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Bright spots have been scarce in the COVID-19 crisis, as the virus continues to run roughshod across America. Poor governmental leadership, premature economic reopenings, and individuals acting irresponsibly have resulted in our downfall.
There has been some progress in therapeutics. But forget hydroxychloroquine. Although there was early hope for this medication for prevention and treatment, there is no evidence it has any significant effect. At least five randomized controlled studies, not confounded by concurrent use of other medications with some therapeutic benefits, have doused that fire of hope.
Remdesivir, an anti-viral agent, and dexamethasone, a corticosteroid, have shown to have important clinical benefits in hospitalized COVID-19 patients. Convalescent plasma infusions from recovered coronavirus patients containing COVID-19 antibodies have also demonstrated potential benefits in significantly ill patients. Another related avenue showing promise is the pharmaceutical production of COVID-19 antibodies, (Eli Lilly and Co. is engaged in this research). This treatment has the possibility of use in less severe cases and even preventively for at-risk exposed individuals.
These are important advances, especially for those seriously ill, but they are not game-changers to reverse the crisis and lead us back to normal life.
However, there is a shining bright spot: COVID-19 vaccine development. This is the potential game-changer. About 250 candidate vaccines are in the process of development, with 30 in some phase of clinical trials.
The effort to rapidly bring an effective vaccine forward for massive distribution and inoculation has been truly amazing and represents an optimally conducted governmental partnership with academia, biotechnology and pharmaceutical companies. This initiative, “Operation Warp Speed,” could result in multiple effective COVID-19 vaccines and hundreds of millions of doses in record time.
It typically takes a decade or more to develop a vaccine. We are anticipating COVID-19 vaccines potentially approved by year-end, available in the spring and widely accessible by summer—less than a year and a half after the beginning of research efforts.
Seven Warp Speed vaccines have been chosen for billions of dollars in federal funding and manufactured at financial risk even before FDA approval. The hope is that one (or more) has proven efficacy in final prelicensure phase 3 clinical trials so it will be immediately ready for Emergency Use Authorization deployment.
Companies involved in these efforts include Moderna; Pfizer; AstraZeneca, in cooperation with Oxford University; Johnson and Johnson (all currently in phase 3 trials); Novavax; and Sanofi Pasteur/GlaxoSmithKline.
Of particular interest are AstraZeneca and CanSino/Lilly studies that induce immunity by stimulating antibody production and provoking T-cells that produce immune memory. Although antibody levels might decrease in time, these T-cells might induce fresh antibody production when the individual is re-exposed to the coronavirus.
Many questions remain regarding producing safe and effective COVID-19 vaccines. How much protection will they provide and how long will immunity last? Will the federal government efficiently coordinate equitable distribution with states? What at-risk population groups will get immunization priority before wide availability?
We anticipate that public acceptance of the COVID-19 vaccine will be relatively poor, with the majority of Americans vaccine-hesitant and one-third refusing vaccination. Will there be political interference pressing for premature FDA emergency authorization without completion of the clinical trials and adequate safety and efficacy assurances?
Judging recent FDA decisions and the president’s remark that he can overrule the FDA, the odds of that are considerable. This would result in even higher vaccine non-acceptance.
Despite the questions, I remain vaccine-optimistic.•
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Feldman is a family physician, author, lecturer and former Indiana State Department of Health commissioner for Gov. Frank O’Bannon. Send comments to ibjedit@ibj.com.
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