Sunday, May 17, 2020

Warp Speed or Wish and a Prayer?

Last Friday President Trump announced a "Warp Speed" project  to produce a Covid-19 vaccine by the end of the year.

Unveiling details of “Operation Warp Speed”, a name that references a concept popularised by Star Trek and other science fiction, Trump said: “That means big and it means fast. A massive scientific, industrial and logistical endeavour unlike anything our country has seen since the Manhattan Project.”
He added: “Its objective is to finish developing and then manufacture and distribute a proven coronavirus vaccine as fast as possible. Again, we’d love to see if we can do it prior to the end of the year.”

Put me down as someone who sees this as more of a "wish and a prayer" than something that I would count on.

It seems to me that President Trump has been spending too much time listening to Dr. Fauci, Bill Gates and others who seem to think that vaccines are the answer to any health issue. 

Why do I have doubts?

First, vaccine development is not something that is done at "warp speed".  It is a difficult process and it takes time to not only figure out how to trigger the immune response in the body but to also insure that it is done safely with no side effects.

Let's consider HIV/Aids which Dr. Fauci and Dr. Birx have spent almost their entire careers working on.

Researchers have been attempting to develop  an HIV vaccine since the 1980's but we still have not seen one. In fact, an optimistic forecast is that we might have one by 2030. That would be about 50 years after the disease was first identified.

This would be a typical timeline for the development of a vaccine. Based on that, we should be looking for a vaccine in 2036.

Credit: The New York Times

Here are the development periods for different vaccines. This assumed an 18 month goal for Covid-19. President Trump's "warp speed" goal is half of that---9 months.

It should also be remembered that Covid-19 is a variant of a coronavirus. To this point there has never been a successful vaccine developed for any type of coronavirus. It is not because many haven't tried. The common cold is a coronavirus. You can imagine the potential market for a vaccine that prevents the common cold yet it has still eluded researchers for decades and decades.

We do have an advantage in attempting to develop a Covid-19 vaccine in that a lot of research was conducted on trying to develop a vaccine for SARS and MERS which are also caused by a coronavirus. However, these diseases died out fairly quickly and work quickly ceased.

Vaccine development is extremely costly. It is a high risk financial proposition. However, that is balanced by the fact that it can be extremely profitable. A therapeutic drug only offers potential profit of those who get sick. A vaccine offers profit potential from the entire population. In addition, in the United States, vaccine producers get liability protection. The same is not true for therapeutic drugs. 

A "warp speed" effort. Huge profit potential. Government backing of the effort. No product liability.

What could go wrong?

This is my other concern about putting much hope or belief in a vaccine solution to Covid-19.

It is important to understand that vaccine trials are very limited in their scope. It is impossible to do widespread testing of vaccines before they are released because of ethical concerns that we may actually be harming, rather than helping, patients.

Initial research and testing of vaccines is typically done with animals first. Have you ever heard of a guinea pig? They were the favorite choice from the early days of vaccine development. More can be done in the lab today but it is important to first see what the effects of any vaccine might have on an animal before thinking of testing it on a human being.


Early human trials are just done to see if there are any immediate side effects from the virus without determining whether it has any immunity benefits. This might involve just a few dozen (Phase 1) or few hundred (Phase 2) subjects to see if there are any ill-effects. Of course, this necessarily is only focused on short-term side effects that might show up. There is little long-term surveillance. In a warp speed effort there would be NONE.

It is also considered unethical and dangerous to purposely infect someone with the virus to see if the vaccine works. Therefore, the only thing that can really be measured in this regard is whether the test subject develops antibodies to the virus. However, this is also inexact as it is known that some people develop immunity with few antibodies being present and others have good antibodies and still get infected.

Pregnant women and children are almost certain to not be tested in any Covid-19 trials because it would be considered too dangerous to do so not knowing potential side effects. The same will be true for the highest risk group for Covid-19---those older and with vulnerable conditions---because this too would be too risky in a test situation.  Test subjects are likely to be the healthiest people that can be found because if something goes wrong they can most easily recover with minimal side effects. Those subjects are much more likely to be age 25 (those at least risk from the virus) than age 75 (those most at risk).

That alone gives me great pause for the safety of any vaccine that might be recommended for older people who are most vulnerable to the disease. How is anyone really going to know how safe this vaccine is for children and older people if no real testing has been done on these populations to begin with?

Count me as someone who would not be first in line for the vaccine even if it wasn't done at "warp speed" knowing what I know about the testing and trial process.

I am old enough to remember a similar effort at mass immunization led by the federal government related to concerns about the swine flu in 1976. That particular strain of flu was considered to have elements of the Spanish flu of 1918 and killed 50-100 million people worldwide. As a result, there was great concern by public health experts about a possible pandemic from that strain of the flu.

The CDC recommended that the federal government institute a mass immunization program for all Americans in order to slow any possible spread of the swine flu. Government funding was passed by Congress as was liability protection for the vaccine producers. 

I remember receiving the vaccine in downtown Atlanta not far from my office as part of a mass community immunization program sponsored by the government.

I was in a line with my co-workers very similar to this when I received the vaccine in the Fall of 1976.

However, it was not long before problems and side effects from the vaccine started to arise. A number of cases of Guillian-Barre syndrome were discovered in people shortly after they were immunized. A study showed that the incidence was four times higher in those that had been immunized as compared to those who were not. In addition, it was also reported that incidences of the flu were actually seven times higher among those that were immunized as those who were not.

Within three months of the immunization program being started, it was disbanded in light of the negative results. Only 25% of Americans ultimately received the vaccine.

These are the reasons that I am not overly optimistic about a Covid-19 vaccine being our savior at warp speed or any other speed. It all seems to be more a wish and a prayer than a realistic solution to our current situation based on any reasonable assessment of the relevant facts.

I continue to believe that therapeutics hold much more promise. We may not be able to prevent the infection from spreading but we should have a better chance of finding drugs and treatments to curb the disease process or find a cure that works quickly and safely.

All that being said, I don't discount that we could see some miraculous advances over the next several months to combat the virus one way or the other. There is a lot of focus on this disease. I dare say that there is more attention, and more resources, committed to this than most anything else in my lifetime for the simple reason that the stakes are so large. What is bigger than the entire world's economy?

Since the stakes are so large, so are the rewards for anyone who figures out how to solve the problem.

Incentives drive results. There is nothing that I am more sure of. That is the prescription for success in almost anything in life.

If you doubt that consider the fact that are already 254 therapies and 95 vaccines for Covid-19 already being explored.

I have no doubt that it will also prove true in dealing with Covid-19.

To believe that you do not need a wish and a prayer.

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