Don’t disparage the pace of COVID-19 research

block

John D. Loike and Salomon Amar :
While scientific misinformation from social media and from high-profile published papers has spread like wildfire in these past four months, there has also been an astoundingly rapid dissemination of validated scientific research published since the first case of COVID-19 was reported. Under normal conditions, scientific research is meant to be a slow, peer-reviewed, and calculated process of developing and testing a hypothesis, reporting the answers, and, finally, waiting for the scientific community to corroborate or disprove the findings. We are experiencing unprecedented times, and the scientific community has stepped up to address this pandemic.
There are many critical research milestones that have been either achieved or in active development and reported in thousands of papers published about the coronavirus pandemic. These include: 1) deciphering the genetic code of the virus and how it infects cells; 2) developing accurate assays to detect the virus in people; 3) developing accurate assays to measure the level of antibody titers that should protect individuals from infections; 4) testing treatments and cures; and 5) conducting clinical trials of vaccines.
In an incredibly short time, scientists at research universities and biotech companies have achieved remarkable successes regarding the first three milestones and have made impressive achievements in the latter two milestones that will hopefully lead to cures and vaccines. Despite the parallel dissemination of scientific misinformation, this progress is still a testament to the machinery of science and the passion of scientists. Comparing the timelines of COVID-19 accomplishments to those of previous RNA virus pandemics highlights just how rapidly research has moved.
The rapid pace of publishing scientific preprints and peer-reviewed articles during this pandemic is bound to result in some mistakes from inaccurate data or poor analyses, but this casualty is worth it in light of the astonishing progress that has been made and will continue to be made in the face of this global threat.
For example, acquired immune deficiency syndrome (AIDS) was a term first used by the US Center for Disease Control on September 24, 1982, almost 18 months after the first cited report (June 5, 1981) of five AIDS patients. And it wasn’t until 1984-almost four years after the first case-when Pasteur Institute and National Institutes of Health scientists independently reported the discovery of a retrovirus (HIV) that caused AIDS. Two years after that, the US Food and Drug Administration (FDA) licensed the first commercial blood test to detect HIV. A year later, in March 1987, the FDA approved the first anti-retroviral drug for AIDS, zidovudine (AZT), in a record 20 months. Finally, the first clinical trial for a vaccine began in August 1987, and VaxGen launched the large-scale trial in 1998. These clinical trials failed, leading this now-merged company (Diadexus Inc.) to bankruptcy in 2016. To date, there are only a few ongoing clinical vaccine studies, but no FDA-approved HIV vaccines.
By comparison, scientific milestones were significantly accelerated in response to the SARS epidemic of 2003. On November 16, 2002, the first case of atypical pneumonia, probably caused by the SARS-CoV virus, was reported in southern China. Less than five months later, the US Centers for Disease Control and Prevention published the genetic sequence of SARS-CoV. By May and December 2003, two articles the New England Journal of Medicine described the application of real-time reverse transcriptase PCR (RT-PCR) to accurately detect SARS-CoV in human blood or tissue. Real-time RT-PCR is a very fast and precise method to amplify viral RNA that quantifies viral particles in human biological samples (that is, blood or a nasal swab), and it is extensively used in the COVID-19 pandemic. Still, the response to the SARS outbreak did not deliver the milestones we’ve seen in just a few short months with COVID-19. Currently, there is no medication that is known to effectively treat SARS. Treatment is only supportive. In part because the SARS pandemic subsided with a few years, there are no listed clinical trials for SARS and no FDA-approved vaccine for this virus.
The rapid progress to achieve scientific milestones is being seen in real time with COVID-19. On Dec 31, 2019, China reported a cluster of cases of pneumonia in people at Wuhan, Hubei Province that later become known as SARS-CoV-2. Less than two weeks later, on January 12, the first genomic characterization of the virus was reported. Across the globe scientists quickly launched trials to examine the potential efficacy of treatments in randomized or open-label clinical trials. The FDA issued its first emergency use authorization (EUA) of a real time RT-PCR diagnostic test in early February. There are now scores of RT-PCR assays with high accuracy and few false-positives with other human coronaviruses or common respiratory pathogens.The FDA issued the an EUA to Abbott for an assay to detect antibodies against this virus in March, and now lists more than a dozen serology tests given EUA.
Vaccine development for COVID-19 has been similarly rapid and robust, with dozens of companies and collaborators developing and trialing both conventional and innovative technologies. Traditional methods include designing a vaccine with an inactive or attenuated virus that will not infect the recipient but trains the immune system to prevent viral infectivity. New technologies include one that introduces a messenger RNA into an individual so that it can direct cells to make critical COVID-19 viral proteins that are viewed by the immune system as “foreign” and enable the body to build effective immunity. This approach, used by Moderna in partnership with the National Institute of Allergy and Infectious Diseases (NIAID), has not been used in any approved vaccines to date. On May 22, 2020, NIAID Director Anthony Fauci said it’s still possible that a coronavirus vaccine using classical or innovative technologies will be available in the US by December. There are now more than 100 potential vaccines in clinical trials running at an unprecedented pace.
The rapid pace of publishing scientific preprints and peer-reviewed articles during this pandemic is bound to result in some mistakes from inaccurate data or poor analyses, but this casualty is worth it in light of the astonishing progress that has been made and will continue to be made in the face of this global threat. History has shown that the scientific community takes full advantage of peer review, collaborations, confirmatory studies from other scientists, and self-assessment to correct scientific mistakes. The rapid pace of scientific research in its ongoing search for truth is not perfect, but the accelerated response has great merit and potential to be used for current and future pandemics.

(John Loike is a professor of biology at Touro College and University System and writes a regular column on bioethics for The Scientist. Salomon Amar is Vice President for Research at New York Medical College, Provost for Biomedical Research, and Chief Biomedical Research Officer at Touro College and University System).

block