Monday, August 15, 2022

How Effective Have They Been?

The Pfizer/BioNTech Covid-19 Phase 3 clinical trial study concluded with this statement when the results were released to the public on November 18, 2020.

Primary efficacy analysis demonstrates BNT162b2 to be 95% effective against COVID-19 beginning 28 days after the first dose.

The vaccine was stated to be 95% effective against COVID-19.

Note that Pfizer/BioNTech did not state that it was 95% effective in reducing symptoms, preventing serious disease, hospitalization of death.

The statement was simply that is was 95% effective against COVID-19 beginning 28 days after the first dose.

43,661 individuals were in the study. 

Moderna reported similar results for its COVID-19 vaccine in the final Phase 3 trial.

The mRNA-1273 vaccine showed 94.1% efficacy at preventing Covid-19 illness, including severe disease. Aside from transient local and systemic reactions, no safety concerns were identified.

94% effective in preventing Covid-19 illness, including severe disease.

Over 30,000 volunteers participated in the Moderna trial.

Based on these studies, the FDA granted emergency use authorization for both vaccines to be administered in the United States.

Those authorizations were provided for the vaccines based on the fact that they would prevent COVID-19 disease.

This is taken directly from the FDA Review Memorandum for the Pfizer vaccine issued on December 11, 2020. The Moderna vaccine had identical wording for its intended use.



Source: https://www.fda.gov/media/144416/download


Since the vaccines were authorized, over 12 billion doses have been administered around the world.

In the United States, over 600 million doses of the vaccines have been administered.

67% (223 million) of every man, woman and child in the nation are fully vaccinated.

Over 100 million have received at least one booster dose.


Source: https://covid.cdc.gov/covid-data-tracker/#vaccinations_vacc-people-additional-dose-totalpophg


Based on the representations made by the Pharma companies and the FDA,  Covid cases should have plummeted as vaccinations were rolled out.

For example, this is a graph of polio cases in the United States before and after the polio vaccine was rolled out in 1955.


Source: https://medicalxpress.com/news/2020-09-lessons-polio-vaccine-lab-americans.html


Compare that to what the experience has been with Covid since the vaccines were initially distributed beginning December 15, 2020.

This chart of cumulative cases shows a steady increase after the vaccines were introduced.




There have been 85% more Covid cases per month on an average basis nationally since the vaccines were introduced compared to the pre-vaccine period.

It can be argued that this is not a completely fair comparison because it takes awhile for the vaccine rollout to gain scale. 

Many would argue that hospitalizations and deaths should also be considered, not cases alone.

I recently undertook to analyze these three dimensions of Covid in my home state of Ohio comparing the one year period of July 1, 2020 to June 30, 2021 to the following one year period.

I considered the former year to be the pre-vaccination base period. Vaccinations were occurring throughout this period  but a substantial percentage of the population was fully vaccinated by June 30, 2021---six months after the vaccines were first made available.

The post-vaccination period was July 1, 2021 to June 30, 2022.

Comparing these two periods should give a fair assessment of just how effective the vaccines have been.

Ohio has a population of almost 12 million making the sample size of my study considerably larger than the 75,000 who participated in the Pfizer and Moderna clinical trials. My study looked at two years. The Pfizer and Moderna trials only lasted two months.

These are the results for the "pre-vaccination" period July 1, 2020 to June 30, 2021 as reported on the Ohio Covid Dashboard.


Source: https://coronavirus.ohio.gov/dashboards


These are the results for the "post-vaccination" period from July 1, 2021 to June 30, 2022.



Source: https://coronavirus.ohio.gov/dashboards


Cases, hospitalizations and deaths were all higher in the post-vaccination period than in the pre-vaccination period.

There were actually 65% more cases in the year in the post-vaccination period than in the pre-vaccination period.

How can you look at this data and conclude the vaccines have been effective?




However, that is exactly what we continue to hear.

For example, the argument is made that despite the 65% increase in cases that the vaccines were still effective in limiting hospitalizations and deaths.

It is true that hospitalizations and deaths have not increased in concert with cases over the last year. However, it is unclear if that is due to the vaccines or the fact that most of the increases in cases were due to the Omicron variant which seems to be much less virulent.

I wrote about data from Africa (where only about 20% are fully vaccinated and less than 3% have taken a booster dose) in an earlier blog post that showed that the death rate from Omicron has not moved in conjunction with the case rate despite the low vaccination rate on that continent.




In the first three waves, deaths mirrored cases but this relationship began to fall apart with Omicron BA 1/2 and has completely disconnected with Omicron BA 4/5.

This suggests the lower death rates from Omicron around the world has more to do with the virus than any significant protection from the vaccines.

The vaccines may have some marginal benefit against serious disease and death but the data suggests that it is far less than what was promised at the outset. That benefit must also be balanced against any risks in taking the vaccine.

The bigger point is that we were promised vaccines that were 94% or 95% effective at preventing Covid disease.

That was how the vaccines were promoted.

That was the basis upon which it was argued that the transmission of the disease would be curtailed.

That was the basis upon which mandates were instituted.

That was the basis upon which people were fired from their jobs if they were unwilling to take the vaccine.

That was the basis upon which students could not attend college if they did not get vaccinated.

That was the basis upon which unvaccinated people were barred from restaurants, cruise ships, concerts and other aspects of life.

It appears that the CDC is even beginning to recognize the obvious.

It modified its guidance last week that makes no distinction between those who are vaccinated and unvaccinated.




The obvious question is why it has taken so long to recognize the obvious when the data (and BeeLine) have been pointing this out for a very long time?

How effective has the CDC been in all of this?

How effective has the FDA been?

How effective has Dr. Tony Fauci been?

After all that we have seen, Fauci is still not willing to admit that there might be the slightest chance that the advice he has been giving on the vaccines might be wrong.

After being double vaccinated and double boosted, Fauci, who just infected with Covid in June (and had a rebound case after taking Paxlovid) has this advice for Americans.


Source: https://www.yahoo.com/video/fauci-stark-warning-those-covid-120836969.html


Coincidentally, the same thing happened to double vaccinated, double boosted Joe Biden a couple of weeks later.

The problem is that the people who should be in trouble don't seem to have the slightest feeling of guilt or remorse for their ineffectiveness and what they have done to the lives of tens of millions of people over the last two years.

Is there any question that the public health establishment has caused greater damage to mankind in its response to Covid that anyone else in human history short of causing a World War?

At this point, pivots in policy and even apologies are small comfort.

Who is going to be held accountable for the incompetence, inanity and intransigence that led us here?




4 comments:

  1. Your presentation of this data is very flawed. To look at whether there is truly and increase in cases that could have been prevented by the vaccine but weren’t, you need to compare those cases in the post vaccine period in which the person had the vaccine vs didn’t. When looking at death and hospitalization difference, and accounting for the smaller pool of people in the unvaccinated group (~30%) vs the vaccinated group pool of the population (a larger ~70%) there is a significant reduction in those metrics. Stop spreading your bullshit statistics when it’s clear your understanding of data metrics and risk reduction/efficacy is lacking.

    ReplyDelete
    Replies
    1. The "bull**** statistics" are not mine---everything cited is from the CDC, Ohio Department of Health or Johns Hopkins.
      You speak as if the vaccine have prevented infection but completely ignore the fact that cases in Ohio increased 65% after the majority of the population was vaccinated.
      How do you explain that away?
      I stated that it is possible that the vaccines have had a marginal benefit on reducing hospitalizations and deaths. However, it is not clear if that is not due to lower virulence of recent variants.
      I wish it was possible to analyze vaccinated vs. unvaccinated populations. However, the CDC and most states do not make that info available.
      San Diego County, CA does but data for the last three months shows that 67% of all cases, hospitalizations and deaths have been among the fully vaccinated. More than half of those have also been boosted. https://twitter.com/justin_hart/status/1559636666851086337/photo/1
      78% are fully vaccinated in the county per New York Times Covid dashboard.
      Comparing 78% fully vaxxed to 67% hospitalizations, deaths would indicate a marginal benefit for vaccines (skewed to older populations) just as I stated in the blog post.
      I have a hard time understanding what your beef is other than the data does not support your beliefs.

      Delete
    2. ~60% of the population in San Diego is vaccinated and boosted and make up 42% of the hospitalizations and deaths (38% of the deaths). So the vaccines are protective. You also have to take into account who is getting vaccinated and who is currently eligible for boosters - a higher proportion of those getting vaxxed are older and have underlying health conditions that put them at higher risk of death and hospitalization even pre-COVID. So that also has to be taken into consideration. If majority of the unvaccinated have the lowest likelihood of severe disease, then the data for deaths and hospitalization will appear skewed (making the vaccine look less effective) because you are comparing apples and oranges. The issue is that you are trying to make assumptions and draw conclusions that you just can’t based on the limited granularity of the data. Has nothing to do with my beliefs. Has everything to do with understanding data sets and spending your life working with them to draw appropriate conclusions about the data. It’s really easy to get lost without granular data about your confounders.

      Delete
    3. I agree with the difficulty to draw conclusions due to confounders. However, there is no way that it can be argued that the vaccines are protective if 42% of the hospitalizations and 38% of the deaths in San Diego County are in those fully vaccinated and boosted. Those numbers are way, way short of what was promised and what people have been told they can expect from the vaccines. I have stated repeatedly in these pages that the vaccines may be argued to have some protective or marginal benefit. This is especially true in looking at the data for older populations. However, this potential benefit must be balanced with any risks in taking the vaccine. In fact, I state that in this post.
      "The vaccines may have some marginal benefit against serious disease and death but the data suggests that it is far less than what was promised at the outset. That benefit must also be balanced against any risks in taking the vaccine."
      Thank you for citing data that supports my point.

      Delete