Why the Public Expects a Coronavirus Vaccine Too Quickly

Last Updated on May 7, 2022 by Shaun Snapp

Executive Summary

  • Expectations have been created in the public’s minds regarding the approval of a coronavirus vaccine that is unrealistic.
  • We cover how this came about.

Introduction

See our references for this article and related articles at this link.

During the coronavirus, the public had come to expect the quick development of a coronavirus vaccine. It has been common to hear projects of roughly 12 to 18 months.

While performing research for this article, it was shocking to learn of the historical timelines for vaccines’ development. So the question arises, why has the public had its expectations of a vaccine set to such a rapid pace?

The Public’s Expectations on a Coronavirus Vaccine

The following is an illustrative quotation on this topic of public expectation.

Almost every day, I hear people making plans around the eventual arrival of a coronavirus vaccine — office reopenings, rescheduled weddings, family reunions and international travel. In recent weeks, colleagues and friends have asked me with growing urgency: “When will we have a vaccine? Will it be any good?” – ProPublica

Journalists Cherry Picking Vaccine Timelines

The desire of government officials to present a rosy scenario regarding the coronavirus is well known. However, there is evidence that media is selectively choosing to present shorter time estimates to their readers.

This is explained in the following quotation.

More than 30 years ago, I was asked the same question about an AIDS vaccine. Being a realistic optimist, my answer was: I do not expect a vaccine earlier than five years from now. None of the many journalists who asked me that question ever quoted those five years. Far too pessimistic! Other scientists spoke about one or two years. They were cited in the newspapers (and I was no longer harassed by journalists).

Three decades later, we are still waiting for an AIDS vaccine effective enough to be licensed.

I learned a valuable lesson then. Today, when I get asked the same question about the novel coronavirus, I respond by repeating the question with a different emphasis: “When do WE (all) get the coronavirus vaccine?” And there are other important questions to be added: Will it be safe? Will it be reliably protective?”

An average vaccine takes about 10-12 years to be developed. – Jens-Peter Gregersen, DVM

This is reinforced with the following quotation.

The grim truth behind this rosy forecast is that a vaccine probably won’t arrive any time soon. (published in April 2020) Clinical trials almost never succeed.(emphasis added) We’ve never released a coronavirus vaccine for humans before. Our record for developing an entirely new vaccine is at least four years — more time than the public or the economy can tolerate social-distancing orders.

But if there was any time to fast-track a vaccine, it is now. So Times Opinion asked vaccine experts how we could condense the timeline and get a vaccine in the next few months instead of years. – New York Times

Furthermore, such fast vaccine development timelines come with the normal risks associated with time compressing projects.

There’s a cost to moving so quickly, however. The potential Covid-19 vaccines now in the pipeline might be more likely to fail because of the swift march through the research phase, said Robert van Exan, a cell biologist who has worked in the vaccine industry for decades.

He predicts we won’t see a vaccine approved until at least 2021 or 2022, and even then, “this is very optimistic and of relatively low probability.” – New York Times

This was published in the New York Times in April of 2020 — so it has been published for a while. However, the information contained in this New York Times article received little replay in other media entities.

It almost appears as if media entities have some incentive to delude their readers on the coronavirus vaccine timeline.

Notice the following graphic, also from the New York Times.

Hmmm…is there a problem with the expectations that are being created for the coronavirus? 

How The Fastest Possible Vaccine Development Time Became the Official Estimate

The 12 to 18-month estimate has become the dominant estimate published in media outlets.

If this estimate is so inconsistent with historical vaccine development durations, where did the number come from? Well, it was pointed out by Gregersen, but it is also explained in the following quotation.

Dr. Zervos says the soonest a COVID-19 vaccine could be ready for widespread use will be 18 months from now—and if that’s the case, it will be the fastest a vaccine has ever been developed. – Henry Ford Health Systems

And this quote

Officials like Dr. Anthony S. Fauci, the top infectious disease expert on the Trump administration’s coronavirus task force, estimate a vaccine could arrive in at least 12 to 18 months. – New York Times

So this means Fauci proposed this optimistic timeline. This comment on the New York Times article discusses how little was behind this estimate when he made it.

To Whit, back in March Dr. Fauci made an incredibly casual guess that the soonest a vaccine could be available within a year to eighteen months. From that, a quasi-religious devotion has developed that one WILL be available. Thus, all we’ve got to do is hide away until then, and we’ll all be safe again. – New York Times

This is what I believe happened.

Journalists asked for the fastest possible time a vaccine could be developed, and this “fastest possible time” became the average time. Obviously, there is an enormous difference between the average time or and the shortest possible time.

This fact reminds me of some of the interviews I have given to journalists. I have had a similar experience when being interviewed by journalists, in that they will look into my quotes rather than taking my quotes for what they are. That is they are leading my quotes, looking to pull what they want out of the quotes — as they have a bias in their head, even though they don’t have any domain expertise on the topic. I also have also been interviewed by journalists who appear to have a short attention span and can’t process the information I provide to them. I also had a journalist tell me that he normally did not change the story after it was published, even though the name of my company, what it does and my title were all incorrect.

What Are the Steps for Developing and Bringing Out a New Vaccine?

The steps of developing a vaccine are the following:

#1: Determine the genetic sequence of the virus.

#2: Develop a vaccine using one of a few different strategies.

#3: Start the first clinical trials using healthy, normal volunteers.

#4: Begin the second round of clinical trials in larger populations of people who are at risk for infection.

#5: Approve vaccine for widespread use.  – Henry Ford Health Systems

And then, of course, produce and distribute the vaccine.

This quote explains how long some of the steps take along with their probability of success.

It is far from guaranteed that the vaccine will be safe and effective. 2013 study calculated that, before entering clinical trials, the average experimental vaccine has a 6 per cent chance of ultimately reaching the market. Of those that make it into trials, a 2019 analysis suggests the probability of success is 33.4 per cent.

That in itself would be a remarkable achievement. The 2013 study found that between 1998 and 2009, the average time taken to develop a vaccine was 10.7 years. It is possible to speed this up to some extent – since then, an Ebola vaccine has become the fastest-developed vaccine ever, being produced in just five years.

And this last point is not something that anyone is interested in hearing — that there may not be an effective vaccine for coronavirus.

Yet there is no guarantee that it is even possible to vaccinate against the coronavirus. There is a lot we don’t know yet about how our immune systems respond to the virus, and whether it is possible to induce long-lasting immunity to it.

But even if the Oxford vaccine succeeds, there will then be the issue of scaling up manufacturing to make hundreds of millions of doses. According to Bottazzi, this is the real bottleneck. Under the best of circumstances, the world is still looking at 12 to 18 months before a vaccine could be widely available, she says.  – NewScientist

The Observations of Others Noticing the Poor Quality Information Getting to the Public

Gregersen then goes on to explain how the vaccine development process is being misexplained to the public.

For comparison here is how coronavirus vaccine development is being explained to the general public:

“Make some milligrams of the desired antigen. Can be done in few weeks or months. Or, if you aim at a DNA or RNA vaccine, it may even be synthesized within days. Immunize mice with it and test the serum for antiviral antibodies. If the serum contains virus-neutralizing antibodies, you have your vaccine.”

Is this really a vaccine? No, it is only a potential vaccine candidate—one of about 100 candidates with a <5% chance to make it to the market. – Jens-Peter Gregersen, DVM

Pinning The Hopes on mRNA Vaccines?

The vaccines being developed are primarily mRNA based. However, there are several problems with this, as the following quotes explain.

“On the other hand,” said Dr. van Exan, “no one has ever made an RNA vaccine for humans.”

Researchers conducting dozens of trials hope to change that, including one by the pharmaceutical company Moderna. Backed by investor capital and spurred by federal funding of up to $483 million to tackle Covid-19, Moderna has already fast-tracked an mRNA vaccine. It’s entering Phase 1 trials this year and the company says it could have a vaccine ready for front-line workers later this year.

“Could it work? Yeah, it could work,” said Dr. Fred Ledley, a professor of natural biology and applied sciences at Bentley University. “But in terms of the probability of success, what our data says is that there’s a lower chance of approval and the trials take longer.”

The technology is decades old, yet mRNA is not very stable and can break down inside the body. – New York Times

And this is reinforced by the following comment on the New York Times article.

RNA Vaccines as a Shot in the Dark?

RNA is a shot in the dark because it’s so fragile. It’s hard to imagine that it can be produced, packaged, shipped, stored, and administered without destroying it. Getting it into cells safely, with no dangerous hitchhikers, is another formidable challenge.

Yes, this sounds very experimental and risky.

The people that are experts in the field seem to think the probability of success is not high. While mRNA is risky, it is being interpreted as a positive because it is “new.” However, it is not new and tested, and it new and untested, as described in the following quotation.

The fixation on mRNA shows the allure of new and untested treatments during a medical crisis. – New York Times

And then there is are the information providers that are motivated by profit.

“Shot in the dark,” “untested approach,” “extremely fragile,” and none of these descriptions or appraisals are being communicated to the public about these vaccines.

Estimates Coming from Pharmaceutical PR Departments

The following addresses the financial bias of who is communicating what is possible to the media.

At this point you might be asking: Why are all these research teams announcing such optimistic forecasts when so many experts are skeptical about even an 18-month timeline? Perhaps because it’s not just the public listening — it’s investors, too.

“These biotechs are putting out all these press announcements,” said Dr. Hotez. “You just need to recognize they’re writing this for their shareholders, not for the purposes of public health.” – New York Times

Interesting Comments on New York Times Article

For every scientist employed by the F.D.A., there are three lawyers. And all they care about is liability.

Comment #1: Only a Small Fraction Fall Ill

We actually have a very similar situation with tuberculosis. Only a fraction of individuals who are exposed to the bacterium fall ill. Of the ones who fall ill, a fairly large number can heal spontaneously (with rest and good food and in fresh air — the treatment before antibiotics and “chemotherapy” was sanitoria, often in the mountains).

Comment #2: Your Need a Good Immune System

A vaccine does not directly protect you against the virus. It marshals your immune system to deal with that specific virus.(emphasis added) The vaccine won’t work if your immune system is dysfunctional. And if it’s strong enough it won’t need the vaccine to do its job.

Comment #3: Can’t Find Vaccines for Other Coronaviruses

COVID-19 is indeed a member of a well studied family of viruses, the corona viruses. Unfortunately this does NOT mean well understood, especially as regards making a vaccine. When I was younger, when a new medical advance like the Salk vaccine dealt a blow against some major disease, people said “but they’ll never find a cure fr the common cold”. Colds are mostly caused by corona viruses. We haven’t found a vaccine for even one of them.
Thompson claims that COVID-19 “does not appear to mutate significantly”. This is a strange assertion. First, corona viruses studied mutate a lot. The nasty corona viruses, including SARS (to which COVID-19 is closely related) and MERS, may mutate more than the common colds. Second, pandemics and severe epidemics bring out more successful mutations. Partly, there are more viruses to mutate. More importantly, a pandemic provides different and changing environments. Most mutations don’t compete well but this gives a chance for more to thrive. In particular, epidemiologists expect that when a virus has come into contact with most people, a more contagious mutation is likely to thrive. The 1918 Flu in its first eight months killed 3-4 million people and had subsided in the USA and the UK. Then came a mutation that let it kill over 50,000,000 more people in record time. Thompson’s central thesis, that we can speed up by starting later processes early, incorrectly supposes that we know what will succeed in the first stages. WE DON’T.

Comment # 4: Bad Response

My initial thought when the President decided to use executive powers to assure that meat production continued was to wonder why he hasn’t done anything about drug and vaccine manufacturing. People got excited when our auto companies turned to producing ventilators and angry when they couldn’t pump them out immediately. The President wanted a factory that figured largely in his campaign to be used; GM chose one more suited that produced electronics and could be more quickly converted to producing ventilators. You can’t just rent a commercial kitchen and mix up a batch of vaccine. You are going to need clean rooms and facilities that can handle complex chemical and processes with precision, under fiercely controlled sanitary conditions. Clean rooms don’t pop up like hospital tents, yet there is no indication that the government has looked for existing ones that can be converted or looked to start building capacity. That is the role of the feds – what a pandemic response team would have already identified and delegated.

Comment #5: How Effective Will the Vaccines Be?

We have had recent reports of COVID19 patients who have recovered and do not have detectable antibodies in their blood. So, it would appear that the virus might not be eliciting an immune response in all individuals. There are also reports that some individuals have recovered and then been re-infected.

These observations, if they are confirmed, would mean that the production of an effective vaccine might be very difficult.

We may be faced with trying to produce a vaccine that elicits a strong immune response, but a response that is not so strong that it results in organ damage as a result of a cytokine storm.

Then, once the vaccine has been identified we need to produce 300 -600 million++ doses.

How easy will this be?

Trump and Jared are in the way. We need Dr. Fauci and adults in charge.

Comment #6: Oversold Vaccine

Do you actually work with biologics or vaccines? I have never seen a production cell line develop in <6 months, let alone the rest of GMP manufacturing process. A lot of these vaccines are novel entities with no developed process yet, and you feel that it will go to large scale clinical manufacturing straight from a lab scale? Evidently my experience in biotech/pharma is very different from yours.

Comment #7: Trusting a Coronavirus Vaccine?

As of late, I’ve been wrestling with the question – should a coronavirus vaccine be able, when should I trust it?

While I trust vaccines that have been on the market for decades (e.g. measles), I do not trust an FDA under control of President Trump, who will quite likely be ordered to just ignore clinical evidence and rubber-stamp whatever the drug companies come up with.

If a vaccine gets approved by regulatory bodies all over the world, including places like Europe which have always had higher safety standards than the U.S., I will likely trust it. If a vaccine is approved only by the U.S., however, I will likely not trust it – especially if that approval ends up being conveniently announced right before the November election.

Comment #8: How They Make Money

Vaccines are not a money maker for Big Pharma without government support because it is a product that you will hopefully only take once, or twice if a booster is needed, or every 10 years, as is the case for tetanus.

Donald Trump-style massively corrupt capitalism will not save us from Covid19.

Comment #9: Natural Immunity in Sweden

Sweden is creating their own vaccine. It’s called careful and controlled and gradual build up of immunity. Yes, their death rate is currently higher than some European countries. But it’s lower than others, including Belgium, Spain, Italy, the UK, France, and the Netherlands, who have been in near total lockdown for weeks. The main difference is that they are much further on their way to herd immunity, with no real long term damage done to their economies. With the more prolonged progression of the pandemic in most of the rest of the world, the death rates in many of these other countries will eventually catch and pass Sweden’s, but with the additional catastrophe of destroying their economies–and all physical and mental suffering and death that will naturally follow–as an added bonus.

The Outcomes from Investment

There is little theoretical understanding why the many dramatic advances in biomedical science in recent decades have not produced proportional growth in the number of new therapies. The problem is well documented; the annual number of approvals of New Molecular Entities (NMEs) has been static [1], clinical development pipelines continue to have high attrition rates [2], and drug development costs are increasing exponentially [3]. While there has been extensive analysis of the clinical and regulatory stages of drug development [2, 4, 5], less is known about the basic and applied research stages of translational science that provide constructive insights into mechanisms of health and disease, identification of potential drug targets, or the initial discovery of promising lead compounds.

Evidence suggests that the inefficiency of these early stages may be limiting the pace of translational science. The FDA and others have noted the lack of growth in the number of drug approvals reflects an underlying paucity in the number of candidate products in the clinical pipeline. Similarly, the President’s Council of Advisors on Science and Technology (PCAST) identified lack of validated targets as a major barrier to building robust clinical pipelines and developing new cures [6].

There has been little empirical or theoretical work on these early stages of translational science. Much of the existing literature is anecdotal, describing experiential insights into the obstacles and opportunities encountered by individuals or companies engaged in target validation, high-throughput screening, lead identification, or preclinical testing. Often, these analyses address the challenges of entrepreneurship and financing, rather than how scientific insights are translated into products.

While some steps in the vaccine timeline can be fast-tracked or skipped entirely, approvals aren’t one of them. There are horror stories from the past where vaccines were not properly tested. In the 1950s, for example, a poorly produced batch of a polio vaccine was approved in a few hours. It contained a version of the virus that wasn’t quite dead, so patients who got it actually contracted polio. Several children died.

Despite dramatic advances in biomedical science and concerted efforts to streamline the clinical and regulatory stages of drug development, the efficiency of clinical development remains unchanged, and may actually be decreasing [1, 3–5]. At the same time, the cost of drug development continues to rise, with the most recent estimates average out-of-pocket cost for each new compound reaching $1.4 billion and fully capitalized costs reaching $2.6 billion [28]. There is accumulating evidence that there are barriers to development occurring in basic and applied research, which generates novel targets, target validation, and enables the subsequent stages of drug discovery and development. The PCAST report identified “rate-limiting knowledge gaps” that limited the number of compounds entering clinical development [4], while an Institute of Medicine report identified a “translational block” in the “transfer of new understandings of disease mechanisms gained in the laboratory” to testing in humans [5]. The present work was undertaken to better understand the relationship between these early stages of enabling research and the efficiency of subsequent development.

Our analysis is grounded in theories of innovation, which posit that new technologies mature through a characteristic growth cycle (S-curve), and that the ability to develop successful products from such technologies is related to the level of maturity. Previous studies have extended these principles to biopharmaceutical development [10, 11] using a bibliometric-based analytical model for the maturation of biomedical technologies. The present analysis models the maturation of target-related technologies as a characteristic S-curve (exponentiated logistic) and identifies the initiation point where exponential growth in publications begins as well as an established point representing slowing of publication activity and end of exponential growth in publication activity.

This work explicitly examines the timelines of translational science for NMEs approved by the FDA between 2010 and 2014. We show that for the 138 NMEs approved in this interval, there were 102 distinct targets, of which 90 exhibited a growth pattern that could be modeled as an exponentiated logistic function with acceptable fit/error. Using this model, we observed a strong association between maturity of the target technology and timelines of translational science for 102/138 NMEs approved from 2010–2014. There are two aspects to this observation.

First, the majority (73/102) only entered clinical trials after the target technology was established, and none of the NMEs approved 2010–2014 were approved before this point. We do not know how many failures might be associated with the lack of maturity of the target technologies. We would caution that these data also do not establish a causal relationship between the maturity of target technologies and clinical failure. Certain targets are traditionally considered “undruggable” due to their biochemical or biophysical characteristics, and some technologies, such as ribozymes, never generate therapeutic products. Moreover, clinical leads may fail for many reasons unrelated to the target such as chemical instability, disadvantageous pharmacokinetics, or idiosyncratic toxicities, and up to one third of leads may fail for “commercial” reasons related to the sponsor’s strategy or finances [2]. For example, data has shown that the probability of success in phase 2 is significantly lower when the trials are sponsored by smaller, biotechnology companies with limited capital resources [29]. Further studies, with cohorts of failed compounds, are required to sort out the relative contribution of technological maturity to development success or failure.

The data generated from this model also do not suggest that technological maturity is sufficient for success, and there is wide variation in the timelines observed between the established point and first approval of NMEs associated with these technologies.

Second, data from this model shows the timeline of clinical development averaged three years shorter for products that entered clinical trials after the established point than for those that entered clinical trials when the target technology was less mature. This result suggests that the efficiency of clinical development was greater as the target technology passed the established point. To put the significance of this three year difference in context, DiMasi has examined the economic benefit of improving the timelines for drug development [32]. Based on his calculations, and using the most recent estimates for the fully capitalized cost of drug development [28], the 3 year (27–35%) average difference in drug development timelines observed here represents a cost differential of $100–200 million dollars in development costs.

Analytical modeling of technology maturation provides an objective means for measuring the timelines of translational science. While it is more common to measure translational progress by tangible measures such as the dates of seminal publications or phases of clinical investigation, such metrics are inherently biased by the differential transparency of research performed in academic, start-up, or large corporate environments, differing standards for progressing through phased clinical trials based on the size or business models of the sponsoring corporation, as well as the subjective nature of a posteriori assessments of the importance of selected papers and milestones in successful development programs. Moreover, analytical metrics that might be calculated in real-time through the translational process have the potential to provide strategic guidance for development decisions and planning. While we have not explored the predictability of the current analytical model, the present results suggest that suitable metrics of technological maturity could be useful in handicapping the likelihood of clinical success and optimizing the timeline of clinical development. – Plos

Concerns Regarding the Covid Vaccines by The Advisory Committee To The FDA

These concerns below were discussed internally, but never communicated to the public.

The FDA has said it would consider granting an emergency use authorization for a vaccine if the human test subjects in a clinical trial of the vaccine have been followed for a median of at least two months after completing the dosing regimen. The median is the midpoint in a set of data, meaning that, by the FDA’s standard, when an authorization is issued, almost half of the test subjects could have been followed for less than two months.

Two months is more than the White House wanted when it was hoping to get a vaccine authorized before Election Day. But members of the advisory committee expressed concern that two months of follow-up might not be enough to determine if the vaccine causes harmful side-effects or if whatever protection the vaccine provides wears off quickly.

Two months is more than the White House wanted when it was hoping to get a vaccine authorized before Election Day. But members of the advisory committee expressed concern that two months of follow-up might not be enough to determine if the vaccine causes harmful side-effects or if whatever protection the vaccine provides wears off quickly. – POGO

Here you can see the political motivation to get the vaccines approved to help Trump get re-elected.

Conclusion

The public is being led astray. The public wants to see and to the social distancing and restrictions on the economy is pinning their hopes on the fast arrival of a vaccine. Governments and media are telling them that this is likely, without providing the history of vaccine development.

However, a primary reason that both the government and the public are so desperate for a vaccine is that governments have followed a lockdown approach to dealing with the coronavirus.

This comment on the New York Times article that I relied upon for many quotes is illuminating.

I’ve been working on vaccines since 1981, first, as a Presidential Appointee fighting for federal funding to create a stockpile and create the Vaccine Injury Compensation system. Then, as the Global VP of Merck’s Vaccine Business. Finally, as an advisor to the DoD on biowarfare countermeasures and an advisor to several global vaccine companies and countries launching new vaccines.

I read this, stood up at my desk and cheered!

Nobody in the vaccine industry or public health sector has been able to communicate what it takes to get a product developed, tested, manufactured and out the door with such clarity. And, believe me, we’ve tried. You’ve added other layers as well, to suggest alternative pathways to success.

Except for one thing: If I read this correctly, you’re projecting about a 3 month distribution period and that’s way too short. Just a warning that even with pharmacists being able to give immunizations, the current US adult vaccination infrastructure would not be capable of immunizing enough adults in that time frame. However, with a vaccine available, if we have the will, we’ll find the way. – Common on New York Times Article from “GMC”

Update for September 2021

This video explains how the vaccines were introduced too quickly, and how they are not like previous vaccines, but shortcuts that are both far more dangerous to recipients, and how alternative methods have been de-emphasized and not funded by the NIH in order to concentrate all resources on the Pfizer, Moderna, etc.. mRNA vaccines. The objective is more profit maximization for NIH-connected pharmaceutical companies than public health. In responding to the coronavirus, Dr. Fauci did the same thing he did in responding to the AIDS epidemic, choosing a solution (in that case AZT) that benefitted the most highly connected pharmaceutical companies to which he and the NIH have financial ties.