Coronavirus vaccine priority list – if I were elected the Emperor of Vaccines

coronavirus vaccine priority list

Despite the wild claims that a COVID-19 vaccine will be available real soon now, the initial limited supply would require a coronavirus vaccine priority list. Despite what Donald Trump says, and his veracity is limited, the supply of the vaccine will be limited for many months after approval, whether that approval is legitimate or not

The supply of a new COVID-19 vaccine is limited by many factors – regulatory review (yes, the FDA and other regulatory agencies must approve the manufacturing facilities for new drugs after the company receives approval to market their drugs), manufacturing bottlenecks, the number of doses required for “immunity,” and distributions problems, especially the need to store these vaccines at extremely low temperatures (no, your home refrigerator won’t get that cold).

In fact, that last point is something that everyone overlooks – your average physician does not have the ultra-low temperature freezers, usually only hospitals and major health departments. And they aren’t cheap. Furthermore, vaccines just don’t show up at a physician’s office or hospital directly from Big Pharma – they are delivered by a massive distributor network that may not have delivery vehicles that can properly store the vaccines as they drive their trucks across the deserts of Arizona in October.

This isn’t just an issue in the USA, it’s across the world. People magically believe that once a vaccine is approved it will suddenly be available to hundreds of millions of people. Nothing could be further from the truth.

Because the Big and Little Pharma companies are being much less transparent than they should, we have really no clue how many doses may be available soon after they get the go-ahead. 

Using the USA as an example, we’ll need around 750 million doses for every individual (assuming that two doses will be necessary and everyone gets the vaccine, which won’t happen). Overlooking the fact that the USA probably has a total vaccine manufacturing capacity of 200 doses at best (most of our current 300 million a year of vaccines are manufactured not only in the USA, but also in Canada, Belgium, Germany, France, and Japan), it’s highly improbable if not impossible to have 750 million doses on day 1. It may take years to manufacture that many.

If there are only 10-20 million doses available on day 1 (I’m highly skeptical of even that), you have to assume that there will be a coronavirus priority list. 

Now, there is a group that will be developing a coronavirus vaccine priority list (they’ll probably give it a better name) – the CDC’s Advisory Committee on Immunization Practices (ACIP). Dorit Rubinstein Reiss reported on a recent ACIP meeting which reviewed the ongoing efforts with the COVID-19 vaccine, but they did not make any recommendations on who should get the vaccine.

In light of that,  if I were elected Emperor of Vaccines, then I would have to create an official coronavirus vaccine priority list so that the right people get the vaccination. Spoiler alert – most of us aren’t on that list. Continue reading “Coronavirus vaccine priority list – if I were elected the Emperor of Vaccines”

Vaccine development process in the world of a coronavirus pandemic

Back before the world of the COVID-19 pandemic, the vaccine development process took a long time. Despite the nonsensical claims of the anti-vaccine zealots, the vaccine development process was robust and thorough. The safety and effectiveness of all of the pre-pandemic vaccines are settled science (read the article before you jump up and down screaming about “settled science”).  

However, the world of the coronavirus pandemic means that if we can save a few months or even years off the development timeline on a new COVID-19 vaccine, it could save hundreds of thousands of lives. This does not mean those political agendas like we’ve seen Trump do with hydroxychloroquine and other things should take precedence over good science. 

So, this article is going to lay out how, in a world without a pandemic, the coronavirus vaccine development process should proceed while ignoring how the politically-driven FDA may subvert the process

Although I am very uncomfortable with the coronavirus vaccine development process over the past few months, it looks like, for better or worse, we’ll probably have one or two different vaccines in unknown quantities by early 2021. 

Of course, much of the optimism comes from experts like Dr. Anthony Fauci, one of the few rational public health experts who are willing to speak up in Washington DC. Maybe he has seen some secret data only available only to him and Bill Gates that supports this optimism. Maybe he just is trying to be the national cheerleader for healthcare.

I don’t know the real answer, but a lot of vaccine experts who have spent their lifetime studying vaccines, like Dr. Peter Hotez, MD Ph.D., who has expressed dismay at how politics may “trump” good science.

So, this article will try to lay out the development process, along with the independent controls that make sure that all vaccines are safe and effective.
Continue reading “Vaccine development process in the world of a coronavirus pandemic”

Trump coronavirus vaccine – in this one specific case, I’m anti-vax

trump coronavirus vaccine

As I’ve discussed previously, the FDA may use its Emergency Use Authorization (EUA) powers to push the Trump coronavirus vaccine out on the citizens of the USA before it’s been fully tested. Using Vladimir Putin’s example of pushing out a vaccine before it’s fully tested, Donald Trump keeps insisting that we’ll get a new COVID-19 vaccine soon, well before phase 3 clinical trials are done.

All vaccines currently on the market have been tested thoroughly. And the science that these current vaccines are very safe and very effective is settled. I am thoroughly convinced of the evidence that we have excellent vaccines, so it is clear that I am thoroughly pro-vaccine – I do not have to convince anyone of that.

However, for the Trump coronavirus vaccine, I am anti-vaccine. But it is a very narrow, very unique situation. 

I have been troubled by the speed of the coronavirus vaccine research. I think it can lead to a bad vaccine on the market. Recently, Astra-Zeneca had to put a hold further testing of the so-called University of Oxford vaccine, because of a suspected serious adverse event in one individual. Astra-Zeneca will investigate the adverse event to determine if the vaccine caused it.

This is not uncommon in clinical trials – there is an abundance of caution while investigating new drugs, despite what people believe about how clinical trials are managed. That’s why vaccine research is difficult and not a slam dunk. 

On the other hand, there will be serious consequences to a rushed Trump coronavirus vaccine, because we might not get these safety signals that can appear in large clinical trials. And if we do this wrong by avoiding large phase 3 clinical trials, people who may be on the fence about vaccines become convinced by anti-vaxxers that this awful process was used by all other vaccines. It wasn’t.

Dr. Peter Hotez, MD Ph.D., one of the leading vaccine scientists in the world,  posted a Twitter thread where he discussed his concerns about a potential Trump coronavirus vaccine.

I want to review each of the 12 concerns he posted along with my own opinions on each. Continue reading “Trump coronavirus vaccine – in this one specific case, I’m anti-vax”

ACIP COVID-19 vaccines meeting – summary of August 2020 discussions

This article about the August 2020 ACIP COVID-19 vaccines meeting was written by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), who is a frequent contributor to this and many other blogs, providing in-depth, and intellectually stimulating, articles about vaccines, medical issues, social policy, and the law.

Professor Reiss writes extensively in law journals about the social and legal policies of vaccination. Additionally, Reiss is also a member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable disease.

On August 26, 2020, the Advisory Committee on Immunization Practices (ACIP) held an emergency meeting to discuss COVID-19 vaccines. This was an emergency meeting, as opposed to one of its three annual scheduled meetings, but it was not “emergency” in the sense of being unplanned – it was announced long in advance, and the announcement was repeated during the June and July emergency meetings.

The ACIP COVID-19 vaccines meeting consisted of four to five hours of presentations from the COVID-19 vaccines workgroup, convened in April, and one hour of public comments that included multiple pro-vaccine speakers and four anti-vaccine individuals.

The main takeaway most people would have from the meetings are, I expect, the same as mine – that COVID-19 vaccines safety is taken extremely seriously by the workgroup and the committee, that there is still a lot of uncertainty about which of the vaccine in the pipeline will be effective, and that there are thorny, hard questions in deciding how to allocate the first vaccine doses.

This will be a very short overview of the meeting. The next meeting is on September 22, and I encourage and urge people to listen and learn from it. The presentation slides for the previous meetings can be found here. Continue reading “ACIP COVID-19 vaccines meeting – summary of August 2020 discussions”

Coronavirus vaccine EUA? Bad science from a desperate president

coronavirus vaccine EUA

Because of recent emergency use authorizations (EUA) from the FDA, there is trepidation that they will approve a coronavirus vaccine EUA to make a big splash for a desperate Donald Trump. This is unsettling to those of us who are “pro-vaccine,” because it could cause hesitancy towards this vaccine, and frankly, all vaccines, to skyrocket.

Democrats in Congress are trying to make sure that a coronavirus vaccine EUA does not endanger the health of the country or cause Americans to become even more vaccine-hesitant. So, this article will examine what is and is not a part of an emergency use authorization. And what this all means for a potential coronavirus vaccine EUA. Continue reading “Coronavirus vaccine EUA? Bad science from a desperate president”

Oleander extract for COVID-19 – another moronic and useless treatment

oleander extract

And here we go again – President Donald Trump is pushing oleander extract as the new miracle cure or prevention for COVID-19. This is right up there with the hydroxychloroquine nonsense he was (and I suppose still) pushing earlier in the pandemic.

So instead of listening to his scientists, public health experts, and anyone else with functioning neurons, Trump pushes these useless treatments instead of actually focusing on leading the country to fight this coronavirus pandemic. It is his fault that nearly 180,000 Americans are dead, but he prefers to push this quackery because it is so much easier to do than the actual work of managing a historic pandemic.

I hope this article will be short because there really isn’t much to say since there is no legitimate evidence that oleander extract works on any disease, let alone COVID-19. But this old feathered dinosaur is here to provide science with an extract of snark, just so you be assured that your best hope for preventing COVID-19 is a vaccine. Continue reading “Oleander extract for COVID-19 – another moronic and useless treatment”

COVID19 vaccine clinical trials – over 30 candidates being tested on humans

COVID19 vaccine

This article about COVID19 vaccine trials will be regularly updated as new clinical trials are registered or early results are published about an ongoing trial. Again, this article will focus on COVID19 vaccine trials – treatments and diagnostic tests are outside of the scope of this article.

Keeping up with COVID19 vaccine candidates has gotten out of hand, so for brevity, I’ve created a separate list of coronavirus vaccine trials. The interest in clinical trials for a new COVID19 vaccine is unprecedented, so I thought this might be the best way to keep loyal readers up-to-date.

Recently, the World Health Organization (WHO) has listed over 140 COVID19 vaccine candidates, which is amazing, but it is way too difficult to tell which ones have any chance of actually becoming a real product.

Right now, there are at least 30 COVID19 vaccine candidates in clinical trials – this article will analyze these coronavirus vaccine trials. Every single day, a new COVID19 vaccine candidate enters clinical trials, so this may be out of date within a few hours! 

Continue reading “COVID19 vaccine clinical trials – over 30 candidates being tested on humans”

Russian coronavirus vaccine – tested by showing it a photo of the word “test”

Russian coronavirus vaccine

A new Soviet Russian coronavirus vaccine, called “Sputnik V” was approved by the Soviet Union Russia. The “first” vaccine to be approved was announced by Soviet General Secretary Russian President Vladimir Putin, otherwise known as Donald Trump’s best friend forever.

Amusingly, the “Sputnik V” name harkens back to the Space Race, a Cold War competition between the USA and the Soviet Union in the 50s and 60s to see which country could build the best space program. Sputnik was the name of the first orbital satellite launched by the Soviets beating the USA to space by two months. It didn’t really do much but beep every few seconds while orbiting the earth – we’ll take that as an excellent metaphor.

Not to be totally cynical, the name is an obvious propaganda statement by Putin that the Soviets Russians won the coronavirus vaccine war. 

Of course, the scientist in me says “not so fast there Comrade.” Let’s take a look at the science, or better still the lack of science, of this new Russian coronavirus vaccine. Considering how skeptical I am of the US coronavirus vaccine effort, you can imagine what I’m going to write about Putin’s effort. Continue reading “Russian coronavirus vaccine – tested by showing it a photo of the word “test””

Hydroxychloroquine ineffective for COVID-19, demon sperm, and zombies

hydroxychloroquine

Just when I thought I was out of the hydroxychloroquine pseudoscience, they pull me back in. And here we are, a group of fools is pushing it again. Sigh.

This all started because of an awful study from France published back in March of 2020. At that time, Donald Trump, desperate for a “win” against the coronavirus along with other non-scientists pushed hydroxychloroquine and azithromycin for coronavirus. Of course, me and many others like Orac, who has written several articles about it,  found the evidence that hydroxychloroquine, usually with the antibiotic azithromycin, had any effect on COVID-19 was very weak, even non-existent. 

And my mind hasn’t been changed in the meantime. And Orac is back calling hydroxychloroquine the “Black Knight,” a reference to a fictional character in the wonderful film, Monty Python and the Holy Grail. Oh, you never saw the movie? Well, I’ll let Orac tell that story:

In the film, King Arthur encounters him guarding a rather pathetic bridge and asks him to join his quest to seek the Holy Grail. The Black Knight refuses and then blocks Arthur’s passage with a menacing, “None shall pass.” The battle is joined, and Arthur, one by one, chops off all of the Black Knight’s limbs in a truly warped comedy sequence. After losing each limb, the Black Knight says things like, “‘Tis but a scratch” and “I’ve had worse.” Before his last leg is chopped off, the Black Knight proclaims (while hopping around), “I’m invincible,” to which Arthur retorts, “You’re a loony.” After losing his last limb, the Black Knight finally concedes, “All right, we’ll call it a draw.” Then, as Arthur crosses the bridge and rides off, the Black Knight yells, “Oh. Oh, I see. Running away, eh? You yellow bastards! Come back here and take what’s coming to ya! I’ll bite your legs off!”

In other words, this damn story about hydroxychloroquine keeps coming back despite having all of its limbs removed. “Tis but a scratch.” 

Now, I prefer zombie metaphors (and I believe so does Orac, but I have to give credit to him for the Monty Python reference), because, like many of the tropes we see in the anti-vaccine world, no matter how many times we kill this belief, it keeps coming back. In the world of zombies, one needs to destroy the brain. That’s why I try to present evidence!

Of course this time around, this claim includes demon sperms and alien DNA. I kid you not.

Continue reading “Hydroxychloroquine ineffective for COVID-19, demon sperm, and zombies”

Moderna vaccine update – are we too excited about it for COVID-19

moderna vaccine

If you have been paying attention to the news, you’ve probably seen reports of the Moderna coronavirus vaccine candidate that is getting a lot of people very excited. I’ve even seen so-called pro-vaccine people, who ostensibly should be following science, breathlessly cheer them on.

Recently, Moderna had released some results in a press release, and you know what I think about press releases. Unfortunately, many vaccine researchers stated that that data was not sufficient to draw any conclusions about the safety or effectiveness of the Moderna vaccine

However, the phase 1 clinical trial results have been published, and the hype has started again. We’ll take a brief look at those results below. 

I know that people want “hope,” as opposed to possibly endless cycles of bouncing between opening up and closing down everything in response to the pandemic, especially in the USA, where the coronavirus pandemic has just gotten worse.

But hope isn’t something that interests me at all. 

As anyone who reads my blog knows that the only thing that matters to me is published scientific evidence. And by published, I mean in a respected, peer-reviewed journal. Sure, I don’t need scientific evidence to support my belief that the New York Mets should be thrown out of baseball, because I hate the team – that’s just an opinion. It’s not based on evidence of any type.

On the other hand, when it comes to vaccines, we have built an amazing system of bringing the most effective and safest medical advances to humanity. Despite the misinformation and FUD of the anti-vaccine zealots, the safety and effectiveness of modern vaccines are settled science

I’m not willing to sacrifice that for a vaccine that may not be effective or safe. That’s why I want to take a very critical look at the Moderna vaccine. And I think there are some reasons to be very concerned about their vaccine, although there might be some reasons to be somewhat optimistic. Continue reading “Moderna vaccine update – are we too excited about it for COVID-19”