The CDC says the ‘safety signal’ wasn’t seen in the Moderna COVID-19 vaccine

By Adam Sabes | Fox News

The Centers for Disease Control and Prevention (CDC) says that a preliminary COVID-19 vaccine “safety signal” has been identified and is investigating whether the Bivalent Pfizer-BioNTech vaccine creates an increased risk of ischemic stroke in people 65 and older.

In the Friday statement, the CDC said that the preliminary signal hasn’t been identified with the Bivalent Moderna COVID-19 vaccine.

“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,” the CDC said.

According to the CDC, an ischemic stroke “occurs when blood clots or other particles block the blood vessels to the brain.”

In the statement, the CDC pointed out that a large study of updated bivalent vaccines from Pfizer-BioNTech “using the Centers for Medicare and Medicaid Services database revealed no increased risk of ischemic stroke.”

The agency also said that the Vaccine Adverse Event Reporting System (VAERS) managed by CDC and FDA has not seen an increase in reporting of ischemic strokes following the updated (bivalent) vaccine.

In a statement to Fox News Digital, a spokesperson for Pfizer said, “Pfizer and BioNTech have been made aware of limited reports of ischemic stroke that have been observed in the CDC Vaccine Safety DataLink (VSD) database in people 65 and older following vaccination with the Omicron BA.4/BA.5-adapted bivalent COVID-19 Vaccine by Pfizer and BioNTech.”

Liesl Eibschutz, a medical student from Dartmouth University, loads a syringe with Pfizer COVID-19 vaccine before giving it to people on the first day that people ages 16 and up can receive the vaccine at Kedren Health in Los Angeles on April 15, 2021. ( Allen J. Schaben / Los Angeles Times via Getty Images)

“Neither Pfizer and BioNTech nor the CDC or the U.S. Food and Drug Administration (FDA) have observed similar findings across numerous other monitoring systems in the U.S. and globally and there is no evidence to conclude that ischemic stroke is associated with the use of the companies’ COVID-19 vaccines,” the spokesperson continued.

“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. The CDC continues to recommend vaccination with the Pfizer-BioNTech Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for all authorized ages and indications.”

This August 2022 photo shows vials of Pfizer’s updated COVID-19 vaccine during production in Kalamazoo, Michigan.  (Pfizer via AP)

The CDC isn’t recommending a change in vaccine practice.

Fox News medical contributor Dr. Marc Siegel said that this isn’t “proof” of a link between the vaccine and strokes.

“This is not proof. This is that they see there may be a link here, and they want to investigate it, and they’re trying to be transparent,” he said.

CDC & FDA Identify Preliminary COVID-19 Vaccine Safety Signal for Persons Aged 65 Years and Older

source CDC

Transparency and vaccine safety are top priorities for the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). 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.

All signals require further investigation and confirmation from formal epidemiologic studies. When one system detects a signal, the other safety monitoring systems are checked to validate whether the signal represents an actual concern with the vaccine or if it can be determined to be of no clinical relevance.

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, Bivalent were more likely to have an ischemic stroke in the 21 days following vaccination compared with days 22-42 following vaccination.

This preliminary signal has not been identified with the Moderna COVID-19 Vaccine, Bivalent. There also may be other confounding factors contributing to the signal identified in the VSD that merit further investigation. Furthermore, it is important to note that, to date, no other safety systems have shown a similar signal and multiple subsequent analyses have not validated this signal:

• A large study of updated (bivalent) vaccines (from Pfizer-BioNTech and Moderna) using the Centers for Medicare and Medicaid Services database revealed no increased risk of ischemic stroke
• A preliminary study using the Veterans Affairs database did not indicate an increased risk of ischemic stroke following an updated (bivalent) vaccine
• The Vaccine Adverse Event Reporting System (VAERS) managed by CDC and FDA has not seen an increase in reporting of ischemic strokes following the updated (bivalent) vaccine
• Pfizer-BioNTech’s global safety database has not indicated a signal for ischemic stroke with the updated (bivalent) vaccine
• Other countries have not observed an increased risk for ischemic stroke with updated (bivalent) vaccines

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. CDC and FDA will continue to evaluate additional data from these and other vaccine safety systems. These data and additional analyses will be discussed at the upcoming January 26 meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee.

No change in vaccination practice is recommended. CDC continues to recommend that everyone ages 6 months of age and older stay up-to-date with COVID-19 vaccination; this includes individuals who are currently eligible to receive an updated (bivalent) vaccine. Staying up-to-date with vaccines is the most effective tool we have for reducing death, hospitalization, and severe disease from COVID-19, as has now been demonstrated in multiple studies conducted in the United States and other countries:

• Data have shown an updated COVID-19 vaccine reduces the risk of hospitalization from COVID-19 by nearly 3-fold compared to those who were previously vaccinated but have not yet received the updated vaccine.
• Data have shown that the updated COVID-19 vaccine also reduces the risk of death from COVID-19 by nearly 19-fold compared to those who are unvaccinated.
• Other preliminary data from outside the U.S. have demonstrated more than 80% protection against severe disease and death from the bivalent vaccine compared to those who have not received the bivalent vaccine.

Overall safety data for the bivalent COVID-19 vaccines are available here.

First reported cases of clots in large arteries causing stroke following covid-19 vaccination

Three cases of ischaemic stroke reported in young adults following administration of the Oxford–AstraZeneca vaccine

Clots in the arteries (arterial thrombosis) are the most common cause of stroke (ischaemic stroke) and have been reported in detail for the first time in young adults who received the Oxford–AstraZeneca covid-19 vaccine in a letter from UK stroke specialists published online in Journal of Neurology Neurosurgery & Psychiatry.

While rare cases of blood clots have been reported previously after administration of the Oxford–AstraZeneca covid-19 vaccine, these have affected veins and most specifically veins in the brain (cerebral venous sinuses).

People who have experienced this unusual form of stroke (cerebral venous sinus thrombosis) have also had low platelet counts (thrombocytopaenia) and antibodies to platelet factor 4 (PF4) – proteins that help form clots.

The most common form of stroke, where blood clots occur in arteries supplying blood to the brain (ischaemic stroke), has not been previously described as the presenting feature of thrombosis following administration of the Oxford–AstraZeneca vaccine, but the authors of this letter report three cases in detail.

In all cases, the ischaemic stroke was associated with blockages of large arteries (both carotid and middle cerebral artery) and two patients also had venous thrombosis involving the portal and cerebral venous system. All three also had extremely low platelet counts, confirmed anti-PF4 antibodies, and raised D-dimer (also linked to clotting).

The first patient, a woman in her 30s, experienced an intermittent headache on the right side and around her eyes six days after the vaccine. Five days later she awoke feeling drowsy and with weakness to her left face, arm and leg. Imaging revealed a blocked right middle cerebral artery with brain infarction, and blood clots in the right portal vein thrombosis. She underwent brain surgery to reduce the pressure in her skull, plasma removal and replacement, and received the anti-clotting drug fondaparinux, but unfortunately died.

The second patient, a woman in her late 30s, presented with headache, confusion, weakness in her left arm and loss of vision on the left side 12 days after having received the vaccine. Imaging showed blockages in several vessels including both carotid arteries (the main blood supply to the hemispheres of the brain), arteries supplying the heart and lungs (pulmonary embolism) and the left transverse sinus (one of the cerebral venous sinuses). Her platelet count increased following plasma removal and replacement and intravenous corticosteroids. She was then given fondaparinux and improved.

The third patient, a man in his early 40s, presented 3 weeks after receiving his vaccination with problems speaking and understanding language (dysphasia). Imaging showed a clot in the left middle cerebral artery, but there was no evidence of clots in the cerebral venous sinuses. He received a platelet and plasma transfusion, and fondaparinux, and remains stable.

The lead author, Professor David Werring from the Stroke Research Centre, UCL Queen Square Institute of Neurology, says that the cases described suggest that, in addition to cerebral venous thrombosis, vaccine-induced immune thrombotic thrombocytopaenia (VTT) can also lead to clots that block arteries supplying the brain, causing ischaemic stroke.

“Young patients presenting with ischaemic stroke after receiving the [Oxford-AstraZeneca] vaccine should urgently be evaluated for VITT with laboratory tests (including platelet count, D-dimers, fibrinogen and anti-PF4 antibodies), and managed by a multidisciplinary team (haematology, neurology, stroke, neurosurgery, neuroradiology) for rapid access to treatments including intravenous immune globulin, methylprednisolone, plasmapheresis and non-heparin anticoagulants, for example fondaparinux, argatroban, or direct oral anticoagulants,” say the authors.

In a linked commentary, Professor Hugh Markus, from the Department of Clinical Neurosciences, at the University of Cambridge, writes: “This report emphasises that the immune mediated coagulopathy can also cause arterial thrombosis including ischaemic stroke, although venous thrombosis and especially cerebral venous sinus thrombosis appear more frequent.”

He adds: “During the current period of covid vaccination a high index of suspicion is required to identify thrombotic episodes following vaccination. However, it is important to remember that these side-effects are rare, and much less common than both cerebral venous thrombosis and ischaemic stroke associated with covid-19 infection itself.”

[Ends]

25/05/21

Notes for editors
Letter: Ischaemic stroke as a presenting feature of ChAdOx1 nCoV-19 vaccine-induced immune thrombotic thrombocytopenia doi: 10.1136/jnnp-2021-326984

Commentary: Ischaemic stroke can follow COVID-19 vaccination, but is much more common with COVID-19 infection itself doi: 10.1136/jnnp-2021-327057
Journal: Journal of Neurology Neurosurgery & Psychiatry

Funding: None declared

Link to AMS labelling system: https://press.psprings.co.uk/AMSlabels.pdf 

Peer reviewed? Yes (internally)
Evidence type: Case studies; Opinion
Subjects: Stroke patients
source

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