NIH Claims Pregnant Women and Newborns Can Benefit From COVID-19 Boosters Based on Flawed Study Data

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The National Institutes of Health (NIH) says mothers and their newborns can benefit from COVID-19 vaccine boosters given during pregnancy after a study showed significantly higher antibody levels in the cord blood of babies born to women who received a booster during pregnancy compared with those who only received the two-dose primary series.

Yet the study cited had some major limitations. It used monovalent COVID-19 vaccines that are no longer available in the United States, did not assess the effectiveness of the vaccine against currently dominant COVID-19 variants, did not provide safety data for a third vaccine dose, and determined the vaccine would be protective based on neutralizing antibody levels alone.

MOMI-VAX Study Findings

In a Multisite Observational Maternal and Infant Study for COVID-19 (MOMI-VAX) published Aug. 14 in the journal Vaccine, researchers at the Infectious Diseases Clinical Research Consortium followed more than 500 pregnant women and their newborns from July 2021 to January 2022 across nine academic sites.

Of the 240 participants whose results were included in the study, 167 received the two-dose primary series of either Moderna or Pfizer’s COVID-19 vaccine during pregnancy, and 73 received a booster dose, also during pregnancy.

Researchers aimed to understand the immune response following vaccination and to determine how much protection against illness vaccines provide. Additionally, they sought to specify whether antibodies from COVID-19 vaccination transfer to babies from vaccinated mothers across the placenta.

According to the study, pregnant women who received a booster dose had substantially more antibodies against SARS-CoV-2, in their own blood and cord blood, compared with those who only received two doses, suggesting that boosting increased their newborns’ protection against COVID-19.

“Findings support the use of a booster dose of COVID-19 vaccine during pregnancy,” the researchers concluded.

Lack of Safety Data

The MOMI-VAX study is sponsored and funded by the National Institute of Allergy and Infectious Diseases—a division of the NIH.

Although both the authors and the NIH said the study’s results support boosting pregnant women, the paper did not provide any data on adverse events experienced by pregnant participants after the initial primary series or after receiving a booster dose, nor was it explained why more than 250 pregnant women were excluded from the study’s results.

Data analyst Albert Benavides has been tracking adverse events reported following COVID-19 vaccination in pregnant women since the rollout.

“The data is very concerning,” Mr. Benavides told The Epoch Times in an email. “Nearly fifteen percent of all pregnancies reported involve spontaneous abortions, not including other types of fetal demise or even maternal death.”

“The NIH suggesting COVID-19 vaccination and boosting during pregnancy benefits pregnant people and newborns is extremely dangerous,” Dr. James Thorp, a maternal-fetal medicine specialist, told The Epoch Times in an email.

No matter how many studies are published to the contrary, Dr. Thorp said COVID-19 vaccines have not been proven safe for pregnant women, as evidenced by Pfizer’s 2021 cumulative analysis of post-authorization adverse events (pdf) showing 1,223 deaths in the first 10 weeks of the COVID-19 vaccine rollout, an 81 percent miscarriage rate, a nearly sixfold increase in fetal death, a 7.9 times increase in neonatal death, and breastfeeding complications in 14.7 percent of newborns.

Data from the Vaccine Adverse Events Reporting System released Aug. 4 by the Centers for Disease Control and Prevention show 9,203 pregnant women reported adverse events related to COVID-19 vaccines, including 5,327 reports of miscarriage or premature births between Dec. 14, 2020, and Aug. 4, 2023.

Lack of Bivalent Vaccine Data

The NIH is recommending pregnant women receive the initial two-dose series that now consists of bivalent COVID-19 vaccines, in addition to recommended boosters, despite the study in Vaccine using monovalent vaccines and both Pfizer and Moderna stating there is no available data regarding the safety of using bivalent vaccines in pregnancy. In addition, the FDA has announced it is once again changing the COVID-19 formula this fall.

The U.S. Food and Drug Administration (FDA), on April 18, 2023, amended emergency use authorization for the Pfizer-BioNTech and Moderna COVID-19 vaccines authorizing current bivalent vaccines for all doses administered to individuals 6 months of age and older. In doing so, the monovalent versions of mRNA vaccines used in the MOMI-VAX study are no longer authorized for use in the United States.

The original monovalent vaccine used in the study for primary and booster doses targeted only the original Wuhan variant. The bivalent vaccine, first authorized as a booster on Oct. 12, 2022, targets the obsolete Wuhan variant and the Omicron BA.4/BA.5 subvariants.

According to the FDA, the 2023-2024 formulation of COVID-19 vaccines for use in the United States beginning this fall will consist of a monovalent COVID-19 vaccine with the XBB-lineage of the Omicron variant.

The FDA’s Healthcare Provider Factsheet (pdf) for Moderna’s bivalent COVID-19 vaccine states: “Available data on Moderna COVID-19 vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy. Data are not available on Moderna COVID-19 vaccine, Bivalent, administered to pregnant women.”

The FDA’s Healthcare Provider Factsheet (pdf) for Pfizer’s bivalent COVID-19 vaccine states: “No data are available regarding the use of Pfizer-BioNTech COVID-19 Vaccine, Bivalent during pregnancy.” It further states, “Available data on Pfizer-BioNTech COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy.”

Boosters are now being recommended to pregnant women based solely on antibody levels generated by vaccines that are no longer authorized for use in the United States. In addition, the bivalent vaccines pregnant women will receive if they’re boosted will be replaced this fall, and there are no available data to assess vaccine-associated risks to pregnant women.

FDA Admits Antibody Levels Do Not Indicate Vaccine Protection

Although the NIH and authors of the study in Vaccine recommend boosting pregnant women based on antibody levels generated after giving women a third vaccine dose, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) established during previous meetings that antibody levels do not necessarily correlate with vaccine protection and called for the FDA in 2022 to establish a better way of measuring vaccine effectiveness.

For example, in a June 28, 2022, VRBPAC meeting, vaccine advisors met to decide whether the monovalent booster computation should be changed to include a strain targeting Omicron subvariants.

Dr. Ofer Levy, VRBPAC member and an infectious disease physician at Boston Children’s Hospital, voted in favor of changing the COVID-19 booster computation from a monovalent to a bivalent vaccine despite an admission by Pfizer’s representative that there is “no established correlate of protection,” referring to the level of antibodies needed to confer protection.

“You have a lot of data now,” Dr. Levy told Pfizer. “What is your relative protection?”

“I would say there is no established correlate of protection,” Kena Swanson, vice president of viral vaccines at Pfizer, told Dr. Levy (pdf).

Later during the meeting, Dr. Levy said he wanted the FDA to explain what their “overall approach will be in the coming year around improving our understanding of correlate protection.”

“We spend a good amount of time reviewing antibody data. We have no doubt antibody data is important. We don’t have a level of antibody that anybody is comfortable stating is correlated [with] protection,” Dr. Levy said. “So yes, the antibodies are important but so are the T cells.”

T cells are a type of white blood cell that helps the immune system fight germs and ward off disease and can be a measure of determining whether a vaccine is effective at providing protection. During the same VRBPAC meeting, Dr. Levy said federal leadership was needed to establish a T cell assay standardization and to encourage and require sponsors like Pfizer and Moderna to gather that information.

“This is an effort that’s critical not just now but for future cycles of vaccine revision,“ Dr. Levy said. ”If we aren’t able to define a correlate of protection, we are fighting with one arm tied behind our back.”

Dr. Peter Marks, director of the Center for Biologics Evaluation and Research within the FDA, said the agency had “conversations” with their colleagues at the NIH and throughout the government about how they might move forward from here.

“It is something that we don’t have an answer to yet,” Dr. Marks said at the time.

Dr. Marks said as vaccines are developed in the future, it will “become even more important” to define a standard of correlate protection because “we won’t be able to have a large naive population to vaccinate with newer vaccines.”

Dr. Paul Offit, VRBPAC member and director of the Vaccine Education Center and professor of pediatrics in the Division of Infectious Diseases at Children’s Hospital of Philadelphia, also raised concerns about using antibody levels as the benchmark for whether a COVID-19 vaccine is effective.

In a July 6, 2022, interview with ZDoggMD, Dr. Offit said he voted against changing the monovalent vaccine to a bivalent vaccine due to a lack of critical data.

“They looked at virus-specific neutralizing antibodies against omicron and … found … when you got the omicron boost, you had a 1.75-fold increase in neutralizing antibodies against omicron,” Dr. Offit said. “Well, the question is, what does that mean? What does that number mean? And the answer is, I think while statistically significant, I don’t think that’s a clinically significant difference.”

Dr. Offit pointed out that when looking at the original COVID-19 vaccines authorized mid-December 2020, there was a twofold difference between Moderna and Pfizer regarding neutralizing antibodies.

“Moderna had a twofold increase in neutralizing antibodies as compared to Pfizer. That did not translate into a clinically significant difference in terms of protection against severe disease, which is the goal of this vaccine,” Dr. Offit pointed out.

More than a year later, the FDA still has not established a correlate of protection. Yet regulatory agencies continue to recommend vaccinating pregnant women with COVID-19 vaccines, including boosters, based on antibody levels alone.

The Epoch Times reached out to the NIH for comment with no response at the time of publication.