Statement by Dr. Robert Kaplan

Kaplan (starting at 1:07:45): “I do have concerns about research integrity and the process used to authorize, approve, and mandate vaccines during this emergency. Let me outline some of my concerns... 

(L)eading authorities have reported that the vaccines dramatically reduce deaths from COVID-19. Yet, inspection of the data from the Moderna and Pfizer clinical trials show that death rates are identical among those randomly assigned to the vaccines or to placebos…

My second concern is that serious scholars have not been able to examine the raw data that justify the FDA and CDC decisions. The evidence we have comes primarily from highly curated, industry-controlled press releases, and press releases do not provide the detail that we, as scientists, need to offer objective evaluations.

More disturbing is that the vaccine manufacturers are not honoring requests to provide raw data. Pfizer, for example, will not make data publically available until 2025. This is really an unacceptable delay for a product that would be used by billions of people worldwide.

Over the last 80 years, the FDA has evolved standards that require multiple studies and longer term follow-up. 
 
My third concern is that the rapid development and deployment of vaccines to hundreds of millions of people required that some of the usual safeguards needed to be relaxed. Vaccines were authorized on the basis of a single trial with relatively short follow-up, in contrast to the typical standard of multiple trials with sufficient time to evaluate durability and harms…

In contrast to usual FDA applications, the vaccine studies have not made much of the information public. Among 72 studies on the Pfizer vaccine that are registered in ClinicalTrials.gov, only one is shown to have been completed, and zero studies have reported their results publically.
 
My final concern is that legitimate, scientific challenges have been set aside as ‘misinformation’…
 
So what needs to be done? First, we need more transparency. We should insist on independent data analysis by investigators who are not employed by the vaccine manufacturers…

In summary, we are making big decisions on the basis of limited, highly selected evidence, a compromised scientific process may lead to poor decisions and it may set a bad precedent. So please remember that if it is in the public interest, in this case affecting hundreds of millions of people, it should be in the public domain.”