According to an investigation by The BMJ, Pfizer failed to inform pregnant women in its trial of maternal respiratory syncytial virus (RSV) vaccine that trials of a similar vaccine were halted due to a potential risk of preterm birth.

Pfizer and GlaxoSmithKline (GSK) have been developing recombinant RSV F protein vaccines to inoculate pregnant women and supposedly protect their babies against RSV.

However, GSK halted its phase 3 vaccine trial in February 2022 due to a safety signal of the possible increased risk of preterm births and neonatal deaths.

“No clear explanation has been found for the increase in preterm births, and experts think that it might be unrelated to the vaccine. GSK told The BMJ that the imbalance was observed primarily in low and middle income countries and not consistently after a peak in late 2021, and that it was still investigating the cause of the preterm births but was no longer developing its vaccine,” The BMJ reports.

Although Pfizer was studying “preterm births as an adverse event of special interest in its own phase 3 trial,” the pharmaceutical giant “continued to enroll and vaccinate women for months after the news of the potential risk of preterm birth in GSK’s vaccine trial was made public,” the investigation found.

The BMJ provided additional details:

After GSK’s trial was halted, opinion was split among clinical trial ethicists and some vaccine researchers over whether Pfizer should have informed all women participating in its trial about the potential risk or updated its consent forms. Some think that only women who had not yet been vaccinated needed to be informed, whereas others think that because there is currently neither convincing evidence nor an explanation for the increased preterm risk, informing expectant mothers would have only caused unnecessary anxiety.

Charles Weijer, bioethics professor at Western University in London, Canada, told The BMJ that informing pregnant women in Pfizer’s trial about GSK’s results would have allowed women who had not yet received the jab to consider whether they still wanted to get it and women who had already received it to seek additional medical advice and follow-up. “Any failure to provide new and potentially important safety information data to trial participants is ethically problematic,” Weijer said.

The independent Data and Safety Monitoring Board (DSMB), which reviews and evaluates study data to protect participants’ safety and monitor the study’s progress, should normally have considered GSK’s results and decided if they merited attention, said Stephen Evans, emeritus professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine. “For Pfizer, the DSMB should have regularly assessed the benefit-harm balance, both on the data in the trial and whether the GSK results affected that balance. They should not base their decision simply on whether a particular result is ‘statistically significant.’ These are difficult decisions, and it is why DSMBs are independent of the company,’ he told The BMJ.

The DSMB for the Pfizer trial didn’t answer The BMJ’s questions about whether it had considered the GSK results, and two trial investigators told The BMJ that they hadn’t received any communication from the DSMB regarding the results. Pfizer has also been criticised for a passage in some of its trial consent forms, seen by The BMJ, saying that its vaccine candidate was risk-free for the baby; a research ethics expert described this assurance as “misleading” and “irresponsible.” Pfizer did not respond to The BMJ’s questions on the issue of informed consent.

According to The Epoch Times, “the British Medical Journal had to do serious leg work in order to figure this all out.”

“The BMJ article demonstrates Pfizer’s continued disregard for the law and patient choice,” attorney Thomas Renz told The Epoch Times via email.

“The entire point of informed consent is to ensure a patient can make a decision based on all available information. Rather than embracing the Nuremberg Code and American laws and regulations, Pfizer seems to view informed consent as a barrier to sales—something that causes vaccine hesitancy or drug hesitancy,” he added.

More from The Epoch Times:

“There should have never been a clinical trial in pregnant women studying any injections aimed at RSV in pregnant women,” Sasha Latypova told The Epoch Times in an email. “Pregnancy and potential to become pregnant is historically the most protected class of human subjects from clinical research because the risks and potential to cause inadvertent harm are too devastating to justify scientific interest in made-up subjects like RSV.”

Ms. Latypova is a retired pharmaceutical industry executive with 25 years of experience in pharmaceutical research and development and co-founder of several organizations that work with pharmaceutical companies to design, execute, collect data, and submit clinical trial data to the U.S. Food and Drug Administration (FDA).

According to Ms. Latypova, what was once considered a harmless cold has since been rebranded as RSV.

“The vast majority of parents have not heard of RSV if they have not been exposed to CDC fear-mongering and renaming of otherwise harmless common colds. The incidence or prevalence of RSV is not known precisely because it poses no danger to anyone,” Ms. Latypova said. “In the U.S., RSV is attributed as a cause of death to about 17 infants per year out of 4,000,000+ babies—based on a review of 12 years’ worth of death certificates.”

“Over a year after GSK’s trial was halted, The BMJ reported in May 2023 that experts had called for further analysis of Pfizer’s phase 3 trial data after the slight numerical increase in preterm births was seen,” The BMJ wrote.

“The imbalance was discussed a week later by the US Food and Drug Administration’s vaccines and related biological products advisory committee. Ahead of the meeting, the FDA published an analysis showing that there was no increase in preterm births in high income countries, but there was a numerical increase in upper middle income countries, driven particularly by South Africa,” the report added.

Ultimately, the FDA committee advised Pfizer’s maternal RSV vaccine candidate was “safe.”

Cont. from The BMJ:

The committee ultimately advised that Pfizer’s maternal RSV candidate was safe, although four of 14 members voted that the data presented by Pfizer were not adequate to support safety after a detailed discussion on the preterm births. Committee member Paul Offit, professor of paediatrics at the Children’s Hospital of Philadelphia, said in a meeting that Pfizer’s and GSK’s vaccines were “almost identical” and so was concerned by GSK’s results. Hana El Sahly, professor of molecular virology and microbiology at Baylor College of Medicine and committee chairwoman, said that the signal of increased preterm births connected to the Pfizer vaccine was “significant in the phase 2, in the phase 3, and in a very similar product,” adding that failing to design the Pfizer phase 3 study to deliver clarity was a “big missed opportunity.”

Regulators have taken different approaches when approving Pfizer’s vaccine, which is called Abrysvo. The FDA approved it with conditions, including only giving it to women who are 32-36 weeks pregnant. “Available data are insufficient to establish or exclude a causal relationship between preterm birth and Abrysvo,” said a warning included in the prescribing information. “To avoid the potential risk of preterm birth with use of Abrysvo before 32 weeks of gestation, administer Abrysvo as indicated in pregnant individuals at 32 through 36 weeks gestational age.” The FDA is requiring Pfizer to conduct postmarketing studies to “assess the signal of serious risk of preterm birth.”

The full report is available at The BMJ.

 

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