Operation Warp Speed Has Been Speedy

Ask the DOC

The mainstream media is so hopelessly anti-Trump that they are loath to report on any successes of the Trump administration, which is why Operation Warp Speed (OWS) is rarely mentioned by the press. If it is mentioned, the reporting covers only the creation of a vaccine for COVID-19. But OWS is so much more.

Starting earlier this year (May 15), after the appearance of the coronavirus, the administration created OWS. It is an effort by the U.S. Department of Health and Human Services and the Department of Defense, in partnership with the private sector, to provide financial investment, scientific support, regulatory expertise, and logistical assistance to deliver vaccines, therapeutics, and diagnostics for SARS-CoV-2 to the American public as quickly as possible. One of the main goals has been to create and deliver substantial quantities of safe and effective vaccines by early next year. Consider that the creation of a vaccine normally takes at least five years yet OWS was able to do it in about eight months, a herculean achievement. In addition, OWS also aims to combat this virus by improving the use of existing therapies and providing additional treatment options, as well as improving diagnostic testing for the virus, thereby ameliorating the pandemic as we wait for the U.S. population to be fully immunized.

In contrast to the opinions of Gov. Cuomo, OWS has made the use of sound science essential. Researchers are constantly evaluating potential therapeutics and have involved government agencies including the National Institutes of Health (NIH), Biomedical Advanced Research and Development Authority (BARDA), and the Defense Advanced Research Projects Agency (DARPA). OWS also sought manufacturability at scale within the desired time frame, making hundreds of thousands of vaccine doses achievable by late this year. OWS researchers used novel techniques to evaluate potential treatments for the virus. For example, rather than create new antiviral medications from scratch, they looked at using existing antiviral medications that are used to treat other viral illnesses to treat COVID-19. A case in point is remdesivir, an antiviral medication used to treat the Ebola virus. Using this technique, researchers were able to shorten the time needed to study the medications. Since remdesivir was already in use with a known safety profile, they were able to skip phase 1 trials, which test safety of a treatment, and proceed directly to phase 2 and 3 trials, which test effectiveness.

OWS researchers also looked at biological treatments for COVID including convalescent plasma (which I discussed in a previous column) and hyperimmune globulin. Plasma has limitations, such as blood-type compatibility, a narrow therapeutic window, and an inability to be used on large populations. Hyperimmune globulin, which contains antibodies to the virus and is made from convalescent plasma, does not have these limitations and can be given by injection, as opposed to the intravenous route required for plasma. Other antibody and biological products have been developed in conjunction with well known private pharmaceutical companies including SAb Biotherapies, Regeneron, Eli Lilly, Astra Zeneca, and Merck, to name a few.

OWS has not only been able to develop a vaccine in remarkable time, but with therapeutics they have been able to make significant inroads against the virus while waiting for the vaccine to be fully deployed. All this means that the mortality rate from the virus has dropped considerably, to well below 1%. Not since the time of FDR at the onset of WWII has there been such a rapid and successful cooperation between government and private industry to fight a common enemy.

For more information go to: www.nih.gov/research-training/medical-research-initiatives/activ/covid-19-theraputics-prioritized-testing-clinical-trials 

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 By Peter Galvin, MD

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