Thursday, December 17, 2020

Amidst All The Vaccine Hype - A Few Of The 'Memos' You May Have Missed



From L.A. to  Montpelier, Vermont hopeful expectation and excitement fill the air as scenes of the Covid vaccine rollout inundate screens large and small.  And why not, after more than 300,000 of our fellow citizens have been felled by this insidious virus which many refuse to take seriously?  Until they get it and end up intubated in an ICU, that is.  So there is good reason to be hopeful and even to assume the end of this pandemic is coming sooner rather than later.  But first, people need to be aware of  a few aspects not given as much prominence as the meme "we'll all be saved" and return to normal predominates.

1.  Just because the vaccine arrives doesn't mean you stop masks or social distancing.

See e.g.

This aspect has been somewhat underplayed by the media, otherwise breathless in its vaccine reporting.  But when Anthony Fauci has appeared for interviews he's emphasized there is  no analogy to just clicking a switch on or off.   For example, yesterday on CBS telling Gayle King that the existing medical precautions - mask wearing and social distancing-  will still need to be adhered to for months. 

So until there exists a recognizable herd immunity from immunization  those measures will still be absolutely necessary.  Just because one does get the vaccine doesn't mean chucking the mask or having social gatherings indoors.   

Americans will cooperate? Don't be so sure! Even with an explosion of cases (1.46 million the past 7 days), too many people are still protesting masking. Already yesterday we beheld the immediate resignation of the mayor of Dodge City, Kan. after getting death threats for supporting a mask mandate.  Then the Denver Post yesterday featured a top story ('Pandemic Backlash Jeopardizes  Health, Public Workers')  which noted:

Across the United States, state and local public health officials have found themselves at the center of a political storm as they combat the worst pandemic in a century. With the federal response fractured, the usually invisible army of workers charged with preventing the spread of infectious diseases has become a public punching bag. Their expertise on how to fight the coronavirus is often disregarded.

Some have become the target of far-right activists, conservative groups and antivaccination extremists who have coalesced around common goals: fighting mask orders, quarantines and contact tracing with protests, threats and personal attacks.

The backlash has moved beyond the angry fringe. In the courts, public health powers are being undermined. Lawmakers in at least 24 states have crafted legislation to weaken public health powers, which could make it more difficult for communities to respond to other health emergencies in the future.

It is because of ongoing national idiocy like this- mainly on the Right-  that I told Janice, vaccine or not, it will be years before we are free of the virus - if we ever are.  There remain too many morons on the loose.

The herd immunity threshold itself may well be delayed if too many Americans -  like the anti- vaxxers and QAnon lot- refuse to get the shots.  At least 75 percent inoculation is the threshold needed and thus far 50 percent of Americans in recent polls vow they will not be getting "jabbed."   (Likely believing the QAnon claptrap that Bill Gates wants to inject them with nanobots to control their febrile brains.)

Herd immunity is also likely to be delayed for months or even up to a year or more until children under 12 are also vaccinated. (WSJ, 'An Uncertain Timeline For Kids' Vaccines', Dec.15, p. A13). In the words of one Harvard epidemiologist (Michael Mina)  quoted in the WSJ piece: "It would be very, very difficult for us to reach herd immunity before vaccines are available for younger individuals."

The hitch?  Clinical vaccine trials have "yet to begin for children under 12", and for older teens the  trials are barely underway.   This is not unusual in drug and vaccine development given adults are generally tested before children.  But it does mean a delay is in place until kids are vaccinated.

2. The "95%  effective" tag doesn't mean what you think it does.

Regarding effectiveness, much is claimed, but precious little elaboration and transparent evidence is forthcoming.  Pfizer claims "95%" effectiveness.  Moderna claims a similar level:  94% — for its own candidate. But what does effectiveness really mean?

To a lay person, a phrase like "95% effective" means one of two things: either that she or he, upon exposure to the virus, is protected 95% of the time, or that 95% of the people who take the vaccine are protected 100% of the time.  In either case, the general public thinks it knows what the term means, but it's not operating in the vernacular of the drug companies.

In the world of drug advertising, the word "effective" doesn't mean what you think it means. Based on the numbers released from phase 3 trials, the Pfizer vaccine is 95% effective, but 1% of the time. Similarly, the Moderna vaccine is 94% effective, but 2% of the time. Digging deeper, for the Moderna vaccine, the phase 3 trial contained 30,000 individuals divided between those given the vaccine and those given a placebo. Assume that individuals in each group were allowed to roam freely, i.e.  told to live their regular lives among the general population, including going out infrequently, staying masked, and practicing social distancing.  This as opposed being proactively and aggressively exposed to the virus by the  vaccine researchers, which would be a violation of medical ethics.

In the Moderna vaccinated group, 11 people out of 15,000 got the virus (by Moderna's definition of what "got the virus means") for an overall infection rate of 0.07%. Disagreement  exists regarding that definition and attendant measurements, i.e. whether well chosen, but interested readers can consult the Forbes article:  "Covid-19 Vaccine Protocols Reveal That Trials Are Designed To Succeed." 

In the Moderna placebo group, 185 people of 15,000 got the virus, for an overall infection rate of 1.23%.  In the words of one medical blogger (Thomas Neuburger ) on smirkingchimp.com:

"Do you see where this is headed? If you divide 0.07% by 1.23%, you get a 5.7% infection rate — or inversely, a 94% protection rate, which is what's claimed. But that's a percentage of a percentage, a ratio of a ratio, something called the "relative rate" in the medical profession. What this really means is that, of the 1.23% of people who would have gotten the virus in the vaccinated group, 94% of them didn't."

But Moderna isn't testing 30,000 people who are infected with the virus, or even 15,000 people. Only 185 people "got the virus" (by their definition) in the placebo group. That population was reduced to 11 people with vaccination. These are very small numbers. As stated above, the Moderna vaccine is 94% effective — but only 1.23% of the time. 

Neuburger again:

"From the start of the pandemic until now, the overall disease rate for Maricopa County, a high-infection zone, is 5034 per 100,000 people, or 5%. At the lower end, the overall disease rate for Multnomah County, a less-infected but still urban county, is 2363 per 100,000 people, or 2.4%.

Both rates are higher than the infection rates of the Moderna and Pfizer placebo groups. As stated, Moderna's placebo group experienced a 1.23% infection rate, and Pfizer's placebo group was infected just 0.75% of the time. Does this indicate a difference in how “infection” is determined, or just something else about these studies? Hard to tell at this point."

Neuburger takes pains to point out that "none of this is to imply dishonesty on the part of the drug companies".  This is given that "measuring effectiveness using the relative rate of infection is common in that world."    Noting that "it's just more meaningful when the overall infection rate of a pathogen is, say, 70% or higher, instead of 5% or less."      

I suggest that Americans need to be more aware of these language and definition subtleties when next they hear a network or cable pundit blabbing that a vaccine is "95 percent effective".

3,  A shortage of critical reagents may well limit initial vaccine supply and delay the herd immunity needed for us to get out of the specter of Covid

 The  existence of a vaccine supply shortage has also been underplayed in the media amidst all the hopeful hype.  It was first prominently pointed out by Pulitzer-Prize winning medical journalist  and author Laurie Garrett ('The Coming Plague') on ALL In a week ago.  Then Ms. Garrett noted the same reagents used in Covid testing were also part of the production of the vaccine and the double demand was limiting supply of available vaccine.  (See also: 'Vaccine Scarcity Means Tough Choices', WSJ, 12/15, p. A7).

The chemical for extracting RNA does not seem to be the only reagent running short as the U.S. tries to quickly ramp up its testing capacity. Last Friday, Christopher Freeman, a laboratory administrator at Columbia University, sent an email to colleagues pleading for another product, used for storing RNA, made by Invitrogen, a unit of lab tools giant Thermo Fisher. He said his lab hoped to validate its Covid-19 test over the weekend, but that it needed the “a basic yet critical reagent that is required as per the FDA submission.” He asked if any laboratory had the reagent stocked in its laboratory.   

This stumble almost coincided with Pfizer's when it realized the raw materials needed for its own reagents - to produce the vaccine- failed to meet standards.  Pfizer did not elaborate what this meant, whether a case of diminution or contamination.   As reported in the WSJ:

"Pfizer sources its raw materials from providers in the U.S. and Europe. Scaling up production of these components proved challenging last month as the company awaited the results of its trials, which came in to be 95% effective and well-tolerated in a 44,000-subject trial.

Pfizer wouldn’t say where shortfalls over ingredients arose as it ramped up production. Vaccines typically contain materials from suppliers that can include antivirus agents, antiseptic liquids, sterile water and elements of the DNA of the virus itself that won’t cause serious symptoms but trigger the immune system to make antibodies."

We note here that (according to the WSJ report) Pfizer and Biotech are still on track to roll out 1.3 billion vaccines in 2021. But depending on how the testing trials for those under 12 go (and how many Americans accept the vaccine) there may be no herd immunity for years.  And that means masking and social distancing - as well as possible lockdowns - for years.

See Also:

by Amanda Marcotte | December 17, 2020 - 7:49am | permalink

It's time to defund the GOP, and there's precedent and strategy for the effort.

The need to cut the party's access to both private and government money is seen in the reaction by some extremist Republicans to news like a New York State lawmaker's proposal to make vaccination against COVID-19 mandatory. Predictably, the far right is freaking out. "Freedom!" they scream as they run around maskless, assaulting their fellow citizens with potentially virus-laden breath.

Large parts of the Republican base now join conspiracists in the misguided belief that vaccine manufacturers are participating in mind-control experiments and that public health measures like masks are "un-American," while we're being sickened and dying from the highest rates of COVID-19 infection and death in the developed world.



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