On July 18, Anthony Fauci, MD, Director of the National Institute of Allergy and Infectious Diseases, addressed attendees of the AOA House of Delegates meeting.
In his speech, he provided updates on recent developments surrounding COVID-19, primarily covering the efforts to develop therapeutics and vaccines. A full video of the speech is available above, but some highlights are below:
Dr. Fauci reported “significant advances” in therapeutic treatments for COVID-19, as well as multiple categories of drugs that are currently being tested for efficacy. Those under investigation, according to his presentation deck, include, but are not limited to:
- Other broad-spectrum antivirals
- Convalescent plasma/hyperimmune immunoglobulin
- Repurposed drugs
- Hydroxychloroquine (which he noted has not been found to have any impact on the virus)
- Host modifiers/immune-based therapies
- Anti-SARS-CoV-2 monoclonal antibodies
With regards to remdesivir, Dr. Fauci cited an article in The New England Journal of Medicine that showed that it was the first randomized, placebo-controlled trial in hospitalized patients requiring oxygen where individuals saw a significant, but modest, improvement in the time it took to recover from the illness. Remdesivir is now being widely used for certain individuals with “promising results.”
He then shared a UK study involving thousands of patients in which the drug dexamethasone reduced 28-day mortality by 35% in ventilated patients and 20% in other patients receiving oxygen. However, for those who did not require oxygen support, the drug had no impact on the death rate, and even made symptoms worse.
Dr. Fauci said this stands to reason given what we know about pathogenesis; early on in the course of a disease, it makes sense to suppress the virus, but keep the immune system intact. When a virus is so advanced that a patient requires ventilation, the virus itself is playing less of a role than the aberrant hyperinflammatory response, he said. Therefore an anti-inflammatory drug like dexamethasone works best at that stage.
NIH treatment guidelines “living document”
Dr. Fauci also noted that the NIH has put together an expert panel that meets regularly and provides a “living document” that is updated as necessary and provides guidelines for COVID-19 treatment. It is available at covid19treatmentguidelines.nih.gov.
Vaccines in progress
Dr. Fauci shared his agency’s “strategic approach” to COVID-19 vaccine research and development. Unprecedented collaboration and resources will be required to research and develop a safe and effective vaccine that can be manufactured and delivered on a global scale, he said. At least five vaccines currently in progress, he said, are being facilitated with help from the U.S. government, primarily the Department of Health and Human Services and the Department of Defense.
This strategic approach is in place to “harmonize the protocols” across different companies so that each is examining the same immunological parameters and operating with similar goals and endpoints. That way, if one study is successful, it can be bridged to another to facilitate approval, if appropriate.
The three major platforms of vaccine candidates, and the companies working in each, are:
- Nucleic acid (mRNA and DNA)
- Developers: Moderna, Biontech, Pfizer
- All have completed Phases I and II of testing. Moderna has started Phase III.
- Viral vector (VSV, ad26, chimp ad)
- Developers: University of Oxford/AstraZeneca, Johnson & Johnson/Janssen, Merck
- Oxford/AstraZeneca has completed Phases I and II. Johnson & Johnson/Janssen is due to start those phases soon. Merck’s timeline is TBD.
- Protein subunits
- Developers: Novavax, GSK/Sanofi
- Novavax’s Phase I and II trials are ongoing, GSK/Sanofi’s are TBD.
Moderna’s mRNA vaccine, reported on in NEJM, has shown promise amongst 45 individuals in a Phase I trial, he noted. A moderate dose of it induced neutralizing antibodies of a titer (concentration) that was equivalent to or more than what is seen in convalescent plasma, he said.
The ultimate goal of the vaccine is to induce a response that is comparable to, and better than, natural infection, which means this is good news, Dr. Fauci said. This vaccine candidate began a Phase III trial this week; Phase III trials for up to three other vaccine candidates should also begin in the near future.