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No Increased Stroke Risk Linked to

Pfizer’s Covid Boosters, Federal
Officials Say
An uptick hinted at in surveillance data was a mirage, the officials
said.

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A booster vaccination clinic in Salt Lake City last year. Kim Raff for The New York Times

By Apoorva Mandavilli

Jan. 13, 2023, 7:14 p.m. ET

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.

“It is very unlikely” that the risk is real, the officials said. They
urged Americans 6 months and older to continue getting booster
shots. Federal officials decided to disclose the concern and the
results of their investigation despite worries that the revelation
might fuel anti-vaccine sentiment.

“We believe it is important to share this information with the

public,” a joint statement from the Centers for Disease Control and
Prevention and the Food and Drug Administration said.

Officials declined requests to discuss details of their investigation.

The bivalent vaccine is designed to thwart the original version of

the coronavirus as well as versions of the Omicron variant that
were circulating in the United States in the summer. The bivalent
vaccines made by Pfizer-BioNTech and Moderna are the only
boosters available in the United States now, and scientists are
engaged in a heated debate over their usefulness compared with
the original vaccines.

It is unclear whether the new reassurance will prompt Americans

to receive a bivalent shot if they have not already done so. Only 39
percent of adults aged 65 and older, and only 16 percent of those
aged 5 and older, have so far received a bivalent booster shot.
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The concerns about a possible link to ischemic strokes — which

can interrupt blood supply to the brain — first emerged late last Everything But the
Girl’s Long-Awaited
year. Data from the Vaccine Safety Datalink, a federal safety Return, and 12 More
New Songs
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-

ioNTech. 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.

Federal officials plan to discuss the findings on Jan. 26 at a meeting

of scientific advisers to the F.D.A. on future Covid vaccines.

The Vaccine Safety Datalink is a real-time surveillance system, a

collaboration between the C.D.C. and integrated health care
organizations and networks across the United States. The system
uses electronic health data from about a dozen sites in the nation to
monitor vaccine safety.

Among about 550,000 people aged 65 and older who had received
the Pfizer-BioNTech bivalent booster, 130 had ischemic strokes in
the 21 days after receiving the shot, raising fears that the two
events were related. But analysis of the data using a different
method did not reveal an increased risk of ischemic stroke.

Another database, the Vaccine Adverse Event Reporting System,

managed by the C.D.C. and the F.D.A., also did not pick up a signal
for ischemic strokes. Neither did a large study of the bivalent
vaccines relying on data from the Centers for Medicare and
Medicaid Services, a preliminary study using the Veterans Affairs
database, nor Pfizer-BioNTech’s global safety database.

Other countries have not observed an increased risk for ischemic

stroke with the bivalent vaccines, the agencies said. About 795,000
strokes are reported in the United States each year , and about 87
percent of those are ischemic strokes, according to the C.D.C.

“There is no evidence to conclude that ischemic stroke is

associated with the use of the companies’ Covid-19 vaccines,” Pfizer
and BioNTech said in a statement. More than 30 million doses of
the companies’ bivalent vaccine have been administered in the
United States so far, according to a spokesman for Pfizer.

“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” after the bivalent shot , the
companies said.
 Apoorva Mandavilli is a reporter focused on science and global health. She was a part of
the team that won the 2021 Pulitzer Prize for Public Service for coverage of the
pandemic. @ apoorva_nyc

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