By Peter C Gøzsche
Today, Carl Heneghan and Tom Jefferson published a highly revealing comment about Pfizer’s trial of its mRNA COVID-19 vaccine Comirnaty in pregnant women and about the kind of advice authorities provide.
The package inserts from the UK, the EMA, the FDA and Canada are cautious, saying that safety data were not available about use in pregnancy.
In contrast, the US Centers for Disease Control and Prevention (CDC), the UK Health Security Agency and the UK National Health Service informed the public that “It’s safe to have the vaccine during any stage of pregnancy.”
The effect of such reckless and horrible misinformation is that people lose trust in the authorities and might refuse to take vaccines that are much, much better than the COVID-19 vaccines, which, moreover, are pretty superfluous because virtually all of us have been infected by now, including my wife and me even though we got two doses of Pfizer’s vaccine.
Four years ago, Pfizer announced with great fanfare in the press that it is critical to develop a vaccine that is safe and effective for pregnant women, and they planned to recruit 4000 women.
Two months ago, Pfizer quietly uploaded their results in a trial register, with no fanfare. So, what did they do and what did they find? It took Pfizer four years to recruit 348 women!
Worse still, women were only enrolled if they had been pregnant for at least 24 weeks. But when do foetal abnormalities develop? In the first trimester, which is up to 12 weeks.
Pfizer’s rigged trial goes directly against FDA advice that “study participants should be representative of a typical patient population for the drug to be studied including race, ethnicity, and trimester of pregnancy.”
The data in Pfizer’s trial showed an increased risk of congenital malformations, adverse events of special interest, including significant congenital anomalies and developmental delay, and preeclampsia. We have no idea whether these are signals to worry about, as none of the risks were statistically significant.
Pfizer argued that they terminated the trial “due to enrollment challenges into a placebo-controlled trial as a result of universal recommendations for COVID-19 vaccination of pregnant women and the increased global availability of COVID-19 vaccines.”
I once worked in the drug industry where I did clinical trials. I am convinced that if Pfizer had wanted to, they could have recruited the planned 4000 women. Moreover, there is no excuse for avoiding the first trimester if one wants to find out if a drug has teratogenic effects. Pfizer seems to have had an extreme lack of interest in getting data on this vitally important issue.
I agree with Carl and Tom that women of reproductive age should not be exposed to Pfizer’s vaccine – or to any other COVID-19 vaccine. They have likely all been infected with COVID-19 and have acquired a much better immunity than any vaccine can provide.