Preliminary Data Suggest Possible Link Between Pfizer-BioNTech Bivalent COVID-19 Vaccine and Increased Ischemic Stroke Risk in Elderly
Pfizer
Pharmaceutical R&D Developer
BioNTech
Developer of Novel Biologics
FDA
U.S. Food and Drug Administration
Centers for Disease Control and Prevention
The Centers for Disease Control and Prevention (CDC) is an agency under the U.S. Department of Health and Human Services, with its headquarters located in Atlanta, Georgia. As a federal government administrative agency, the CDC provides reliable information to protect public health and safety. Through strong partnerships with national health departments and other organizations, it aims to enhance health-related decision-making and promote the well-being of citizens.
U.S. health authorities' preliminary data analysis shows that a safety monitoring system indicates the updated COVID-19 vaccine from American pharmaceutical company Pfizer (PFE.US) and German partner BioNTech (BNTX.US) might be linked to a type of brain stroke in elderly people, according to the Zhitong Finance APP.
The U.S. Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) said on Friday that a potential safety issue was identified in CDC's vaccine database: adults aged 65 and older who received the Pfizer/BioNTech bivalent vaccine booster were more likely to experience ischemic stroke within 21 days compared to the period between 22-44 days. Ischemic stroke, also known as cerebral ischemia, is caused by blockage of arteries supplying blood to the brain.
FDA and CDC stated that other large-scale studies, CDC's Vaccine Adverse Event Reporting System, databases from other countries, and the Pfizer-BioNTech database have not flagged this safety issue, adding that further investigation is needed.
Health authorities stated: "Although all current data suggest that the signal in the VSD (Vaccine Safety Datalink) is unlikely to represent a true clinical risk, we believe it is important to share this information with the public."
In response, Pfizer and BioNTech stated in a declaration that they have learned about the limited reports of ischemic stroke in people aged 65 and above after receiving the latest vaccine.
"Pfizer and BioNTech, along with the CDC or FDA, have not observed similar findings in many other surveillance systems in the U.S. and globally, and there is no evidence suggesting that ischemic stroke is related to the use of the companies' COVID-19 vaccine."
Moderna (MRNA.US) bivalent vaccine has not found this safety issue, and the CDC and FDA continue to recommend that all people aged 6 months and above receive the COVID-19 vaccine promptly.