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Lifestyle

Pfizer confirmed not to carry stroke risks

by Joseph Brown

January 30, 2023

Image source: The New York Times Pfizer: Vaccinations in general and Covid-19 booster doses in particular are critical, however, some ...

Image source: The New York Times Pfizer: Vaccinations in general and Covid-19 booster doses in particular are critical, however, some people still choose not to get the shots out of fear in becoming sick. Seniors worry about the injections' possible negative effects since many of them have acquired a stroke fear. The Centers for Disease Control and Prevention, however, has done research to soothe these worries.

Surveillance

The findings that Pfizer's omicron Covid variant booster dosage was connected to a higher risk of stroke in persons 65 and older led to the development of a CDC surveillance system. The Vaccine Safety Datalink (VSD) system was created in cooperation with networks around the US, the CDC's Immunization Safety offices, and a comprehensive healthcare organization. Utilizing electronic health data from affiliated facilities, it keeps track of and assesses the safety of immunizations. It contains details on the kind given, the date of vaccination, and any other vaccinations received. Additionally, the VSD makes use of data on health issues discovered during ER, urgent care, and hospital stays.

Statement

On Friday, the CDC posted a press release to its website. "Following the availability and use of the updated (bivalent) COVID-19 vaccines, CDC's 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, Vivalent were more likely to have an ischemic stroke in the 21 days following vaccination compared with days 22-42 following the vaccination." A review of the Centers for Medicare and Medicaid Services database found that there was no increased risk of stroke as a result of the modified vaccines. Additionally, Pfizer-BioNTech's global safety database has not discovered any signs of stroke in connection with the updated injections. Read also: At-Home Covid Tests: What is it and How to Use it?

Detection

According to a CDC representative, the issue was initially raised in late November. When it was identified in the middle of December, the CDC started investigating the likelihood of seniors having a stroke 21 days after receiving the Pfizer injection, and concerns lingered. The initial signal and outcomes were the same for Moderna boosters. According to the spokesperson, strokes occurred in 130 individuals aged 65 and older who received the Pfizer omicron booster injection within 21 days. The data was submitted by more than 550,000 seniors who had their booster shot. The CDC reports that other monitoring systems have not found any problems with the Pfizer booster to date.

Data

Researchers analyzed the information from the following sources:

Center for Medicare and Medicaid Services
The Department of Veterans Affairs
The Vaccine Adverse Reporting System
Pfizer's global safety database

"Although the totality of the data currently suggests that it is very unlikely that the signal in VSD represents a true clinical risk, we believe it is important to share this information with the public, as we have in the past, when one of our safety monitoring systems detects a signal," the CDC wrote. The CDC claims that signals from sources unrelated to immunization are picked up by the monitoring system. The agency spokeswoman stated that in the following weeks, the investigations should provide a more accurate picture and more information.

Investigation

On January 26, the Food and Drug Administration will hold a panel discussion with independent vaccination authority to assess the problem. Furthermore, according to a statement released by Pfizer on Friday, there is no evidence linking the Covid vaccine to ischemic strokes. According to company spokesman Kit Longley, Pfizer, BioNTech, the CDC, and the FDA have not found any ties between the various monitoring systems in the United States. "Compared to published incidence rates of ischemic stroke in this older population, the companies to date have observed a lower number of reported ischemic strokes following the vaccination with the omicron BA.4/BA.5-adapted bivalent vaccine," said Longley. The CDC continues to recommend Pfizer's omicron injection. The initial vaccination series must be finished, and applicants must be five years of age or older to receive the booster. The youngest children who are eligible for an omicron injection are those between the ages of six months and four years old. Reference: CDC says it’s ‘very unlikely’ Pfizer booster carries stroke risk for seniors after launching review CDC & FDA identify preliminary COVID-19 vaccine safety signal for persons aged 65 years and older

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