FDA Completes Review of J&J Vaccine Manufacturing Facility

April 28, 2021 - FDA recently completed an inspection of Emergent BioSolutions, a proposed manufacturing facility for Johnson & Johnson’s COVID-19 vaccine. 

The agency’s assessments reviewed the quality of manufacturing procedures, including records, staff training, facility operations, drug production and testing, and the systems used to ensure quality product.

During the inspection, FDA cited a total of eight observations that brought up questions about whether the facility’s processes met its requirements and standards.

The agency stated that BioSolutions failed to conduct thorough investigations into unexplained discrepancies. And the building used for the manufacturing of the product was not maintained in sanitary conditions and was not of suitable size, design, or location for proper operations. 

Additional observations that FDA noted included: 

• Written production and processes control procedures to prevent cross-contamination were not followed
• Written procedures that assure drug substances have the strength, quality, and purity they purport were inadequate
• The product containers were not handled or stored in a manner to prevent contamination
• Employees were not trained in the operation they performed
• The equipment used was not adequate to facilitate operations 

FDA stated that its observations are intended to identify certain conditions observed during an inspection that may lead to quality issues during the manufacturing of a product.

Once the agency observes the conditions, it can work with a company to help pave a path forward and combat these issues. 

At the agency’s request, Emergent BioSolutions has agreed to pause new production while it works to resolve potential quality issues.  

The products that have already been manufactured will undergo additional testing and will be evaluated to ensure their quality before any potential distribution. FDA said that it will not allow the release of any product until it meets the agency’s expectations for quality. 

“We are doing everything we can to ensure that the COVID-19 vaccines that are given to the people of this nation have met the agency’s high standards for quality, safety and effectiveness,” an FDA spokesperson said in the announcement. 

“We know that every time an American, including members of our own families, receives a COVID-19 vaccine dose, they are putting their trust in us. We are working hard to maintain that trust,” the agency continued. 

Johnson & Johnson’s Vaccine Efficacy Consistent Against Symptomatic COVID-19 

Johnson & Johnson recently announced that its COVID-19 vaccine was 85 percent effective against severe or critical coronavirus.   

The Phase 3 trial results, published in the New England Journal of Medicine, showed that despite the high prevalence of emerging SARS-CoV-2 variants, the vaccine prevented hospitalization and death across all 43,783 study participants. 

The trial met its co-primary endpoints of protecting against moderate to severe COVID-19, achieving 67 percent efficacy 14 days after vaccination and 66 percent efficacy at 28 days after vaccination.

The vaccine was also 64 percent effective against moderateto severe disease of the South African strain, B.1.351, and 81.7 percent effective against severe or critical disease 28 days post-vaccination. 

Efficacy was also maintained in participants against the Brazil variant, P2 lineage, with 68.1 percent efficacy against moderate to severe disease and 87.6 percent against severe to critical disease.

Overall, the trial data demonstrated that a single shot of the vaccine offers a high level of activity across all variants and regions studied.  

Sanofi Signs Agreement for Fill/Finish Manufacturing of Moderna’s Vaccine

Moderna recently announced that it entered into an agreement with Sanofi for fill/finish manufacturing services and to supply packaging for up to 200 million doses of its COVID-19 vaccine in the US.

As part of the agreement, Sanofi will leverage its manufacturing infrastructure site in New Jersey. Manufacturing will begin in September of this year. 

At the beginning of January, Moderna released a COVID-19 vaccine manufacturing update for its mRNA-based vaccine, mRNA-1273, increasing the base-case global production estimate from 500 to 600 million doses for 2021. 

Juan Andres, chief technical operations and quality officer of Moderna, stated that with the help of Sanofi, additional production will significantly scale up manufacturing capacity in the US.