Saturday, July 3, 2021

CDC/FDA/NEJM paper on pregnancy vaccinations

I (and several others it seems) failed to take into account the short 2.5 month period during which the data were collected for this study.  That means women vaccinated in their first or second trimester did not have enough time to have a full term pregnancy.  The early miscarriages were logged, but because the study only looked at completed pregnancy outcomes, no full-term births for those inoculated early in pregnancy had time to occur.

So the miscarriage rate, compared to the rate of normal births, cannot be calculated from these data. 

But 4 months have elapsed since the data collection ended.  So CDC now has 4 more months of data, and the necessary calculations could be made at this time or in the near future. Then we would know about the benefit vs risk in pregnancy.  

Please excuse my error.


Meryl Nass, M.D. said...

Dr. Nass, this NEJM paper published in April and again in June needs a lot of exploration, particularly because data parameters may be unclear based in part on what lead author Dr. Shimabukuro of the CDC reported March 1 to ACIP on pregnancies and V-Safe data; and in NEJM paper later on, with ostensibly NINE more days of data, from Feb. 20-Feb. 28. Shimabukuro, March 1, 2020 report to ACIP: "[V-safe pregnancy registry enrollment as of February 19, 2021. . .Enrolled N=1,815]" "[In the enrolled population, there have been 275 completed pregnancies, including 232 live births]" The ACIP reports 15% of 1,815 participating in a “V-safe pregnancy registry enrollment as of February 19, 2021” had miscarriage at less than 20 weeks of gestation. This report does not specify a count, thus range could be from 263 to 280; of which “93% of these were pregnancy losses <13 weeks of age.” This report says the "background rate" of miscarriage at 26%, versus Shimabukuro reporting 15%. The Shimabukuro/NEJM paper states: "[persons enrolled in the v-safe pregnancy registry who were vaccinated through February 28, 2021 (3958 persons)]" and ["Data on pregnancy loss are based on 827 participants in the v-safe pregnancy registry who received an mRNA Covid-19 vaccine (BNT162b2 [Pfizer–BioNTech] or mRNA-1273 [Moderna]) from December 14, 2020, to February 28, 2021, and who reported a completed pregnancy.]" This Shimabukuro data: Spontaneous abortion <20 weeks: 104/827 (12.6%) Published Incidence [background rate?]: 10%–26% [[104/827 (12.6%)]] ++ ++ In nine days, from 1,815 enrolled, as of Feb. 19, 2021; to 3,958 enrolled as of Feb. 28, 2021, for the NEJM paper first published in April and again in June. This is 2,143 additional enrolled in nine days. Is all of this accurate, and / or is the March 1 ACIP based on all the data available at the time, etc. etc.? 275 completed pregnancies -- with "232 live births" --; versus 827 completed pregnancies and "a live birth in 712", [according to the Shimabukuro data presented to ACIP March 1 vs. NEJM paper] This is the confusion, in a nutshell. Since just about all deaths occurred less than 20 weeks of gestation. The proportions or percentages used to calculate the "background rate" or "published incidence" rate are based on less than 20 weeks. However, the data reported by Shimabukuro in both the ACIP and the NEJM --- CALCULATE THIS USING THE "V-safe pregnancy registry overall" number that includes the full term, for ACIP; and ditto for NEJM. At least this is what this appears to my eyes. And therefore, Shimabukuro is grossly deflating the percentages IN TERMS OF EXPECTED OUTCOMES: by --- using as denominator the full term numbers in the March 1 ACIP report and the NEJM paper; at least this is what it appears. Help us out here, Dr. Shimabukuro.

Anonymous said...

The paper presented in the NE Journal seems intentionally deceptive. The numbers were presented in a way to hide issues with the recommendation that mRNA vaccines are safe for pregnant women.

In the data set used for this study, women for the mRNA gene-editing procedure at different times during the 39 weeks. This means there is difficulty using aggregates to draw broad conclusions. This is especially so, since we are talking about a study subject that is changing rapidly, both mother and child, during the period of review.

There is a very alarming result in this study that appears to have been covered up by the good doctor who wrote the paper.
Of the 127 women who received the gene-editing procedure (aka vaccine) before week 20, 104 had a spontaneous miscarriage. That means 82% of the babies DIED - if the mothers received the mRNA injection before week 20 of their pregnancy.

The good Dr. Shimabukuro tried to hide this fact by using in the denominator an additional 700 women who got the injection later than week 20, and than reported a rate of ~12%.


Anonymous said...

12 live births; and only data from at most 127 pregnant woman vaccinated in trimesters 1 or 2 examined

12 live birth is the result, from gestating women -- that got a covid vax in first or second trimester: from 827 “completed pregnancies,” according to V-SAFE data, NEJM study reports.

And, data involving at most 127 pregnant woman vaccinated in trimesters 1 or 2 has been examined.

Keep in mind the NEJM received correspondence post March 1, 2021 – when Dr. Tom Shimabukuro, MD, MPH, MBA, of the CDC, who is of their “COVID-19 Vaccine Task Force Vaccine Safety Team” . . . when on March 1 he presented the first look at the V-SAFE data.

This was based on V-SAFE data through Feb. 19, “COVID-19 vaccinated pregnant women as of February 18, 2021”; and “Characteristics of COVID-19 vaccine pregnancy reports to VAERS through February 16, 2021”.

To this day, the V-SAFE data remain hidden to the public, and is not accessible online to any of us; except what’s in the NEJM paper authored by Shimabukuro et al. VAERS, make of it what you will –

Keep in mind the NEJM response to correspondence germane to the Shimabukuro March 1 claims, that he reported to the CDC’s Advisory Committee on Immunization Practices (ACIP) – was to publish more Shimabukuro, on April 21, 2021.

On June 17 NEJM published it again, that includes in the paper, this: “Editor’s Note: This article was published on April 21, 2021, at”

A completed pregnancy is when it is terminated, either with
1] spontaneous abortion: conception < 20 weeks
2] stillbirth [abortion]: 20 weeks < birth
3] a new-born emerges from womb, a live birth

The Shimabukuro NEJM paper delineates as follows:
1] “attempted to contact 5,230 persons who were vaccinated through February 28, 2021”
2] 3,958 enrolled and found eligible, of whom 3,865 got shot in:
3] first trimester <14 weeks = 1,132
4] second 14<28 weeks = 1,714
5] third trimester 28> = 1,019

The NEJM says
1] 827 “completed pregnancies”
2] 712 “live births”
3] 115 dead babies – 104 spontaneous abortions; 10 induced abortions; 1 stillbirth

The NEJM says: “700 of 712 pregnancies that resulted in a live birth (98.3%) were among persons who received their first eligible vaccine dose in the third trimester.”

1] 12 “live births” were among those that received covid shot < 24 weeks of gestation: in semester 1 or 2; 2] the paper does not delineate the 12 births, to show first or second trimester

Comment A:
1] 827 completed pregnancies analyzed in paper out of 3,865 that got the shot, or 21.4% of 3,865.
2] Why, more than four months after the Shimabukuro March 1 report to CDC: only 21.4% barely 1 in 5?

Comment B:
1] 84.6% -- at least 84.6% of completed pregnancies examined, 700 of 827, got shot in third trimester
2] 15.4% -- at most 15.4% of completed pregnancies examined, 127 of 827, got shot in 1 or 2 trimester
3] Why, more than four months after the Shimabukuro March 1 report to CDC: only 127 pregnancies in 1 or 2 trimester examned?

Dr. Shimabukuro, help us out.

A Post Script under separate post on matter of expected rate of spontaneous abortion will be posted, soon, should Dr. Nass be so kind.


Anonymous said...

According to Nathan Thomas, MD, “Fifteen to 20 percent of recognized pregnancies end in spontaneous abortion”

Note that the ‘expected rate’ of spontaneous abortion used in the NEJM paper and the Shimabukuro March 1 report to the CDC rely on this – an “estimate”: “It is estimated that as many as 26% of all pregnancies end in miscarriage and up to 10% of clinically recognized pregnancies”

What is this parameter, what is the expected value here? Apparently, we have one? “up to 10% of clinically recognized pregnancies.” But what is it for spontaneous abortions?

The April 21 NEJM paper states: “Published Incidence” at “10% to 26%.

The March 1 report to CDC states: “Background rates” of “26%”

If goal is to accurately delineate any potential risk from covid vax to pregnant women, the above is garbage, or at least, worthlessly imprecise.

Survival increases during first trimester the longer the gestation period.

Thus, we need – from the CDC, from Dr. Shimabukuro et al., from the NEJM, etc. a serious recognition of this fact.

Otherwise this is a failure or at best, is not being serious about this potentially catastrophic situation with pregnant women getting vaxed.

A parameter, or a statistic, of the actual expected value of spontaneous abortions < 20 weeks and in particular, the first trimester, <13 weeks is sine qua non.

Because otherwise, without an expected value, how can we detect any signal that something is wrong? Of course, more and more are saying that sort of slap dash has been the CDC game all along, and is this also the NEJM game? Who else is playing this game? This is not a game, dear Medical Overlords; please act like medical experts instead of rank jackasses.

Why can't you all just: Add the requisite number of columns to the charts to properly delineate this essential information, assuming you are all serious about detecting signals 'based on science'.


“For the first time, the rate of spontaneous abortion is reported in a multicenter study of three different gynecological centers. In 1987 and 1988, the average spontaneous abortion rate in 315 pregnancies was 3.3%, after foetal heart actions had been verified by ultrasonic examination between the 7th and 12th week of gestation. A statistical significance has been calculated between the spontaneous abortion rate of 6.3%, if foetal heart beats were seen between the 7th and 9th week, and the spontaneous abortion rate of 1.0% with an evidence of foetal life (p less than 0.01) between the 10th to 12th week of gestation. The rate of spontaneous abortion of women above 34 years of age (8.9%) is statistically different (p less than 0.01) to that of women under 35 (1.9%). In women older than 34, the spontaneous abortion rate before the 10th week of gestation is 22.2% in contrast to 3.2% of women younger than 35 (p less than 0.01). Considering the evidence of foetal heart actions between the 10th and 12th week, the spontaneous abortion rate of women above the age of 34 is 1.9%, compared to 0.8% of women younger than 35. The statistical higher spontaneous abortion rate of women above the age of 34 before the 10th week of gestation and the lack of statistical difference of the abortion rate in this defined age group for foetal life to be proven from the 10th week on, should be an argument in favour of the 10th week of gestation as the earliest date of prenatal diagnosis.”

From a 1990 study, “Rate of spontaneous abortion in relation to the time of fetal viability assessment”

Published at NIH.GOV


Anonymous said...

I concur, based on what NEJM published, and despite their incomplete data, with Stephanie Seneff, senior research scientist at MIT,

"Stephanie Seneff

Jul 3
Peer-reviewed NEJM article on COVID vaccines and pregnancy got it terribly wrong.
They used the wrong denominator to get 12% miscarriage rate. Among first trimester women, the rate was 82%."

I would say: of 827 completed pregnancies, at least 700 were from third semester covid 19 vax shots.

Thus, at most, 127 otherwise, either trimester 1 or 2/

Thus at least 104 spontaneous abortions, divided by at most 127, equals a miscarriage rate of at least 81.88976%

104/127 = 82%