Pfizer’s COVID-19 vaccine under FDA’s examination following new research into adverse side effects

pharmafile | January 13, 2023 | News story | Medical Communications  

The FDA, along with Taiwanese medical institutions, have been evaluating Pfizer’s mRNA COVID-19 vaccine, questioning the CDC’s omission of known severe “adverse events of special interest” (AESIs) which appeared in post-vaccination studies.

The FDA initially published its research in the Elsevier journal Vaccine in May, however this focused significantly on the oldest section of US society, rather than young people, who are now known to have greater post-vaccination risk for heart inflammation.

More recently, researchers have reviewed the Centers for Medicare and Medicaid Services data which covered more than 30 million elderly people, scouring the data for evidence of 14 “outcomes of interest” following vaccination against COVID-19. Pfizer’s vaccine was shown to meet “the threshold for a statistical signal” on increased risk for pulmonary embolism (54%), acute myocardial infarction (42%), full-body blood clots (91%) and a rapid decrease in platelet levels (44%). This data remained significant when compared to the “background rates from the flu-vaccinated population as the historical comparator.”

Dr Joseph Fraiman, who had co-authored a previous study in Vaccine about AESIs in vaccine trials and is on Florida’s new Public Health Integrity Committee, commented: “If FDA reported any other drug increased lung blood clots by 50%, can you imagine our media staying silent?”

However, FDA researchers have stressed that “more robust epidemiologic studies with adjustment for confounding, including age and nursing home residency, are underway to further evaluate these signals.” They continue, explain that the agency “strongly believes the potential benefits” of the COVID-19 vaccination outweigh its risks.


Betsy Goodfellow

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