by Brenda Baletti, Ph.D., Childrens Health Defense:

The first post-authorization safety analysis of Pfizer’s Abrysvo RSV vaccine found the average time between vaccination and preterm birth was three days. Two-thirds of reported cases occurred within a week.

A new preprint study shows a statistically significant safety signal for preterm birth associated with Pfizer’s respiratory syncytial virus (RSV) vaccine, Abrysvo.

The first post-authorization safety analysis of Pfizer’s RSV vaccine — RSV prefusion F protein (RSVPreF) — found the average time between vaccination and preterm birth was three days.

Two-thirds of reported cases occurred within a week.

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“This study highlights ongoing concern about preterm birth among pregnant individuals following RSVPreF vaccination,” the authors wrote.

Canadian researchers at the University of Ottawa School of Epidemiology and Public Health assessed all adverse events reported to the Vaccine Adverse Event Reporting System (VAERS) database following RSV immunization between Sept. 1, 2023, and Feb. 23, 2024.

Among the 77 reports submitted to the database — 55% of which were classified as serious — preterm birth was the most common pregnancy-specific adverse event, followed by preterm premature rupture of membranes, cesarean section, cervical dilatation, and hemorrhage during pregnancy.

Other non-pregnancy-specific adverse events included headache, injection site erythema and injection site pain.

60-year history of RSV vaccine issues

Dr. David Healy, a drug safety expert, told The Defender that the RSV vaccines developed so far have a 60-year history of causing problems.

“It looks like our latest efforts to overcome these problems have not helped and are leading to preterm births which have lifelong knock-on effects along with more serious RSV infections in children where these should be harmless,” said Healy, author of “Pharmageddon.”

“Sixty years ago we recognized the problems and stopped. But now we seem determined to press ahead regardless,” Healy said. “The intense push to get these vaccines means we will all have affected family members — this is not an abstract concern,” he added.

The U.S. Food and Drug Administration (FDA) approved Pfizer’s Abrysvo for pregnant women in August 2023. In September 2023, the CDC recommended it be administered to pregnant women during weeks 32-36 of their pregnancies to protect babies from RSV-associated lower respiratory tract disease after birth.

The American College of Obstetricians and Gynecologists also recommends a single dose of Pfizer’s RSV vaccine for pregnant women.

In a BMJ letter to the editor on Monday, Dr. Peter Selley, a retired U.K. general practitioner, said the preliminary findings by the University of Ottawa researchers provide “good reason” why the U.K.’s vaccine advisory committee “should not rush … into making recommendations on an immunisation policy until further safety studies have been reported.”

Selley told The Defender that although the study is not yet peer-reviewed, it is published on a highly regarded preprint server, medRxiv. “It provides yet another pointer to preterm births being a problem,” he said.

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