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”

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”