Last week’s news of a manufacturing blunder that occurred at a contract manufacturing facility and caused a lot of 15 million doses of Johnson & Johnson’s COVID-19 vaccine to ruin is disappointing. Disappointing not only for those seeking to be vaccinated, but for Johnson & Johnson as well. Yet an incident such as this was probably bound to happen given the sheer scope of the effort. The good news is that the error was discovered prior to lots being shipped.
One year ago, there was a no existing supply network dedicated to produce COVID-19 vaccines at volume. In a matter of months there is now the extraordinary high-volume ramp-up of global-wide production and distribution networks to be able to inoculate in excess of 7 billion people. That sheer scope is one that the pharmaceutical industry has limited experience except for a chosen few volume vaccine producers. In the case of the new m-RNA type vaccines, its an entirely new challenge never before accomplished.
The Incident
The Baltimore based production facility operated by Emergent BioSolutions, had contracts to produce both the Johnson & Johnson and AstraZeneca developed vaccines. In what is being cited by government regulators as human error, a batch of the J&J vaccine was accidently conflated as one of more workers reportedly confused the ingredient mix among the two vaccines.
According to reporting from the New York Times, citing people familiar to the incident, the mistake went unnoticed for days until J&J’s quality inspections uncovered the mishap. That obviously should be cause for concern.
Thankfully, none of this vaccine lot was shipped because the production facility was still awaiting FDA certification as a volume producer. Existing U.S. supply of the J&J vaccine has up to now been produced at a facility in the Netherlands and approved by regulators.
According to existing reporting, indications are that this snafu will supposedly not hinder the plan to deliver 75 million doses by the end of May and a cumulative 100 million doses of the J&J vaccine to the U.S. by the end of June. However, it could impact the 24 million doses planned for shipment from the Emergent facility for this month, and without added assurances of quality oversight, could jeopardize the overall Q2 plan. For its part, J&J has indicated in a statement that steps that are now being taken with contract producer Emergent would allow the April commitment to be made. Reportedly, J&J has contracted with 8 producers in order to produce that company’s vaccine at volume to meet ongoing supply contracts.
In the wake of this incident, scrutiny has now turned to Emergent’ s past track record in the production of biologics. According to the Associated Press, the company has a track record for being repeatedly cited with quality control and employee training lapses. The Emergent Bayview facility was reportedly never utilized up to now, to produce millions of doses of vaccine for distribution. There is other reporting citing this contract manufacturer’s record of high levels of political lobbying of the former Trump Administration in order to be sourced for Federal contracts for certain strategic public health vaccine supply such as that to combat anthrax.
Mitigation Actions
On its part, J&J has augmented its on-site quality inspection teams assigned to monitor the Emergent facility. That of course raises the question as to why, with Emergent’ s prior track record of cited quality lapses, was there not a stricter monitoring and oversight process on the part of J&J before this discovery?
Obviously, there is a broader supply risk and quality lapse mitigation message for all vaccine providers. With the sheer volume and scale of supply required over the coming months, along with certain realities that production levels will be sub-contracted or shared with other partners, the industry and associated government regulatory agencies will need to step-up their collective efforts to ensure that any further oversights or quality lapses are discovered before vaccines are shipped.
Vaccine makers are fully aware of the risks for making vaccine at volume, but with the overall scope, scale and timeliness required for the various approved COVID-19 vaccines, producers have to step-up their quality monitoring and conformance processes. That includes use of advanced technology in the monitoring of multiple facilities both owned and contracted. This goes beyond singular facilities but the entire pharmaceutical industry as a whole.
There is too much riding from a public health perspective to not do so.
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