Operation Warp Speed

 

“Very, very low chance.”
9/3/20: Dr. Moncef Slaoui, chief adviser for the White House vaccine  Program, on the probability of a vaccine being ready by November 1st

According to the Centers for Disease Control website, there are many examples of rushed vaccine release that produced disastrous consequences. The most famous: “In 1955, some batches of polio vaccine given to the public contained live polio virus, even though they had passed required safety testing. Over 250 cases of polio were attributed to vaccines produced by one company: Cutter Laboratories. This case, which came to be known as the Cutter Incident, resulted in many cases of paralysis. The vaccine was recalled as soon as cases of polio were detected.

“The Cutter Incident was a defining moment in the history of vaccine manufacturing and government oversight of vaccines, and led to the creation of a better system of regulating vaccines.  After the government improved this process and increased oversight, polio vaccinations resumed in the fall of 1955.” The website also describes responsive legislation that “compensates” those injured or killed from a failed vaccine. Money, not restored life or health.

“At the time [1955], there was no system in place to compensate people who might have been harmed by a vaccine. Today we have the National Vaccine Injury Compensation Programexternal icon (VICP), which uses scientific evidence to determine whether a vaccine might be the cause of an illness or injury, and provides compensation to individuals found to have been harmed by a vaccine. The VICP remains a model method for ensuring that all persons harmed by vaccines are compensated quickly and fairly, while also protecting companies that make lifesaving products from financially unsustainable liability claims through the tort system.”

We know that the entire COVID-19 process from Washington has become totally politicized. As the President has preordered one hundred million+ units of untested vaccine from prominent vaccine makers, targeting November 1^st (two days before the election) as the due date – Operation Warp Speed – the feds have sent a rather chaotic and generally confusing message that governors need to have plans to deploy that vaccine to the general population. Priorities. Procedures. Places. But there is no vaccine that clearly is ready or that absolutely will be ready in time. We don’t even have enough glass phials to hold that vaccine. The White House still has not issued clear and viable national COVID-19 containment policies and is still shunting responsibility to the states to solve the problem.

What’s worse, this accelerated rush to release a vaccine smacks of the lack of care described in the polio vaccine rush of 1955. There are growing number of Americans who simply are not ready to be what they believe to be human guinea pigs, because the vaccines in the pipeline will not have been through normal and customary full clinical trials that insure safety. They want to wait to see what happens to those who step up first… assuming any of the promised dates are met. After all, the President promised the release of a comprehensive new national healthcare program proposal by the end of August. Hmmmm. Still waiting.

But if sufficient vaccinations are not accepted, if the combination of those vaccinated or previously infected does not hit at least 60% of the population, the disease will not be contained. Despite the occasional outlier quack doctor to the contrary (Trump always seems to find one), the medical community overwhelmingly informs us that herd immunity will not otherwise take place.

Clearly caving to massive political pressure from the White House, the CDC, Surgeon General, National Institutes of Health, National Institute of Allergy and Infectious Diseases, FDA, etc. – all federal institutions Americans used to have faith in – are making statements and pledges about the vaccine that are just plain questionable if not terrifying. Liz Szabo (of Kaiser Health News, a nonprofit news service covering health issues), writing for the September 3^rd Los Angeles Times, explains: “Although two ongoing clinical trials of 30,000 volunteers are expected to conclude by the end of the year, Fauci said an independent board has the authority to end the trials weeks early if interim results are overwhelmingly positive or negative.

“The Data and Safety Monitoring Board could say, ‘The data is so good right now that you can say it’s safe and effective,’ Fauci said Tuesday [9/2]. In that case, researchers would have ‘a moral obligation’ to end the trial early and make the active vaccine available to everyone in the study, he said, including those who had been given placebos — and accelerate the process to give the vaccine to millions.

“Fauci’s comments come at a time of growing concern about whether political pressure from the Trump administration could influence federal regulators and scientists overseeing the nation’s response to the COVID-19 pandemic, and erode shaky public confidence in vaccines. Prominent vaccine experts have said they fear that President Trump is pushing for an early vaccine approval to help win reelection.

“Fauci, the director of the National Institute of Allergy and Infectious Diseases, said he trusts the independent members of the Data and Safety Monitoring Board — who are not government employees — to hold vaccines to high standards without being influenced by politics. Members of the board are typically experts in vaccine science and biostatistics who teach at major medical schools… ‘If you are making a decision about the vaccine, you’d better be sure you have very good evidence that it is both safe and effective,’ Fauci said. ‘I’m not concerned about political pressure.’…

“Safety boards set ‘stopping rules’ at the beginning of a study, making their criteria for ending a trial very clear, said Dr. Eric Topol , executive vice president at Scripps Research in San Diego and an expert on the use of data in medical research… Although the safety board can recommend stopping a trial, the ultimate decision to halt a study is made by the scientists running the trial, Topol said.

“A vaccine manufacturer could then apply to the Food and Drug Administration for an emergency use authorization, which can be granted quickly, or continue through the regular drug approval process, which requires more time and evidence… Safety monitors also can stop a trial because of safety concerns, ‘if it looks like it’s actually harming people in the vaccine arm, due to a lot of adverse events,’ Fauci said…

“Topol and other scientists have sharply criticized the FDA in recent weeks, accusing Dr. Stephen Hahn , the agency’s commissioner, of bowing to political pressure from the Trump administration, which has pushed the agency to approve COVID-19 treatments faster.

“Stopping trials early poses a number of risks, such as making a vaccine look more effective than it really is, Topol said…. ‘If you stop something early, you can get an exaggerated benefit that isn’t real,’ because less positive evidence only emerges later, Topol said.

“Stopping the studies early also could prevent researchers from recruiting more minority volunteers. So far, only about 1 in 5 trial participants are Black or Latino. Given that people in these groups have been hit harder by the pandemic, it’s important that they make up a larger part of vaccine trials, Topol said.

“Ending vaccine trials early also carries safety risks, said Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia… A smaller, shorter trial could fail to detect important vaccine side effects, which could become apparent only after millions of people have been immunized, said Offit, who serves on a National Institutes of Health advisory panel.” Masks are politicized. Safe distancing and opening businesses and schools are politicized. And even the manufacture and non-fully tested release of a potential vaccine are politicized. All focused on November 3^rd, come hell or high water. Election day. And the second wave is looming!

            I’m Peter Dekom, and as ethically bound medical doctors and scientists are pushed aside, politicians making their usually litany of “promises” have rushed in to take their place under a White House mandate.