J&J says Covid-19 vaccine still on track despite manufacturing snafu

Johnson & Johnson said Thursday it still expects to meet its commitments for the promised delivery of an additional 24 million doses of its Covid-19 vaccine...

Posted: Apr 1, 2021 8:13 PM

Johnson & Johnson said Thursday it still expects to meet its commitments for the promised delivery of an additional 24 million doses of its Covid-19 vaccine in April, even after a quality problem at one of the company's contract manufacturers.

The plant that had the problem, run by Baltimore-based Emergent BioSolutions, has not yet been authorized by the US Food and Drug Administration to make the vaccine and has not made any of the doses that are in the current vaccine rollout.

Emergent told CNN the problem affected a single batch of "bulk drug substance" used to make vaccine.

In an emailed statement to CNN, Emergent said its quality control systems caught the batch that "did not meet specifications and our rigorous quality standards" before it got any further. The company said it isolated the material and will now dispose of it.

It did not detail what the ingredient was or how important it was for any resulting vaccine.

The New York Times reported Wednesday. that workers at Emergent accidentally mixed up some of the ingredients that would have gone into as many as 15 million potential doses of vaccine. But Emergent CEO Bob Kramer told CNBC there was not a mixup between vaccines being made at the plant.

"It wasn't the case where an ingredient from one vaccine contaminated or impacted the other," he said.

He would not confirm the estimate that the batch would have affected 15 million doses.

"Importantly, the quality control systems worked as designed to detect and isolate this single batch," Emergent's statement said. "Discarding a batch of bulk drug substance, while disappointing, does occasionally happen during vaccine manufacturing, which is a complex and multi-step biological process."

Emergent added that it is confident the company will meet the FDA's requirements for authorization to make this vaccine. Emergent is also working on Covid-19 vaccines made by other companies.

It's still unclear when Emergent may get FDA authorization. Johnson & Johnson said it is continuing to work with the FDA and Emergent toward the authorization of the facility.

J&J said that it sent additional quality, manufacturing and technical operations experts to be on site to supervise and support the manufacturing of their vaccine.

A source tells CNN the FDA is demanding more information from Johnson & Johnson on what went wrong and said the FDA has been on the phone with J&J almost constantly since Wednesday.

Even without Emergent, Johnson & Johnson was able to meet its commitment to deliver 20 million doses in March, and the company said it is still on track to deliver 24 million more in April.

An official with the Biden administration said the April rollout of the vaccine will likely look a lot like March, where only a few doses go out at the beginning of the month, and then there will be a lot more doses available near the end of the month.

For now, the administration said, the vaccine materials will continue to come from J&J's vaccine arm Janssen in the Netherlands and will go to fill and finishing plants that have been doing the final stage process of the vaccines.

For the final stages of the manufacturing in the US, J&J has worked with contract manufacturers Catalant in Bloomington, Indiana and with Grand River Aseptic Manufacturing in Grand Rapids, Michigan. Both plants have been working 24 hours a day, seven days a week to finish the vaccines.

On Wednesday evening, Biden administration officials stressed that the quality issue with Johnson & Johnson's Baltimore manufacturing plant won't affect the president's ultimate goal of making vaccines available to all Americans by May.

Local health departments don't believe the supply "will be terribly impacted" by this manufacturing issue, according to Lori Freeman, the CEO at the National Association of County and City Health Officials.

Freeman said that they were told on a White House call this week that "supplies would remain relatively flat over the next three weeks," with roughly 16 million doses of vaccines made by Pfizer and Moderna, and an additional 5.1 million J&J vaccines sent to states, tribes, and territories. J&J 's supply will fluctuate, adding additional 4 to 6 million doses weekly to 16 million per month.

Freeman added that "interestingly," nothing was mentioned about the J&J challenges during their White House calls earlier in the week.

The only potential problem Freeman could foresee is if the federal government adds more vaccine distribution channels.

"The more the distribution channels expand from the federal government channels (to Dialysis Centers, Community Health Centers, the ramp up of the Federal Pharmacy Program from 17,000 stores to 40,000 stores) -- if there are disruptions in the supply chain, somewhere along these distribution channels, things could change or vaccine administration could slow," Freeman said in an email to CNN.

Jennifer Kates, the senior vice president and director of global health and HIV policy at the Kaiser Family Foundation said that in the grand scheme of things this is "a hiccup."

"It's an unfortunate setback in some ways, but the good news is the US government has already purchased enough doses that are scheduled to be delivered between Pfizer and Moderna, and Johnson & Johnson."

The US is scheduled to receive 600 million doses of the two-dose vaccines from Pfizer and Moderna, and now has 20 million doses of the Johnson & Johnson single-dose shot.

"So, that's enough to vaccinate 320 million people, that's the goal, enough to vaccinate everybody, in the US and that's not affected by this," Kates said.

She said public health officials do always worry that stories about a "hiccup" in manufacturing could increase the reluctance of those who are vaccine hesitant, but the positive news is that the problem was stopped before it ever reached the American public and it shows that the safety systems are working.

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told CBS This Morning the incident shows the quality controls are working.

"That's the reason why the good news is that it did get picked up," Fauci said.

Kates added that if there is any kind of delay with J&J vaccine, it could negatively impact people who are harder to reach.

A Kaiser Family Foundation poll published Tuesday found that the majority of people who were on the fence about the Covid-19 vaccine -- those who wanted to "wait and see" -- preferred a single-dose shot, if they were to get one at all.

"So it does mean that if there is a delay, it could reduce the likelihood that the option is there for those individuals who may be more reluctant, as well as harder to reach individuals like the homeless populations, so it could mean having to work harder to reach people, Kates said.

"But hopefully J&J can get this figured out and fix it," she added. "The good news is, we're in a good place in terms of overall supply."

Minnesota Coronavirus Cases

Data is updated nightly.

Cases: 604509

Reported Deaths: 7638
CountyCasesDeaths
Hennepin1249671779
Ramsey52513897
Dakota46840471
Anoka42774458
Washington27428291
Stearns22557225
St. Louis18138313
Scott17551136
Wright16379149
Olmsted13399102
Sherburne1202095
Carver1067448
Clay826192
Rice8202110
Blue Earth762644
Crow Wing681795
Kandiyohi667985
Chisago619952
Otter Tail585884
Benton582998
Goodhue483874
Douglas475581
Mower470533
Winona461351
Itasca459763
Isanti440064
McLeod430661
Morrison424762
Beltrami407861
Nobles407650
Steele397816
Polk389072
Becker386755
Lyon363853
Carlton353056
Freeborn347033
Pine334923
Nicollet331245
Mille Lacs311854
Brown307840
Le Sueur297326
Cass286232
Todd285633
Meeker263443
Waseca238023
Martin235332
Roseau211221
Wabasha20793
Hubbard196641
Dodge18783
Renville182446
Redwood176539
Houston174616
Cottonwood167124
Wadena163323
Fillmore157610
Faribault154719
Chippewa154038
Pennington153820
Kanabec146828
Sibley146810
Aitkin138937
Watonwan13579
Rock128719
Jackson122712
Pipestone116726
Yellow Medicine114920
Pope11306
Murray107110
Swift106918
Koochiching95418
Stevens92411
Clearwater89016
Marshall88817
Lake83220
Wilkin83213
Lac qui Parle75622
Big Stone6044
Grant5948
Lincoln5853
Mahnomen5669
Norman5479
Kittson49022
Unassigned48193
Red Lake4017
Traverse3775
Lake of the Woods3453
Cook1720

Iowa Coronavirus Cases

Data is updated nightly.

Cases: 371101

Reported Deaths: 6053
CountyCasesDeaths
Polk58263640
Linn21221339
Scott20308248
Black Hawk16157312
Woodbury15240230
Johnson1462385
Dubuque13510211
Dallas1129199
Pottawattamie11228174
Story1071648
Warren583791
Clinton561593
Cerro Gordo554095
Sioux517574
Webster515894
Muscatine4882106
Marshall486976
Des Moines467672
Wapello4338122
Buena Vista426940
Jasper421172
Plymouth403181
Lee382356
Marion366076
Jones300957
Henry294637
Bremer288461
Carroll287152
Boone268634
Crawford268240
Benton259855
Washington257351
Dickinson249344
Mahaska232651
Jackson225242
Clay216727
Kossuth216166
Tama212071
Delaware211143
Winneshiek198735
Page194522
Buchanan194033
Cedar192423
Hardin187544
Fayette186643
Wright186040
Hamilton181951
Harrison180073
Clayton171057
Butler166335
Madison164619
Mills163824
Floyd163442
Cherokee159338
Lyon158841
Poweshiek157036
Allamakee152952
Hancock150334
Iowa149824
Winnebago144531
Cass139255
Calhoun138913
Grundy137233
Emmet135841
Jefferson133535
Shelby131837
Sac130920
Union130035
Louisa129649
Appanoose129049
Mitchell126643
Chickasaw124917
Franklin123523
Guthrie123332
Humboldt119626
Palo Alto113623
Howard105022
Montgomery103638
Clarke100924
Keokuk96732
Monroe96431
Unassigned9540
Ida91535
Adair87332
Pocahontas85822
Davis85225
Monona82931
Osceola78916
Greene78011
Lucas77923
Worth7618
Taylor66812
Fremont6269
Decatur6169
Ringgold56424
Van Buren56318
Wayne54423
Audubon53311
Adams3444
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