Therapies & Vaccines
The National Institutes of Health (NIH) created a guidelines panel that regularly updates treatment recommendations at covid19treatmentguidelines.nih.gov based on newly published data and expert opinions, said Dr. Fauci. Two therapeutics have been recommended by the guidelines panel so far: remdesivir, an antiviral drug, for hospitalized individuals who have lung involvement, and dexamethasone, a corticosteroid, for hospitalized individuals who have ventilatory and/or high-flow oxygen requirements. A randomized, placebo-controlled trial showed that dexamethasone had a clear-cut benefit in reducing 28-day mortality in those patients, he said.8 Other investigative therapies include monoclonal antibodies and immunomodulators.
Potential vaccines are being developed with a strategic approach, with major investments by the U.S. government in the development and/or facilitation of testing of six of 11 current vaccine candidates, Dr. Fauci said.
“Harmonization of the protocols includes a common data and safety monitoring board, common primary and secondary endpoints, and common immunological laboratory parameters in order to bridge between each study,” he said. Multiple vaccine candidates are likely to be successful, because early data from animal studies and phase 1 trials showed robust levels of neutralized antibodies. “This makes us cautiously optimistic that we will have a successful vaccine by the end of this calendar year, and that we may be able to deploy a vaccine earliest in individuals at high risk, including medical personnel and people with underlying medical conditions, beginning in 2021,” he said.
Rheumatologists may view COVID-19 prevention trials or sign up to volunteer for any U.S. trial at www.preventcovid.org, he concluded.
(Author’s note: On Nov. 9, manufacturer Pfizer announced that BNT162b2, its two-dose mRNA vaccine candidate co-developed with German partner BioNTech, has demonstrated an efficacy rate of more than 90% against COVID-19 seven days after the second dose in previously uninfected individuals compared with placebo. The trial is not complete, but Pfizer distributed preliminary data in a press release, which noted that the final efficacy rate may vary and that no serious safety concerns have been noted among participants in the trial.9)
Susan Bernstein is a freelance journalist based in Atlanta.
References
- Paules CI, Marston HD, Fauci AS. Coronavirus infections: More than just the common cold. JAMA. 23 Jan 2020;323(8):707–708.
- Our World in Data. Daily confirmed COVID-19 cases, rolling 7-day average. Global Change Data Lab. https://ourworldindata.org/grapher/daily-covid-cases-7-day?tab=chart&stackMode=absolute&time=2020-10-16..latest®ion=World.
- Gygli SM. Coronavirus phylogenetic tree: Human coronaviruses. National Institute of Allergy and Infectious Diseases.
- Wu Z, McGoogan JM. Characteristics of and important lessons from the coronavirus disease 2019 (COVID-19) outbreak in China: Summary of a report of 72 314 cases from the Chinese Center for Disease Control and Prevention. JAMA. 24 Feb 2020;323(13):1239–1242.
- Oran DP, Topol EJ. Prevalence of asymptomatic SARS-CoV-2 infection: A narrative review. Annals Int Med. 2020 Jun 3:M20-3012.
- Feldstein LR, Rose EB, Horwitz SM, et al. Multisystem inflammatory syndrome in U.S. children and adolescents. N Engl J Med. 23 Jul 2020;383:334–346.
- Hooper MW, Nápoles AM, Pérez-Stable EJ. COVID-19 and racial/ethnic disparities. JAMA. 11 May 2020;323(24):2466–2467.
- RECOVERY Collaborative Group. Dexamethasone in hospitalized patients with COVID-19: Preliminary report. New Engl J Med. 2020 Jul 17. Online pub ahead of print.
- Pfizer Inc. press release: Pfizer and BioNTech announce vaccine candidate against COVID-19 achieved success from first interim analysis from phase 3 study. 2020 Nov 9. https://tinyurl.com/y53g6ogz.
