CDC along with the FDA made an announcement that they were being honest about the fact that reports of ischemic stroke among recipients of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent, attained a level that requires deeper examination.
U.S. government agencies use multiple, complementary safety monitoring systems to help detect possible safety signals for vaccines and other medical countermeasures as early as possible and to facilitate further investigation, as appropriate; often, these safety systems detect signals that could be due to factors other than the vaccine itself, stated a press release from the CDC and FDA.
According to the agencies, this does not indicate that the vaccination caused that adverse effect, and it does not suggest that there will be a change in the recommendations about vaccines in the near future. In addition, the authorities stated that comparable safety signals did not arise following the administration of the Moderna bivalent vaccine.
It is not yet known if the signal indicates that there is a genuine cause for concern regarding the vaccination or whether it can be established that it has no therapeutic value.
The officials in charge of public health emphasized that it is essential to remember that, as yet, no other security measures have demonstrated a signal that is comparable to this one and that several subsequent assessments have not corroborated this signal. These are the ones:
• Pfizer-BioNTech’s worldwide security records don’t show an indication for ischemic stroke associated with the informed (bivalent) vaccine.
• Operating data from the Centers for Medicare and Medicaid Services, a big study was conducted on updated (bivalent) vaccinations (from Pfizer-BioNTech and Moderna), and the researchers found that there was no increased risk of ischemic stroke.
• Other countries have not reported any cases
• A preliminary investigation via the Veterans Affairs records did not find a higher likelihood of ischemic stroke adhering to an updated (bivalent) vaccine.
• The Vaccine Adverse Event Reporting System handled by the CDC and FDA has not observed a rise in declaring of ischemic strokes adhering to the latest (bivalent) vaccine.