Pfizer and Moderna mRNA COVID vaccines are really vaccines – obviously

person aspirating the vaccine from the vial

Here we go again – I keep seeing the new anti-vaxxer claim that the mRNA COVID-19 vaccines from Pfizer and Moderna are not, in fact, vaccines but are either “medical devices” or “gene therapy.” I keep trying to stay up with every single myth and trope pushed by the anti-vaxxers, but I swear that there’s a new one every day.

I would really love to write about something other than COVID-19 vaccines – I’ve got a ton of articles I want to write about GMOs, supplements, and cancer that are just sitting in a virtual pile on my desk. Unfortunately, I’m very worried that the anti-vax hatred of these new vaccines will allow this pandemic to keep going. That’s why many of us keep doing the best we can to stamp out the myths.

Just to be clear, the Pfizer and Moderna COVID-19 mRNA vaccines are actually vaccines – they are biological preparations that provide active acquired immunity to an infectious disease, in this case, COVID-19. But, I’m going to have to debunk these myths.

Continue reading “Pfizer and Moderna mRNA COVID vaccines are really vaccines – obviously”

COVID-19 vaccine facts and myths – UPDATED info about the new vaccines

COVID-19 vaccine facts

There are so many myths about the COVID-19 vaccine, I wanted to post some facts about the new vaccines which we can use for debunking purposes. I used to think that the HPV vaccine brought the most hatred and misinformation from the anti-vaccine world, but it’s clear that the new COVID-19 vaccines are their new targets.

This article will only focus on the five vaccines that I believe will eventually receive FDA or European Medicines Agency (EMA) approval – Pfizer, Moderna, AstraZeneca, Johnson & Johnson (JNJ Janssen), and Novavax vaccines. I remain unconvinced that any vaccine made in China or the Russian Sputnik V vaccine will ever get approved by countries with robust drug regulatory agencies. However, if they are, I will certainly add them to a future iteration of this list.

I’m going to make this in a basic chart form for ease of use. I will link to supporting evidence wherever relevant.

Continue reading “COVID-19 vaccine facts and myths – UPDATED info about the new vaccines”

Experimental COVID vaccines? Another anti-vaxxer trope to be debunked

pexels-photo-5863391.jpeg

And here we go with another one of those silly anti-vaxxers tropes – the COVID-19 vaccines are experimental, and the government/Big Pharma/Bill Gates are conspiring to test the vaccine on innocent people. Nothing could be further from the truth.

The claim that the COVID-19 vaccines are experimental probably arises from the fact that most of them received anEmergency Use Authorization (EUA) in the USA and other countries. The anti-vaxxers what to use the EUA to make a strawman argument that EUA is equivalent to “a risky, experimental drug that will cause great harm to you.”

But if these anti-vaccine activists spent just a little bit of time to understand the high-quality science behind these vaccines and the Emergency Use Authorizations, they might move on to some other topic. But in case someone finds this article among all of the nonsense on the internet, looking to find out if COVID-19 vaccines are, in fact, experimental, let’s debunk that with actual facts.

Continue reading “Experimental COVID vaccines? Another anti-vaxxer trope to be debunked”

America’s Frontline Doctors anti-vaccine affidavit – expert analysis

America's Frontline doctors affidavit

This article, about America’s Frontline Doctors anonymous anti-vaccine affidavit, was written by Kelsey S Hollenback, a Ph.D. student in Systems & Information Engineering at the Center for Risk Management of Engineering Systems, Department of Engineering Systems and Environment, School of Engineering and Applied Sciences, University of Virginia.

On reviewing America’s Frontline Doctors anonymous affidavit, part of a recent lawsuit over the COVID-19 vaccines, my first and most important takeaway is that, while Jane Doe apparently wishes to assert that she has discovered excess mortality associated with COVID-19 vaccines, what she describes in her affidavit bears absolutely no resemblance to how to conduct an actual such analysis.  Not even a little bit.

My second takeaway, which almost doesn’t matter given the first, is that, insofar as it’s possible to determine the methodology she used from the extremely limited description provided, that methodology is…flawed. 

Flawed in what ways? It counted more deaths associated with a COVID-19 vaccine than there are total deaths recorded in VAERS. It doesn’t account for differences between the CMS patient population and the general population. Depending on what criteria Jane Doe used to query the CMS claims database, she may have pulled patients receiving any vaccine, not just the COVID-19 vaccine; she may have pulled only patients receiving Moderna, or only Pfizer, or only Johnson & Johnson; she may have failed to pull patients receiving a no-cost or government-provided vaccine; and/or she may have oversampled patients at higher risk generally for all-cause mortality.

My third and final takeaway is that, while America’s Frontline Doctors affidavit does not in any way describe either a valid method for identifying excess mortality associated with the COVID-19 vaccine, doesn’t do anything at all to establish causality, and certainly doesn’t expose any cover-up, it does possibly reveal a serious HIPAA violation.

Continue reading “America’s Frontline Doctors anti-vaccine affidavit – expert analysis”

Drug development – explaining a complicated process, including vaccines

Based on some of the comments I see on the internet, I think that that people believe that drug development is easy. Anyone can do it. And all you have to do is invent a drug and, voila, it’s approved and you can make billions of dollars in gold

I might be over-exaggerating, but I’ve always thought that the anti-vaccine crowd believes in their heart that the development of vaccines includes throwing a bunch of stuff in a blender along with dollops of mercury, formaldehyde, aborted babies, and aluminum, which is poured into a vial and sold for billions of dollars. Despite those anti-vaccine myths, pharmaceutical drug development (including vaccines) is a difficult process that fails 99% of the time.

Drug and vaccine development is the total opposite of easy. It takes time, a lot of brilliant minds, and some luck. Sure, some worthless drugs do get approved (we’re eyeballing you Biogen), but almost every drug that fails to have a significant benefit to cost (in terms of safety and price) ratio will fail to get FDA approval.

The myths about drug development are filled with controversy, false claims, and conspiracy theories. Yes, occasionally, we can point out problems with the process. Unless you’re using confirmation bias, you will see that the vast majority of pharmaceuticals are very safe and very effective (or at least the benefits outweigh the risks).

One of the largest myths is that there really isn’t any regulation – Big Pharma owns the FDA (and other regulatory agencies) and does whatever it wants. But let’s look at the process of drug and vaccine development carefully, including how most drugs are investigated and brought to the market. Let’s try to separate the myths from the facts of pharmaceutical drug development.

Continue reading “Drug development – explaining a complicated process, including vaccines”

Guillain-Barré syndrome may be linked to the JNJ COVID-19 vaccine

Guillain-Barré syndrome

The US Food and Drug Administration (FDA) is warning that the Johnson and Johnson (JNJ) COVID-19 vaccine may be linked to Guillain-Barré syndrome, a relatively rare autoimmune disorder. Unfortunately for the confidence in the vaccine, this follows up on several other missteps and potential cardiovascular issues with the vaccine.

Nevertheless, it is clear that the COVID-19 vaccines’ benefits, preventing the disease, far exceed the extremely rare risks.

Because there is a lot of confusion about Guillain-Barré syndrome and whether there is a causal link to the JNJ vaccine, I will try to present the facts as they are known today. Of course, things change, and the CDC’s Advisory Committee on Immunization Practices (ACIP) will meet on 22 July 2021 to further discuss this issue, so stay tuned for more information.

Continue reading “Guillain-Barré syndrome may be linked to the JNJ COVID-19 vaccine”

FDA approval of Alzheimer’s disease drug aducanumab – Inspector General may investigate

Alzheimer's disease drug

Last week, the US Food and Drug Administration (FDA) approved the first new drug, Aduhelm (aducanumab), for Alzheimer’s disease in 18 years. The new drug is manufactured by Biogen, a US-based pharmaceutical company, and if you read the news reports and social media posts, you’d think the new drug is a miracle.

Given that Alzheimer’s disease afflicts over six million Americans each year, we wanted to celebrate aducanumab as a miracle. Except, there’s really nothing to celebrate here.

The FDA ignored the advice of its own expert advisory committee, which voted overwhelmingly (eight against approval, one for, and two abstained) to not recommend the drug because, according to the FDA’s own analyses, the drug failed to show that it can do anything to treat Alzheimer’s devastating cognitive decline. Plus aducanumab costs $56,000 per year (yes, $56,000) and comes with a relatively high risk for brain swelling and bleeding.

In response to the outcry, Acting FDA Commissioner Janet Woodcock wrote a letter to the acting inspector general of the Department of Health and Human Services, acknowledging that there has been “significant attention and controversy” surrounding the approval of Aduhelm. In particular, Woodcock said, concerns continue to be raised about the agency’s contacts with Biogen, including “some that may have occurred outside of the formal correspondence process.”

So we have to ask why would the FDA approve this new drug for Alzheimer’s disease, even though aducanumab is expensive, has serious side effects, and probably doesn’t do anything to improve the outcomes of Alzheimer’s patients? And because the drug is so expensive and everyone will demand the drug for the disease, this could add hundreds of billions of dollars to the cost of healthcare in the USA and across the world (don’t believe for a second that this possibly worthless drug is going to cost only $5.00 in Denmark, because it won’t).

The answers to these questions are complicated, and I’ll try to explain. But I think what happened here is disturbing and tragic. And it could have implications for any new drug approved by the FDA.

Continue reading “FDA approval of Alzheimer’s disease drug aducanumab – Inspector General may investigate”

COVID vaccines effectiveness against new Delta variant

COVID vaccines effectiveness Delta

With the spread of the Delta variant (known as B.1.617.2 by the CDC) from India, scientists have been concerned about the effectiveness of COVID vaccines against it. The good news is that the Pfizer and AstraZeneca vaccines seem to fairly effective against this new variant of SARS-CoV-2 virus.

Let’s take a look at the paper that describes the effectiveness of the vaccines against the COVID-19 Delta variant.

Continue reading “COVID vaccines effectiveness against new Delta variant”

Myocarditis and COVID mRNA vaccines – very rare adverse event

myocarditis covid mRNA vaccines

Regulatory agencies, such as the FDA and CDC, are monitoring reports of myocarditis, a heart inflammation, after COVID-19 mRNA vaccines from Moderna and Pfizer. Although myocarditis after these vaccines are exceedingly rare, anti-vaccine activists have already jumped on this issue to make it appear that COVID-19 vaccines are dangerous.

My job is to look at this data and give you a scientific analysis of the observations and whether they are actually related to the vaccine.

Like with reports of other conditions, such as blood clots, after receiving COVID-19 vaccines, we need to examine whether myocarditis is actually related to the vaccine or just random events in which the incidence is no different than what would be predicted in a similar group of unvaccinated people. And if it is linked, we need to look at the potential risk and compare it to the risks of COVID-19 itself.

Continue reading “Myocarditis and COVID mRNA vaccines – very rare adverse event”

COVID-19 vaccines and myocarditis – what are the facts

medical stethoscope and mask composed with red foiled chocolate hearts

Regulatory agencies, such as the FDA and CDC, are monitoring reports of myocarditis, a heart inflammation, after COVID-19 vaccines. Although if there is a link, it is exceedingly rare, anti-vaccine activists have already on this issue to make it appear that COVID-19 vaccines are dangerous.

My job is to look at this data and give you a scientific analysis of the observations and whether they are actually related to the vaccine.

Like with reports of other conditions, such as blood clots, after receiving COVID-19 vaccines, we need to examine whether myocarditis is actually related to the vaccine or just random events in which the incidence is no different than what would be predicted in a similar group of unvaccinated people. And if it is linked, we need to look at the potential risk and compare it to the risks of COVID-19 itself.

Continue reading “COVID-19 vaccines and myocarditis – what are the facts”