Sensationalism, promoted through mass media coverage, that has little to nothing to do with reality. And science, itself, has become little more then system of belief, that generates ‘celebrity’ status and profits. That reality saddens me, personally. I like the idea of reproducible results and being able to verify results.. Nature has that down pat. Science, does not.
Vaccine experts say Moderna didn’t produce data critical to assessing Covid-19 vaccine
"But was there good reason for so much enthusiasm? Several vaccine experts asked by STAT concluded that, based on the information made available by the Cambridge, Mass.-based company, there’s really no way to know how impressive — or not — the vaccine may be.The silence of the NIAID
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 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." ( Did they?)
*45 subjects - keep that in mind because as you’ll read the numbers change..
"Later, the statement indicated that (just) 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.
We don’t know results from the other 37 trial participants."
*So 45 test subjects, drops down to eight subjects? Where did the other 37 go?
"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."
* Eight of the 45 tests subjects, age unknown? Quite an omission. Yet the age of test subjects who had an immune response is of the utmost importance! If no immune response occurred in the older test subjects the vaccine would fail to help those that need it the most. One wonders why Moderna omitted that data? Unless it would have shown that it was only or mostly the youngest test subjects that had the response? Yes, that would be a problem
"There’s no way to know how durable the response will be
The report of neutralizing antibodies in subjects who were vaccinated comes from blood drawn two weeks after they received their second dose of vaccine."
* Two weeks.
“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.
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.
STAT asked Moderna for information on the antibody levels it used as a comparator. The response: That will be disclosed in an eventual journal article from NIAID, which is part of the National Institutes of Health."*Moderna didn't disclose the requested information
“The convalescent sera levels are not being detailed in our data readout, but would be expected in a downstream full data exposition with NIH and its academic collaborators,” Colleen Hussey, the company’s senior manager for corporate communications, said in an email.
Durbin was struck by the wording of the company’s statement, pointing to this sentence: “The levels of neutralizing antibodies at day 43 were at or above levels generally seen in convalescent sera.”
“I thought: Generally? What does that mean?” Durbin said. Her question, for the time being, can’t be answered"
Moderna’s approach to disclosure
"The company has not yet brought a vaccine to market, but it has a variety of vaccines for infectious diseases in its pipeline. It doesn’t publish on its work in scientific journals. What is known has been disclosed through press releases. That’s not enough to generate confidence within the scientific community.* Well none of that is confidence inspiring, in fact, it reads very much like other vaccine information I've researched.
“My guess is that their numbers are marginal or they would say more,” Rose said about the company’s SARS-2 vaccine, echoing a suspicion that others have about some of the company’s other work.
“I do think it’s a bit of a concern that they haven’t published the results of any of their ongoing trials that they mention in their press release. They have not published any of that,” Durbin noted."
Potential additional problems
"Researchers are still trying to determine, from the blood samples of recovered patients, what a meaningful immune response looks like. Specific numbers of antibodies initially observered could therefore be misleading, Zaks suggested.* Confidence and context as opposed to accurate data is what's important? Inaccurate data, that's a real problem running through the Covid-1984 crisis
"I don't think it'd be appropriate to just give a number out there because what's relevant is not the number; it's our confidence and context of what that number means," Zaks told analysts in a conference call Monday"
"Moderna recognized this issue in its Securities and Exchange Commission filing on its share sale, stating blood samples "have been taken from a small number of people and may not be representative of the antibody levels in a broader population of people who have recovered from COVID-19."* That's a change in tune from what we've read earlier
"The vaccine's safety profile is still uncertain, despite the early and generally positive results. This is especially noteworthy because Moderna's technology, which tells cells to produce the coronavirus' characteristic spike protein, triggering an immune attack, has never been used in a drug that has received Food and Drug Administration approval*Severe systemic symptoms? What does that mean exactly? And fever like doesn't seem to cut it!
Patients receiving the 25 and 100 microgram doses experienced mostly mild injection site reactions, but a third dose group, receiving two shots of 250 micrograms, produced severe "systemic symptoms," which Moderna described as fever-like"
* Severe "(of something bad or undesirable) very great; intense."
* Systemic: "relating to a system, especially as opposed to a particular part."
* Systemic disease A systemic disease is one that affects a number of organs and tissues, or affects the body as a whole.
Rheumatoid Arthritis is an example of a systemic disease- so it's really unclear what is being referred to when it's claimed those receiving the higher dose had "severe systemic symptoms"
Finally: Anthony Fauci is a big fan of the Moderna vaccine
Pushing it in the investment news department