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Vaccine Makers Can Skip U.S. Pre-production Inspections

Typically, before a new drug is released, the U.S. Food and Drug Administration regularly inspects the drug manufacturing plants and processes to ensure that quality and safety standards are up to par. This comes after the FDA has examined and approved the safety and efficacy profile of any new drug. Only after both inspections are done will the FDA gives its imprimatur on the production of a new drug. But that won’t be the case for COVID-19 vaccine developers. It seems that the vax makers will apply to the FDA for Emergency Use Authorization (EUA) of their vaccines, which will eliminate the requirement for a manufacturing pre-approval inspection.

Even though by asking for EUA approval in order to avoid the lengthy inspection process, vaccine developers still have to submit complete details of their manufacturing process and show they’ve established a quality control unit, but this is not the same as a full inspection. And the vaccine itself still need to be approved for efficacy and safety.

This represents quite a conundrum; we all want a vaccine as quickly as possible and this EUA would greatly help make that happen and reduce morbidity and mortality caused by the virus. We also want to know that our medicines are produced in as safe a way as possible, which also would reduce possible morbidity and mortality caused by tainted vaccines. It seems that we have to choose one of these desires and sacrifice the other; we cannot have both. Do we bow to  our reasonable fear of this nasty virus and growing need to return to normal and go for the earliest vaccine? Or do we act cautiously and risk more people dying and more economic devastation in order to ensure that vaccine production is safe?

There are several examples of vaccine production errors that led to tragic consequences. In 1955, the Salk polio vaccine was rushed into production just hours after it was approved. This was an inactivated virus, which means that live virus was grown, then killed, then injected. Some lots from one of the manufacturers, Cutter Laboratories, were not fully inactivated and some patients received injections of live virus leading to tragic results. The problem involved a production error. Similar production errors have led to people being infected with live measles virus, and respiratory syncytial virus. Then, in 1976, an H1N1 flu that was similar to the 1918 Spanish flu reached pandemic stage. The US rushed out a vaccine that was associated with a spike in the very rare Guillame Barre disease, which is a type of paralysis. It is believed that the rushed vaccine somehow caused the small, but significant spike in the disease in fewer than 500 patients across the country (note: your humble blogger was a college student and working in a hospital physical therapy clinic at the time, and worked with two GBD patients).

Based on this prior experience with problems in vax production, it seems that it is more likely that delaying a vaccine would lead to more COVID-19 disease than would be caused by tainted vaccines, hence the willingness of the FDA to waive pre-production inspections. All policy decisions entail risks and benefits, and when lives are at stake, it is generally accepted that it is better to err on the side of overreaction rather than underreaction.

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