© Reuters.
(This Jan. 13 story was resubmitted with an edited headline to clarify that the link to stroke is possible, not definitive.)
(Reuters) – A security monitoring system said the US drugmaker Pfizer Inc (NYSE:) and German partner BioNTech’s updated COVID-19 injection could be linked to a type of stroke in older adults, according to preliminary data analyzed by US health authorities.
The US Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) said Friday that a CDC vaccine database had discovered a potential safety issue in the that people older than 65 years were more likely to have an ischemic stroke 21 days later. after receiving the Pfizer/BioNTech bivalent injection, compared with days 22 to 44.
An ischemic stroke, also known as cerebral ischemia, is caused by blockages in the arteries that supply blood to the brain.
The FDA and CDC said other large studies, CDC’s Vaccine Adverse Event Reporting System, databases from other countries, and Pfizer-BioNTech databases had not flagged this safety issue, adding which requires further investigation.
“Although the totality of the data currently suggests that the VSD (Vaccine Safety Datalink) signal is highly unlikely to represent a true clinical risk, we believe it is important to share this information with the public,” the health authorities said.
Pfizer and BioNTech said in a statement that they have been made aware of limited reports of ischemic strokes in people 65 years and older after vaccination with their updated vaccine.
“Neither Pfizer nor BioNTech nor the CDC nor the FDA have observed similar results in many other monitoring systems in the US and around the world, and there is no evidence to conclude that ischemic stroke is associated with the use of companies’ COVID-19 vaccines,” the company added.
This security issue has not been identified with Modern (NASDAQ:) and both the CDC and FDA continue to recommend that everyone 6 months and older stay up-to-date with their COVID-19 vaccinations.
