204. Prior mRNA vaccine studies in rats resulted in the rats producing super numerary ribs. These are a sign of maternal distress are they not? 205. Given that animals studies indicated maternal distress from the mRNA vaccines why didn’t Pfizer perform more comprehensive studies on pregnant and breastfeeding women before rolling it out to the general population? Furthermore, why didn’t the TGA ask that Pfizer be more thorough in its investigations before approving for pregnant and breast feeding women in Australia?

Question Number: 165
PDR Number: SQ22-000162
Date Submitted: 24/02/2022
Department or Body: Department of Health

204.

Supernumerary ribs naturally occur in rats and it is common in this species and the number of animals with supernumerary ribs may vary between studies. In the rat study with the Pfizer vaccine, supernumerary ribs were seen in both control (rats received saline) and treated rats (rats received the vaccine). While the number of animals with supernumerary ribs was higher in the vaccine group than in the control group in the study, higher number of animals with supernumerary ribs had been seen in rats of the same strain in other studies conducted by the same testing laboratory. This is referred to as historical control data.

The study author, Pfizer, and all regulatory agencies worldwide (including the Therapeutic Goods Administration (TGA)) concluded that the supernumerary ribs seen in the rat study were not related to the vaccine. There was no sign of maternal stress in the rat study. Rat pups of vaccine-treated rats developed normally.

205.

As noted in response to Q204, there was no sign of maternal stress in the rat study.

Further, relevant responses explaining the thorough toxicology studies conducted on the vaccine have been previously provided in:

• SQ21-001264 – Testing on pregnant women and the safety of vaccines (answer date: 28 January 2022, Q125), and
• SQ21-001176 – COVID vaccine approval process (answer date: 31 January 2022, Q119).