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CDC vaccine advisers will meet Friday to discuss the J&J vaccine. Here's what could happen next

Vaccine advisers to the Centers for Disease Control and Prevention meet Friday to make recommendations for use of the Johnson & Johnson Covid-19 vaccine afte...

Posted: Apr 22, 2021 9:39 AM
Updated: Apr 22, 2021 9:47 AM

Vaccine advisers to the Centers for Disease Control and Prevention meet Friday to make recommendations for use of the Johnson & Johnson Covid-19 vaccine after it was put on hold to investigate a potential link to serious blood clots.

The CDC and US Food and Drug Administration recommended a pause on use of the J&J coronavirus vaccine last week following six reported US cases of a rare and severe type of blood clot.

They are investigating whether there are more cases and whether other types of blood clots might be associated with the vaccine. The pause was also intended to give experts time to inform doctors about how to look for and treat these clots.

The CDC's Advisory Committee on Immunization Practices met on April 14, but members said they needed more information about the J&J vaccine and the blood clot cases.

Dr. William Schaffner, a non-voting ACIP member and infectious diseases professor at the Vanderbilt University School of Medicine, told CNN that the committee delayed making a decision because there will likely be more reports of blood clots connected to the vaccine, and members need to understand the demographics of those cases.

Schaffner said Friday's meeting could play out a few different ways.

ACIP could recommend that use of the vaccine resume with no changes, or the committee could recommend that the US stop using the J&J vaccine altogether.

Schaffner said it's more likely that ACIP will recommend that use of the vaccine resume with a warning about possible adverse effects -- and potentially, advice to the highest-risk populations to steer clear of this vaccine altogether.

ACIP chair Dr. Jose Romero told CNN that the committee also has the option to recommend the pause continue until more information is gathered -- though he believes enough data has been generated at this point for ACIP to make a decision.

Romero said he has yet to examine the data that will be considered Friday but does not believe the committee will decide to recommend a complete stop to use of the vaccine in the US.

"CDC scientists can make an estimate of what the benefit-risk analysis would be, and that's certainly going to inform us in our decision," said Romero. "Whoever uses the vaccine -- as with any vaccine in this country -- they should be informed about any risks associated with it."

He noted that a potential Covid-19 vaccine booster dose may eventually need to be considered.

"If there's a high-risk population that is indicated that they should not receive the vaccine, then I would imagine the CDC will make recommendations about what the alternative vaccine would be in that group," Romero said.

What action could ACIP take?

One blood clot case in a 25-year-old man was reported during the vaccine's clinical trial. Though the six cases that led to the pause last week were all among women between the ages of 18 and 48, Schaffner said that may not be an accurate representation of risk.

Nearly 8 million people in the US have now received the J&J vaccine. Doctors could realize now that cases of these rare blood clots that they've recently seen were connected to the vaccine, and new cases could emerge among people who have received the vaccine in recent weeks.

"Some of the ACIP members are concerned that this additional reporting may show cases of men or older persons, who are currently not represented in the reporting of the six cases, and so they didn't think the entire picture of risk has been developed," said Schaffner.

CDC Director Dr. Rochelle Walensky said Monday that the agency is now looking through a handful of reported adverse events after use of the J&J vaccine.

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said Sunday that he expects the vaccine to come back on the market with restrictions or warnings after Friday's meeting.

J&J Chief Scientific Officer Dr. Paul Stoffels said Tuesday the company believes the benefits of the vaccine outweigh the risks.

"The safety and well-being of the people who use our product is our number one priority and we strongly support awareness of the signs and symptoms of this extremely rare event to ensure the correct diagnosis, appropriate treatment and expedited report by health care professionals," Stoffels said.

Romero, who also serves as Arkansas' secretary of health, said there could be additional recommendations for states and physicians around how to manage J&J doses that have already been distributed. He said he believes states will accept the committee's recommendations.

"My counsel to the governor as we go forward will be, 'Let's see what the CDC says,'" said Romero. "More than likely -- I mean more than 98% -- I'm going to say I agree with the recommendations issued by the committee, and those are the ones we should follow in our state."

Though there is some concern that the J&J vaccine pause will fuel vaccine hesitancy, an Axios-Ipsos poll published Tuesday showed that 88% of Americans think the CDC and FDA were acting responsibly when they recommended the pause.

"I really think, and I really hope that the American public will look at this pause and look at what we have done during this pause as an indication of how safe the vaccine system and the vaccine pipeline is in this country," said Romero.

Will this impact vaccine supply in the US?

President Joe Biden and other officials have said whatever decision is made about the Covid-19 vaccine, it will not hinder the vaccination effort in the US.

The FDA requested Monday that manufacturing of the J&J vaccine be paused at a Baltimore Emergent BioSolutions facility while it conducts an investigation into contamination that affected at least one batch of J&J's vaccine.

"We want to convey to the American public we have two vaccines that are readily available -- the Pfizer and Moderna -- and people should continue to roll up their sleeves to get vaccinated," CDC Director Dr. Rochelle Walensky said last week.

Walensky said that while the CDC conducts a risk-benefit analysis of the J&J vaccine, the agency has reached out to more than 10,000 providers to inform them about what to watch out for, in case other people experience similar adverse events.

Those who have received the J&J vaccine within the last three weeks have a very low risk of developing the rare blood clot that will decrease over time, the CDC says. The agency recommends those who experience certain symptoms, including sudden, severe headache, leg swelling and shortness of breath, seek immediate medical treatment.

Indiana Coronavirus Cases

Data is updated nightly.

Cases: 749532

Reported Deaths: 13746
CountyCasesDeaths
Marion1030911775
Lake554681006
Allen41636691
St. Joseph36947564
Hamilton36527416
Elkhart29363459
Tippecanoe22862225
Vanderburgh22542400
Porter19331325
Johnson18405388
Hendricks17588317
Clark13200193
Madison13120344
Vigo12604253
LaPorte12394221
Monroe12163175
Delaware10947198
Howard10263225
Kosciusko9614119
Hancock8549144
Bartholomew8162157
Warrick7854156
Floyd7772180
Grant7229179
Wayne7155201
Boone6917103
Morgan6736141
Dubois6211118
Marshall6206116
Cass5991108
Henry5894108
Dearborn588978
Noble580186
Jackson508674
Shelby500897
Lawrence4732121
Gibson444093
Harrison440773
Clinton440055
DeKalb438785
Montgomery434690
Whitley406042
Huntington402281
Steuben399259
Miami392768
Jasper386954
Knox375790
Putnam372160
Wabash360583
Ripley346570
Adams344955
Jefferson335685
White330253
Daviess3031100
Wells295181
Decatur289992
Greene286385
Fayette284864
Posey273735
LaGrange272872
Scott269955
Clay265848
Washington244934
Randolph244683
Jennings235149
Spencer234231
Starke227558
Fountain218647
Sullivan213943
Owen211058
Fulton201542
Jay200932
Carroll193420
Orange188055
Perry186937
Rush175726
Vermillion173644
Franklin170235
Tipton165846
Parke149016
Pike138034
Blackford136132
Pulaski120247
Newton112736
Brown103943
Crawford102316
Benton101014
Martin91515
Warren83615
Switzerland8098
Union72810
Ohio57811
Unassigned0420

Ohio Coronavirus Cases

Data is updated nightly.

Cases: 1107225

Reported Deaths: 20091
CountyCasesDeaths
Franklin1285061459
Cuyahoga1156322204
Hamilton812991245
Montgomery524951040
Summit48356999
Lucas43309817
Butler38903603
Stark33297929
Lorain25641502
Warren24558303
Mahoning22332601
Lake21139385
Clermont20098252
Delaware18819135
Licking16649222
Fairfield16564204
Trumbull16527479
Medina15597270
Greene15256246
Clark14223306
Wood13281197
Portage13229214
Allen11903239
Richland11598211
Miami10837223
Wayne9116222
Columbiana9023230
Muskingum8889135
Pickaway8652122
Tuscarawas8639247
Marion8635138
Erie8052164
Ashtabula7139179
Hancock6996131
Ross6934161
Geauga6832150
Scioto6530104
Belmont6149174
Union583849
Lawrence5723102
Jefferson5669158
Huron5539122
Sandusky5437125
Darke5415129
Seneca5344126
Washington5308109
Athens523360
Auglaize501687
Mercer487285
Shelby476295
Knox4568112
Madison443765
Ashland435197
Putnam4334103
Fulton431871
Defiance431798
Crawford4033110
Brown401961
Logan387377
Preble3847103
Clinton378566
Ottawa372781
Highland359465
Williams347878
Champaign343858
Guernsey324253
Jackson317554
Perry297150
Morrow291340
Fayette285350
Hardin274865
Henry273267
Holmes2699101
Coshocton268459
Van Wert247264
Adams242956
Pike242735
Gallia240550
Wyandot234556
Hocking220162
Carroll196948
Paulding176342
Meigs148240
Monroe136144
Noble135839
Harrison113738
Morgan109624
Vinton85417
Unassigned03
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