Several hours after that news came out, the internet is awash with comments about guinea pigs and lab rats. The concern is understandable, and, well, the news about Russian practices isn’t all that comforting. Nevertheless, I think we might be giving the Russians short-shrift on this, so maybe now is the time for a little sobriety.
I know people conjure up images of mad scientists whenever the words “clinical trials” are mentioned, but is that really how it is?
Here’s how the US National Institutes of Health describes the stage three clinical trials of another drug manufacturer’s vaccine candidate:
The trial is designed to evaluate the safety of mRNA-1273 and to determine if the vaccine can prevent symptomatic COVID-19 after two doses. As secondary goals, the trial also aims to study whether the vaccine can prevent severe COVID-19 or laboratory-confirmed SARS-CoV-2 infection with or without disease symptoms. The trial also seeks to answer if the vaccine can prevent death caused by COVID-19 and whether just one dose can prevent symptomatic COVID-19, among other objectives.
Trial volunteers will receive two intramuscular injections approximately 28 days apart. Participants will be randomly assigned 1:1 to receive either two 100 microgram (mcg) injections of mRNA-1273 or two shots of a saline placebo. The trial is blinded, so the investigators and the participants will not know who is assigned to which group.
Volunteers must provide informed consent to participate in the trial. They will be asked to provide a nasopharyngeal swab and a blood sample at an initial screening visit and additional blood samples at specified time points after each vaccination and over the two years following the second vaccination. Scientists will examine blood samples in the laboratory to detect and quantify immune responses to SARS-CoV-2.
Investigators will closely monitor participant safety. They will call participants after each vaccination to discuss any symptoms and will provide participants with a diary to record symptoms and a thermometer for temperature readings.
If a participant is suspected to have COVID-19, the participant will be asked to provide a nasal swab for testing within 72 hours. If the test is positive for SARS-CoV-2 infection, the participant will be followed closely and referred for medical care if symptoms worsen. Participants will be asked to provide a daily assessment of symptoms through resolution and have saliva sampled periodically, so investigators can test for SARS-CoV-2 infection.
Study investigators will regularly review trial safety data. An independent data and safety monitoring board (DSMB) will review blinded and unblinded data—including safety data and cases of COVID-19 in both groups—at scheduled data review meetings.
Phase 3 clinical trial of investigational vaccine for COVID-19 begins
Hardly Frankenstein’s lab, right?
Remember that a drug at phase three clinical trials has, obviously, undergone phases 1 and 2. Thus, Phase 3 trials are conducted to confirm and expand on safety and effectiveness results from Phase 1 and 2 trials, to compare the drug to standard therapies for COVID19, and to evaluate the overall risks and benefits of the drug.
“Aha! So there ARE risks!”
Well, of course there are risks. But, these trials are conducted on volunteers who know the risk going in, and are conducted under close medical supervision – which means that the volunteers actually get better care than just about everyone else. So yes, there are risks but the risks apply only to a small group of volunteers, and the risks are managed professionally. In other words, there is no grave danger posed to the general population, as some people might believe. In fact, ABS-CBN reports that 10,000 residents of Cavite have been signed up to participate in clinical trials for two other vaccines.
Make no mistake about it. Participating in these trials is a gamble, but I understand the sort of balancing of interests that must’ve gone into the decision to volunteer that the Phase 3 clinical trials be held here. We have the highest rate of infection in (I think) Asia. Our ability to control the spread of the virus has long been proven to be painfully inadequate. And I honestly believe that we – whether thru the mismanagement of the response or simple hard luck – have gotten to the point that nothing, short of a vaccine, will work to stop the rampaging virus.
In the meantime, in exchange for exposing some volunteers to possible side-effects of an experimental treatment, under conditions where these risks are closely managed and mitigated, the rest of us get a real shot at securing prioritized for access to the vaccine once it gets cleared for mass market distribution. And that is clearly an outcome that benefits everyone.
Considering the potential rewards, maybe it’s not so bad that we give this a try.
