US to resume J&J COVID vaccinations despite rare clot risk

The CDC halted the distribution of Johnson & Johnson coronavirus vaccines after health officials said they could be the cause of potential blood clots.

Health officials have lifted it's pause on the Johnson & Johnson vaccine.

Posted: Apr 23, 2021 8:09 PM
Updated: Apr 26, 2021 9:55 AM

ASSOCIATED PRESS - U.S. health officials lifted an 11-day pause on COVID-19 vaccinations using Johnson & Johnson's single-dose shot on Friday, after scientific advisers decided its benefits outweigh a rare risk of blood clot.

The government uncovered 15 vaccine recipients who developed a highly unusual kind of blood clot out of nearly 8 million people given the J&J shot. All were women, most under age 50. Three died, and seven remain hospitalized.

But ultimately, federal health officials decided that J&J's one-and-done vaccine is critical to fight the pandemic — and that the small clot risk could be handled with warnings to help younger women decide if they should use that shot or an alternative.

The Centers for Disease Control and Prevention said the J&J vaccine has important advantages for some people who were anxiously awaiting its return. And the Food and Drug Administration updated online vaccine information leaflets for would-be recipients and health workers, so that shots could resume as early as Saturday.

“This is not a decision the agencies reached lightly,” FDA Acting Commissioner Janet Woodcock told reporters late Friday.

CDC Director Dr. Rochelle Walensky added that the pause should increase confidence in vaccine safety, showing “that we are taking every one of those needles in a haystack that we find seriously.”

The U.S. decision — similar to how European regulators are rolling out J&J's shot — comes after advisers to the CDC debated in a daylong meeting just how serious the risk really is. Panelists voted 10-4 to resume vaccinations without outright age restrictions, but made clear that the shots must come with clear warnings about the clots.

“I think we have a responsibility to be certain that they know this," said Dr. Sarah Long of Drexel University College of Medicine, who voted against the proposal because she felt it did not go far enough in warning younger women.

The committee members all agreed the J&J vaccine "should be put back into circulation,” panel chairman Dr. Jose Romero, Arkansas' health secretary, said in an interview after the vote. “The difference was how you convey the risk ... It does not absolve us from making sure that people who receive this vaccine, if they are in the risk group, that we inform them of that.”

European regulators earlier this week made a similar decision, deciding the clot risk was small enough to allow the rollout of J&J's shot. But how Americans ultimately handle J&J’s vaccine will influence other countries that don’t have as much access to other vaccination options.

Dr. Paul Stoffels, J&J's chief scientific officer, pledged that the company would work with U.S. and global authorities “to ensure this very rare event can be identified early and treated effectively.”

At issue is a weird kind of blood clot that forms in unusual places, such as veins that drain blood from the brain, and in patients with abnormally low levels of the platelets that form clots. Symptoms of the unusual clots, dubbed “thrombosis with thrombocytopenia syndrome,” include severe headaches a week or two after the J&J vaccination — not right away — as well as abdominal pain and nausea.

The government initially spotted six cases of the rare clots, with nine more cases coming to light in the last week or so. But even the first handful of reports raised alarm because European regulators already had uncovered similar rare clots among recipients of another COVID-19 vaccine, from AstraZeneca. The AstraZeneca and J&J shots, while not identical, are made with the same technology.

European scientists found clues that an abnormal platelet-harming immune response to AstraZeneca’s vaccine might be to blame -- and if so, then doctors should avoid the most common clot treatment, a blood thinner called heparin.

That added to U.S. authorities’ urgency in pausing J&J vaccinations so they could tell doctors how to diagnose and treat these rare clots. Six patients were treated with heparin before anyone realized that might harm instead of help.

Dr. Jesse Goodman of Georgetown University closely watched Friday's deliberations and said people should be made aware of the clotting risk but that it shouldn't overshadow the benefits of COVID-19 protection.

“We need to treat people as adults, tell them what the information is and give them these choices,” said Goodman, a former vaccine specialist at the FDA.

Two-dose vaccines from Pfizer and Moderna, which are made differently and haven't been linked to clot risks, are the mainstay of the U.S. vaccination effort. But many states had been counting on the easier-to-store, one-dose option to also help protect hard-to-reach populations including people who are homeless or disabled.

The CDC's advisers struggled to put the rare clot cases into perspective. COVID-19 itself can cause a different type of blood clots. So can everyday medications, such as birth control pills.

The side effect debate isn't the only hurdle facing J&J. The FDA separately uncovered manufacturing violations at a Baltimore factory the company had hired to help brew the vaccine. No shots made by Emergent BioSciences have been used — J&J's production so far has come from Europe. But it's unclear how the idled factory will impact J&J's pledge to provide 100 million U.S. vaccine doses by the end of May and 1 billion doses globally this year.

Mississippi Coronavirus Cases

Data is updated nightly.

Cases: 319381

Reported Deaths: 7354
CountyCasesDeaths
DeSoto22264265
Hinds20634421
Harrison18381316
Rankin13862282
Jackson13677248
Madison10234224
Lee10050176
Jones8458167
Forrest7821153
Lauderdale7257242
Lowndes6498149
Lamar633688
Lafayette6298120
Washington5418136
Bolivar4835133
Panola4663110
Oktibbeha466098
Pearl River4597146
Marshall4572105
Warren4440121
Pontotoc424973
Monroe4155135
Union415576
Neshoba4059179
Lincoln4007111
Hancock386087
Leflore3515125
Tate342386
Sunflower339391
Pike3366110
Alcorn324172
Scott319374
Yazoo314171
Itawamba305077
Adams304885
Copiah299766
Coahoma298383
Simpson298189
Tippah291568
Prentiss283561
Leake271774
Marion271280
Covington267083
Wayne264442
Grenada264087
George251951
Newton248563
Tishomingo231267
Winston229981
Jasper222148
Attala215073
Chickasaw210459
Holmes190374
Clay187554
Stone187433
Tallahatchie180041
Clarke178980
Calhoun174032
Yalobusha167840
Smith164034
Walthall135247
Greene131833
Lawrence131024
Montgomery128643
Noxubee127934
Perry126638
Amite126142
Carroll122330
Webster115032
Tunica108027
Jefferson Davis107833
Claiborne103030
Benton102325
Humphreys97533
Kemper96628
Franklin85023
Quitman81816
Choctaw79018
Wilkinson69332
Jefferson66228
Sharkey50917
Issaquena1696
Unassigned00

Alabama Coronavirus Cases

Cases: 547873

Reported Deaths: 11274
CountyCasesDeaths
Jefferson809141565
Mobile41984826
Madison35629523
Tuscaloosa26147458
Shelby25580254
Montgomery25075611
Baldwin21805313
Lee16248175
Calhoun14710325
Morgan14618285
Etowah14160362
Marshall12446230
Houston10757288
Elmore10292212
Limestone10179157
St. Clair10155250
Cullman9928200
Lauderdale9591248
DeKalb8963189
Talladega8455184
Walker7330280
Autauga7229113
Blount6937139
Jackson6905113
Colbert6406139
Coffee5622126
Dale4929114
Russell454541
Chilton4470116
Franklin430783
Covington4267122
Tallapoosa4127154
Escambia401180
Chambers3723123
Dallas3606156
Clarke352861
Marion3237106
Pike313978
Lawrence3124100
Winston283272
Bibb267664
Geneva257081
Marengo250665
Pickens236662
Barbour234559
Hale226678
Butler223771
Fayette217762
Henry193743
Cherokee187245
Randolph186944
Monroe179141
Washington170439
Macon162951
Clay160159
Crenshaw155157
Cleburne153144
Lamar146237
Lowndes142053
Wilcox127030
Bullock124242
Conecuh113230
Coosa111429
Perry108726
Sumter105732
Greene93434
Choctaw61725
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