The FDA Will Not Inspect Vaccine Production Plants

Shortage because of high demand for flu vaccine

ZOETERMEER, NETHERLANDS – OCTOBER 27: View of influenza vaccine syringes at a general practitioner’s office on October 27, 2020 in Zoetermeer, Netherlands. The demand for flu vaccines is so high there is currently a shortage. The Dutch government has therefore asked healthy people between the ages of 60 and 69 not to take the vaccine so people over 70 and medically vulnerable people can get it first. (Photo by Niels Wenstedt/BSR Agency/Getty Images)


Approval of a vaccine by the Food and Drug Administration (FDA) typically requires inspection of the vaccine’s manufacturing plants. In a Covid-19 world, this will not be the case. Covid-19 vaccine candidates will get a pass on FDA plant inspections, according to Bloomberg. As candidates reach the final phases of testing, emergency use authorization will be granted without pre-approval inspection, said FDA Director of Viral Products Jerry Weir.

Beware of lower safety standards with fast-tracked Covid-19 treatments. Vaccines and therapies are being rushed through the testing and approval process without substantial evidence of success. Shorter test periods reduce the confidence that they will be safe and effective. I have described some of the uncertainties and potential hazards of rushed trails elsewhere.

Under normal circumstances, the FDA requires several batches of vaccines and drugs to be made, all meeting the same safety, consistency, and potency standards using the same facilities as will be used to sell the drug or vaccines. These requirements prevent quality control issues on the side of the pharmaceutical company.

Drug and vaccine manufacturing plant inspections are routine and any violation of protocols is cited. Just last year, an Eli Lilly pharmaceutical plant was cited by the Food and Drug Administration (FDA) for quality control issues, according to Reuters. Sources close to the situation told Reuters that Eli Lilly had falsified records pertaining to FDA manufacturing standards. That same Eli Lilly plant is set to manufacture a Covid-19 treatment used by the president during his infection.

All biological drugs including vaccines, antibodies, and other proteins are subject to additional scrutiny because the preparations are likely to vary from batch to batch. Several of the leading vaccine candidates deploy entirely new technologies, technologies that have not been previously approved for human use.  Verification that a new manufacturing process yields the desired product is especially important. The rushed time frame also obligates the FDA to forgo stability tests of the new vaccines, if they are to be used before the end of this year or early2021. There simply is not time to do what is routine.

Pushing Covid-19 vaccines and treatments through the approval process may have already contributed to health complications. Major vaccine trials like AstraZeneca and Johnson & Johnson paused testing due to severe illness in some participants. AstraZeneca has since restarted, but concerns about short and long-term health safety continue.

The recent history of other pharmaceuticals pushed through the emergency use authorization process is instructive. Hydroxychloroquine was granted authorization back in March. The FDA’s authorization letter cited only a 36-person French study. Three months later, post-authorization monitoring found an increased risk of heart problems in hydroxychloroquine users, in addition to little evidence of reduced Covid-19 symptoms. The authorization was promptly revoked. Remdesivir was recently approved by the FDA. A recent WHO controlled trial found no benefit of remedesivir for hospitalized patients in a multi-country study.

The dangers of unregulated Covid-19 drugs and vaccines are clear and present. Normal circumstances require years for a vaccine to be produced. I know pandemic fatigue is setting in for many. Many hope for a vaccine to stop the disease instantly. They will be sadly disappointed. Even if a vaccine is approved early next year, and even if it is safe and effective, the hoped-for relief will be months in coming. People may forgive the failure of a vaccine because of the intense difficulty of preventing Covid-19 infections. They will not forgive a vaccine that endangers their life because of manufacturing errors. People my age still remember the Cutter laboratory disaster with improperly inactivated polio vaccine preparations in the 1950s.

FDA regulations are ultimately in place designed to protect us. They should not abrogate the essential duty for speed under any circumstance.


Read the article on Forbes.

Originally published on October 29, 2020. 

© William A. Haseltine, PhD. All Rights Reserved.