Reuters - "FDA, CDC see early signal of Pfizer bivalent COVID shot's link to stroke

[womanofthehills]

No problem with Moderna

(Reuters) -A safety monitoring system flagged that U.S. drugmaker Pfizer Inc and German partner BioNTech's updated COVID-19 shot could be linked to a type of brain stroke in older adults, according to preliminary data analyzed by U.S. health authorities.

The U.S. Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) said on Friday that a CDC vaccine database had uncovered a possible safety issue in which people 65 and older were more likely to have an ischemic stroke 21 days after receiving the Pfizer/BioNTech bivalent shot, compared with days 22-44.

An ischemic stroke, also known as brain ischemia, is caused by blockages in arteries that carry blood to the brain.

The FDA and CDC said that other large studies, the CDC's Vaccine Adverse Event Reporting System, other countries' databases and Pfizer-BioNTech's databases had not flagged this safety issue, adding that it requires more investigation. https://www.msn.com/en-us/health/other/u-s-fda-cdc-see-early-signal-of-pfizer-bivalent-covid-shot-s-link-to-stroke/ar-AA16kqXg

[marybourg]

1. I'm confused. The NYT has a story today that says the opposite.

Paywall. https://www.nytimes.com/2023/01/13/health/covid-boosters-stroke.html?action=click&module=Well&pgtype=Homepage&section=Health

[musette_sf]

2. I saw that too in the NYT.

That being said, I got Moderna for all my vaccine doses.

[Celerity]

6. Misleading headline.

Evidence that it is misleading:

From the NYT article:

The concerns about a possible link to ischemic strokes — which can interrupt blood supply to the brain — first emerged late last year. Data from the Vaccine Safety Datalink, a federal safety surveillance system, hinted that Americans aged 65 and older might be at increased risk of an ischemic stroke in the 21 days after receiving a Pfizer-BioNTech bivalent shot.

That signal was specific to the bivalent vaccine made by Pfizer-BioNTech. No similar concerns were linked to the original Covid vaccines or to Moderna’s bivalent boosters.

The data prompted federal officials to comb through other vaccine safety databases, as well as observations from the United States and other countries. The investigators did not find evidence of an increased risk of strokes in any of these sources, federal officials said in their statement.

and the OP article:

The FDA and CDC said that other large studies, the CDC's Vaccine Adverse Event Reporting System, other countries' databases and Pfizer-BioNTech's databases had not flagged this safety issue, adding that it requires more investigation. "Although the totality of the data currently suggests that it is very unlikely that the signal in VSD (Vaccine Safety Datalink) represents a true clinical risk, we believe it is important to share this information with the public," the health authorities said.

Pfizer and BioNTech said in a statement that they have been made aware of limited reports of ischemic strokes in people 65 and older following vaccination with their updated shot.

"Neither Pfizer and BioNTech nor the CDC or 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 companies added.

This safety concern has not been identified with Moderna's bivalent shot and both the CDC and FDA continue to recommend that everyone aged 6 months and older stay up-to-date with their COVID-19 vaccination.

[obamanut2012]

14. The OP is anti vax

Well known. I knew she was the OP when I saw the thread title.

For any alerters: I am not being trollish, the OP hss been very public with her vax views for a long time on DU.

[Roisin Ni Fiachra]

16. Lying POS Q-nut anti-vaxxers killed my brother.

He was an 84 yr old Democrat and they convinced him that if he got vaccinated it would kill him. I knew the primary care giver who he employed for some home health care. She's a christo-fascist worshiper of the MAGAt king who told me that people who wear masks and get vaccinated are the people who spread Covid. The anti-vaxxers frightened him out of getting vaccinated.

He later got Covid while in a nursing home, and a month later he was dead, another innocent victim of ignorant red state fascism.

[Orangepeel]

3. quote from NYT

Jan. 13, 2023, 7:14 p.m. ET
3 MIN READ
Fears that the Covid booster shots made by Pfizer-BioNTech may increase the risk of strokes in people aged 65 and older were not borne out by an intensive scientific investigation, federal officials said on Friday.

[NickB79]

5. Let me guess: VAERS strikes again?

The favorite correlation (but not causation) database for antivaxxers.

[womanofthehills]

8. The CDC also has another monitoring system on your phone

The CDC has a second monitoring system called V
-Safe - it’s monitors people after they get the vaxx through text.

https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/vsafe.html

“Enroll in v-safe and tell CDC how you, or your dependent, feel after getting any dose of COVID-19 vaccine, including updated boosters. Your participation in v-safe helps us monitor the safety of COVID-19 vaccines for everyone. Ready to enroll? Click below.”

[womanofthehills]

10. Actually it's not info from VAERS or V-Safe

It’s from VSD - Vaccine Safety Datalink - info compiled from participating below agencies. I was unaware of this datalink.
https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/vsd/index.html


Participating VSD Healthcare Organizations
Sites that do not provide data are denoted with an asterisk(*).

Participating VSD Healthcare Organizations in the US Map
Kaiser Permanente Washington, Seattle, Washington
Harvard Pilgrim Health Care Institute, Boston, Massachusetts
HealthPartners Institute, Minneapolis, Minnesota
Kaiser Permanente Northwest, Portland, Oregon
Kaiser Permanente Northern California, Oakland, California
Kaiser Permanente Colorado, Denver, Colorado
Denver Health, Denver, Colorado
Marshfield Clinic Research Institute, Marshfield, Wisconsin
Kaiser Permanente Southern California, Los Angeles, California
Kaiser Permanente Mid-Atlantic States (Rockville, MD)
Acumen (Burlingame, CA)
*Indiana University (Indianapolis, IN)
*OCHIN (Portland, OR)

[obamanut2012]

15. OP is anti vax

[womanofthehills]

4. It's really weird now

Some sites saying it does and some saying it doesn’t - all saying no problem with Moderna.

Bloomberg- https://www.bloomberg.com/news/articles/2023-01-13/pfizer-bivalent-vaccine-linked-to-stroke-in-preliminary-data. The agencies said the possible link to stroke was seen in the CDC’s Vaccine Safety Datalink. Investigation of the signal raised a question of whether people 65 and older who received the Pfizer-BioNTech bivalent shot were more likely to have an ischemic stroke, a loss of blood flow in the brain, in the 21 days following vaccination compared with days 22-44 following vaccination, the agencies said in the statement.


https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/bivalent-boosters.html
From CDC
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.

[chowder66]

7. Dr. Peter Hotez.....

Link to tweet

Link to tweet

[herding cats]

9. Extensive review affirms covid booster is safe after system flagged risk

A deep dive into several large databases has failed to confirm the preliminary information, according to the CDC and FDA

A vaccine safety monitoring system in late November picked up a signal that the updated Pfizer coronavirus vaccine booster was possibly linked to an increased risk of strokes in people 65 and older. But a deep dive into several large databases failed to confirm the preliminary information, leading federal health officials to conclude the risk is extremely low — and probably nonexistent, those officials said Friday.

Snip

Government vaccine safety experts have combed through databases containing millions of records in the United States and consulted with regulators in other countries but have not found any indication that the statistical signal represents a clinical risk to patients. They said they would continue to analyze the data.

“We have looked at the totality of the evidence, and there are no concerns at this time that this represents a true safety signal,” an FDA official said.

The FDA official said the government’s sensitive vaccine safety systems are like a radio with the volume turned up high. Sometimes, when listening, “like with a radio, you are going to hear some static in the background,” the official said, adding it does not mean someone is talking. Chances are “this is just static and not someone real talking.”

The review is happening as the pandemic grinds on, with the number of daily deaths rising and an increasingly frustrated White House urging Americans to get the booster to bolster their protection. Uptake remains low: Only 16 percent of people 5 and older and only 39 percent of those 65 and older, the most vulnerable group, have received the booster, according to the CDC.

The CDC and FDA described the early signal in a statement updating their websites Friday afternoon. The signal set off a debate among officials about whether and how to release the information. CDC officials argued for releasing it, while some other officials, including at the FDA, were concerned that putting out unconfirmed data would fuel anti-vaccine sentiment and scare older Americans into avoiding the boosters. Ultimately, the agencies decided to release the information in the hopes that transparency “will build confidence,” said a CDC official.

https://www.washingtonpost.com/health/2023/01/13/pfizer-covid-vaccine-safety/

I'm beginning to grasp the our epidemiology community is so frustrated with the CDC.

[womanofthehills]

11. There is an upcoming meeting on Jan 26 to discuss this

From CDC

“ 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.”

[herding cats]

12. It's a nothing burger.

Wait and see.

Bookmark me. This is background noise and not true data.

[womanofthehills]

13. As long as there are two boosters

Makes sense to go with Moderna for now.