Thursday , July 29 2021

J&J says Covid-10 vaccine still on track despite manufacturing snafu

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.

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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.

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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.

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“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.”

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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.

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“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.”

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