We Will Have Vaccines Quickly—Due to Science, Not Politics

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We Will Have Vaccines Soon—Because of Science, Not Politics

Guest contribution by Gregory J. Rummo.

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It was a week after the 9/11 terrorist attacks that envelopes containing a white powder appeared in random locations in four states. Including a newspaper office in Florida, the Washington DC office of the then Senate Majority Leader, Tom Daschle, NBC News and the New York Post. The white powder turned out to be anthrax spores that could be easily dispersed and inhaled – a potentially deadly weapon of bioterrorism.

Anthrax infections are treated with antibiotics. There are two that are most effective; Ciprofloxacin and doxycycline. At the time, I was CEO of a small pharmaceutical company that represented foreign API manufacturers in the United States. We had a large domestic customer base to whom we marketed dozens of anti-infectives, including antibiotics. Doxycycline was one of them.

We had worked with Zenith Laboratories, a generic drug maker in South Florida (currently part of Teva Pharmaceuticals), to get our doxycycline approved for use in their formulations. Typically, the FDA turnaround time to approve a drug, even a generic copy of an existing drug (which was doxycycline), is well over a year, and often two.

But that was different. The US faced a crisis in the form of a possible bioterrorism attack. The federal government's response to anthrax quickly became a national emergency. Zenith Laboratories, along with other manufacturers, received an order to supply tablets and capsules to the Department of Defense's Strategic National Stockpile. In less than a month, the Food and Drug Administration cleared the emergency and overnight we became approved suppliers of doxycycline.

Fortunately, anthrax never became the bioterrorism threat that many feared. Five people died as a result of contact with envelopes contaminated with the spores that had been delivered through the postal system.

Our government's coordinated response in 2001 to pressure drug manufacturers and their own Food and Drug Administration to expedite the approval of life-saving treatment for a bio-terrorist weapon bears an uncanny resemblance to the national health crisis we are facing.

Every drug, be it an antibiotic, a monoclonal antibody cocktail or a vaccine, goes through a rigorous scientific process long before it ever falls into the hands of government regulators or even politicians. Drug development begins with a conceptual design model, followed by research, engineering, small-scale manufacturing, and multiple testing phases. usually first in animals and then in humans. Errors are common at every step of this process. It is estimated that over 90 percent of drugs never make it to market. Safety and efficacy must be demonstrated by the manufacturer before the FDA approves any drug use in public.

Currently, the mRNA vaccines of the two leading candidates – Pfizer and Moderna Inc. – are known to demonstrate safety and efficacy in late-stage phase 3 clinical trials.

Participants like me received the first and second booster injections and provided blood samples to researchers. It's not hard to believe that as early as next month, coronavirus vaccines will be approved under FDA emergency clearance for distribution to at least healthcare workers and those most at risk of severe morbidity.

This is not politics, but the result of science – a lot of science – and shame for those politicians who continue to make this an issue of everything else.

Gregory J. Rummo is a lecturer in chemistry at Palm Beach Atlantic University and a co-author of the Cornwall Alliance for the Stewardship of Creation. He is the former CEO of New Chemic US Inc and is patient 001 in Moderna's Phase 3 study, mRNA-1273, currently conducted at the Palm Beach Research Center in West Palm Beach, FL. The views expressed in his columns are his own.

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