FDA adds warning of rare reaction risk to J&J COVID vaccine

Credit: Johnson & Johnson Services, Inc. | Image Source

U.S. regulators added a new warning to Johnson & Johnson’s COVID-19 vaccine about links to a rare and potentially dangerous neurological reaction.

Posted: Jul 12, 2021 4:54 PM

WASHINGTON (AP) — U.S. regulators on Monday added a new warning to Johnson & Johnson’s COVID-19 vaccine about links to a rare and potentially dangerous neurological reaction, but said it’s not entirely clear the shot caused the problem.

The Food and Drug Administration announced the new warning, flagging reports of Guillain-Barre syndrome, an immune system disorder that can causes muscle weakness and occasionally paralysis. Health officials described the side effect as a “small possible risk" for those getting the shot.

The action comes after the FDA and the Centers for Disease Control and Prevention reviewed reports of about 100 people developing the syndrome after receiving the one-dose vaccine. Almost all of them required hospitalization and one person died, the FDA said.

Guillain-Barre syndrome occurs when the body’s immune system mistakenly attacks some of its nerve cells, causing muscle weakness and sometimes paralysis that typically is temporary. An estimated 3,000 to 6,000 people develop the syndrome each year, according to the CDC.

The number of cases reported in connection with J&J's vaccine represents a tiny fraction of the nearly 13 million Americans who have received the one-dose shot. Most cases were reported in men — many 50 years old and up — and usually about two weeks after vaccination.

J&J said in a statement it has been discussing the reports with the FDA and other health regulators around the world.

The CDC said it would ask its panel of outside vaccine experts to review the issue at an upcoming meeting.

The government said the vaccines most used in the U.S., made by Pfizer and Moderna, show no risk of the disorder after more than 320 million doses have been administered.

The new warning will be included in pamphlets given to people getting the J&J shot. They should seek medical attention if they experience any symptoms, which include tingling sensations, trouble walking and double vision, the FDA said.

Vaccines historically provide broad protection with little risk but come with occasional side effects just like other drugs and medical therapies. The three COVID-19 vaccines used in the U.S. were each tested in tens of thousands of people, but even such huge studies can’t rule out extremely rare side effects.

The CDC and the FDA have been monitoring side effect reports submitted by physicians, drugmakers and patients to a federal vaccine safety database.

Guillain-Barre can be triggered by a number of infections, including flu, cytomegalovirus and Zika virus. But there have been rare cases in which people develop the disorder days or weeks after receiving certain vaccines.

J&J’s vaccine was highly anticipated because of its one-and-done formulation and easy-to-ship refrigeration. But early on, it was linked to another rare risk, of blood clots, and the company hasn’t been able to produce as much as expected because of problems at a Baltimore factory that helps make the shots.

Mississippi Coronavirus Cases

Data is updated nightly.

Cases: 512632

Reported Deaths: 10262
CountyCasesDeaths
Harrison34853555
DeSoto33162432
Hinds32556641
Jackson24830389
Rankin22442402
Lee16238242
Madison14874283
Jones14086247
Forrest13741259
Lauderdale12249324
Lowndes11286193
Lamar10644140
Pearl River9707244
Lafayette8827143
Hancock7835132
Washington7550169
Oktibbeha7204138
Monroe6989179
Pontotoc6970109
Warren6849178
Panola6746134
Neshoba6726210
Marshall6653141
Bolivar6440151
Union633897
Pike5924156
Alcorn5862107
Lincoln5525136
George510180
Prentiss500884
Tippah490282
Itawamba4829107
Scott477499
Adams4766125
Tate4748116
Leflore4723144
Copiah455895
Yazoo455591
Simpson4543117
Wayne442772
Covington432895
Sunflower4299106
Marion4265112
Coahoma4227109
Leake413790
Newton395581
Tishomingo381793
Grenada3775109
Stone365666
Jasper340166
Attala337790
Winston317792
Chickasaw313367
Clay311878
Clarke301195
Calhoun284449
Holmes271289
Smith268952
Yalobusha243747
Tallahatchie231453
Greene224749
Walthall221366
Lawrence217840
Perry213356
Amite209557
Webster205148
Noxubee188642
Montgomery181557
Carroll174441
Jefferson Davis173643
Tunica163239
Benton152639
Kemper144941
Choctaw136527
Claiborne134238
Humphreys131139
Franklin124929
Quitman107528
Wilkinson105939
Jefferson96834
Sharkey65121
Issaquena1957
Unassigned00

Alabama Coronavirus Cases

Cases: 844951

Reported Deaths: 16115
CountyCasesDeaths
Jefferson1161002006
Mobile741871379
Madison53279732
Shelby38325368
Baldwin38068589
Tuscaloosa36009641
Montgomery34482781
Lee25550263
Calhoun22585518
Morgan22451406
Etowah20013517
Marshall18777316
Houston17727425
St. Clair16875358
Limestone16135218
Cullman16044303
Elmore15904294
Lauderdale14968306
Talladega14189299
DeKalb12967269
Walker12020380
Blount10714192
Autauga10517157
Jackson10157194
Coffee9414192
Colbert9334208
Dale9018191
Tallapoosa7254201
Russell707765
Chilton7018170
Escambia6955143
Covington6932195
Franklin6340108
Chambers5783142
Marion5401130
Dallas5285209
Pike5118109
Clarke484986
Lawrence4826129
Winston4780110
Geneva4642136
Bibb434094
Barbour369480
Butler3434100
Marengo342393
Monroe337066
Randolph334367
Pickens333188
Fayette330085
Henry320666
Hale318189
Cherokee317563
Crenshaw260477
Washington256952
Cleburne254460
Lamar251253
Clay250869
Macon244764
Conecuh192762
Coosa184947
Lowndes178168
Wilcox177438
Bullock152645
Perry141840
Sumter139241
Greene130245
Choctaw93228
Out of AL00
Unassigned00
Tupelo
Clear
43° wxIcon
Hi: 62° Lo: 29°
Feels Like: 43°
Columbus
Partly Cloudy
47° wxIcon
Hi: 60° Lo: 28°
Feels Like: 47°
Oxford
Partly Cloudy
41° wxIcon
Hi: 60° Lo: 28°
Feels Like: 41°
Starkville
Partly Cloudy
° wxIcon
Hi: 61° Lo: 27°
Feels Like: °
High pressure will continue to dominate our weather forecast for our Saturday. This will keep us filled with plenty of sunshine in our weather forecast for our Saturday.
WTVA Radar
WTVA Temperatures
WTVA Severe Weather