CDC and FDA announce safety signal related to Pfizer-BioNTech’s bivalent COVID-19 vaccine

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The FDA and the Centers for Disease Control and Prevention (CDC) released a joint statement on Friday which was written on the latter’s website and informed the public that the two agencies were evaluating data to find out if any of the vaccines bivalents increased the risk of ischemic stroke in the elderly population.

The CDC’s Vaccine Safety Datalink (VSD), a near real-time surveillance system, met the statistical criteria to trigger further investigation to determine if there was a safety concern for ischemic stroke in older adults. 65 and older who have received the Pfizer-BioNTech COVID-19 vaccine, Bivalent, the CDC/FDA statement reads. The signal rapid-response survey in the VSD raised the question of whether people 65 years of age and older who received the Pfizer-BioNTech COVID-19, bivalent vaccine were more likely to have ischemic stroke in 21 days post-vaccination versus 22-42 days post-vaccination.

On the CDC website, they also stated that government agencies use various surveillance systems to detect possible vaccine safety signals. They will investigate further if necessary. Often these safety systems detect signals that could be due to factors other than the vaccine itself, the website says.

The FDA and CDC have also said that this preliminary signal has not been identified in the Moderna bivalent vaccine. To date, only Moderna and Pfizer-BioNTech vaccines use mRNA technology.

In the statement, the agencies pointed out that other studies and monitoring systems have reported the following:

A large study of updated (bivalent) vaccines (from Pfizer-BioNTech and Moderna) using the Centers for Medicare and Medicaid Services database found no increased risk of ischemic stroke A preliminary study using the database of Veterans Affairs did not report an increased risk of ischemic stroke after an updated (bivalent) vaccineThe Vaccine Adverse Event Reporting System (VAERS) run by the CDC and the FDA did not find an increase the number of ischemic stroke reports following the (bivalent) vaccine update The Pfizer-BioNTechs Global Safety Database did not indicate a report of ischemic stroke with the updated (bivalent) vaccineD other countries have not observed an increased risk of ischemic stroke with updated (bivalent) vaccines

As such, the CDC does not recommend any changes in vaccination practice. The CDC continues to recommend that anyone 6 months and older stay up to date with the COVID-19 vaccination; this includes people who are currently eligible to receive an updated (bivalent) vaccine, the joint statement said.

According to the CDC, VSD is an ongoing collaborative project between the CDC’s Office of Immunization Safety, integrated healthcare organizations and networks across the United States. The VSD has been around for over 30 years and monitors vaccine safety and conducts studies of rare and serious adverse events after vaccination. There are 13 VSD sites that provide clinical, methodological and data expertise.

The FDA and CDC wanted to make it clear that they were being transparent and wanted to let the public know that they were reviewing the data.

Although the totality of the data currently suggests that the signal in the VSD is very unlikely to represent a true clinical risk, we believe it is important to share this information with the public, as we have done in the past, when one of our security monitoring systems detects a signal. The CDC and FDA will continue to evaluate additional data from these and other vaccine safety systems.

Additionally, at the upcoming FDA Vaccines and Related Biologics Advisory Committee (VRBPAC) meeting on January 26, additional data and analysis will be presented on this safety signal to this FDA advisory committee. They had already planned to meet to discuss whether currently available COVID-19 vaccines should be changed and how and if the composition and timing of booster doses should be adjusted in the future.

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