An Open Letter to NEJM Editors: Indiscriminate COVID-19 Vaccination of Pregnant Women With Recent SARS-CoV-2 Infections May NOT Be Safe.

It may not be safe for pregnant women with asymptomatic, mildly symptomatic or recent SARS-CoV-2 infections to undergo indiscriminate COVID-19 vaccination.

Dear Dr. Rubin,

I am writing your in your capacity as the editor-in-chief of the New England Journal of Medicine (NEJM).

Yesterday, April 21, 2021, NEJM published a paper entitled “Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons” by Shimabukuro et al.

In this article, the authors state that “Preliminary findings did not show obvious safety signals among pregnant persons who received mRNA Covid-19 vaccines.”

A total of 35,691 pregnant women were studied, who received either the Pfizer or the Moderna mRNA vaccines. Superficially glanced, this may appear to be a relatively large subject group of pregnant women studied, in whom no statistically significant complications seem to have occurred. Certainly, this “bird’s eye” surveillance does suggest that the COVID-19 mRNA vaccines are safe in the vast majority of patients — as they are in the case of the overall population.

However, as I hope you know, safety for a majority does NOT guarantee safety in minority subsets of persons at risk and it certainly CANNOT obviate duty to identifiable minority subsets of persons, who are or may be at risk of serious injury or death.

As you know, my specific safety concern and prognostication about the COVID-19 vaccines has been that with millions of persons across the world recently or asymptomatically infected with SARS-CoV-2, indiscriminate vaccination of such persons could pose a risk of serious injury or death to at least some in this subset.

Unfortunately, the study by Shimabukuro et al. only included a total of 78 patients with SARS-CoV-2 infections (Table 3). Of this group 56 had infections before vaccination, 10 had infections ≤14 days after first eligible dose of vaccination, and 12 had infections >14 days after first eligible dose of vaccination.

Any public health expert, or even member of the laity, could easily recognize that 78 patients, some of whom may have had natural infections months prior to their vaccination, is a totally insufficient subset analysis to be able to claim safety with any degree of statistical confidence.

Dr. Eric Rubin is the chief editor of the New England Journal of Medicine. Sadly, in the past NEJM editors have demonstrated a clear bias towards utilitarian “majority benefit” — and a shocking inability to size up, identify and mitigate against “minority harm”. The COVID-19 pandemic seems to be no different.

In other words, let’s say that the incidence of serious complications after indiscriminate COVID-19 vaccination in asymptomatic or mildly symptomatic infected pregnant women is one in several hundred, a subject group containing less than 78 such women is highly unlikely to capture the safety signal. The Shimabukuro et al. study is simply NOT powered enough to answer this critical safety question.

Additionally, Shimabukuro et al. have made no effort to even determine if the recently infected women included in their study experienced any more severe symptoms than their uninfected counterparts. So not only is this subset under-powered to answer a safety question, it is also totally under-analyzed for evidence pointing to a potential safety concern.

It is critical for you to note that this particular subset I have raised concern about is not a random or small subset of women at potential risk of harm by indiscriminate COVID-19 vaccination— there are literally millions of pregnant women across the world at any moment in time. And because of the pandemic nature of COVID-19, it is likely that a significant proportion of these expecting mothers have asymptomatic, mildly symptomatic or recent SARS-CoV-2 infections. Unfortunately, the NEJM paper by Shimabukuro et al. does NOT demonstrate the safety of the COVID-19 vaccines in these women. Therefore, In the absence of convincing safety data to justify COVID-19 vaccination in the subset of pregnant women with asymptomatic, mildly symptomatic or recent infections it is impossible to ethically endorse indiscriminate COVID-19 vaccination in ALL pregnant women.

BUT, given that it is imminently feasible to exclude the recently infected and naturally immune from the pool of pregnant women being vaccinated, it is incumbent on the US FDA and CDC to immediately establish a guidance to screen all pregnant women for evidence of natural SARS-CoV-2 infection.

It is my opinion that any pregnant women whose PCR or Rapid Antigen Testing for SARS-CoV-2 yields a positive result should be supportively cared for and delay their vaccination until after delivery. Furthermore, any pregnant women with serology evidence of natural immunity to SARS-CoV-2 should be advised to delay their vaccination until after delivery.

I am very concerned that the mainstream media and the CDC are misusing the NEJM paper by Shimabukuro et al. to encourage indiscriminate vaccination of pregnant women — in a setting where there is good scientific and clinical rationale, along with no convincing safety data, to be concerned that recently naturally infected pregnant women may be at risk of serious harm.

Here I write to inform you of your duty to immediately call for a halt to indiscriminate COVID-19 vaccination of pregnant women — and to focus your colleagues’ attention on the need for institution of a #ScreenB4Vaccine practice guidance to maximize safe COVID-19 vaccination of pregnant women.

Dr. Rubin, my final request of you is that if you have daughters or granddaughters of child-bearing age, ask yourself: “Would I encourage her to take the COVID-19 vaccine if there is any chance she is asymptomatically or recently infected — or if she is already naturally immune?” If your answer, as the chief editor of the nation’s most prestigious medical journal is “YES”, then I believe that our entire medical system has failed. And I shall pray that your answer to my question is “NO”.

I write here in defense of US public health, in defense of minority subsets of people in harm’s way and in the name of Dr. Amy Josephine Reed of Yardley, PA.

Hooman Noorchashm MD, PhD

Hooman Noorchashm MD, PhD is a physician-scientist. He is an advocate for ethics, patient safety and women’s health. He and his 6 children live in Pennsylvania.

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