FDA made significant changes to COVID-19 vaccines available in the United States last week. In its recent actions, the FDA displays pattern of blatant rule breaking that indicates negligence and corruption. Here are three examples.
Pfizer. FDA gave license to vaccinate middle-schoolers twelve years and older with COMIRNATY by its supplement approval letter of July 8, 2022. This approval was issued in response to Pfizer’s submission of pediatric Study C4591001 regarding safety and effectiveness of COMIRNATY in children 12 through 15 years of age. However, Pfizer reports that this study relied on data from a trial using 16 to 25 year-olds conducted prior to Delta and Omicron surges, raising questions regarding its relevance.
FDA rules require manufacturers to inform FDA within 6 months of “a permanent discontinuance in manufacturing”, or “an interruption that could lead to a meaningful disruption in the supply of the product in the United States” (page 7, lines 208-210), even if the manufacturer decides to cease production for business reasons (lines 221-222). COMIRNATY has never been available in the United States in the eleven months since initial approval. I am not an attorney, but this seems like a meaningful supply disruption of the licensed product to me, which should trigger a reconsideration of the vaccine’s license. An expansion of COMIRNATY’s license while the product is still unavailable violates the spirit, if not the letter, of FDA’s own rules. Instead, the approval appears to be merely a merit badge providing a marketing advantage to Pfizer without changing that fact that no approved vaccines are yet available to Americans.
Novavax. The predicted authorization of the all-protein Novavax vaccine happened with fanfare last week. FDA’s press release welcomed the arrival of “another option” for Americans, and assured that “the American public can trust that this vaccine, like all vaccines that are used in the United States, has undergone the FDA’s rigorous and comprehensive scientific and regulatory review.” I have issues with both statements.
The use of emergency use authorization to provide “another option” violates the rules governing emergency use authorizations. The purpose of the EUA is to make products available when “there are no adequate, approved, and available alternatives.” There are approved alternatives—COMIRNATY and SPIKEVAX—which are, by manufacturers’ choice, unavailable. But adequate alternatives are available. Search vaccine.gov to see whether you can find vaccines in your area. If you cannot, please let me know. If you can, another unapproved option is unneeded.
The assurance of “rigorous and comprehensive scientific and regulatory review” is misleading, since that describes the approval process, not the authorization process. EUA is for emergencies, like bailing water out of a sinking ship. “Rigorous and comprehensive” describes a process to assure seaworthiness before putting the ship into water and results in a license to sail. Novavax has no license. It has not been through a truly rigorous and comprehensive scientific and regulatory review.
Moderna. Authorization letters require manufacturers to comply with section 502(a) and (f) of the FD&C Act, which prohibits false or misleading labelling. Yet children ages 6 through 11 are to be vaccinated with Moderna Purple, which is labelled “BOOSTER DOSES ONLY” because Moderna Teal is still unavailable. Unreliable labelling is a setup for medical error, which is why the rules prohibiting misleading labels are so clear. Instead of insisting that Moderna relabel product before distribution, FDA issued a “Dear Healthcare Provider” letter, instructing caregivers to ignore the printed label.
This is the current state of vaccines in America. We did not get here honestly. Instead, we got here by bending, twisting, and breaking the rules established to keep us safe.
FDA is a law enforcement agency that should respect rules. If you come under FDA’s jurisdiction, you rigorously follow its rules and regulations because FDA has the power to shut you down. Just ask Abbott Nutrition, the operator of the Michigan baby food plant forced to cease production earlier this year. The resulting baby formula shortage is a serious emergency, yet there have been no emergency use authorizations for manufacturers racing to have new product approved. Meanwhile, we still have an emergency declaration that short-circuits the process for vaccines.
The FDA has compromised its rules related to vaccines. It is a clear signal of negligence and corruption. There is something pathologic at the FDA.
