The CDC and FDA published an announcment on Friday according to which the agencies' surveillance system flagged a possible link between the new Pfizer-BioNTech bivalent Covid-19 vaccine and strokes in people aged 65 and over.
The agencies announced that they were continuing to recommend the shots.
“Although the totality of the data currently suggests that it is very unlikely that the signal represents a true clinical risk", the CDC and FDA said, "we believe it is important to share this information with the public, as we have in the past, when one of our safety monitoring systems detects a signal.”
In responsed Pfizer and BioNTech said: "There is no evidence to conclude that ischemic stroke is associated with the use of the companies’ COVID-19 vaccines.”
Poltico reported that House Energy and Commerce Chair Cathy McMorris Rodgers said in response: “These agencies must rapidly investigate, in an open and transparent manner, whether or not the vaccine may have contributed to the reported strokes. If there’s one lesson that the CDC and FDA should have taken away from the pandemic, it’s the importance of providing honest, clear, precise, and timely information to the American people about the potential risks and benefits of COVID-19 interventions, including vaccination.”