sure about how precise the numbers in these studies are, they insist on very high doses to address their uncertainty.

After the introduction of COVID-19 vaccines and Paxlovid, the Biden administration declared victory and walked away. Federal government agencies have devoted some resources to exploring new treatments and preventatives for Long COVID, though many people with the disease say the government should be doing much more. For example, in recent years, the Department of Health and Human Services (HHS), has developed programs devoted to exploring new treatments and preventatives for Long COVID through several organizations: FDA, the Department of Defense, and the National Institutes of Health (NIH).

Interestingly, not one of those federal health agencies ever contacted Invivyd to explore our medicine in the context of Long COVID, despite Invivyd being the only novel mAb option authorized since 2022. Plus, all attempts by Invivyd to contact the Biden White House were rebuffed. They didn’t care.

COVID-19 and Long COVID continue to erode public health, and many Americans live in justified fear of reinfection and its possible consequences. The government’s message to people like me is clear: keep boosting and try not to die. For the immunocompromised, the message is less bleak but still unfair: on top of the stressors of existing health conditions, you must work hard to access and coordinate infusion of extra protection or be left exposed. This paradigm must change.

Political change is in the air these days, and in my opinion, it’s an opportunity to be heard more clearly; many of these choices belong in the hands of the public. FDA and other governmental entities must embrace scalable, innovative solutions that empower patients with options. If they do, America can do what it does better than any country in the world: innovate and make progress.

To accomplish change, we need to make ourselves heard. Call your representatives and federal health agencies. Post on social media and tag your representatives, HHS, FDA, CDC, and NIH, and use the hashtag #demandmoreoptions. Tell them that for so many, COVID-19 remains a crisis. Ask them to prioritize choices for people in need. Advocate for access to options because the status quo is failing us.

For me, this fight is not just professional, it is deeply personal. COVID-19 will likely never go away, and my options to stay well today are inadequate. We cannot allow bureaucracy and indifference to dictate our medical choices. Get angry. Demand more. I will — my life depends on it.

Get angry. Demand more. I will — my life depends on it.

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Marc Elia has served as a member Invivyd’s Board of Directors since June 2022 and as Chairman of the Board since July 2022. Since September 2019, Mr. Elia has served as the founder and chief investment officer of M28 Capital Management L.P., a healthcare sector investment fund and investor in Invivyd. Prior to that, Mr. Elia held various positions in the investment and biotechnology industries.

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