Did Pfizer stop recruiting for their pregnancy trial because of adverse events in infants?

I would not put it past them

I had been keeping my eye on this Pfizer trial of pregnant women. It’s unique because it’s a randomized study which they, imo, really sold to the public. We will have 4,000 women in the trial, they said. But then, a few months back, I was talking to Marty Makary and he said “whatever happened to that Pfizer trial”? I had to admit, I did not know. What did happen?

Marty then wrote an article in Tablet pointing out it was never completed. But the CDC, true to form, made a decisive recommendation for pregnant women to get vaccinated without the critical supporting data.

There is nothing surprising here.

But then something happened. Someone very close to me- who honestly has played faithful devil’s advocate with me all along and my concerns about the COVID vaccines- asked “are the COVID-19 vaccines safe to take during pregnancy? What do we know?” This person (not a physician) is one of the smartest people I know and I answered the only thing I could: “I don’t think we know.” He said that is what he suspected.

A lot of people cite observational data. But this is really problematic. In most places, women who get vaccinated tend to be healthier than those that don’t. You can see that in this recent JAMA Pediatrics Study from Ontario Canada. I actually use Ontario Canada as an example of a place with healthy vaccinee bias for the COVID-19 vaccines when I give my lecture on this topic!

As you can see above, the vaccinated women are more likely to have high income and less likely to be a minority. So you would expect worse birth outcomes in the unvaccinated and that is what they found. The question is: what would they have found in a randomized study where the two groups of women had the same baseline risk for adverse pregnancy outcomes?

Enter the randomized trial.

Today, I posted on X Pfizer had completed their randomized study but instead of enrolling the planned 4,000 moms-to-be, they enrolled 683 and only 161 women received 2 vaccines and 159 got placebo & completed the blinded period.

Why did the trial stop enrolling when it was so tiny? Did they not have enough money to fund the full trial? 🤔 Lol. No, that’s not it…

Could it be they found a concerning signal and did not want to chance letting it become significant? 🤔 Hmmm. That sounds more likely.

Could it have been this 👇🏻? That 5.1% of infants of vaccinated moms had adverse events of special interest (AESI) between birth and 6 months while only 1.3% of infants in the control arm had AESIs?

Because they limited the size of the trial, Pfizer can always say they didn’t find a significant signal. But if they don’t look, how can they find it?

Please note we don’t know what these adverse events were. Pfizer also didn’t report any efficacy data.

Also, why are there only 156 infants in the vaccine arm and 159 in the placebo arm when 161 women received the vaccine and 159 received the placebo (and completed the blinded period)?

We don’t know because they fail to report the pregnancy outcomes such as miscarriage/fetal loss. Why do a vaccine safety in pregnancy study and not report the pregnancy outcomes?

They did however report some outcomes in the infants and there were higher rates of atrial septal defect, meconium aspiration, low Apgar scores, bronchiolitis, low birth weight, jaundice were higher in the vaccine group (again none of this appears significant, which is expected owing to the trial’s very small size)… but how well did the vaccine protect against COVID-19 you ask? We don’t know. And the FDA did not ask for the data.

And the CDC. Why did they act so certain the mRNA covid vaccines were safe and effective in pregnancy? The answer is the same as it ever was: either they were basing their guidelines on feelings instead of data or, even worse, they were simply repeating what they were told to say.