A few days ago, Moderna released a cheery press release supposedly claiming a ‘win’ in the mRNA vaccine touted by Bill Gates and Anthony Fauci. But, the results actually raised more questions than it answered.
A few things to keep in mind:
Moderna has NOT published any scientific data… just issued a press release.
Moderna tried the vaccine on 45 supremely healthy individuals.
Moderna never released any information on the “mouse trials” it supposedly conducted with the COVID vaccine.
20 Perecent of the human test subjects who received the high dosage developed serious complications.
With those thing in mind Fort Russ.com reported:
The vaccine, developed and championed by Anthony Fauci and financed by Bill Gates, used an experimental MRNA technology that the two men hoped would allow rapid deployment to meet President Trump’s ambitions “warp speed” time line.
[mRNA vaccines are highly untried and operate by actually altering the messages used in your DNA.]
Three of the 15 human guinea pigs in the high dose cohort (250 mcg) suffered a “serious adverse event” within 43 days of receiving Moderna’s jab.
Moderna did not release its clinical trial study or raw data, but its press release, which was freighted with inconsistencies acknowledged that three volunteers developed Grade 3 systemic events defined by the FDA as “Preventing daily activity and requiring medical intervention.”
Moderna allowed only exceptionally healthy volunteers to participate in the study. A vaccine with those reaction rates could cause grave injuries in 1.5 billion humans if administered to “every person on earth.”
That is the threshold that Gates has established for ending the global lockdown.
Moderna did not explain why it reported positive antibody tests for only eight participants. These outcomes are particularly disappointing because the most hazardous hurdle for the inoculation is still ahead; challenging participants with wild COVID infection.
Past attempts at developing COVID vaccines have always faltered at this stage as both humans and animals achieved robust antibody response then sickened and died when exposed to the wild virus.
Moderna’s press announcement heralded “Positive Interim Phase 1 findings.”
While Moderna blitzed the media, it revealed very little information — and most of what it did disclose were words, not data.
That’s important: If you ask scientists to read a journal article, they will scour data tables, not corporate statements. With science, numbers speak much louder than words.
Even the figures the company did release don’t mean much on their own, because critical information — effectively the key to interpreting them — was withheld.
Experts suggest we ought to take the early readout with a big grain of salt. Here are a few reasons why.
The silence of the NIAID
The National Institute for Allergy and Infectious Diseases has partnered with Moderna on this vaccine. Scientists at NIAID made the vaccine’s construct, or prototype, and the agency is running the Phase 1 trial. This week’s Moderna readout came from the earliest of data from the NIAID-led Phase 1.
NIAID doesn’t hide its light under a bushel. The institute generally trumpets its findings, often offering director Anthony Fauci — who, fair enough, is pretty busy these days — or other senior personnel for interviews.
But NIAID did not put out a press release Monday and declined to provide comment on Moderna’s announcement.
The n = 8 thing
The company’s statement led with the fact that all 45 subjects (in this analysis) who received doses of 25 micrograms (two doses each), 100 micrograms (two doses each), or a 250 micrograms (one dose) developed binding antibodies.
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Later, the statement indicated that eight volunteers — four each from the 25-microgram and 100-microgram arms — developed neutralizing antibodies. Of the two types, these are the ones you’d really want to see.
Separately, while the Phase 1 trial included healthy volunteers ages 18 to 55 years, the exact ages of these eight people are unknown. If, by chance, they mostly clustered around the younger end of the age spectrum, you might expect a better response to the vaccine than if they were mostly from the senior end of it. And given who is at highest risk from the SARS-CoV-2 coronavirus, protecting older adults is what Covid-19 vaccines need to do.
The report of neutralizing antibodies in subjects who were vaccinated comes from blood drawn two weeks after they received their second dose of vaccine.
“That’s very early. We don’t know if those antibodies are durable,” said Anna Durbin, a vaccine researcher at Johns Hopkins University.
There’s no real way to contextualize the findings
Moderna stated that the antibody levels seen were on a par with — or greater than, in the case of the 100-microgram dose — those seen in people who have recovered from Covid-19 infection.
But studies have shown antibody levels among people who have recovered from the illness vary enormously; the range may be influenced by the severity of a person’s disease. John “Jack” Rose, a vaccine researcher from Yale University, pointed STAT to a study from China that showed that, among 175 recovered Covid-19 patients studied, 10 had no detectable neutralizing antibodies. Recovered patients at the other end of the spectrum had really high antibody levels.
So though the company said the antibody levels induced by vaccine were as good as those generated by infection, there’s no real way to know what that comparison means.
So, essentially, whatever the results of the vaccine, many experts expect that it will be championed in the media as COVID salvation.