FDA notes lack of data regarding Moderna’s booster vaccine “[u]se in pregnancy and while breastfeeding, long term safety, use in immunocompromised subjects, interaction with other vaccines, use in frail subjects and unstable health conditions and comorbidities, and use in subjects with autoimmune or inflammatory disorders.”
- The Wall Street Journal (WSJ) reported Tuesday that the U.S. Food and Drug Administration (FDA) “in an unusual move didn’t take a stance on Moderna Inc.’s application for a booster dose.”
- The piece suggested the FDA’s unwillingness to endorse Moderna’s booster shot might be “indicating there may not be sufficient data to support the extra dose.”
- Noting the rarity of the FDA not taking a stance on whether such a new drug should be “given a go-ahead,” WSJ revealed that documents made public Tuesday show the “FDA staff simply restated Moderna’s request and analyzed Moderna’s study data” without endorsing the injection.
POTENTIAL REASONS FOR THE FDA’S SILENCE REGARDING MODERNA’S VAX:
- The FDA document reveals “[s]evere solicited adverse reactions occurred in 0% to 7.9% of booster dose recipients” in its “Executive Summary” section.
- The FDA document also mentions “serious adverse events and other adverse events of interest” among those who took Moderna’s booster shot, noting specifically “myocarditis, pericarditis, neurologic, neuro-inflammatory and thrombotic events” and “death.”
- The FDA document also “identified as missing information” data regarding “anaphylaxis, myocarditis, and pericarditis as important identified risks, and vaccine associated enhanced disease including vaccine-associated enhanced respiratory disease as an important potential risk” as well as “[u]se in pregnancy and while breastfeeding, long term safety, use in immunocompromised subjects, interaction with other vaccines, use in frail subjects and unstable health conditions and comorbidities, and use in subjects with autoimmune or inflammatory disorders.”
- The document also discusses a recommendation “to conduct one or more post-authorization observational studies to evaluate the association between Moderna COVID-19 Vaccine and pre-specified list of AESIs, including myocarditis and pericarditis, along with deaths, hospitalizations, and severe COVID-19.” It goes on to recommend, “The study population should include individuals administered the authorized Moderna COVID-19 Vaccine under EUA in the general U.S. population (18 years of age and older), individuals that receive a booster dose, and populations of interest such as pregnant women, immunocompromised individuals, and subpopulations with specific comorbidities. The studies should be conducted in large-scale databases with an active comparator.”
- The FDA document concludes by scheduling a meeting with the Vaccines and Related Biological Products Advisory Committee to take place on October 14 “to discuss whether the data presented by Moderna support the safety and effectiveness of Moderna COVID-19 Vaccine.”
Jon Fleetwood is Managing Editor for American Faith and author of “An American Revival: Why American Christianity Is Failing & How to Fix It.“