US health agencies, such as the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA), prioritize transparency and vaccine safety. As per the CDC, they both use multiple, complementary safety monitoring systems to detect potential safety signals for vaccines and medical countermeasures as early as possible to allow research when needed.
CDC noted that these safety measures usually identify signals that may be due to reasons other than the vaccination itself. All signs require further investigation and validation through epidemiology examinations. When one system detects a signal, the other safety monitoring systems will be evaluated to check for any real problem with the vaccination or see if it does have a little clinical significance.
Link Between Pfizer-BioNTech COVID-19 Vaccine and Stroke
According to early data assessed by US health officials, a safety monitoring system suggested that Pfizer Inc (PFE.N) and German partner BioNTech's modified COVID-19 injectable might be connected to a kind of cerebral stroke in older persons.
The CDC and the FDA announced on Friday that a CDC vaccine database found that people 65 and older were more likely to have an ischemic stroke 21 days after receiving the Pfizer/BioNTech bivalent shot, compared to days 22-44.
As Reuters reported, the US health agencies stated that other big trials, the CDC's Vaccine Adverse Event Reporting System, databases from other countries, and Pfizer-BioNTech databases have not detected this safety problem and that further study is required.
Health officials said that it is necessary to convey to the public this kind of information, although generally the data currently shows that the signal in Vaccine Safety Datalink (VSD) reflects an actual clinical risk.
Pfizer and BioNTech stated that they had been made aware of a small number of cases of ischemic strokes in adults 65 and older following immunization with their revised injection.
The companies said that neither they nor the CDC or FDA have observed similar findings across numerous other monitoring systems in the US and in the world. More so, there is no evidence to conclude that ischemic stroke is associated with the use of the Pfizer-BioNTech COVID-19 shot.
This safety issue has not been discovered with Moderna's (MRNA.O) bivalent injection, and the CDC and FDA continue to recommend that everyone aged 6 months and older have their COVID-19 vaccine up to date.
CDC Continues To Recommend COVID--19 Vaccination
The FDA does not advise any changes in vaccination practice. They both recommend that everyone aged 6 months old and older get vaccinated, especially those who are currently eligible to receive an updated bivalent vaccine.
They noted that staying up-to-date with vaccines is the most effective tool to reduce death, hospitalization, and severe disease from the deadly infection. Multiple studies conducted in the US and other countries have shown how vaccines significantly protect people from COVID-19.
Data shows that the updated COVID-19 vaccine reduces the risk of hospitalization due to COVID-19 by three-fold compared to those previously vaccinated but who have not received the updated vaccine. Other data also show that it reduces the risk of death compared to those unvaccinated.
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