Earlier this month, the U.S. Centers for Disease Control and Prevention asked state public health officials to prepare to distribute a potential vaccine to high-risk groups as soon as late October. Previously, the best hope had been to have one ready by the end of the year, or early 2021, by fast-tracking development, manufacturing and distribution plans that typically take up to several years.
The eagerness to secure an effective vaccine is palpable. Since COVID-19 surfaced, it has killed upwards of 900,000 people worldwide — including more than 192,000 across the United States; nearly 100 in Hawaii. Its ongoing impact on public health and economies is devastating.
With some Phase 3 trials underway in the U.S. — the large-scale efficacy test that precedes securing approval for early or limited use — it seems sensible to begin planning for vaccine distribution sooner rather than later, especially since initially a limited count of doses will be available.
Even so, recent national polls indicate that many people are a bit leery about the prospect of offering an arm for a shot produced by speeding up an already accelerated race. Further raising eyebrows is President Donald Trump’s assertion on Labor Day that a vaccine could be ready weeks before the Nov. 3 presidential election.
Clearly, there’s no room for political or undue pressure to cut corners in this race. To that end, it’s a confidence-booster that nine drug companies pledged last week that they will not submit vaccine candidates for U.S. Food and Drug Administration (FDA) review until their safety and efficacy is shown in large clinical trials.
Further assuring, as Drs. Cindy Pau and David Fitz-Patrick at the East-West Medical Research Institute in Honolulu point out, is that results of clinical trials cannot be released without the approval of a Data and Safety Monitoring Board, which continuously monitors for safety and efficacy. This board consists of scientists and statisticians who are independent of pharmaceutical companies and the FDA.
At the local level, it’s encouraging that a clinical trial now underway at the East-West Medical Research Institute is generating a good deal of community support. The institute is one of more than 120 facilities around the world conducting a COVID-19 vaccine clinical trail, with a collective aim of enrolling 43,000 participants. So far, about 350 Hawaii residents are taking part, and enrollment is continuing.
In a written statement, Pau stressed the importance of representing all ethnicities in the research, given that there may be differing responses to the vaccine in different groups or based on gender. Pau noted that “Hawaii, being the melting pot with rich ethnic diversity, plays an important role” toward forging vaccines that are safe and effective for the broad population.
Volunteers can register to take part in the trial, in which half of participants will receive the vaccine, while the other half are given a placebo, at www.eastwestresearch.com.
Overall, researchers are testing more than three dozen vaccines in clinical trials on humans; and the FDA has said it intends to limit consideration for authorization to those that reduce infections in a research group by at least 50%. The likely upshot of that halfway mark, of course, is that many people could still get infected; but even a partially effective vaccine could make the pandemic more manageable.
While our wait continues, everyone must continue to do their part in complying with public health directives, one of which is to get an annual flu shot. Vaccination is especially important amid the COVID-19 pandemic, since the double threat posed by coronavirus and flu cases could quickly overwhelm Hawaii’s health care system. Let’s do what we can to avoid that.