Safe and Effective

I’m flippin’ mad.

How is it that we are finding out only now from a COVID hearing at the European Parliament – from a senior executive at Pfizer – that they never tested the new vaccine technology to see if it prevented transmission of the COVID-19 virus?

Janine Small said, they had to:

"Move at the speed of science to understand what is happening in the market."

And from, Kathrin Jansen, also a Pfizer vaccine R&D executive:

"We flew the aeroplane while we were still building it. We got creative — we couldn’t wait for data, we had to do so much ‘at risk."

This, of course, then begs the question: What were they doing?

How does anyone say they don't have time to wait for data and then try to call it science?

Anyone who knows anything about research and studies knows this does not fly.

I suppose now, with this tidbit of information, it should come as no surprise that the injections did not prevent us from spreading COVID to one another.

They should have just told us.

The vaccine development timeline for mRNA was compressed from 10 years to nine months. So what does the "speed of science" even mean? And how does that square off with the fact that they didn't even try to test the vaccine for transmission prevention?

Even so, in those nine months, I don't understand why the question going into the clinical trials wasn't, "Will this vaccine prevent us from spreading COVID to one another?" I mean, that was the whole point, according to every health and government official. It's also what we were promised in no uncertain terms..

This, of course, then begs the question: What exactly does safe and effective mean? (Emphasis on effective.)

We also recently learned from Dr. Paul Offit, who is a renowned vaccine expert at the Children’s Hospital of Philadelphia and known for developing a rotavirus vaccine, that we are being asked to "trust mouse data," for the bivalent boosters in place of data that should have been gathered from an actual study on humans that tests for safety. There has been a lot of back and forth on why that is, namely that bivalent is just an updated version of the original monovalent design. Updated or not, the fact that they did test it on mice would indicate testing was warranted. I would argue that if testing is deemed necessary, at all, then it should be tested on humans to get an actual read on the effects and efficacy, for better or worse. After all, humans are the ones it is intended to protect. Not mice.

Dr. Offit thinks it is a bad idea to rely on mouse data alone, even though he is on the FDA’s vaccine advisory committee, which ultimately approved the booster based on the study. He, like many other doctors and scientists, are crying foul on this one.

His stance seems reasonable and is not one recommending against boosters. But rather, he is recommending a sensible pause until there is enough data to make an informed decision about what is going into our bodies. What he left out, however, was that the study justifying the go-ahead on the next round of shots was a study of 8 mice.

Anyone who knows anything about research and studies, knows this does not fly either.

Finally, we have Kate Baldwin on CNN interviewing a guy whose adverse reaction to the vaccine was Guillan Barré Syndrome, a neurological disorder where the immune system attacks the nerves. All she really had to say was that he was one of the "unlucky ones." Easy for her to say and I doubt she would be saying it with such ease if it had happened to her.

If this can happen, and has happened, then again, what exactly does safe and effective mean? (Emphasis on safe.)

To date, the CDC continues to tout safety and effectiveness, while at the same time, warning of the following side effects.

• Anaphylaxis

• Thrombosis with thrombocytopenia syndrome (TTS) after J&J/Janssen COVID-19 (Blood clots)

• Guillain-Barré Syndrome (GBS)

• Myocarditis and pericarditis (Heart attacks and cardiac arrest)

• Death

The CDC also acknowledges there is a small, but increased risk, of myocarditis in boys ad young men after the mRNA COVID-19 shots.

And this is where my blood starts to boil. Where is the guidance? Where is the conversation? Where is the consideration? Where is the love and kindness for the "unlucky ones" who are suffering?

All the CDC has come up with is to say that these events are rare. Really? Rare is really not the point. Rare means real. Rare means parents lost kids. Rare means kids lost parents. Rare means hearts are broken and lives are shattered. Does it really matter how many?

No.

To be clear, I am all for new medical technologies. I, myself have been guinea pig on multiple occasions, but by choice.

How on God's green earth is it possible that one human being could have ever said to another, "You have no choice but to inject this substance into your body... and it may kill you?"

It is becoming clearer with time that the answer to my question, "What is safe and effective?" is that no one actually knows. And now the reasons for that reality are revealing themselves with each day.