As the China virus pandemic wears on, the American electorate should brace themselves for a possible stupendous October surprise that may have profound political ramifications for generations to come.
The Trump administration’s engineering the fastest-ever launch of a Manhattan Project-style vaccine trial for COVID-19 known as Operation Warp Speed, could be a potential game-changer in the pandemic’s trajectory, days - and just before an election.
Using the resources of the federal government and the U.S. private sector to develop safe and effective vaccines, therapeutics, and diagnostics quickly without compromising safety, ‘Warp Speed’ — shortening the development time from years to months — is a historic breakthrough that will hopefully save countless lives.
The pace and scope of such a vaccine effort are unprecedented. The initiative was premised on setting a ‘stretch goal’ — one that initially seemed impossible but that is becoming increasingly achievable. SARS-CoV-2 vaccine development began in January, Phase I clinical studies in March, and the first Phase III trials in July.
Similarly, the U.S. could have a capacity of 3 million coronavirus tests per day this month, and scale as high as 135 million tests a month by October. As of September 18, 2020, the U.S. had performed over 95 million tests for COVID-19, the second-highest number of any country worldwide.
Given that it takes five to ten years to develop a vaccine, the fastest that scientists have developed a new vaccine to date was four years (for the mumps).
The safety benchmarks are higher for vaccines than for other drugs because vaccines are given to vastly more people. Under the Food and Drug Administration (FDA) guidelines, a vaccine will need to be at least 50% effective to win approval before clearing it for distribution to the public.
Since the U.S. Centers for Disease Control recently notified states to be ready to distribute a vaccine by November 1, concerns that the Trump administration will try to play politics with a COVID-19 vaccine is deceptive, misleading, and another case of political claptrap.
The FDA also said last month COVID-19 vaccines may not necessarily need to complete Phase III clinical trials — large-scale testing intended to demonstrate safety and efficacy — as long as officials are convinced the benefits outweigh the risks.
This prompted a call for caution from the ‘China-centric’ World Health Organization, as well as democrats trying to sow doubt in the minds of Americans.
Reports of success based solely on its earliest results means leading vaccine candidates start of Phase III trials for their prospective vaccines by the end of the month, could shake the foundations of the coronavirus swamp.
However, the emphasis on producing a vaccine quickly risks casting doubt on its scientific underpinnings. Researchers say a proven vaccine is highly unlikely before the election but, there may yet be positive news for President Donald Trump to tout.
Some of the vaccines and antibodies linked to a secretive Pentagon Defense Advanced Research Projects Agency (DARPA) could be ready later this year, which would mark one of the speediest responses to a global pandemic in the history of medicine.
DARPA’s antibody program known as the Pandemic Prevention Platform, or P3 and others has quietly been seeding the ground for the U.S. to produce a rapid cure for a pathogen like COVID-19 for years. Their goal: to find a way to produce antibodies for any virus in the world within 60 days of collecting a blood sample from a survivor.
But DARPA’s story is an example of U.S. government foresight, one that began more than a decade ago intending to find super-fast ways to protect American troops if they were to confront a deadly new virus in the field.
Established years before the current pandemic, the program was halfway done when the first case of the novel coronavirus arrived in the U.S. early this year. Everyone involved in the effort by DARPA knew their time had come, but ahead of schedule.
And the P3 program has already led to the world’s first study in humans of a potential COVID-19 antibody treatment. If successful, antibody treatments would offer months of immunity with a single shot. Unlike vaccines, they could also help heal people already infected with the virus.
Designer antibodies could battle COVID-19 before vaccines arrive. Clinical trials of these monoclonal antibodies, which could both prevent and treat the disease, are already underway and may produce signs of efficacy in the next few months.
Antibody-based therapies have several advantages due to their well-understood development and production processes, in addition to their relatively known safety margins.
Likely to be more effective than the repurposed drugs now available, such as Remdesivir and Dexamethasone, antibodies could protect the highest risk health care workers from becoming infected while also lessening the severity of COVID-19 in hospitalized patients.
While Remdesivir may benefit patients earlier on in infection, Dexamethasone showed to lower the fatality rate of patients with more severe disease.
Where we are now
Today, RNA vaccines, although still experimental, are among the fastest-moving candidates in the race to stop COVID-19.
Three major drug manufacturers are in various stages of clinical trials with Pfizer-BioNTech saying the BNT162 vaccine might be ready for regulatory review by mid-October and AstraZeneca saying inoculation of the AZD1222 vaccine has begun a large-scale Phase III trial.
Moderna, the first company funded by DARPA has reached the Phase III trial of the mRNA-1273 vaccine at a record pace and is the first in the U.S. to start enrolling 30,000 participants tested at 89 sites spread across 30 states and the District of Columbia.
However, vaccines are rarely 100% effective, and many Americans may decline a vaccine or skip immunization for varied reasons — mainly since there are no immunizations against any coronaviruses in humans.
Even in the most ideal scenario with a highly effective vaccine, getting to herd immunity would require immunizing millions of people. Besides, you would need to vaccinate about two-thirds of the American population to stop spread.
The Trump administration sweeping plan to make the COVID-19 vaccine, once decided upon, available for free to all Americans and the U.S. military controlling distribution, ensuring that vaccines go to the right people is indeed, the right course of action in ending the pandemic.
With U.S. jobs numbers soaring past expectations during a global pandemic, there is no comparable example in U.S. history or any country’s history of an economic crisis being handled adroitly while the medical community gets closer to coronavirus treatment or herd immunity.
Dr. Joe Tuzara, a humanitarian advocate, was a clinical research-physician-general surgeon for Saudi Arabian, Philippine and American healthcare systems and is currently an American freelance writer as well as an op-ed contributor.