In February 2021, Moderna scientists published results from the Phase 2 trial of the company’s mRNA Covid jab in the journal Vaccine.
Moderna had started the “P201” trial with 600 healthy volunteers on May 29, 2020, mostly to examine if the shots were safe.
The company had good news on that front. In the “Highlights” section at the top of the paper, Moderna’s scientists reported:
No serious adverse effects were observed.
That statement was untrue.
Oddly, later in the paper, Moderna’s scientists contradicted what they had said in the Highlights section. They noted the company had received a single report of a serious side effect in a jab recipient, a case of pneumonia that lasted almost a month.
That statement was also untrue.
Two months before the Vaccine paper, Moderna had reported not one but three cases of serious side effects in P201 trial subjects who received mRNA to the Food and Drug Administration.
The FDA downplayed the side effect reports, including the pneumonia case, saying it did not believe they were related to the shot.
But serious side effects in the jab recipients continued after the company’s initial disclosures to the FDA.
By the time Moderna’s scientists finished revising the Vaccine paper in early February, the company may have received up to four more reports of serious side effects. In all, during the placebo-controlled phase of the trial, which ended in early 2021, seven of the 400 healthy volunteers who received a two-shot regimen of Moderna’s vaccine suffered serious side effects. (Two hundred of those volunteers received the 100-microgram dose that became the approved version, while another 200 received a lower 50-microgram dose.)
The problems included a heart attack and two miscarriages.
In comparison, the 200 people who received a placebo shot without any mRNA had no serious side effects.
Seven vs. zero.
And after the placebo-controlled phase of the trial ended, more side effects piled up when trial subjects received a booster. Those problems included a third miscarriage.
By the time Moderna stopped collecting safety data from the trial in mid-2021, 14 out of 550 people who received jabs in the trial had suffered serious side effects. (The number of subjects who received mRNA in the P201 trial rose in early 2021 when Moderna broke the trial blind and offered placebo recipients the shot. 158 of them took it.)
The company never updated the Vaccine paper with any of these reports. On December 30, 2022 the federal clinicaltrials.gov Website quietly posted final safety data from P201, including all the serious adverse event reports.
(THE REAL DATA FROM THE PLACEBO-CONTROLLED PHASE OF THE P201 TRIAL, REVEALED IN LATE DECEMBER 2022, ALMOST TWO YEARS AFTER IT WAS COLLECTED)
(WHAT MODERNA SAID ABOUT THE P201 TRIAL IN THE VACCINE PAPER:)
Why Moderna did not disclose accurate side effect data in the Vaccine paper is not clear, especially considering that the FDA had already mentioned some of the reports, albeit in an appendix on the final page of a 54-page report.
The company may simply not have wanted to admit them in February 2021, as complaints of side effects flooded into the federal VAERS database, raising concerns the jabs were not as safe as regulators and the companies had claimed.
Moderna declined to respond to or even acknowledge a detailed list of questions sent repeatedly to its press office for this story.
(THE FDA’S DISCLOSURE, SHOWING THAT MODERNA KNEW OF AT LEAST THREE SERIOUS ADVERSE EVENTS IN DECEMBER 2020, TWO MONTHS BEFORE THE PAPER IN VACCINE WAS PUBLISHED.
NOTE ALSO THAT MODERNA TOLD THE FDA THE PNEUMONIA CASE OCCURRED 25 DAYS AFTER VACCINATION – INSIDE THE 28-DAY WINDOW FOR ADVERSE EVENTS THE COMPANY HAD SET AS A PRIMARY TRIAL ENDPOINT. IN THE VACCINE PAPER IT REPORTED THE CASE OCCURRED 33 DAYS AFTER VACCINATION, OUTSIDE THE WINDOW.)
Beyond calling Moderna’s honesty into question, the P201 data raise a broader and arguably even more troubling issue.
Because it started in May 2020, two months before the big pivotal trials, the P201 trial had a placebo-controlled arm for longer than any other mRNA Covid jab trial.
Regulators and public health experts had always believed that if the shots had side effects, they would be evident quickly. Moncef Slaoui, the head of Operation Warp Speed, the government program that helped develop the jabs, told federal officials that 99 percent of side effects from vaccines became visible within 60 days.
But the gap in serious side effects between placebo and vaccine recipients widened for as long as the P201 trial progressed, belying Slaoui’s assumption.
The P201 results raise the question of what might have happened if regulators had forced Moderna and Pfizer to continue collecting placebo-controlled safety their much larger pivotal Phase 3 clinical trials for even two or three more months in early 2021.
Instead, almost immediately after regulators okayed the use of the mRNA Covid shots in December 2020, Pfizer and Moderna offered placebo recipients in P201 and the big trials the chance to take the active vaccine. Most did.
As a result, we do not have and will never have long-term safety data comparing people who received the jabs with those who received a placebo. The P201 safety dataset is the longest publicly available.
It is not comforting.
The miscarriage reports are striking, given the small number of women of childbearing age – almost certainly no more than 150, and possibly closer to 100 – in the trial.
Worse, in its final report on side effects, Moderna disclosed a third miscarriage in 2021 in a P201 trial subject after she received a booster shot. (Moderna began testing boosters on the P201 trialists in January 2021, at a time when the public was being told that Covid boosters would probably not be needed for years, if ever.)
In all, in its final report, Moderna counted a total of 11 people who suffered serious side effects among about 350 people who received the jabs plus a single booster shot.
In addition, two placebo recipients suffered serious side effects after the trial was unblinded and they took the jab. Finally, in the trial’s final phase, Moderna gave 60 people a second booster; one of those 60 developed stage four cancer.
In all, 14 people who received jabs in the trial suffered serious side effects.
These trialists were a generally healthy group – healthier than the Phase 3 trialists, or average Americans. For example, Moderna excluded people with diabetes from P201, and few people in the trial were obese.
Aside from miscarriages, the other serious side effects are mainly cardiovascular, with six total. Despite the relative health of the participants, they include heart rhythm disorders, the heart attack, pericarditis, and a pulmonary embolism.
Throughout the trial Moderna downplayed the significance of the side effects to regulators, claiming they were unrelated to the jabs. In a December 2021 report on the side effects that followed the booster shot, Australian regulators reported that “all were considered by the investigator [the Moderna-paid scientists who conducted the trial] to be not related to mRNA-1273.”
And Moderna would never lie.