Early Signal Of Possible Pfizer Bivalent COVID Vaccine Link To Stroke
 Science/Medical
Tuesday 24th, January 2023
International
A safety monitoring system in the United States has flagged Pfizer and BioNTech's updated COVID-19 vaccine for a possible link to a type of brain stroke in older adults, according to preliminary data analysed.

The CDC in the United States, Centers for Disease Control and Prevention, and the Food and Drug Administration (FDA) said on Friday the 13th January 2023 that a CD vaccine database ha uncovered a possible safety issue which looks to affect people 65 and older. People in this age group were more likely to have an ischemic stroke 21 days after receiving the Pfizer/BioNTech bivalent shot, compared with days 22 to 44.

The CDC and FDA have said that other large studies, the CDC's Vaccine Adverse Event Reproting System and other countries' databases and Pfizer/BioNTech's databases had not flagged this safety issue, further investigation is required.

Health authorities in the United States said, "Although the totality of the data currently suggests that it is very unlikely that the signal in VSD (Vaccine Safety Datalink) represents a true clinical risk, we believe it is important to share this information with the public,".

Pfizer and BioNTech stated, "Neither Pfizer and BioNTech nor the CDC or FDA have observed similar findings across numerous other monitoring systems in the U.S. and globally and there is no evidence to conclude that ischemic stroke is associated with the use of the companies' COVID-19 vaccines,".

The safety concern has not been identified with Moderna's bialent shot and both the FDA and CDC continue to recommend that everyone aged 6 months and older stay up to date with their COVID-19 vaccination in the United States.
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