Ahead of the Martin Luther King Jr holiday weekend, federal health officials announced that they were looking into a potential stroke risk in seniors who received the Pfizer-BioNTech bivalent (two-strain) COVID-19 booster. However, follow-up investigations in the United States and other countries and by the company have not found the same signal.
In a Jan 13 statement, the Food and Drug Administration (FDA) said it and the Centers for Disease Control and Prevention (CDC) said the CDC's Vaccine Safety Datalink (VSD) system, which tracks vaccine safety in nearly real-time, met the statistical level to prompt an investigation into whether there is a safety concern about whether people ages 65 and older who received the new Pfizer booster were more likely to have an ischemic stroke in the 3 weeks following vaccination compared to 22 to 44 days after vaccination.
It's unlikely that the signal in the VSD represents a true clinical risk.
The FDA said the preliminary signal hasn't been seen with the Moderna bivalent booster and that there may be other confounding factors in the VSD that require further investigation. It added that no signs of an increased stroke risk have been found in three other federal vaccine safety tracking databases. Also, the signal hasn't turned up in Pfizer's global safety database or in monitoring systems in other countries.
Considering all the data, it's unlikely that the signal in the VSD represents a true clinical risk, the FDA said, adding that it's important to share information about any potential safety signal with the public. The FDA's vaccine advisory committee will discuss the issue at its Jan 26 meeting.
In light of the new development, federal officials said there are no changes in COVID-19 vaccination recommendations, which is for everyone ages 6 months and older to stay current with their COVID-19 vaccinations, including those who are eligible to receive the bivalent boosters, which target the original virus plus Omicron variants.