Stop slow-walking synthetic vaccines! Our bureaucracy is killing us!

The world is entering an economic recession and health crisis partly due to the continuing lack of imagination and capability among experts in the bureaucracy. Perhaps these supposed experts are suffering from a disease first named by C. Northcote Parkinson several decades ago: injelitance or the rise to power of incompetents who are skilled only in the arts of preventing problems from being solved by the capable.

The now legendary failure of the CDC to manage the task of developing an effective test for the virus is being compounded by the efforts of state and federal government bureaucrats to block Americans who developed their own tests, including the heroes at the Seattle Flu Study.  U.S. public health officials have advised Americans not to wear face masks  that work and can be made at home, and even though some countries are requiring masks to slow virus transmission. 

Many millions of Americans now on lock down are paying with their liberty for the freedom accorded to a few hundred thousand travelers from China and Europe over the last two months by incompetent government agencies like Homeland Security, despite President Trump’s clear intention to close the border to the disease.

And now health bureaucrats are slow-walking their testing of possible vaccines.  Nowhere is this more evident than in the lethargic actions of the National Institute of Allergy and Infectious Diseases (NIAID).

Massachusetts-based Moderna Therapeutics completed the world’s first candidate COVID-19 vaccine in just 42 days and rushed the first vials to NIAID on February 24. But then NIAID bureaucrats started slow-walking it. They told TIME that they and the rest of the National Institutes of Health (NIH) couldn’t possibly prepare the vaccine for human testing before April, at the very earliest. Finally, perhaps due to intervention by the Trump administration, they discovered that they could, after all, begin human testing on March 16.

Meanwhile, NIAID Director Anthony S. Fauci has repeatedly told reporters that no vaccine could possibly be approved in less than a year to a year and a half. In fact, one of the first times he said this, he was directly contradicting President Trump who had just said that he expected a vaccine in months, or a year at the most. The question becomes: Is Fauci’s bureaucracy intentionally slow-walking the approval process?

But the problem is not just bureaucratic lethargy, it is also a regulatory system that was designed to protect the public from vaccines made from attenuated pathogens, not vaccines that are synthesized in the lab. Attenuated viruses are dangerous. Sometimes they mutate within the body so that they can reproduce themselves and produce a disease. The following appears in a 2019 Medical Journal article, available on the NIH website:

A significant drawback to using attenuated pathogenbased vaccines is the risk of reactogenicity and reversion to a virulent pathogen following vaccination, usually in immunocompromised infants, elderly people or in individuals with a specific immunodeficiency. Although the use of OPV [Oral Polio Vaccine] has decreased the number of polio cases by more than 99% since 1988, there are still disease outbreaks of vaccineassociated paralytic polio (VAPP) that arise due to small genetic changes occurring during OPV replication in humans.

In contrast, synthetic vaccines cannot possibly reproduce themselves. They are constructed within the laboratory and don’t have any reproductive capabilities whatsoever. The main problem for synthetic viruses is not safety, but efficacy. In other words, most of them don’t work.

Fortunately, there are a lot of them under development right now. Although a few of the COVID-19 vaccines being developed, including the Oxford vaccine, are made from attenuated viruses, the rest, including the Moderna vaccine and Israel’s MIGAL vaccine, are synthetic.

Moreover, whether a synthetic vaccine works can be determined quickly by testing for the creation of the desired antibodies during human safety trials and by testing for effectiveness against the actual disease in animals (the closer to man, the better). There is no good reason why safety and efficacy studies for synthetic vaccines cannot be conducted simultaneously.

Even if the safety and efficacy tests are conducted sequentially, the entire procedure for testing a synthetic vaccine could be completed in just 3 months – 1 month for safety testing, 1 month for efficacy testing, and 1 month for bureaucratic paperwork  –  according to Dr Chen Katz, leader of the group that develops MIGAL’s synthetic vaccines. He told Times of Israel:

The clinical testing experiments themselves are not so long, and we can complete them in 30 days, plus another 30 days for human trials. Most of the time is bureaucracy — regulation and paperwork.

Dick Morris went further than us in a March 19 op-ed. He called for skipping the efficacy testing altogether and releasing COVID-19 vaccines as soon as their safety testing is complete. He wrote:

The conventional scientists at the FDA may object to bypassing the efficacy tests. They will warn that some vaccines are not fully effective. They will want to wait until they know which shots work best.

But why should we wait? If we can confer some degree of immunity on tens of millions of people, let’s do it! As long as we are not hurting anyone and are fulfilling the Hippocratic Oath’s admonition to “first do no harm,” we should go full-speed ahead!

Unlike Morris, we do not call for skipping the efficacy testing. Instead, we call for quickly conducting the safety and efficacy testing and then quickly releasing the vaccine to the public for prescription by doctors who agree to track it for effectiveness and side effects. The information reported by doctors should then be collected by NIH for constant updating on a website made available to both doctors and the general public.

An effective vaccine would stop COVID-19 in its tracks, and it would save the world from the crippling economic measures currently being attempted in a hugely costly effort to slow the spread of the virus. Trillions of dollars and many tens of thousands of lives are riding on the success of the vaccine effort. The usual bureaucratic delays are not only unacceptable, they are deadly.

The Richmans co-authored the 2014 book Balanced Trade published by Lexington Books, and the 2008 book Trading Away Our Future published by Ideal Taxes Association.

The world is entering an economic recession and health crisis partly due to the continuing lack of imagination and capability among experts in the bureaucracy. Perhaps these supposed experts are suffering from a disease first named by C. Northcote Parkinson several decades ago: injelitance or the rise to power of incompetents who are skilled only in the arts of preventing problems from being solved by the capable.

The now legendary failure of the CDC to manage the task of developing an effective test for the virus is being compounded by the efforts of state and federal government bureaucrats to block Americans who developed their own tests, including the heroes at the Seattle Flu Study.  U.S. public health officials have advised Americans not to wear face masks  that work and can be made at home, and even though some countries are requiring masks to slow virus transmission. 

Many millions of Americans now on lock down are paying with their liberty for the freedom accorded to a few hundred thousand travelers from China and Europe over the last two months by incompetent government agencies like Homeland Security, despite President Trump’s clear intention to close the border to the disease.

And now health bureaucrats are slow-walking their testing of possible vaccines.  Nowhere is this more evident than in the lethargic actions of the National Institute of Allergy and Infectious Diseases (NIAID).

Massachusetts-based Moderna Therapeutics completed the world’s first candidate COVID-19 vaccine in just 42 days and rushed the first vials to NIAID on February 24. But then NIAID bureaucrats started slow-walking it. They told TIME that they and the rest of the National Institutes of Health (NIH) couldn’t possibly prepare the vaccine for human testing before April, at the very earliest. Finally, perhaps due to intervention by the Trump administration, they discovered that they could, after all, begin human testing on March 16.

Meanwhile, NIAID Director Anthony S. Fauci has repeatedly told reporters that no vaccine could possibly be approved in less than a year to a year and a half. In fact, one of the first times he said this, he was directly contradicting President Trump who had just said that he expected a vaccine in months, or a year at the most. The question becomes: Is Fauci’s bureaucracy intentionally slow-walking the approval process?

But the problem is not just bureaucratic lethargy, it is also a regulatory system that was designed to protect the public from vaccines made from attenuated pathogens, not vaccines that are synthesized in the lab. Attenuated viruses are dangerous. Sometimes they mutate within the body so that they can reproduce themselves and produce a disease. The following appears in a 2019 Medical Journal article, available on the NIH website:

A significant drawback to using attenuated pathogenbased vaccines is the risk of reactogenicity and reversion to a virulent pathogen following vaccination, usually in immunocompromised infants, elderly people or in individuals with a specific immunodeficiency. Although the use of OPV [Oral Polio Vaccine] has decreased the number of polio cases by more than 99% since 1988, there are still disease outbreaks of vaccineassociated paralytic polio (VAPP) that arise due to small genetic changes occurring during OPV replication in humans.

In contrast, synthetic vaccines cannot possibly reproduce themselves. They are constructed within the laboratory and don’t have any reproductive capabilities whatsoever. The main problem for synthetic viruses is not safety, but efficacy. In other words, most of them don’t work.

Fortunately, there are a lot of them under development right now. Although a few of the COVID-19 vaccines being developed, including the Oxford vaccine, are made from attenuated viruses, the rest, including the Moderna vaccine and Israel’s MIGAL vaccine, are synthetic.

Moreover, whether a synthetic vaccine works can be determined quickly by testing for the creation of the desired antibodies during human safety trials and by testing for effectiveness against the actual disease in animals (the closer to man, the better). There is no good reason why safety and efficacy studies for synthetic vaccines cannot be conducted simultaneously.

Even if the safety and efficacy tests are conducted sequentially, the entire procedure for testing a synthetic vaccine could be completed in just 3 months – 1 month for safety testing, 1 month for efficacy testing, and 1 month for bureaucratic paperwork  –  according to Dr Chen Katz, leader of the group that develops MIGAL’s synthetic vaccines. He told Times of Israel:

The clinical testing experiments themselves are not so long, and we can complete them in 30 days, plus another 30 days for human trials. Most of the time is bureaucracy — regulation and paperwork.

Dick Morris went further than us in a March 19 op-ed. He called for skipping the efficacy testing altogether and releasing COVID-19 vaccines as soon as their safety testing is complete. He wrote:

The conventional scientists at the FDA may object to bypassing the efficacy tests. They will warn that some vaccines are not fully effective. They will want to wait until they know which shots work best.

But why should we wait? If we can confer some degree of immunity on tens of millions of people, let’s do it! As long as we are not hurting anyone and are fulfilling the Hippocratic Oath’s admonition to “first do no harm,” we should go full-speed ahead!

Unlike Morris, we do not call for skipping the efficacy testing. Instead, we call for quickly conducting the safety and efficacy testing and then quickly releasing the vaccine to the public for prescription by doctors who agree to track it for effectiveness and side effects. The information reported by doctors should then be collected by NIH for constant updating on a website made available to both doctors and the general public.

An effective vaccine would stop COVID-19 in its tracks, and it would save the world from the crippling economic measures currently being attempted in a hugely costly effort to slow the spread of the virus. Trillions of dollars and many tens of thousands of lives are riding on the success of the vaccine effort. The usual bureaucratic delays are not only unacceptable, they are deadly.

The Richmans co-authored the 2014 book Balanced Trade published by Lexington Books, and the 2008 book Trading Away Our Future published by Ideal Taxes Association.