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  • OTLT.USA
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  • OTRI.USA
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Medically NecessaryNews

Problematic vaccine plant still lacks approval after some doses cleared

FDA OK’d millions of J&J doses after mix-up

The news: A problematic Maryland vaccine plant making Johnson & Johnson’s COVID-19 vaccine still doesn’t have regulatory approvals, even after the Food and Drug Administration declared several batches from the plant were safe.

FDA on June 11 cleared two batches of the Johnson & Johnson vaccine produced at the plant, and cleared a third batch this week.

The FDA has cleared a total of 25 million Johnson & Johnson doses from the Maryland plant, according to The Wall Street Journal. Additional batches are still under review.

But the FDA also determined that 60 million doses should be discarded, according to The New York Times

The plant, operated by contract manufacturer Emergent Biosolutions, was previously producing COVID-19 vaccines for both Johnson & Johnson and AstraZeneca. No doses produced at this plant have been distributed in the U.S.

The cleared doses will come with a warning about the quality issues if they are exported.

The backstory: In late 2020 and early 2021, workers at the plant accidentally contaminated Johnson & Johnson’s doses with waste from AstraZeneca’s COVID-19 vaccine, according to an FDA report.

Near the end of March, Johnson & Johnson reported the quality issues to the FDA and stopped production. Production for the AstraZeneca vaccine had already been paused.

Following the mistake, AstraZeneca started looking for a new manufacturing partner to produce its vaccine. 

The company is still testing 60 million doses that may have been contaminated at the Emergent plant, and the FDA could make a decision about the fate of those doses soon, according to The Wall Street Journal.

(Photo: FDA)

In April, FDA inspected the plant and issued a report criticizing the condition of the facility. In response, Emergent submitted a “quality enhancement plan.” 

In May, Emergent CEO Robert Kramer told lawmakers that the FDA was evaluating 100 million doses of Johnson & Johnson’s vaccine for possible contamination.

The effect: The revelation about the mistake at Emergent’s plant came at the worst possible time, right when vaccine distribution was at its peak.

Almost 135 million people have been fully vaccinated using Moderna and Pfizer’s two-dose mRNA vaccines. Meanwhile, about 11.6 million Americans have received Johnson & Johnson’s one-dose vaccine. 

Where are we now? In a statement earlier this month, Emergent noted that it’s working to resolve issues identified by the FDA and plans to resume manufacturing of the Johnson & Johnson vaccine soon.

“We look forward to working with the FDA and Johnson & Johnson toward the release of additional batches and resuming production at our Bayview facility,” Kramer said in a press release.

In early 2021, Johnson & Johnson had a relatively small manufacturing network, according to documents submitted to Congress

The company listed only three sites — the Emergent plant in Maryland as well as sites in India and the Netherlands — that would make drug substance. Following the mistake in Maryland, the company appears to be expanding that network. 

“We’re working very hard with the emergent facility in Maryland, but we’re not only dependent on that,” Johnson & Johnson Global Head of Research & Development Mathai Mammen said at an investor conference earlier this month.

“We have a number of other facilities in the world that are making both vaccine and drug substance … . These will come online very shortly.”

In addition to the newly cleared batches, FDA extended the vaccine’s shelf life from three months to four and a half. That should make it easier to give doses to patients rather than letting them go to waste. 


Civica Rx expands program to combat expensive generics 

In 2019, Civica Rx partnered with a manufacturer to produce two antibiotics that are often in short supply. (Photo: Civica Rx)

The news: The nonprofit drug company Civica Rx is partnering with the health insurer Anthem to expand its program to reduce prices on expensive generic drugs. Civica Rx created the program, now called CivicaScript, with 17 Blue Cross Blue Shield health plans last year.

Civica is aiming to produce six to 10 high-cost generic drugs at an affordable price. The company is partnering with contract manufacturer Catalent to produce the drugs. They hope drugs through this program will be available in early 2022. 

The backstory: Generic drugs make up a huge portion of the drugs used in the U.S., but account for only a small portion of drug spending, according to a study by the generic medicines trade group Association for Accessible Medicines

For some generic drugs, competition is fierce. This can drive down the cost of drugs substantially. Sometimes profit margins are pushed so low that manufacturers don’t have a strong incentive to make the drug, which can contribute to shortages.

However, other generic drugs suffer the opposite problem: limited competition and high prices. Drugs for rare diseases with relatively low demand may be especially prone to this problem, according to a 2020 paper published in JAMA Network Open.

In another 2020 paper, drug researchers Jonathan Alpern and Arman Shahriar highlighted the case of the anti-parasitic albendazole, used to treat hookworm infections.

The average wholesale price of the drug increased by more than 4,000% from 2010 to 2018, when there was only one manufacturer making the drug. Since then, more manufacturers have entered the market, but the price hasn’t fallen as quickly as anticipated, according to Alpern and Shahriar.

The plan: Allan Coukell, head of public policy at Civica, says the plan is to sell the drugs on a cost-plus model: the cost of production plus a fair profit margin.

“Many generic drugs are very inexpensive, in some cases unsustainably inexpensive. But there are some products where there are still pretty healthy margins, and we see the potential to reduce those costs,” Coukell told FreightWaves.

Coukell said the organization also hopes to work with distributors and other companies in the health care supply chain to make sure those savings get passed on to patients.

The impact: Civica isn’t saying which drugs it’s targeting with the expanded CivicaScript program. Shahriar said the drugs that Civica chooses will have a big impact on who benefits. 

A press release notes that Civica plans to make “common but high-priced generic medicines.” 

The 2020 paper in JAMA, co-authored by Shahriar, identified hundreds of drugs with low levels of competition. Many of these drugs were used to treat rare diseases, but others were more common.  

Shahriar said targeting only common drugs would still leave a gap for drugs treating rare diseases.

He also said it will be important for Civica to focus on the clinical impact of the drugs. Producing a drug for a rare disease without a cheap substitute might have a bigger impact than making a drug for a common condition with an affordable alternative.

“Albendazole for example is the gold standard for several infections. It’s much better than anything else,” he told FreightWaves. “Making that available to people is very different, for example, than making available a diabetes medication that has low-cost alternatives of similar efficacy.”

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