The coronavirus vaccine warp speed project from old Bonespurs, aka President Trump, is causing Scotty to yell, “Aye, the haggis is in the fire now for sure.” Operation Warp Speed is moving ahead at full power with not a single Starfleet Officer of note on board.
Not on board with the Star Trek metaphors?
Well, the coronavirus vaccine warp speed operation is President Bonespurs’, I mean Trump’s, new task force that will bring us a new vaccine in a matter of months. That’s not going to happen in any case, especially when the President Bonespurs, OK, Trump, didn’t add any of the country’s top vaccine researchers to the task force.
Instead, he opted for industry hacks who have made some curious choices on the top vaccine candidates to support. Let’s take a look at the coronavirus vaccine warp speed directive.
Operation Warp Speed is a plan established by the White House to get a COVID-19 vaccine available to Americans as quickly as possible. They intend to invest billions of dollars to get a vaccine – although doing this is admirable and necessary, it is obvious that it is just a distraction by the White House to show it’s doing something or anything given that the disease has killed over 100,000 Americans.
We do need a coronavirus vaccine quickly since the herd effect for coronavirus is unattainable without the said vaccine. Speeding up the development of a vaccine by even a few days could mean that we save hundreds, if not thousands, of lives across the world.
But, it cannot be at the cost of a vaccine that has been shown to be effective and safe. It takes time to determine if a vaccine works – and if we rush a vaccine which ultimately doesn’t have long-term effectiveness, we actually put more people at risk because they think they are immune.
And safety is another concern. Despite the protestations of anti-vaxxers, all vaccines are extremely safe and extremely effective. We have these outstanding vaccines not because of luck, but because of well-designed and well-managed clinical studies. Plus diligent regulation and oversight from regulatory agencies like the FDA and EMA (European Medicines Agencies).
Vaccines that don’t work or have been shown to have safety signals just fail in clinical trials and never get regulatory approval. As I’ve written many times, most, if not the vast majority, of drugs, including vaccines, never get to the market.
The coronavirus vaccine warp speed effort has selected vaccines from Moderna, the University of Oxford/AstraZeneca, Johnson & Johnson, and Merck for the sped-up development program, which aims to have enough “safe and effective vaccines” immunize 300 million Americans by January 2021.
According to an article in The New York Times, Operation Warp Speed will give the chosen companies:
…access to additional government money, help in running clinical trials and financial and logistical support for a manufacturing base that is being built even before it is clear which if any of the vaccines in development will work.
Of course, the New York Times article offered no scientific or technical rationale for the vaccine selections. And these choices seem to contradict the original plan that singled out 14 vaccines out from the more than 100 vaccine candidates in development at companies and universities.
Dr. Peter Hotez, MD, Ph.D. stated:
It’s typical Operation Warp Speed, where everything is sort of cryptic and it’s unclear what they’re actually saying. What have these vaccines been chosen to do?
Well, most of us don’t know.
Operation Warp Speed lacks Scotty and Spock
If you’re not familiar with my Star Trek metaphors, that’s sad. Nevertheless, Scotty was the amazing engineer and Spock was the Science Officer that got Captain Kirk out of hundreds of problems, except when Kirk cheated.
And this is what the coronavirus vaccine warp speed effort is lacking – leadership from scientists and engineers.
This task force should have the best vaccine scientists in the country. Dr. Hotez is leading an effort to develop a COVID-19 vaccine, not because he just wants to join in the process. It’s because he actually has led the development of a SARS (which is very closely related to COVID-19) vaccine.
Another vaccine scientist that’s not included in this effort is Dr. Paul Offit, MD, who is the number one bogeyman of the anti-vaccine crowd. Dr. Offit spent nearly 25 years developing the rotavirus vaccine, which can save hundreds of thousands of lives across the world every year.
Drs. Offit and Hotez are just two examples of dozens of vaccine scientists in the USA who have the actual knowledge of vaccine development. They could actually do more to speed up the process of giving us coronavirus vaccines that are safe and effective.
Dr. Offit recently stated that the coronavirus vaccine warp speed committee appears to have selected vaccines based on the ability to manufacture them rather than on scientific evidence for their safety and effectiveness. In other words, they chose the ones that could be the first to be manufactured for political expediency rather than science-based evidence.
This is, and will always be, my concern about coronavirus vaccine development. Every single vaccine on the market got there because they have been shown in large clinical and epidemiological studies to be safe and effective. I don’t want that to change.
According to a news article in Science, Dr. Offit expressed some other important concern:
Offit also questions the lack of diversity in the five selected vaccines, which rely on just three different technologies. Two candidates exploit messenger RNA to produce the surface protein for SARS-CoV-2, the viral cause of COVID-19. Two engineer theoretically harmless adenovirus vectors, which can infect cells but do not copy themselves, to hold the gene for that same protein, known as a spike. One relies on a replicating vector, vesicular stomatitis virus (VSV), to do the same thing. “We don’t really know anything about the safety or efficacy of these vaccines yet,” Offit says. “Shouldn’t we broaden our chances?”
Yes, Dr. Offit, absolutely yes.
Instead of scientific leaders in vaccine research, Trump included executives like a former Moderna executive. Dr. Hotez recently stated:
The biotechs are being very aggressive in their press statements. What they’re doing is talking to their investors. I think you have to filter that away from what the FDA is thinking. A wishlist from the CEO of a biotech or a pharma company means nothing to me. It’s what the clinical trialists are finding in collaboration with the FDA that matters.
But Operation Warp Speed not only needs science officers like Spock, but it also needs goods engineers like Scotty. Manufacturing vaccines is not easy, despite the claims of Trump and his acolytes. There are dozens, if not hundreds, of bottlenecks in producing millions of vaccines.
I think Trump believes that you push a button, and, voila, vaccines come out the other end. Sure, money can speed up the process, but not by that much. Vaccine manufacturing equipment, quality control standards, vials, syringes, and hundreds of other items need to be designed and evaluated.
Operation Warp Speed needs to include experts in pharmaceutical and vaccine manufacturing who know how to beg, cajole, or incentivize various vendors across the world to get manufacturing to a level that can give us 300 million vaccines.
The coronavirus vaccine warp speed effort demands not only a captain like Kirk but also a science officer like Spock and an engineering officer like Scotty. Not only do we lack a leader (we’ve got Admiral Bonespurs) but the best vaccine scientists and engineers in the country aren’t on the team.
If we do this right, maybe we can get a coronavirus vaccine a few months, maybe even a year faster. That would save lives, possibly millions of lives.
But if we do this wrong, we can get a vaccine that has little or even no effect on the pandemic. And people will think that they are protected against COVID-19, but they’re not.
And the safety issue is even more important. Despite the false claims of the anti-vaccine world, vaccines on the market meet incredibly high standards for safety. If this new coronavirus vaccine has some serious safety signal that can only be observed after a few months, then it could mean a massive fall in confidence for all vaccines.
Operation Warp Speed sounds like a good idea to get us a coronavirus vaccine as quickly as we can. But it’s being managed poorly and it lacks the world-renowned experts in vaccines and vaccine manufacturing.
I want Kirk, Spock, and Scotty running this show. But it seems like we don’t have that, so we’ll just end up being a bunch of redshirts.
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