Dubai, United Arab Emirates (CNN) – The US Centers for Disease Control and Control reported, on Friday, that there may be a safety problem with the bivalent Covid-19 vaccine manufactured by Pfizer and BioNTech, but it is unlikely. be a real danger.
Despite this, the agency confirmed that it continues to recommend that everyone receive COVID-@DIGITS vaccines on their respective schedule.
She explained that one of the vaccine safety monitoring systems, a “near-real-time monitoring system” called Vaccine Safety Datalink, detected a potential increase in the incidence of a certain type of stroke in people 65 and older among those who recently received one of the company’s updated booster doses. Pfizer.
A rapid response analysis revealed that older adults who received a bivalent booster may have an increased risk of ischemic strokes during the first three weeks after receiving the dose, compared to the following weeks, i.e. between the fourth and sixth weeks.
The Vaccine Safety Datalink system provides data on the safety and effectiveness of vaccines through patients’ electronic health records.
The CDC noted that potential confounding factors have been identified in the data from the vaccine surveillance system that may need further investigation.
Among the nearly 550,000 seniors who got the Pfizer bivalent booster shot and tracked by the Vaccine Safety Datalink system, 130 had a stroke in the three weeks after receiving the dose, an agency official who declined to be named told CNN. They are not allowed to share data.
No death resulted from the infection among the 130 injured.
Dr. William Schaffner, an infectious disease expert at Vanderbilt University, said the number of strokes detected is relatively small.
He pointed out that these strokes “are not confirmed as negative effects (of the vaccine) at this time,” adding that they represent an alert for further investigation.
However, the same safety profile has not been disclosed for the use of the moderna bivalent booster dose, according to a CDC notification.
The agency said it looked for the same increase in strokes and failed to find it in other large collections of medical records.
The agency said that Pfizer and other countries using the vaccine did not see any increase in this type of stroke, and this symptom was not detected in any other databases.
The Centers for Disease Control indicated that it does not recommend any change in vaccination practices currently, and that the risks of “Covid-19” to the elderly still outweigh any potential problems related to the safety of the vaccine.
The CDC and the Food and Drug Administration will continue to evaluate additional data from these and other vaccine safety systems.
This additional data and analysis will be discussed during the upcoming January 26 meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee, according to the notice.
For its part, Pfizer said in a statement, Friday, that “neither Pfizer, BioNTech, nor the Centers for Disease Control and Control, or the US Food and Drug Administration, have observed similar results across many other monitoring systems approved in the United States and globally.” There is no evidence to conclude that an ischemic stroke is associated with receiving our COVID-19 doses.”