New HHS initiatives put spotlight on long COVID

The U.S. Department of Health and Human Services (HHS) recently announced two major initiatives to shed light on long COVID, a condition affecting millions. First, the agency plans to establish the Office of Long COVID Research and Practice. HHS is also set to launch new long COVID-19 clinical trials through its RECOVER initiative. Jointly, the long COVID drug development efforts highlight the need for therapies and create openings for pharmaceutical companies to drive research and drug development related to the condition.

HHS has earmarked $1.15 billion for the RECOVER Initiative to explore novel therapies for the condition estimated to have affected between 7.7 and 23 million Americans. To date, the RECOVER Initiative has enrolled more than 24,000 participants in observational studies on long COVID. New clinical trials, beginning enrollment in summer 2023, will test experimental therapies across five focus areas to identify therapies that can alleviate symptoms and…

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‘Long vax’ phenomenon gets closer look in recent studies

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In 2020, researchers witnessed the emergence of post-acute sequelae of SARS-CoV-2 (PASC) — more commonly referred to as “long COVID.” Now, the notion of “long vax,” persistent and varying symptoms following COVID-19 vaccination, has come into focus, as Science has noted. This phenomenon, while not as widespread as long COVID, has concerned some in the medical community, potentially fueling vaccine hesitancy.

Still, serious adverse events stemming from COVID-19 vaccination are rare, typically occurring within six weeks of vaccination, as CDC notes. In addition, the majority of side effects following vaccination disappear within a few days. While such side effects are generally minor, a number of patients have had acute spells of dizziness post-vaccination, chronic hives and heart palpitations.

For those with long COVID and post-vaccination malaise, symptoms can include postural orthosta…

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Axcella touts positive results from Phase 2a long COVID study

The biotech Axcella Therapeutics (Nasdaq:AXLA) has announced positive topline results from a Phase 2a randomized, double-blind, placebo-controlled study of the metabolism-modulator AXA1125 in patients with fatigue from long COVID.

The Phase 2a study was among the first drug studies to focus on long COVID.

In February, FDA granted a Fast Track Designation to AXA1125 to treat non-alcoholic steatohepatitis (NASH) with liver fibrosis.

Because of AXA1125’s potential to improve mitochondrial function, bioenergetics and inflammation, Axcella decided to study its ability to improve fatigue symptoms from long COVID. Fatigue is among the most common symptoms associated with long COVID.

Long COVID appears to be similar to post-viral fatigue syndrome and myalgic encephalitis.

Partnering with the University of Oxford, Axcella identified multiple endpoints to consider in studying AXA1125 in long COVID patients. Endpoints included phosphocreatine recovery…

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Study bolsters case that vaccines protect against long-COVID

A scanning electron microscope image shows SARS-CoV-2 (yellow). Credit: NIAID-RML

It may be too soon to know how often the omicron variant is associated with so-called long-COVID, but research from the Leavitt Partners’ COVID-19 Patient Recovery Alliance confirms that vaccination protects against the condition. 

Those who received at least one authorized COVID-19 vaccine dose before diagnosis were between seven and 10 times less likely to report two or more long-COVID-19 symptoms, according to the preprint study conducted before the surge of the delta variant. 

Those who received a vaccine four weeks after diagnosis were four to six times less likely to develop the condition.

There are limits to how well researchers understand the condition given the fuzziness of the definition of long-COVID and the continual emergence of SARS-CoV-2 variants, said Michael A. Simon, principal data scientis…

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