137. In the post marketing data only 32 of 270 pregnancies were reported on and most of the 32 were miscarriages. Why didn’t the TGA follow up on the other 238 pregnancies and given the missing data how could the TGA say that the vaccine was safe for pregnant women? Was there ever any follow up on the other woman who didn’t initially provide data? 138. I note that the TGA has previously said “Post-market global surveillance data from large numbers of pregnant women have not identified any significant safety concerns with mRNA COVID-19 vaccines given at any stage during pregnancy. There is no evidence of decreased fertility, increased risk of miscarriage or teratogenic risk” Why would the TGA say this given the missing data in the post marketing data and the fact that the vaccine was only tested on pregnant rats?

Question Number: 256
PDR Number: SQ22-000626
Date Submitted: 21/11/2022
Department or Body: Department of Health

Question 137 It is not clear what data set the Senator is referring to and whether the claims made in the question are accurate. However, in any group of 270 pregnancies in any group of women it would not be uncommon for 32 of them to sadly end in miscarriage. The Therapeutic Goods Administration (TGA) does not follow up on individual patients who are part of the original clinical trials unless if it appears that the data submitted is incomplete. See the response to Q138 for references on the safety of the vaccines during pregnancy. Question 138 It is incorrect to state that the COVID-19 vaccines have been “only tested on pregnant rats”. The TGA continues to closely monitor the safety of COVID-19 vaccines, including use during pregnancy. To date, neither the TGA nor other major regulators have found any evidence that COVID-19 vaccination increases the risk of having a miscarriage, including from analysis of data in Australia. Similarly, post-market global surveillance data from large numbers of pregnant women, as well as other international research, has not identified any significant safety concerns with mRNA COVID-19 vaccines given at any stage of pregnancy. In particular, there is no evidence of decreased fertility, increased risk of miscarriage, or birth defects. These findings are supported by the work of other regulatory authorities. In June 2021, the New England Journal of Medicine published Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons (Shimabukuro et al, 2021), available at: www.nejm.org/doi/full/10.1056/nejmoa2104983. This study of more than 35,000 pregnant women showed no difference in side effects between those who were pregnant and those who were not. Women who were pregnant did not show any unique side effects. In January 2022, the European Medicines Agency also conducted an extensive review which provides reassurance about the use of mRNA vaccines during pregnancy, available at: www.ema.europa.eu/en/news/covid-19-latest-safety-data-provide-reassurance-about-usemrna-vaccines-during-pregnancy. In October 2022, Health Canada announced in their safety bulletin that a review of the available information found no evidence that vaccination with Comirnaty (Pfizer) or Spikevax (Moderna) increases the risk of having a miscarriage, pre-term birth, or other pregnancy complications. In addition, no increased risk for adverse events in breastfeeding individuals and breastfed newborns/infants was observed following maternal vaccination with Comirnaty or Spikevax.