5 Years, 5% of Americans still sick, $1.6B, ZERO treatments. Enough is ENOUGH!

Hundreds of thousands of Americans have been profoundly impacted by Long COVID. According to a survey conducted between August 20 and September 16, 2024, around 5.3 percent of all adults in the United States were currently experiencing Long COVID. For over five years, many have endured this relentless condition that has brought lives to a standstill. We've seen previously strong, healthy individuals, grappling with worsening symptoms for nearly five years. We are in dire need of effective treatments, but the options are dishearteningly scarce. 

Long COVID clinics, our support mainstay, have proven to be virtually powerless. Their ineffectiveness isn't due to a lack of will or competence, but stems from a devastating dearth of approved interventions for Long COVID. This lack of authorized treatment is like sinking in quicksand while the watching world stays idle. Pictured above - Amy Engebretson uses a walker to move around her house in St. Paul. The OB-GYN had to give up her practice due to long COVID. (Aaron Lavinsky/The Minnesota Star Tribune) Five years later, long COVID remains a frustrating medical mystery for thousands

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Amid this bleak scenario, there's a glimmer of hope - Pemgarda. This monoclonal antibody treatment has shown promise, yet it hangs in a bureaucratic limbo, awaiting the approbation of higher authorities. To those suffering, this delay is not a minor inconvenience; it's a matter of life and quality of life.

Pemgarda is the only FDA EUA alternative prophylactic treatment for the prevention of COVID infections, but amazingly Long COVID patients are unable to even get this to prevent reinfection because we're not considered high risk by the FDA. Patients whose lives have been turned upside down by COVID aren't able to get a treatment that could prevent reinfection!

FDA Authorizes COVID Drug Pemgarda for High-Risk Patients

Marc Elia, Chairman of the Board at Invivyd, maker of Pemgarda - himself a former endurance athlete, suffering from Long COVID since late 2021 laments, "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.” 

Invivyd Chairman Marc Elia: The bureaucracy is killing people with Long COVID - The Sick Times https://thesicktimes.org/2025/02/14/invivyd-chairman-marc-elia-the-bureaucracy-is-killing-people-with-long-covid/

Here's what we want:

1. Extend the current FDA emergency use authorization approval for Pemgarda to include Long COVID patients in the high-risk category, making them eligible for the treatment. Pemgarda results in a 70% risk reduction of developing symptomatic COVID-19 compared to a placebo and would provide an alternative to vaccination, which carries the risk of PVS according to a Yale study. Pemgarda has already been safely used for nearly a year to help moderately to severely immunocompromised people, including organ transplant recipients, stem cell transplant recipients, and those who are on chemotherapy for cancers to prevent COVID infections. Preventing reinfection is critical for Long COVID patients' recovery.
2. We need a warp speed 2.0 for Long COVID treatments. Fast track clinical studies of Pemgarda or other monoclonal antibodies for the treatment of long COVID patients. The NIH was granted $1.6 billion dollars 4 years ago for the RECOVER initiative, but has yet to produce a single viable FDA approved treatment. We fast tracked the vaccination for millions in just 9 months, but 5 years on Long COVID patients continue to suffer while they desperately wait for treatment.

Together, let's give a voice to all of us who have been invisible in this fight against Long COVID. Please sign the petition and amplify our plea for expediting Pemgarda's approval for the prevention of COVID and the treatment of Long COVID.