In February 2021, Moderna announced that “no serious adverse effects were observed” in an article about the preliminary results of the mRNA vaccine trial published in the medical journal Vaccine.
Moderna was halfway through phase 2 of its P201 vaccine trial that enlisted 600 participants. Phase 2 vaccine testing aimed to further determine vaccine safety, document short-term side effects, and observe immune system responses to the vaccine.
Of the 600 considered healthy volunteers, 200 received the 100-microgram dose that became the approved version, 200 received a lower dose, and 200 received a placebo. Two variants of the vaccine were tested in the trial.
The company had good news. The “highlights” section at the top of the paper announced that no serious adverse effects (SAE) had occurred during the P201 trial.
However, the P201 trial would continue until October 28, 2021, and its final results proved to be very different.
The Dec. 30, 2022, update of the trial results, as posted on the federal clinicaltrials.gov website, shows that no less than seven of the 400 initially vaccinated volunteers suffered an SAE—not zero.
After the positive preliminary results were announced, placebo recipients in the P201 trial were offered the vaccine—158 took it. More side effects piled up when trial subjects received booster shots later on.
In the end, 14 out of 660 people suffered a severe reaction. This translates to 2.1 percent of vaccinated volunteers. Documented SEAs include one acute heart attack, other cardiovascular diseases, and three miscarriages.
Though the Vaccine article touted a complete absence of SAEs, it referred to a severe case of pneumonia in a 65-year-old participant that lasted 25 days. Still, the illness was considered unrelated to the trial.
A Dec. 17, 2020, FDA report (pdf) shows that Moderna had reported two other instances of SAE to the FDA. Still, they were also deemed unrelated to the trial: a 72-year-old participant was diagnosed with cardiac arrhythmia after being struck by lightning, and an 87-year-old showed worsening of a pre-existing heart condition 45 days after vaccination.
Since the three reported SAEs were dismissed as irrelevant, the Vaccine article could boast the good results of the trial as it did.
Omitting these cases, 11 people out of 660 experienced severe side effects from the vaccine, or 1.6 percent, as the final report shows.
The reporting dates of the individual instances of SAE are unknown. Unless false information was provided, all the SAEs must have occurred in the eight months after the publication of the Vaccine article.
Moderna didn’t update the Vaccine article with later information.
From NTD News