Vaccines

 In early 2020 as the virus was raging but people still didn't know how long it would be with us or what the total impact would be, then-President Donald Trump announced "Operation Warp Speed" which would speed up development and production of vaccines against the virus.

Operation Warp Speed had a few components to it

• The FDA would be strong-armed into actually doing something to improve the lives of Americans, rather than its normal role of preventing sick Americans from getting the help they need.
• The Government would pre-purchase millions of doses of any promising vaccine as a way of encouraging companies to put the effort into developing it.
• Since the vaccine was purchased with public dollars, the vaccines would be free to all eligible Americans.
• All of this would happen before the end of the 2020.

This program was met with immediate skepticism.  Normally, the development of a vaccine takes years.  Even accounting for the fact that the FDA would get out of the way, developing, testing, approving, manufacturing and delivering a vaccine in less than a year seemed impossible. And yet, it was done by companies all around the world.

In the US, the two most common vaccines were developed by Pfizer-BioNTech and Moderna.  They used a technology called mRNA.  I had heard of mRNA vaccine development for several years as companies were trying to develop a cancer vaccine using that technology.  mRNA stands for "Messenger RNA" which actually doesn't help me a whole lot, but apparently it's a piece of RNA that the body can latch on to to develop antibodies against some foreign agent, be it a virus or possibly cancer.  To date, mRNA work on cancer continues but is seemingly no farther along than it was before the rona hit.

However, anything with "RNA" in the name sounds scary to a lot of people.  While most people don't know what RNA is, most people know it is somehow related to DNA which is your genetic make up.  So  adding in bits of RNA would seem to open the door for mutations.  As such, pregnant women or women that hoped to be pregnant soon were less than thrilled with the prospect of producing mutant offspring.

Also, the FDA, does have some role in drug safety, and so bypassing those safeguards seems risky.  Particularly since there would be no long-term safety information.  Who's to say what would happen in a couple of years?  Just because a few thousand people took the vaccine and didn't suffer side-effects doesn't mean that a few hundred million will be OK.

These questions are not unfounded.  mRNA vaccines may have been under development for decades, but they weren't being used for anything.  If they are so effective and safe, why aren't they being used?  (Of course, the FDA can be blamed for at lease some of the delay as I've alluded to numerous times.)  And it's not like pregnant women don't have reason to worry.  Most people have heard the horror stories of birth defects due to thalidomide, which was commonly used to manage nausea during pregnancy during the 1950s and 1960s.  It's not like thalidomide was pulled off the market after the first baby with flippers was born.  Not every baby was so unlucky and it took many years to establish a link between birth defects and thalidomide.  Who knows if these new untested mRNA vaccines won't have a similar fate?  Maybe 1 in 1000 babies are born with a birth defect if their mother is vaccinated while 1 in 2000 are born with a birth defect ordinarily.   

Now, I tend to think these fears are overblown.  I personally have been vaccinated (to be fair, I'm not in a position to pass by genes on to another generation) and so far there has been little cause for alarm.  Some people have had bad reactions, to be sure, but the numbers are relatively modest, at least to me.  But I want to be fair to their position.  This was an untested drug, after all.  Famously, Phase 2 and Phase 3 trials were done simultaneously.  Now, I'm not even sure what the difference between a Phase 2 and Phase 3 trial.  One is aimed at efficacy and one is aimed at negative consequences, maybe.  But it's still cutting corners.

And after all, it was evident early on that young people were relatively unaffected by the coronavirus.  Why put them or their children at unnecessary risk?

Before the mRNA vaccines came out, there was a fiesty group of "anti-vaxxers" that were convinced that modern vaccines were causing autism.  Those people typically were on the left.  Some vaccines are generated from the stem-cell lines of aborted fetuses, so that's another group that's opposed to their use.  That group would be on the right.  Altogether, they represented a relatively small group of people, but concentrated enough that in some school districts the rate of measles and other commonly vaccinated-against diseases was actually going up prior to 2020.  The rapid development of the mRNA vaccines definitely kicked that anti-vax movement into high gear and, to some extent, took it mainstream.

But what about Johnson and Johnson?  They also developed a vaccine, which was a bit more conventional in that it was made up of a piece of de-activated virus that the body could use to generate antibodies against the real thing.  However the J&J vaccine was associated with heart problems and J&J vaccine was more morally compromised in terms of use of aborted cell lines.  As of this writing (February 2022), the J&J vaccine is a small fraction of the total vaccines and, in fact J&J has halted production of the vaccine.

At the end of 2020, Donald Trump lost re-election and was replaced with Joe Biden, a Democrat of Strict Observance, who was much more inclined to view the population as a herd of sheep needing to be lead than a band of constituents needing to be served.  So "Government-provided" vaccine, quickly became "Government-mandated" vaccine.  Not everyone had to get it, but the feds were able to force most large businesses (including  mine) to force their employees to get vaccinated.  The reasons given were that universal vaccinations would

1. Stop the spread of the virus
2. Prevent people from getting sick, partially due to the lower spread and partially due to the protection from the vaccine.
3. Give the hospitals and staff a break due to fewer sick people
4. Reduce deaths from the virus, due to all of the above.

As of today, the CDC  estimates that seventy-five percent of the population is at least partially vaccinated (ie, they got one of the two required doses of Pfizer or Moderna), sixty-four percent are fully vaccinated (ie, they got both doses of Pfizer or Moderna or they got the one-shot J&J), and forty-two percent of those (which I guess means around 27 percent of the population) has been "boosted" (ie, getting three shots of Pfizer or Moderna or two shots of J&J or some combination).  Given that the typical coverage of flu shots is around 50%, you'd think these numbers should warn the heart of every public health official in the country.  But you'd be wrong.

Current CDC director Rachel Walensky is on TV almost every single day with her sad and frightened face imploring more people to get vaccinated.   Long ago the idea of "herd immunity", where the virus would stop spreading when 70% or 80% of the population were immune (through previous infection or vaccination) would stop the virus, has been abandoned.  Now everyone needs to be vaccinated.  And the pressure campaign mounts.  Vaccines are needed to work. Vaccines are needed in some places like New York to go to a restaurant.  Vaccines are needed to go to school in some places.  And only vaccines.  Natural immunity doesn't count, regardless of the CDC's own data showing that natural immunity is at least as good as vaccination.

Vaccines, vaccines, vaccines!  And thanks to FDA bungling and outright malice, no treatments.

That may seem a little strange, but a quick check of the CDC's website will explain a lot.  Consider the recommendations for measles.  Front and center: vaccination.  Or consider rubella. After stating that most symptoms are mild, the next two sections (as of February 2022) are about vaccination.  Or consider chickenpox. More vaccinations needed!  Now, I'm not opposed to vaccines.  Vaccines are good and necessary to keep people healthy.  But it does put the CDC's fascination with vaccines in perspective.  The CDC seems to primarily see itself as a vaccination advocate.

So let's think about this for a minute.  What do you expect from a vaccine?  In the FDA's press release announcing the approval of the Pfizer/BioNTech vaccine, we see this statement.

Based on results from the clinical trial, the vaccine was 91% effective in preventing COVID-19 disease.

"91% effective in preventing COVID-19 disease".  Let's put our lawyer hats on for a minute and parse that sentence.  Does that mean that 

1. You won't catch the virus, or
2. If you catch the virus you won't get sick, or 
3. If you catch the virus and get sick you won't get seriously ill?  

I think most people would assume Option 1.  However, as it turned out in the months following the roll out of the vaccine, the correct answer in the case of the mRNA vaccines is Option 3.  Again, this is probably an result of the limited testing.  During the initial testing phase, there were no variants (which is a story for another day)  but after the introduction of the vaccine there seemingly were new variants popping up every few months and some like "Delta" and "Omicron" were much more transmissible.  But the vaccines had not been tested against them so the statement above wouldn't have covered those variants.

So are the vaccine "effective" if they don't stop you from catching the disease or getting sick, but "only" stop you from getting seriously ill and possibly dying?  They might still be nice to have around, but it changes the dynamic a little.

To answer the question, let me pose another thought experiment:  How many times have you had the measles?  Or chicken-pox? Or the mumps?  All of these diseases are considered to be "one-and-done"  you either catch them or get vaccinated and are "protected" for life (whatever that means).  So if you had the measles as a child, you'd assume that you'd never catch it again.  But maybe you did?  It takes a few days for your body to mount an immune response so how do you know that you didn't come into contact with the virus, get infected and even start feeling a little down before your immune system was able to defeat the infection. During that time, you "had" the virus and you were even "sick" from the virus, but since you never got tested you might have attributed your symptoms to a cold, or stress, or allergies, or something you ate. And you likely didn't consider it serious enough to stay in bed or stay home from work.  And you might have passed it on.

Or maybe not, what the hell to I know?

But if the rona vaccine is in the same category, then I'd assume that it's "working" even if I still catch the virus and even feel like crap for a few days (which I did).  If I didn't get tested (which I didn't), I might not even think it was the rona, unless everyone else in town had it a the same time (which they did).

However, that means that a lot of the reasons for mandating the vaccine -- like preventing spread in schools and other crowded settings -- are wrong.  If you can spread the virus during the few days that you have it, then the vaccine may limit the time you are infectious, but you're still going to spread it.  You'd think doctors would know that. 

People figured it out.  Then the Delta wave hit, a lot of people who were vaccinated and assumed that they'd be protected still got sick.  And the rate of vaccination didn't seem to affect the rate of transmission.  So the local governments and school boards, who are populated with small-minded control freaks at the best of times reimposed masking mandates.  But if you have to wear a mask even if you're vaccinated, what's the point of getting vaccinated?  

Remember, masks are largely untested.  Regardless of the FDA's incompetence, they did actually collect and review data.  And that data shows that vaccines gives some protection (of some category). Texas recently started reporting vaccine results, showing large levels of protection in catching and dying from the virus.  There is no data like that for masks.  And yet masks are the default go-to everytime someone has a cough?

But wait: the CDC is on the case.  Ever the promoter of vaccines, the CDC has decided that boosters are necessary for complete protection.  There are a couple of practical issues that I have with this: first of all the people most at risk are the unvaccinated.  Requiring or recommending boosters will do nothing to convince them to get vaccinated.  Boosters just make more money for Pfizer and Moderna.  Secondly the reason for boosters is typically reported as "a drop in antibodies", but a quick check with doctors will reveal that antibodies are only a part of the immune system.  Equally if not more important are T Cells and Memory B Cells and those seem to stick around.

This gets back to my questionable "measles" analogy.  I was vaccinated against measles a long time ago. I'd expect my antibody levels to be low (if not, surely my blood would be like maple syrup with all the antibodies for every virus I've ever been exposed to floating around) but my immune system still knows about measles and can mount a defense against it.  But that takes a few days (presumably if I had active antibodies in my blood it would take less time).  And that's the same scenario I'd expect for the rona.  Yeah, if I had a bunch of antibodies in my blood I might not get sick at all, but in either case I don't expect to get seriously ill.

Again, what do I know?  I'm just a jackass with a computer and internet.

Finally, the reason I'm skeptical about boosters is that I'm not convinced the FDA approved these vaccines correctly in the first place.  When Pfizer and Moderna were testing them, they had to get the data quick. So they tested the vaccines as two shots given three or four weeks apart (three for Pfizer and four for Moderna if I recall correctly).  So when the FDA approved them, they approved them as two shots given three or four weeks apart.  But that's just what Pfizer and Moderna did.  They could have given the shots 6 weeks apart or 6 months apart or 6 years apart.  But that's the data the FDA had, so that's what how they directed Americans to get vaccinated.  In other countries, a different approach was taken.  Since one shot of the vaccine gives 75% protection or so, the UK decided to give all of it's citizens one shot and after that round was complete to give the second shot, which ended up being around 6 months after the first dose was given.   90% of the population being 75% protected being deemed better than 50% of the population being 95% protected.  And the strangest thing happened: I didn't read any reports of bodies stacked up in the streets because the vaccines weren't given three or four weeks apart.

There was some evidence at the time that antibody levels were better with the extended vaccination gap than the 3 or 4 weeks the FDA clung to like a monkey with a banana.  But it ended up not mattering because even the UK rolled out booster doses.  Antibodies may not be the entirety of the immune system, but as has been stated several times, it's easy to measure.

Again, you'd think doctors would know that.  But you'd be wrong.  

In a similar vein, the J&J vaccine as a single shot gave 60-75% protection (the FDA considers anything over 50% to be "effective").  That's about the same as a single shot of Pfizer.  So maybe the J&J could be given as a two-shot series like Pfizer and Moderna is?  But that's not have J&J submitted their application.  In the end, now J&J is recommended as a two-shot regimen (but as a "booster" not as regular vaccination).  Given all the talk about how the FDA cut corners approving the vaccines,  it seems strange to fault them for approving ONLY what was submitted, but it's just frustrating to see this.  The anti-vax crowd commonly claimed that vaccines cause autism, so it's ironic that the FDA clung to every jot and tittle of the applications in such an autistic fashion.

Then there's the question about transparency in the data.  The drug companies submitted a bunch of data with their applications.  The FDA refuses to release it.  When a Freedom of Information Act request was put in, the FDA helpfully offered to release the data in 75 years.  Many people are calling bullshit on that.  A judge told the FDA it had to release the first batch of data by the end of January 2022 but as of today, I don't think any of it has.  That doesn't inspire confidence.  The drug companies are already shielded fro liability, so it doesn't seem like the FDA needs to protect them.  I'm sure it's just a coincidence that the former head of the FDA is on Pfizer's board.

But to be honest, I don't know whether this is a big deal or not. I'm not aware if any other trial data has ever been released, so I don't know if it's a problem that this trial isn't released.  But it makes one wonder what the FDA is hiding?

But what do I know?  A little restraint in the panic, a little creativity in application and a little independence from Pfizer's marketing department is all I ask.

To Summarize, I think that vaccines were on whole a blessing.  They probably saved hundreds of thousands of lives.  The excessive bleating from the local tin-pot dictators that blight our existence was a big turn off.  And our public health authorities were found to simultaneously know nothing about the public (in terms of what the public wants and how to communicate with them) and little about health either (in terms of how the immune system works).  The net effect is that while I've been vaccinated, I never got the booster shot and if my company required it  I'd have to make a difficult decision.  I know of people that wish they never got the vaccine because the media and public health authorities were such dicks about it.  I'm not at that point, but I'm getting close.