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CDC vaccine advisers put off decision on Johnson & Johnson Covid-19 vaccine

Vaccine advisers to the US Centers for Disease Control and Prevention put off making any decision on Wednesday about the recommendations for Johnson & Johnso...

Posted: Apr 14, 2021 7:29 PM
Updated: Apr 15, 2021 9:38 AM

Vaccine advisers to the US Centers for Disease Control and Prevention put off making any decision on Wednesday about the recommendations for Johnson & Johnson's coronavirus vaccine, saying they need more information about a rare type of blood clot.

Members of the Advisory Committee on Immunization Practices said they did not have enough information to make changes in their recommendations, or even to suggest extending a pause in administering the vaccine.

The CDC and the US Food and Drug Administration recommended that the United States pause the use of the Johnson & Johnson vaccine on Tuesday after six reported cases of a rare but dangerous and hard to-treat form of blood clot among people who had recently been vaccinated.

On Wednesday, the CDC advisers also heard about a possible seventh case, and details of one case in a volunteer during trials of the vaccine -- a case that J&J initially said was not linked to the vaccine.

ACIP staff said they would quickly look for a time within the next week to 10 days that the committee could meet again so the vaccine is not unnecessarily delayed if they decide it's safe to continue giving it.

'We will find a time to reconvene,' ACIP executive secretary Dr. Amanda Cohn told the meeting. 'We will try to identify what that date is by Friday of this week so that people have a little bit more time to get it on the calendars.'

Federal regulators are keen to get more information about the blood clots, called cerebral venous sinus thromboses (CVST), that are found in combination with a shortage of blood-clotting cells called platelets. The combination makes the condition extra dangerous, because using the blood thinners typically employed to treat blood clots can cause hemorrhaging in these patients.

At least four of the six cases were treated with the blood thinner heparin when they first developed symptoms, Dr. Aran Maree, chief medical officer for pharmaceuticals at J&J's Janssen vaccine arm, told the meeting.

He gave details of what's known about the cases, which include: a 45-year-old woman who died; a 38-year-old woman who has not recovered; an 18-year-old woman who has not recovered; a 48-year-old woman who has not recovered; a 26-year-old woman who has recovered and a 28-year-old woman whose status is unknown.

They also include a possible seventh case -- a 59-year-old woman who has not yet recovered and whose blood clots might not fit the same profile as the others.

Maree said the company still feels the vaccine is safe enough to use.

'I'd like to reiterate that based on the current data, Janssen believes the overall benefit-risk profile for our vaccine is positive across the population for which it's authorized,' Maree told the meeting.

'We strongly support ensuring awareness of the signs and symptoms of this very rare event, as well as recommendations to ensure the correct diagnosis, treatment and reporting by health care professionals.'

ACIP staff said the committee could consider recommending changes in who gets the vaccine -- for instance, only men, as most cases of the clots are among women, or only people over 50, as most of the cases were in people under 50.

But members said they may not know enough yet to make such recommendations.

'I do not want to vote on this issue today. I do not want to vote not to recommend the vaccine -- I think that is not really something I necessarily believe,' Dr. Beth Bell, a clinical professor at the University of Washington in Seattle, told the meeting.

'I just don't feel there's enough information to make an evidence-based decision. We won't have all the information, but I think there are some things that we can gather relatively quickly, which all have to do with the benefit/risk balance,' Bell said.

'We do need to better understand the risk, which we know is going to be very rare, very low, but we really don't know exactly how low and how to correctly characterize it,' Bell added.

'I think we need to not vote and gather the necessary information so we can make an evidence-based decision.'

Bell, who chairs the ACIP's working group, said earlier it was also unclear if the blood clots seen in people who got the Janssen vaccine were the same as those seen in people in the UK and Europe who got the AstraZeneca vaccine, which is not yet authorized in the US.

Both vaccines use adenoviruses, a type of common cold virus, to carry genetic material from the coronavirus into the body to elicit immunity. One theory is that these adenoviruses somehow prompt an immune response that causes the low platelet count and the blood clots.

'The extent to which the cases seen after each of these adenoviral vector vaccines represent exactly the same syndrome is not entirely clear at this time,' Bell told the meeting.

The group has a scheduled meeting in three weeks -- on May 5 -- or could schedule another emergency meeting.

But Dr. Nirav Shah, director of Maine's Center for Disease Control and Prevention and representative for the Association of State and Territorial Health Officials, said waiting was equally bad.

'We are in a situation where not making a decision is tantamount to making a decision,' Shah said, noting that people who could benefit from getting a one-dose vaccine would go unvaccinated as a result of further delay.

Dr. Camille Kotton of Massachusetts General Hospital and Harvard Medical School, said the country needs the one-shot vaccine.

'Putting this vaccine on pause for those of us that are frontline health care workers has really been devastating,' Kotton told the meeting.

'I agree in general that we don't have data to make a decision at this time. But we were planning on using this vaccine in the state of Massachusetts for people who are homebound and otherwise not able to get a vaccine.

'We were planning on using it for our vulnerable in-patient population often with many comorbidities and at high risk for disease but who haven't been able to get vaccinated otherwise. And then it certainly was going to be used in what may be otherwise underserved populations or populations that aren't able to get mRNA vaccines,' Kotton added.

The mRNA vaccines made by Moderna and Pfizer/BioNTech require special refrigeration and are given in two-dose regimens.

'So I definitely want us to be cautious and very careful with our decision making, but I also just want to emphasize that this one-and-done vaccine that didn't require the cold chain that the mRNA vaccines do, it's a significant loss,' Kotton said.

Dr. Paul Offit, a member of the US Food and Drug Administration's vaccine advisory committee, called it 'an unfortunate non-decision.'

'One thing they could have said was, 'Just explain to people that there is this very rare, but very real side effect, remembering that of every million people that get Covid, 1,850 will die,'' said Offit, director of the Vaccine Education Center at Children's Hospital of Philadelphia. 'There are no risk-free choices -- just choices to take different risks.'

Earlier, CDC Director Dr. Rochelle Walensky said it was not clear her agency had heard about every blood clot that might be linked to the vaccine. 'Right now, we believe these events to be extremely rare, but we are also not yet certain we have heard about all possible cases, as this syndrome may not be easily recognized as one associated with the vaccine,' she told a media briefing.

She said while people need to be aware of the potential symptoms, the vaccine surveillance system is working. 'Jointly, CDC and FDA were able to identify these rare events and act quickly to alert healthcare providers and the public. This demonstrates that the safety systems we have in place are working,' she said.

Symptoms people should be on the lookout for after getting the Janssen vaccine include severe headache, abdominal or leg pain or shortnessof breath, Walensky said.

Indiana Coronavirus Cases

Data is updated nightly.

Cases: 944708

Reported Deaths: 15343
CountyCasesDeaths
Marion1287051987
Lake634321097
Allen53759760
Hamilton43980448
St. Joseph42010590
Elkhart33651491
Vanderburgh30486449
Tippecanoe26872250
Johnson23685417
Hendricks22354341
Porter21799347
Clark17493231
Madison17439384
Vigo16209284
Monroe14515191
LaPorte14350239
Delaware14134222
Howard13921273
Kosciusko11448135
Hancock10886166
Warrick10715177
Bartholomew10589169
Floyd10471206
Wayne10020226
Grant9165204
Morgan8895160
Boone8417111
Dubois7748123
Dearborn764990
Henry7648130
Noble7435101
Marshall7384128
Cass7209117
Lawrence6999153
Shelby6616111
Jackson659186
Gibson6177107
Harrison606286
Huntington603195
Montgomery5830105
DeKalb578391
Knox5506104
Miami545788
Putnam540568
Clinton535965
Whitley526553
Steuben499768
Wabash486292
Jasper481860
Jefferson472892
Ripley456077
Adams445568
Daviess4209108
Scott407965
White392957
Clay392857
Greene390592
Wells388784
Decatur385996
Fayette377278
Posey361541
Jennings354356
Washington333747
LaGrange323575
Spencer319536
Fountain317955
Randolph314889
Sullivan308449
Owen284863
Starke281464
Fulton280054
Orange276859
Jay256338
Perry252552
Carroll244929
Franklin240538
Rush235630
Vermillion234450
Parke221020
Tipton210555
Pike209539
Blackford169634
Pulaski165551
Crawford146718
Newton145245
Benton143516
Brown135546
Martin129317
Switzerland126210
Warren115516
Union97711
Ohio80111
Unassigned0479

Ohio Coronavirus Cases

Data is updated nightly.

Cases: 1373275

Reported Deaths: 21596
CountyCasesDeaths
Franklin1527821560
Cuyahoga1349902327
Hamilton979751320
Montgomery674391141
Summit564421047
Lucas51165863
Butler47623655
Stark41836976
Lorain31748532
Warren30182331
Mahoning27127639
Clermont25753292
Lake24662417
Delaware22415145
Licking20587241
Fairfield20543221
Greene20436272
Trumbull19983509
Medina19884287
Clark17992328
Richland16428234
Portage16225229
Wood15771208
Allen14196256
Miami13889253
Muskingum12762152
Wayne12044238
Columbiana11800241
Tuscarawas11064269
Marion10797148
Pickaway10519129
Scioto10394127
Erie9784171
Ross9502176
Lawrence8809125
Hancock8514141
Ashtabula8376185
Geauga8196156
Belmont8180187
Jefferson7589172
Huron7476128
Union736651
Washington7245120
Athens701765
Sandusky6885134
Darke6789136
Knox6724122
Seneca6422137
Ashland5989113
Auglaize590488
Shelby5774101
Brown568571
Mercer560290
Defiance5511101
Crawford5477114
Madison546771
Highland545081
Fulton536283
Clinton529280
Logan514282
Preble5033110
Putnam4859106
Guernsey474764
Williams462282
Perry456452
Champaign448864
Ottawa439084
Jackson429562
Pike392643
Morrow389051
Coshocton381666
Fayette378453
Adams363575
Hardin362069
Gallia349856
Henry327368
Holmes3273108
Van Wert316170
Hocking305169
Wyandot282658
Carroll264752
Paulding243543
Meigs217442
Monroe190849
Noble171140
Morgan168129
Harrison159340
Vinton139318
Unassigned05
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