by Michael Nevradakis, Ph.D., Childrens Health Defense:
Pfizer launched the study in November 2022, but has not publicly released interim data and now says the study won’t be complete until November 2030. Some experts said the vaccine maker may be attempting to delay disclosure of data that could raise questions about the vaccine’s safety.
Pfizer is drawing criticism for delaying — until November 2030 — completion of its myocarditis safety study in children and young adults under 21.
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Pfizer launched the study in November 2022, but has not publicly released interim data. Some experts said Pfizer may be attempting to delay disclosure of data that could raise questions about the vaccine’s safety.
Last month, the U.S. Food and Drug Administration (FDA) approved updated versions of package inserts for the Pfizer and Moderna COVID-19 vaccines to include stronger warnings about the risks of myocarditis and pericarditis.
Pfizer originally planned to complete its study later this year, but pushed it back to 2030, nearly a decade after Pfizer-BioNTech’s first COVID-19 vaccine was released.
According to TrialSite News, the delay has “raised public concern about whether Pfizer is delivering on its post-marketing surveillance obligations in a timely and transparent manner.”
Karl Jablonowski, Ph.D., senior research scientist for Children’s Health Defense (CHD), said, “It is possible the clinical study results are worse than what independent researchers already know to be true. Pfizer’s delay — while the most vulnerable are still exposed to the hazards of their product — will exacerbate the atrocity.”
The study, performed in collaboration with the U.S. government’s National Heart, Lung, and Blood Institute, assesses the long-term health outcomes of 300 patients ages 21 and younger who developed myocarditis or pericarditis after receiving Pfizer’s COVID-19 vaccine.
The study also includes a control group of 100 patients who developed those conditions following COVID-19 infection or after contracting multisystem inflammatory syndrome associated with COVID-19.
Internal medicine doctor Clayton J. Baker said Pfizer likely would have published the interim data if it had been positive. He said:
“If their findings to date were reassuring for their product, there would be a strong incentive for them to simply publish those reassuring findings this year, as originally promised.
“The ethical and scientifically sound course would be to publish the data they have gathered to date now, continue to follow the subjects and publish another update in 2030.”
Pfizer study limits myocarditis diagnoses to within 7 days of vaccination
In an op-ed for TrialSite News, Dr. Robert W. Malone, a physician-scientist known for his early contributions to mRNA technology, said there is “no sign of anything nefarious” with Pfizer’s study or its move to extend it. Malone is a newly appointed member of the Centers for Disease Control and Prevention’s (CDC) vaccine advisory panel.
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