Other safety alerts
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| The United States: CDC and FDA identify preliminary COVID-19 Vaccine safety signal for persons aged 65 years and older |
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The US Food and Drug Administration (FDA) announces that, following the availability and use of the updated (bivalent) COVID-19 vaccines, the Centers for Disease Control and Prevention’s (CDC) Vaccine Safety Datalink (VSD), a near real-time surveillance system, met the statistical criteria to prompt additional investigation into whether there was a safety concern for ischemic stroke in people ages 65 and older who received the Pfizer-BioNTech COVID-19 Vaccine, Bivalent. Rapid-response investigation of the signal in the VSD raised a question of whether people 65 and older who have received the Pfizer-BioNTech COVID-19 Vaccine, Bivalent were more likely to have an ischemic stroke in the 21 days following vaccination compared with days 22-44 following vaccination.
This preliminary signal has not been identified with the Moderna COVID-19 Vaccine, Bivalent. There also may be other confounding factors contributing to the signal identified in the VSD that merit further investigation. Furthermore, it is important to note that, to date, no other safety systems have shown a similar signal and multiple subsequent analyses have not validated this signal:
- A large study of updated (bivalent) vaccines (from Pfizer-BioNTech and Moderna) using the Centers for Medicare and Medicaid Services database revealed no increased risk of ischemic stroke.
- A preliminary study using the Veterans Affairs database did not indicate an increased risk of ischemic stroke following an updated (bivalent) vaccine.
- The Vaccine Adverse Event Reporting System (VAERS) managed by CDC and FDA has not seen an increase in reporting of ischemic strokes following the updated (bivalent) vaccine.
- Pfizer-BioNTech’s global safety database has not indicated a signal for ischemic stroke with the updated (bivalent) vaccine.
- Other countries have not observed an increased risk for ischemic stroke with updated (bivalent) vaccines.
Although the totality of the data currently suggests that it is very unlikely that the signal in VSD represents a true clinical risk, FDA believes it is important to share this information with the public when one of its safety monitoring systems detects a signal. CDC and FDA will continue to evaluate additional data from these and other vaccine safety systems.
No change in vaccination practice is recommended.
Please refer to the following website in FDA for details:
http://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/cdc-and-fda-identify-preliminary-covid-19-vaccine-safety-signal-persons-aged-65-years-and-older
In Hong Kong, Comirnaty Original/Omicron BA.4-5 Dispersion For Injection COVID-19 MRNA Vaccine (Nucleoside Modified) (15/15 Micrograms)/Dose (HK-67666) is a pharmaceutical product registered by Fosun Industrial Co Limited. The product is a prescription-only medicine. The Department of Health will remain vigilant on safety update of the product issued by FDA and other overseas drug regulatory authorities.
Ends/Wednesday, Jan 18, 2023
Issued at HKT 15:00
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