When a COVID-19 vaccine is developed and made available to the public, will it be safe? Should we be concerned about it being rushed?

Several points reassure us. First, and foremost, the work of developing vaccines is the work of scientists in the trenches of research, not political appointees. Although appointees and their representatives may be the public face of corporations and agencies engaged in research or charged with overseeing approvals, they are not the ones doing the science.

The need for a vaccine is a massive public issue, far too large for obscurity in the scientific review – the issue is simply too big to escape the light of full inquiry and the matter is too weighty for us to take chances on getting it wrong.

We have learned from the past. For much of the last century, fear of polio was second only to that of atomic warfare.

Over 60 years ago the first polio vaccine, developed by Cutter Laboratories sickened 40,000 children, but other companies were able to make safe versions, and new government vaccine regulation arose. Much of the shortening in the development and review of potential vaccines focuses not on the science but on the timing. Every University has an institutional review board (IRB) that provides internal review, in addition to corporate, state, federal, and other reviews, and delays can accrue in scheduling, as with any bureaucracy.

The current crisis is cutting through red tape in delays – administration of the development and approval process – and it means we are making more efficient use of all our traditional and more recent tools (like artificial intelligence). This does not mean the scientific process itself takes short-cuts; it is just more efficient. The consequences would be too deadly and the peer scrutiny is too critical. It is hard to imagine a scientist who would end their career by playing a role in cheating the science.

Yet scientists are not perfect, and yes, some are capable of fraud. For that is what a compromised scientific development and review would be. So let’s take a quick look at that.

Scientific fraud occurs just like any other kind of fraud, but reaction is swift and correcting. The scientific method requires deliberate exposure of method and data to peer review. It is a reiterated feedback system designed to address errors and advance knowledge.  Double-blind studies further insure impartiality. Thus, fraudulent studies are rare results of specific individuals rather than systemic conspiracies and do not commonly survive the vetting process. Meta-analyses make fraudulent studies much easier and faster to catch than in the past. Such was the case with the bone fracture researcher Yoshihiro Sato, whose statistical anomalies became readily apparent to other scientists.

Fraud is so unlikely, due to enormous world scrutiny of the scientific community on COVID-19 that we are left with the seemingly more likely possibility of error rather than fraud.

Errors can be deadly, and with vaccines, so deadly that researchers and regulators are hyper vigilant.  For example, in 2013 Merck recalled a batch of HPV vaccine as a precaution prior to any health problems being reported.  In 2010, an H1N1 vaccine in Finland had a correlation with narcolepsy. One of the abiding maxims of science is that correlation is not causation, nevertheless, the international scientific community immediately conducted further studies and that vaccine never even made it to the United States despite no evidence of causation.

The stakes were simply too high. They are higher now and we will get it right.


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