In December 2020, just before the vaccines for COVID-19 were first released to the public, Dr. Mandy Cohen, the Secretary of the Department of Health and Human Resources in North Carolina, urged everyone to get vaccinated as soon as they were able. “Corners were not cut,” Cohen said with confidence.
Then as now, pregnant women asked if COVID vaccines were safe for them. Public health officials said “yes” when the correct answer should have been “we don’t know yet,” given that pregnant and breastfeeding women were excluded from the original COVID vaccine trials. With Cohen set to replace Dr. Rochelle Walensky as director of the Center for Disease Control at the end of June, it is a good time to consider how Walensky performed on COVID—and in particular, on Women’s health issues—and ask whether Cohen will be any different.
In February 2021, to settle the controversy over whether the COVID vaccines should be used during pregnancy, Pfizer launched a randomized controlled trial of 4,000 pregnant women. But five months into the study, after enrolling 349 women, the study mysteriously stopped recruiting. Pfizer never offered a reason. Most concerning, the pregnancy outcomes of those who participated in the trial, and their babies, are still not public today, nearly two years later.
But the CDC did not wait for good data to make a decisive recommendation. In April 2021, just four months after the COVID vaccine was first granted an emergency use authorization and two months into the then ongoing Pfizer pregnancy trial, Walensky decided not to wait for the trial results, and instead recommended that all “pregnant people” get the vaccine. Three months later, the American College of Obstetricians and Gynecologists (ACOG) followed the CDC and “enthusiastically” recommended it as well.
Concerned by the zealousness and absolutism of this recommendation in the absence of evidence, a group of scientists and I petitioned the FDA to add a disclaimer to the vaccine label stating that no randomized trial data is available on the vaccine in pregnant women.
A few months ago, the FDA’s Dr. Peter Marks wrote back to us, denying our request. “The Petition fails to explain how including the fact of no results being reported would be relevant information that would contribute to the safe and effective use of the vaccine,” he claimed.
In other words, women don’t need to know. Just get vaccinated.
Can a vaccine have a different safety profile in pregnant women than in the general population? There’s actually a precedent. The CDC advises that pregnant women not receive the HPV, MMR, or chickenpox vaccines, and instead recommends taking them before or after pregnancy, when indicated.
Remarkably, as the now outgoing CDC director—along with the ACOG—was pushing COVID vaccine absolutism for all pregnant women (regardless of preexisting natural immunity), a June 2021 New England Journal of Medicine editorial on COVID vaccines warned readers of “the dearth of safety information about pregnancy.” The article added the importance of waiting for Pfizer’s pregnancy trial to shed light on the matter, but alas, the early results are still locked up.
Pharma companies actually have a track record of halting trials that aren’t going their way and hiding results they don’t like. It allows them to control the narrative and manipulate markets. In many cases where data is hidden, Pharma companies play doctors like a fiddle.
A 2021 study by Yale, Stanford, and the University of Pennsylvania published in The BMJ found that out of 58 new drugs that the FDA approved in a two-year period, 33% did not make their trial results public, according to the researchers’ review of the data six months after the drugs’ approval. In 2004, Merck famously withheld clinical trial findings that Vioxx, their newly approved drug that was being used by 80 million Americans, increased heart attack risks. Vioxx was eventually pulled off the market.
In the case of the COVID vaccine trial in pregnant women, the trial may have been terminated not because the results were unfavorable, but because no data was needed. The medical and public health establishments had already made up their minds, declaring it safe and effective regardless of what the data was going to show. Why evaluate a product if the CDC and ACOG are already sold on the product?
Using the same groupthink science, the CDC and ACOG are now blindly recommending boosters and the new bivalent vaccine for healthy pregnant women, and once again ignoring the role of natural immunity. The ACOG website does not cite any clinical trials to back their recommendation, of course. Not only does the new bivalent vaccine lack any randomized trial data in pregnant women, it lacks any randomized trial data in humans (it was authorized based on data from eight mice).
Recently, public health officials went a step further and proposed the idea that people will need an annual COVID shot. That would mean that the average 5-year-old girl would need 77 mRNA COVID vaccine shots in her lifetime. Given the known risks of myocarditis and blood clots with each shot, such a sweeping recommendation should be based on trial data, not dogma. A recent study authored by Dr. Joseph Fraiman in the journal Vaccine identified the rate of “serious adverse events” after the COVID vaccine to be 1 in 662 doses.
To their credit, ACOG’s website does acknowledge COVID vaccination could delay menstruation. A large COVID vaccine study published last July found that “periods were late by less than 1 day on average.” When asked about this, Dr. Anthony Fauci told Fox News’ Bret Baier, “The menstrual thing is something that seems to be quite transient and temporary. We need to study it more.” But saying for two years that we don’t have enough studies is ironic when Fauci himself commanded an annual research budget of $6 billion. A Swedish study published last month in The BMJ found that an adjusted 26% increased risk of menstrual disturbance after the COVID vaccine in women age 12-49.
Since early 2021 women were reporting changes to their periods and unexpected vaginal bleeding, calling for proper study. Last October, the European Union’s regulator advised that “heavy menstrual bleeding” be added as a side effect on Pfizer and Moderna vaccine labels. Here in the U.S. there’s been no such update to product labeling.
This lack of humility was also evident when healthy young women were told with incredible absolutism that the COVID vaccine cannot affect fertility. The right answer should have been: We don’t think it will affect fertility but we don’t have any good data on the question. A Journal of the American Medical Association (JAMA) study published last fall concluded that, “Findings of this study suggest that receipt of the first inactivated COVID-19 vaccine dose 60 days or less before fertilization treatment is associated with a reduced rate of pregnancy.”
The medical establishment has also blindly pushed for universal COVID vaccination and boosters in lactating mothers. This recommendation came before a study in JAMA Pediatrics discovered vaccine mRNA particles in breast milk. The finding was so unexpected that it became the journal’s No. 1 most discussed study of 2022, according to the JAMA website. Coming in second was a study reporting myocarditis after COVID vaccination, and third was a study I authored with my teams at Johns Hopkins on durability of natural immunity. It’s telling that the most discussed JAMA studies of 2022 were all on topics that public health officials have consistently downplayed.
In the absence of good data, organized medicine chose the path of stern paternalism. But in my experience as a physician, it’s far better to properly inform a patient rather than steamroll their questions. It may be that Pfizer’s pregnancy trial would have been favorable to the vaccine, showing that the benefits outweigh harms, but Pfizer has not released the data. Perhaps the data was not favorable, or perhaps Pfizer realized they had convinced the medical establishment without data, so why run the risk of sharing what a placebo-controlled trial shows?
Perhaps the most famous example of hidden trial data is the 1989 Minnesota study that found there were more deaths in the group that ate a low-fat diet than in the control group that did not. The study was completed in 1973, 16 years before it was released to the public. When asked about the delay, the lead investigator, Dr. Ivan Frantz, famously said “we were just so disappointed in the way they turned out.”
The FDA recently authorized a second round of COVID bivalent vaccines for people over the age of 65, with no supporting clinical data. The authorization came a month after the FDA leaked to the press their intention to do so. This is the Biden administration’s new way of running the FDA. Leak something to the media, gauge public backlash, and fast track authorization of the drug without the supporting data typically required.
Is the COVID vaccine safe in pregnancy? Probably. But cutting corners on research and pushing vaccines without data is dangerous. It’s probably why 58% of women under age 50 say they do not trust public health officials when they say that the COVID vaccine is safe and effective in pregnancy, according to a University of Pennsylvania study published last month. Overall trust in the CDC is down from 69% pre-pandemic to 44% today. Dishonesty has consequences.
Even if the vaccine’s benefit outweighs the risks in healthy pregnant women, a review of 65 studies published in The Lancet in February concluded that natural immunity is at least as effective as vaccinated immunity, and probably more effective. So why is the medical establishment blowing through so much political capital on a blanket campaign to immunize those already immune?
For those who think the boondoggle of COVID policy has ended, consider the fact that just two months ago, public health officials beclowned themselves by insisting Novak Djokovic could not enter the U.S. to play tennis outdoors because he’s not vaccinated. This position, known as Biden’s “Djokovic doctrine,” embodies persistent errors in public health groupthink today, from ignoring natural immunity to downplaying vaccine induced myocarditis in young males to overlooking data on how extremely low risk the virus is for healthy young people to segregating people by vaccine status.
And just this week, the Biden White House required college athletes who won national championships visiting the White House to mask and stay six-feet apart if they are not vaccinated. Even if they have natural immunity. What does Mandy Cohen have to say about this standing policy still in place today?
To rebuild trust, the medical establishment—including physician associations and academic leaders—should be honest about what is known and unknown, rather than lock arms and broadcast its dogmas as science. For every subgroup in the population, medical science has long held high the principle of requiring data before making strong recommendations. Women should not be treated any differently.