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Pfizer: Despite the necessity of Covid-19 booster doses and vaccinations in general, some people still opt not to get the shots due to fear of getting sick.
Seniors, in particular, are anxious about the injections’ potential side effects since many have developed a phobia of strokes.
However, the Centers for Disease Control and Prevention has conducted studies to dispel such concerns.
Surveillance
The discovery prompted the implementation of a CDC surveillance system that Pfizer’s omicron Covid variant booster dose was linked to an increased risk of stroke in adults 65 and older.
In collaboration with networks across the US, the CDC’s Immunization Safety offices, and a comprehensive healthcare organization, the Vaccine Safety Datalink (VSD) system was developed.
It monitors and evaluates the safety of vaccinations using electronic health data from affiliate facilities.
It includes information on the type administered, the vaccination date, and any other vaccines received on the same day.
The VSD also utilizes information on health problems identified during doctor visits, ER visits, urgent care visits, and hospital stays.
Statement
The CDC issued a press release on its website on Friday.
“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: Covid-19 surges among senior citizens or ‘senior waves’
Detection
A CDC spokesperson said the problem was first brought up in late November.
The CDC began looking into the possibility of seniors suffering a stroke 21 days after receiving the Pfizer injection when it was discovered in the middle of December, and worries persisted.
For Moderna boosters, the initial signal and results were the same.
The representative stated that 130 patients 65 and older who had the Pfizer omicron booster injection suffered strokes within 21 days.
More than 550,000 seniors who had their booster injection reported the data.
According to the CDC, no other monitoring system has so far detected any issues with the Pfizer booster.
Data
No extra stroke risk was noted when researchers examined the data 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 asserts that the monitoring system picks up signals from sources unrelated to immunization.
The agency spokesperson noted that the investigations should provide a clearer view and additional facts in the upcoming weeks.
Investigation
The Food and Drug Administration will convene a panel discussion with independent immunization authorities on January 26 to tackle the issue.
Furthermore, Pfizer said in a statement made on Friday that there is no proof between the Covid vaccination and ischemic strokes.
Pfizer, BioNTech, the CDC, and the FDA have not discovered any connections between the different monitoring systems in the United States, claims company spokesperson Kit Longley.
“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 omicron injection from Pfizer is still prescribed by the CDC.
Those who have finished the primary vaccine series and are five years of age or older are eligible for the booster.
Ages six months to four years old are the youngest children that can receive an omicron injection.
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
