This is from the Australian Government’s “COVID-19 vaccination decision guide for people [men get preggers too, don’t you know] who are pregnant, breastfeeding or planning pregnancy,” dated 19 August 2021. Of the key points, this is central: “Real-world evidence has shown that Comirnaty [Pfizer] is safe for those who are pregnant and breastfeeding.”
The “real-world evidence,” mainly relied upon, is the preliminary findings of a study published on the website of the New England Journal of Medicine (NEJM) on 21 April 2021. This is the conclusion:
“Preliminary findings did not show obvious safety signals among pregnant persons who received mRNA Covid-19 vaccines. However, more longitudinal follow-up, including follow-up of large numbers of women vaccinated earlier in pregnancy, is necessary to inform maternal, pregnancy, and infant outcomes.”
Notice the word “preliminary” and the need for follow-up longitudinal studies. But anyway, back to the Government’s decision guide, where it is noted: “This [NEJM] study also reported the pregnancy outcomes for 827 people whose pregnancies were completed. They did not identify any safety concerns for those who received an mRNA COVID19 vaccine in pregnancy.”
Hold on here, subsequently (September 8), the NEJM published a letter on its website validly questioning the statistical methodology of the study. To wit: “As stated in the article [the study], among the 827 participants with a completed pregnancy, 700 received their first eligible vaccine dose in the third trimester. These participants should be excluded from the calculation [of spontaneous abortions] because they had already passed week 20 when they received the vaccination.” In other words, the conclusions of the study are worthless. The study relied upon in the Government’s decision guide for pregnant women.
Now, true, the authors of the study cobbled together additional research (also referenced on the NEJM website on September 8) before reaffirming their conclusion. But, I suspect, there might be more to play out. In any event, are (provisional and qualified) preliminary findings compelling enough evidence to advise pregnant women that the vaccines are safe?
I’m not a doctor. I’m not saying that pregnant women should not get vaccinated. Apparently getting Covid-19 presents distinct risks for pregnant women and their babies. What I’m querying is whether the headlong rush to have everyone vaccinated, is taking away from the abundance of caution which is normally applied when prescribing medicine to pregnant women (and I should add to children).
(PS: For clarification, I am not the Peter Smith, who as a guest of doverObeach, wrote that excellent preceding piece.)