Moderna Is Still A Very Murky Company, In Case You Didn’t Know: Part 2

In Part 1, we talked about many of the irregularities of Moderna’s COVID vaccine development. Moderna certainly did not go through a standard regulatory process for pharmaceutical development. One of the biggest anomalies was that FDA reviewers absolutely knew about serious issues with Moderna’s COVID product but they looked the other way.

What Did FDA Know, And When Did They Know It?

There were several things FDA knew about Moderna’s COVID-19 vaccine. These items were unfavorable, and they knew the vaccine was uncertain. Signs were visible by December 2020; for example, Bell’s palsy had started to show up, and FDA actually wrote that a “vaccine contribution could not be ruled out.” FDA also noted that the vaccine trials done could not establish long-term safety, duration of protection, or many outcomes in populations that had been insufficiently studied. Read that sentence again. But Moderna stayed on the market.

There’s even stronger evidence that FDA had safety concerns, and the strongest example is myocarditis/pericarditis, especially in younger males. By June 2021, FDA and CDC surveillance data showed elevated myocarditis after the second mRNA dose, with the highest rates in males between 18 and 24 years of age.

FDA even added myocarditis/pericarditis warnings to the Moderna (and Pfizer) fact sheets on June 25, 2021. And for Moderna specifically, FDA acknowledged (much later I might add) that they knew by November 19, 2021 about significant public and non-public data suggesting that myocarditis/pericarditis occurred more often in males under 40 who had received Moderna (vs. Pfizer). By the say, non-public data means FDA had information relevant to Moderna’s comparative risk BEFORE all of the underlying data were made public. In other words, they had a big head start.

For an FDA memo, the wording is unusually explicit, reporting that data from jabbed people age 18–39 showed 13.3 excess myocarditis/pericarditis cases per million Moderna second doses, compared with Pfizer. For males specifically, the data showed 21.5 excess cases per million. Even with the explicit language, FDA muddied the waters, noting that “the evidence was not yet definitive.” However, FDA appeared concerned enough, so much so that the agency did not initially authorize Moderna for adolescents. By November, FDA knew from SEVEN surveillance systems that Moderna carried a 2- to 7-fold higher myocarditis/pericarditis risk compared with Pfizer in this young population. This is not to say that Pfizer had no associated myocarditis, it’s just that Moderna was worse. The FDA should have pulled them both from the market, but instead, one of their reasons for not giving Moderna to teens was that Pfizer was SO AVAILABLE, so teens could get that instead.

In June 2021, FDA did not approve Moderna’s EUA request to expand the vaccine to ages 12-17. The FDA did not formally reject the application either. They should have based on the cases above, but they didn’t. Instead, the FDA deferred action.

One year later, in June 2022, the FDA vaccine advisory committee reconsidered Moderna, this time for children much younger, ages 6-17. Three days after the committee “studied” this, the vaccine had EUA status, not for age 6 but for age 6 MONTHS to age 17. And the FDA formal decision clearly states it was a carryover from the original June 2021 EUA submission, noting Moderna’s updated May 9, 2022 submission.

Another year went by, and in September 2023, FDA granted Moderna full approval rather than just an EUA, for Spikevax for ages 12 and older. In 2025, FDA made some tweaks; anyone 65+ should get Spikevax, but only age 6 months to age 64 if they are at high risk for severe COVID. And they strengthened the myocarditis warning, requiring Moderna (and Pfizer) to update the labels with newer estimates of myocarditis risk.

You see how this works, right? Updated labels. Sternly-worded letters, and details in fine print. All of that, but never a “pull from the market” scenario.

Here’s Something You Never Hear About

Did you know that after FDA allowed Pfizer and Moderna to market these vaccines, the agency required the companies to conduct post-market long-term myocarditis studies to determine whether vaccine-associated myocarditis has long-term cardiac effects?

Pfizer’s study, C4591036 (NCT05295290), is being conducted with the Pediatric Heart Network and follows people under age 21 with myocarditis/pericarditis after receiving the Comirnaty jab. The registry currently reports 319 enrolled participants, and the study target completion date is April 2029. Pfizer has completed the myocarditis study, C4591038, examining myocarditis/pericarditis, and issued a final report in June 2025. The report is publicly available here: HMA-EMA Catalogues

Moderna’s long-term study is mRNA-1273-P911, Long-term Outcomes of Myocarditis Following Administration of Spikevax. It follows vaccine-associated myocarditis cases for up to five years and won’t be completed until November 2028.

FDA also conducted its own study of 300 people hospitalized with vaccine-associated myocarditis. The results drove new labeling (akin to a sternly worded letter) regarding myocarditis, but no teeth, and certainly no removal of the vaccine from the market. Keep in mind that 96% of the study participants presented with chest pain three days after vaccination, and 82% had MRI imaging evidence of myocardial injury. Even after five months, study participants still COMMONLY had abnormal cardiac-MRI findings. Even with this, FDA concluded that long-term cardiac problems remained unknown. And, these studies are “ongoing” and “in progress”. Results won’t be available for years.

Let Me Count The Ways

So what exactly is FDA’s reason for this debacle? Let’s critically explore several options.

Option 1: The FDA is incompetent. Nope, not buying this one, given the painstaking detail outlined above and in Part 1. Incompetence is not an option.

Option 2: The FDA was busy. Remember the 75-year sealed records thing? FDA was pretty busy at that time, you know, being litigated and forced to release huge quantities of COVID-vaccine regulatory records after the agency proposed very lengthy production schedules of 75 years. Keep in mind FDA’s original decision not to offer Moderna to teens was because of myocarditis. Then, they had to be sued under FOIA by Public Health and Medical Professionals for Transparency (PHMPT), to release that data. Granted, these were Pfizer records and not Moderna records, but still…the FDA identified 329,000 pages and proposed a snail’s pace of 500 pages per month for release that would have taken a minimum of 55 years. When FDA found additional records, it revised its estimate to 75 years. FDA is quick to say they didn’t want the records sealed for 75 years, oh no, just that it would take them that long to release them. THIS from the agency that approved Moderna for a 6-MONTH-OLD BABY in roughly 30 days.

A judge ordered them to produce 55,000 pages—not 500—every month. FDA fought this issue for years, so much so that the judge actually said he was “exhausted by the FDA’s continued attempts to pause the production” of COVID-19 vaccine information. The FDA was definitely busy; were too busy to pay true attention to Moderna. Still not buying it. By the way, a Texas court order mandates FDA to produce 9.1 million pages of COVID-19 vaccine records by October 1, 2026. Let’s see what happens. FDA already released the Moderna Spikevax records. Read them here.

The Big Question Is…Why Did FDA Appear to Protect Moderna?

The last option, Option 3, is the most credible. Is FDA protecting Moderna? The evidence certainly points to that for anyone willing to think logically. But why? I offer a possible explanation.

Moderna would generally have paid an FDA user fee that accompanied any application. Let’s use the more recent mRNA flu vaccine mFlusiva as an example. In February 2026, the FDA refused to accept the mFLusiva application but that doesn’t mean Moderna got a waiver or a refund on the fee. FDA later accepted the amended application on August 5, accompanied by yet another fee. While FDA does not disclose the exact dollar amounts, these fees can be estimated and are quite substantial. This is a statutory user fee system that funds the FDA review of drugs and biologics.

What is interesting and unusual about this situation is that Moderna’s original application was refused, only to be accepted in amended form two weeks later. Moderna certainly had to pay some sort of second fee, but it could have been reduced, credited, or whatever.

Did you know that the fees can be discovered in the SEC filings? They can, and Moderna paid, for the mFlusiva application $~4.7 MILLION. Moderna most certainly had to pay twice, but FDA rules say that when there is an original refusal, the applicant pays the second fee, another $4.7 MILLION but is eligible for a 75% refund of the first fee. So, a 75% discount would be roughly $3.5 MILLION, so Moderna’s net fee cost was $5.8 MILLION. And that’s for mFlusiva. Imagine the fees for all their mRNA products!

Given all the options, this last option 3 seems the most credible. It would be difficult for the FDA to turn Moderna down given the lucrative upside to the agency.

At last, I think we’ve found the smoking gun. Because in the end, it’s all about the money.