Politics Over Science

The big news on Monday was the FDA approval of the Pfizer Covid vaccine.

The vaccine was approved and the FDA provided a license to Pfizer to manufacture the vaccine as specifically stated in the approval letter as follows.

Under this license, you are authorized to manufacture the product, COVID-19 Vaccine,mRNA, which is indicated for active immunization to prevent coronavirus disease 2019(COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)in individuals 16 years of age and older. (emphasis added).

What I found interesting in this decision is how clearly this shows how politics is driving almost all of the decisions around Covid, rather than science.

Of course, that is not what we are told. We are told that science is behind every decision.

Let's look at the facts and start with the most important question.

Does the Pfizer vaccine "prevent coronavirus disease 2019 (Covid-19)"?

Let's look at evidence in Israel that has exclusively used the Pfizer vaccine and actually started its mass vaccination program before the United States.

78% of the population of Israel that is eligible to receive the vaccine have been fully vaccinated.

Does this look like evidence of a vaccine that PREVENTS Covid-19?

Compare as well Israel's death rate from confirmed Covid cases with some of its neighbors. Those neighboring countries have all fully vaccinated less than 10% of their populations.

Yes, those countries may not be counting Covid cases and deaths as accurately as Israel.

However, have we ever had a vaccine, where after it was administered to a large share of the population, cases went higher rather than declined?

It defies all known medical history not to mention common sense.

Israel has already started administering booster shot of the Pfizer vaccine to those over age 50.

They took that action after data showed that 90% of new infections are among the highly vaccinated group of those age 50+.

Counter to the narrative we hear in the news in the United States, severe disease in those who are older and fully vaccinated is rising on the same slope as the cases are.

Source: https://twitter.com/EricTopol/status/1429887609254268931/photo/1

A booster is going to fix this?

Again, when in medical history has any vaccine needed a booster after 6 or 8 months if it was working properly to prevent disease?

Some might point to flu vaccines which are typically annual shots. However, flu vaccines are reformulated every year into a new vaccine meant to target a predicted strain of the flu that is expected that year. Those are not booster shots.

The Pfizer booster shot is exactly the same formula that was given in the first two doses. It has not been reformulated to better target the Delta or any other variant.

In what sane world is the FDA approving a vaccine when it has already been admitted that it does not work as originally authorized?

Another important fact to consider in all of this is that the standard FDA protocol for clinical trials is a two year period of data collection and assessment of the vaccines. This approval is based on only six months of data.

There has never been a faster approval process in the history of the FDA.

Even worse, a normal trial maintains a control group of participants who took the placebo in the original trial so that longer-term implications of the vaccine can be assessed and studied.

In the case of the Pfizer (and other Covid vaccines) the FDA allowed the vaccine makers to "unblind" the placebo participants to be able to take the vaccine for "ethical" considerations.

You might also think that a federal agency like the FDA would not have such blatant conflicts of interest in the drug approval process as they do.

Is it any wonder that the FDA approval process was so fast?

The facts indicate that the Covid vaccines were going to be approved no matter what the data showed. Politics made sure of it.

If you doubt that consider the fact that a concern of the Pfizer and other Covid vaccines has been that they are causing heart issues such as myocarditis and pericarditis.

The FDA approval letter states that they don't have enough data and information to assess known serious risk of these issues with the vaccine.

Therefore, the FDA directs Pfizer in the approval letter to conduct more studies on this risk. However, look at how long it will be before the full risks are known.

There is a scientific reason why clinical trials and approvals are not rushed through in six months.

There also seems to be continuing concern at the FDA about the safety of these vaccines in pregnancy and their effects on infant outcomes.

Recall that in the original Emergency Use Authorization, the FDA specifically did not recommend the vaccine for pregnant women because it had not sufficiently been tested in the clinical trials.

The FDA still seems to have questions involving the risks in pregnancies as this is an additional study that Pfizer is obligated to perform.

The only problem with that is that I guess we will only find out about the infant outcomes involved with the women who took the vaccine while pregnant when the children are about ready for kindergarten!

Science can't be rushed.

It takes time to find out what is real and what is not. 

 

Politics is always in a hurry.

Everything is about approval polls and the next election.

Short-term interests are paramount. Long term implications and effects are rarely a concern. That will be someone else's problem.

If there is a problem with the vaccines it is going to be the people's problem. The government has no liability. The vaccine makers have no liability. Now employers and others who mandate the vaccine will apparently have no liability as well since it is "approved".

People's health should not be ruled by politics.

Politics is mandating everything to do with Covid.

There is surely more to come on this story.

My prediction is that it will not be good.