Did COVID-19 vaccines skip animal trials?
Fact checking the fact checkers.
Watch video on Streamyard here >
What was the fact check on Reuters about?
Fact Check-COVID-19 vaccines did not skip animal trials because of animal deaths >
Whilst that was correct, it gave the appearance that everything was fine. It represents a partial truth which can be more dangerous than a lie.
Information from Pfizer in September 2020
Note that the paper mentioned as the Pfizer reference is still in the preprint stage of approval. Why is that?
A prefusion SARS-CoV-2 spike RNA vaccine is highly immunogenic and prevents lung infection in non-human primates
Interesting article from a blog by EFPIA and Vaccines Europe
While usually regulators require that the industry shows a product is safe in animals before it goes to clinical trials, for COVID-19 vaccines, regulators accepted that preclinical studies could be conducted in some cases in parallel to the first clinical studies to save time considering the urgent need for COVID-19 vaccines.
Let us look at the timeline regarding Pfizer vaccine development. The text in the following 4 bullets are taken from the following paper:
Khehra, Nimrat, et al. "Tozinameran (BNT162b2) vaccine: the journey from preclinical research to clinical trials and authorization." AAPS PharmSciTech 22.5 (2021): 1-9.
Preclinical Animal trials - (unable to find start date in paper) “During the trial, macaques were randomly administered two I.M. injections of 30 μg or 100 μg BNT162b2 or saline at days 0 and 21”. BNT162b vaccines protect rhesus macaques from SARS-CoV-2 - Read here >
Phase 1/2 Human Clinical Trials - “In Germany, the study design in phase 1/2 took place between April 23, 2020, and May 22, 2020, consisting of 60 healthy male and nonpregnant female participants (96.7% Caucasian, one African American, and one Asian) between the ages of 18 and 55 years divided into 1 μg, 10 μg, 30 μg, and 50 μg dose groups”.
Phase 2/3 Human Clinical Trials - “From July 2020 to November 2020, the multination phase 3 randomized, placebo-controlled, observer-blinded clinical trials consisting of subjects from diverse backgrounds took place in the USA, Germany, Turkey, South Africa, Brazil, and Argentina”.
Phase 3 Human Clinical Trials: Adolescents - “In February 2021, phase 3 clinical trials were conducted in 2260 young participants in the USA between the ages of 12 and 15, reflecting 100% efficacy post-BNT162b2 vaccination”.
Are there any ongoing animal trials? Have humans become the animal trials?
What happened to the macaques in the original Pfizer trial? They are all dead because necropsy (autopsy) was done up to 16 days post challenge studies.
Read supplementary report here >
There do not seem to be any ongoing parallel studies in animals. Is that good enough considering we went on to give booster doses?
Should animal studies have been ongoing to demonstrate safety?
I just watched your presentation. I'm not a doctor. I'm very much a layman. What I gather from your talk is that the animal trials were done just long enough to show evidence of covid vax benefit, but the animals were prematurely put to death--less than two months after the second dose. They were killed before we could know how they would do in the long run with variants and wild viruses, and other unexpected illness. Is that a fair summation?
What I'm getting in all this is that I'm finding myself now firmly in the camp that using animals for trials is unethical.