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Emergent Response to New Congressional Report

There is nothing new. This report details the same information we have transparently given to regulators and the media over the past two years. Emergent has been open and forthcoming with the FDA, Congress and our partners about the work at our Bayview site and the challenges that were encountered, including providing thousands of documents and willingly participating in a congressional hearing. Despite this overwhelming level of cooperation, we are dismayed that the first time we learned of the report was through the media. 

Emergent disputes the claim that 400 million doses of vaccine were rendered unusable, as the report alleges. It is very difficult to estimate dose equivalents for batches that do not complete the manufacturing process or leave the facility to be turned into vaccine. While unfortunate, a batch of drug substance may test out of specification for a variety of reasons whether during the manufacturing process or after the process is complete. Rigorous testing and reporting when such events occur is critical, and it is what happened in the case of the single batch of J&J drug substance found to be out of specification in March 2021. To equate these quality control actions with a “discarded dose” figure displays a lack of understanding regarding the biomanufacturing process.  

Emergent also refutes the allegation that it knowingly misled the FDA or any of our public and private partners. Emergent has sought to be overly transparent with all our manufacturing partners. During the last few years, the FDA and other international regulatory authorities have visited Emergent facilities dozens of times. On several occasions, Emergent invited FDA personnel to visit Bayview to review our progress, assess our capabilities, and provide feedback on our facilities, processes, and systems when no FDA inspection was required. Further to that point, the single contaminated batch was brought to the attention of the FDA by Johnson & Johnson and Emergent.  

The effort to manufacture two novel viral vaccine candidates in the same facility was unprecedented and potential risks were well known to all parties involved, including the FDA. It was for this reason that Emergent stayed in constant communication with the FDA, BARDA and our clients every step of the way.  

Emergent has publicly and privately acknowledged its challenges in manufacturing Covid-19 vaccine drug substance, including transitioning Bayview from a clinical to a commercial site and hiring sufficient staff to operate the facility. Emergent has also highlighted the failures of the public-private partnership model due to the government’s lack of adequate investment and engagement with partners in the program prior to the start of the pandemic.  

While it’s important to analyze past decisions to inform future plans – we must do so in the proper context and avoid the temptation to Monday morning quarterback with the benefit of what we know today. Emergent and our government partners were attempting to compress into a few months the development and scale up of drug substance manufacturing processes that normally take years. We were always transparent with our public and private partners about our process and capabilities and often welcomed BARDA, Johnson & Johnson and AstraZeneca personnel onsite daily.  

Emergent remains committed to being a trusted partner of the U.S. and allied governments helping to supply medical countermeasures for biological, chemical and nerve agent attacks. We will continue to use our more than 20 years of public health preparedness experience to help inform an all-of-the-above approach to help prepare for the public health challenges to come.