J&J Takes Over Vaccine Production at Plant That Spoiled 15M Doses

April 06, 2021 - The Biden Administration recently appointed Johnson & Johnson to lead COVID-19 vaccine production at a Baltimore manufacturing plant that contaminated 15 million doses of the pharmaceutical company’s COVID-19 vaccine. 

The New York Times reported that Emergent BioSolutions, a contract manufacturer that has been manufacturing both the Johnson & Johnson and AstraZeneca vaccines, mixed up ingredients from the two. 

This led regulators to delay authorization of the plant’s production lines. HHS’s ultimate goal was to stop the plant from making another mistake with AstraZeneca’s vaccine. 

Now with AstraZeneca’s vaccine out, the plant can be solely devoted to the Johnson & Johnson single-dose vaccine and avoid future mishaps, the report explained. 

As part of the initiative, HHS directed Johnson & Johnson to install a new leadership team to oversee all aspects of production and manufacturing at the Emergent Baltimore plant. 

As part of Operation Warp Speed, Emergent was awarded $628 million by the government last June and secured deals totaling over $740 million with Johnson & Johnson and AstraZeneca to produce vaccines for both companies at the Baltimore site. 

An Emergent spokesperson said in a statement that it was “assuming full responsibility” for the vaccine made at its plant and that it would continue making AstraZeneca doses until it received a contract modification from the federal government. 

But federal officials are worried that the mix-up may cause public mistrust and lack of confidence in COVID-19 vaccines. 

So far, vaccine development has not been the industry’s challenge. But building confidence in authorized vaccines has been a setback.   

For example, a Kaiser Family Foundation report found that Black Americans would not get a COVID-19 vaccine even if it was deemed safe by scientists and freely available. 

Safety concerns (39 percent) and distrust (35 percent) were cited as the top reasons. But a majority of Black adults also had little to no confidence that the vaccine development process was taking the needs of Black people into account.

Intellectual property (IP) has also challenged public perception and confidence in the vaccines.

During the COVID-19 pandemic, the world has benefited from the innovation support from intellectual property. 

But when India and South Africa proposed to suspend IP provisions of the TRIPS Agreement last October, PhRMA and over 30 leaders in the biopharmaceutical industry warned that eliminating IP protections in vaccine development could create confusion that could potentially undermine public confidence in vaccine safety and create barriers to information sharing.

The mix-up and HHS’ initiative is also a “significant setback and public relations debacle” for Emergent. Even prior to the contamination of 15 million COVID-19 vaccine doses, the company received a string of citations from US health officials for quality control problems. 

In April 2020, an investigator from the FDA reported problems at a Baltimore plant operated by Emergent, including that employees had not been properly trained and records were not adequately secured. 

Additionally, established testing procedures were not being followed and a measure to protect potential mix-ups was deficient. 

Nina DeLorenzo, senior vice president of global communications and public affairs at Emergent said in a statement to The Washington Post that Emergent hosted two on-site FDA visits associated with its COVID vaccine efforts.

These efforts included reviews of the progress on the items cited in past FDA visits. 

John Grabenstein, scientific director of the Immunization Action Coalition and former global director of medical affairs for Merck vaccines stated that all vaccines have batches that don’t meet specifications and need to be discarded, even vaccines with years of experience. 

But Grabenstein cannot recall another instance where two different products had a mix-up within the same facility. To him, the current situation is “not unprecedented, but it is unusual.”