A supposed leaked document on adverse events to Pfizer’s Covid-19 vaccine has dominated South African Twitter trends this week. However, Pfizer says the report circulating social media is “unauthenticated”.
The 38-page document details alleged adverse events that have been recorded into the Pfizer safety database.
An adverse event is any untoward or undesirable occurrence with the use of a medical product in a patient.
Pfizer's External Communications Manager for East and Southern Africa, Willis Angira, told IOL News that the biotech company takes adverse events potentially associated with its vaccine very seriously.
“Unfortunately we cannot authenticate documents that are being circulated on social media. The documents Pfizer and BioNTech, submitted to the FDA Vaccines and Related Biological Products Advisory Committee as part of Emergency Use Authorization, as well as subsequent submissions, are publicly available on the FDA website,” he said.
On Twitter, under the hashtags #Pfizer and #VaccineSideEffects, users found the document to be concerning as the listed adverse events took up nine pages of the alleged report.
Close to 1 300 reported side-effects were listed in the report, some of which include acute kidney injury, cardiac arrest, deep vein thrombosis, facial paralysis, liver injury, myocarditis, and pneumonia.
“Pfizer takes adverse events that are potentially associated with our Covid-19 vaccine very seriously. We closely monitor all such events and collect relevant information to share with global regulatory authorities.
“It is important to note that serious adverse events that are unrelated to the vaccine are unfortunately likely to occur at a similar rate as they would in the general population,” said Angira.
Of the 32 million Covid-19 vaccines that have been administered in South Africa, 24 million have been Pfizer’s two dose regimen.
Spokesperson for the South African Health Products Regulatory Authority (SAHPRA), Yuven Gounden, said they are examining the veracity of the document.