WILL WE EVER HAVE A COVID VACCINE?

I’ve had nearly every common and exotic shot and oral immunization available. In my youth I was given all the typical ones nearly every Canadian receives when little, like measles and diphtheria. I’ve had nearly every other less common one, such as rabies, too. Also, having travelled to rural parts of Southeast Asia and Africa has also meant I've needed immunization for typhoid, Japanese encephalitis, yellow fever, and more. And I've taken every kind of drug out there as a prophylaxis or cure for all manner of wild and mundane illnesses and infections. So, I'm nothing like a vaccine skeptic or someone who avoids pharmaceuticals. I've taken all of these preventatives and cures very happily, and on at least two occasions these marvels likely saved my life. So, I don't think I could be any more pro-vaccine and an advocate for everyone getting their shots.

That said (and now you know what’s coming), despite my intention to get fully vaccinated I feel like everyone has lost their mind with regard to these COVID vaccines. And I took the morning away from thesis writing to spell out my recollection of the very recent past – that which the entire planet appears to have blocked out. You know, just for the historical record, and all that...

THE CONSENSUS

From the start of this pandemic we knew that arriving at a vaccine at all, ever, required a whole series of miracles and was at best unlikely. This was not the speculation of B-rated media personalities or some random’s feelings expressed in an op-ed from in a magazine no one reads. This was the expertise offered by every trusted authority – effectively every single person in or adjacent to any relevant profession or area of study questioned on the topic (and every minute from pandemic declaration to shots arriving on the scene). “The fastest vaccine development to date was for mumps and that took four years, and only after forty years of prior research.” “Vaccine production is like having a child: it takes the time it takes; you can add all the sperm/eggs, pregnant women, and midwives you want but none of that changes the underlying biology.” This was the expert consensus. And you probably reiterated it to someone or just added it to your inventory of understanding about the pandemic. (Which is why it's so weird to be walking through what we all watched happen, and very recently...)

PROCLAMATION TIMELINE

Since early February of 2020, I’d been following Laurie Garrett (and a pretty closely: taking notes and citing her – which is why this is so burning for me). I liked her. She was sassy and seemed incapable of bullshit. She was also brought in across American media as an expert health science communicator and was making similar noises to others about a timeline for a vaccine or, more accurately, the total absence of any reasonable expectation for a vaccine (never mind a timeline!) In The New York Times and on CNN, MSNBC, and Democracy Now the award-winning journalist (reporting on public health and emerging diseases for thirty years, with recent books on pandemics and bioterrorism, fellow at Harvard’s School of Public Health, and member of the Council on Foreign Relations) made perfectly clear that a vaccine would be required to go back to anything approximating normal; but, very importantly, that vaccines and normalization would require a whole series of miracles – and arrive in concert with accomplishing everything we’ve done globally and over half a century to eradicate smallpox, cholera, and typhoid, say, but in only a matter of months or a few years. In such appearances, Garrett also regularly noted that, by her expert opinion and that of everyone she knew in public health, COVID-19 was the most serious thing anyone had seen since HIV. She also liked to remind people that, just as we didn’t 'go back to normal after 9/11,' we most likely would not ever return to anything we once knew.

Other expert opinion was of similar tone. Director of the Mayo Vaccine Research Group, Dr. Gregory Poland, was, like Garret, everywhere in the media as well. He agreed that “bringing a vaccine from lab to public deployment proceeds at a glacial pace, and it’s a costly expedition.” Patrick Boyle, senior staff writer at the American Association of Medical Colleges, assured the world, in an article published on the AAMC website in March of 2020, titled Here’s why we can’t rush a COVID-19 vaccine, that human biology operates slowly and, because of that, we put procedures in place that take all the time required to determine both effectiveness and to minimize harm. Dr. David Kelvin, professor of Microbiology and Immunology at Dalhousie University (Canada Research Chair specializing in emerging infectious diseases and someone who just received a $1M grant from the Canadian Institutes of Health Research to evaluate COVID-19 patients) felt no different than Boyle, Poland, or Garrett. As he explained to CBC, Canada should be “preparing for a scenario in which there is no vaccine in the short or even in the medium term,” noting that in the seventeen years since SARS no effective vaccine emerged (and the ineffective ones occasionally resulted in more severe illness.)

Of course, we all knew that despite dire global need and tremendous awareness and resources (and in the West disproportionately impacting wealthy, gay, white men) we’ve never seen a vaccine for HIV/AIDS in almost 40 years. In April The New York Times ran an exhaustive piece covering the full spectrum of reasonable expectations of leading experts. It starts:

…the Trump administration’s coronavirus task force estimate a vaccine could arrive in at least 12 to 18 months. The grim truth behind this rosy forecast is that a vaccine probably won’t arrive any time soon. Clinical trials almost never succeed. We’ve never released a coronavirus vaccine for humans before. Our record for developing an entirely new vaccine is at least four years…

Then the article hits up every expert worth questioning on the subject. “If you want to make that 18-month time frame, one way to do that is put as many horses in the race as you can,” said Dr. Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine. The piece then explains how fewer than 10% of drugs that make it to the rare clinical trial stage are ever approved, either because they are unsafe or ineffective. Along with this they note 14 leading vaccine candidates from around the world, all names you’ve heard by now. (So, doing the math then, 10% of 14, we might have expected, what, eventually one or at most two safe and effective vaccines out of this lot? Right.) But, as Dr. Robert Van Exan, long-time pharma insider and director of Immunization Policy at multinational vaccine giant Sanofi-Pasteur, argued, “Covid-19 vaccines now in the pipeline might be more likely to fail because of the swift march through the research phase.” He then assured readers that “we won’t see a vaccine approved until at least 2021 or 2022, and even then, ‘this is very optimistic and of relatively low probability.’” Dr. Akiko Iwasaki, professor of immunobiology at Yale University School of Medicine and investigator at the Howard Hughes Medical Institute adds, “if we do it the conventional way, there’s no way we’re going to be reaching that timeline of 18 months.” Everyone agreed that 2036 would be a best case scenario for arriving at a vaccine, if one ever arrived, observing standard medical ethics, development, and production.

Despite all of the above, in May of 2020, Donald Trump said we’d have a vaccine by the end of the year. As ever, Trump’s stupidity was mocked far and wide. The world’s media, public health officials, virologists, and first year biology students alike related his statement to his penchant for nonsense promotion. This was akin to his support of conspiracy theories like #Birtherism, #Pizzagate, #QAnon. Even his own White House walked back his comments, claiming he was just confused and actually referencing a prospective Ebola vaccine he’d been earlier briefed on. And everyone saw his motives as both transparent and selfish, as ever.

"Beyond the obvious public health benefits,” Aaron Rupar at Vox explained, “a vaccine could help allay fears, stabilize markets, and quell criticisms that his administration was unprepared for or mismanaged the response to the outbreak. What is harder to wrap one’s brain around, however,” Rupar continued, “is the level of ignorance Trump displayed about how vaccines work.” This was the consensus shared by the CDC, Health Canada, Provincial health authorities, vaccine researchers at our leading universities, pharmaceutical company insiders, and on. Laurie Garrett responded to Donald Trump on television and in print, saying that she couldn’t imagine a vaccine anytime in the next year and that her most optimistic estimate (based on decades of study, interviews, and reporting on AIDS, Ebola, SARS and more) would see something emerge in not less than 36 months.

As all this was happening the WHO’s Scientific Advisory Group shared their “Coordinated Global Research Roadmap” and a global strategy for accelerating vaccine development. They’d worked for months establishing novel protocols for arriving at a novel vaccine for this novel virus. Through a series of unprecedented and drastic measures, and record-breaking funding, they determined it would be possible to radically reduce research, development, and approval times while ramping up global vaccine production and distribution capacity. Key to getting there would be:

1. Skipping clinical trial preparation and entire trial phases

2. Starting phases in parallel, before previous stages were complete, rather than waiting for results and further research as happens normally in sequence

3. Immediately begin preparation and construction of new manufacturing and distribution infrastructure

4. Going all-in on the likelihood of a successful mRNA vaccine (despite never before being approved for use in humans) and

5. Fast-tracking government regulatory approvals at all stages

Under ideal circumstances and without any hitches (including a previously unimaginable level of international cooperation, pulling out all the stops and flattening all bumps and hurdles, along with unprecedented stretching of the rules, waiving liability, testing at scale, streamlining everything, bypassing conventional trade rules, avoiding all the typical patent disputes, etc…) we could shrink the normal timeline from pre-clinical testing to distribution down from the conventional decade or more to approximately three years. Doing so was pushing the limits of ethics and technology, they told us in reports and press releases across the globe, but all of this was warranted under the circumstances.

In response, still in May of 2020, NPR shared a conversation with Dr. Carlos Del Rio (MD and Distinguished Professor of Medicine in the Division of Infectious Diseases at the Emory University’s Vaccine Center, in Atlanta). Of the prospect for a vaccine, he explained that "Well, I'd say there's some skepticism just because getting a vaccine at all is pretty optimistic.” Though, he added, he was cautiously optimistic that one of the dozens of vaccines currently being developed might turn out, at some point, to work well enough to administer to humans. He spelled out that developing a safe and effective vaccine is only half the battle; "...producing 300 million doses of the vaccine to immunize everybody in the U.S. - it's not an easy task. It's going to take some time. So even if you have a vaccine approved by next January, getting all the doses you're going to need may take another year." So, going into the Summer of 2020, 'a single vaccine may one day become available' remained all this leading infectious disease expert was willing to cautiously wager.

Around that same time, the WHO and USFDA established guidelines for vaccine approval, setting a proven 40-60% efficacy as the minimum bar. CNBC reported that “a coronavirus vaccine that is safe and at least 50% effective would be a ‘game changer’ in battling the pandemic.” Dr. Del Rio was cited there, noting that “Developing vaccines against respiratory virus is incredibly difficult. If you think about the flu vaccine that we use every year, it’s only about 40% to 60% effective.” Dr. Poland, director of the Mayo Vaccine Research Group referenced earlier, agreed. He explained to Reuters reporters that the COVID vax efficacy guidelines were comparable to other vaccines. “They look pretty much like influenza vaccine guidelines”, he said. Further, he added, “I don’t think that’s a high bar. I think that’s a low … bar for a first-generation COVID-19 vaccine.” So, we knew what was in the realm of possibility and, therefore, (plus or minus 10%) what could reasonably be expected.

A TSUNAMI OF EXTREMELY SAFE AND HIGHLY EFFECTIVE VACCINES

Then, suddenly (BAM!!!), in July China divulged that it had already rolled out two experimental vaccines. (Later we learned that they put it in hundreds of thousands of military personnel and employees of state-owned companies.) Just as with Trump’s statement, no body was holding back in their condemnation of what everyone understood was at minimum unethical and not in line with long-established protocols, all of which could only have been bypassed. And, of course, also running against global norms, China refused to make any of their work available for review. William Haseltine (professor and founder of research departments for cancer and HIV/AIDS at Harvard Medical School, chair of the non-profit Access Health International, and founder of eight biotech companies) had just a few weeks earlier written for Scientific American about the threats posed by rushing vaccines to market. In The Risks of Rushing a COVID-19 Vaccine: Telescoping testing timelines and approvals may expose all of us to unnecessary dangers, the infectious disease and global health expert noted many of the issues surrounding safety, efficacy, and public trust of vaccines under conventional terms. When China announced their vaccine he responded by warning that "Any statement that says you vaccinated over 100,000 people and yet we see no serious or severe effects cannot be true."

Only a month later, in August, also out of the blue (KA-POW!!!), Russia came out with their own vaccine and made it immediately available to the public and began selling to its international partners. Scientists globally condemned the decision, calling the move unbelievably irresponsible. Of course, like China, Russia could not possibly have completed large-scale trials for safety or efficacy. Experts on every continent admonished them, saying that distributing an inadequately vetted vaccine could not only endanger those receiving it but also threaten the global effort to vaccinate the world. Francois Balloux, geneticist at University College London, shared his assessment with the UK Science Media Centre, Nature, and with his followers on Twitter that:

This is a reckless and foolish decision. Mass vaccination with an improperly tested vaccine is unethical. Any problem with the Russian vaccination campaign would be disastrous both through its negative effects on health, but also because it would further set back the acceptance of vaccines in the population.

Then, in November of 2020 (just three months later, only 15% into the WHO’s 36-month coordinated global blueprint for COVID vaccine development), Moderna released preliminary data from “Phase 3” of its mRNA vaccine clinical trial. The data it shared indicated its vaccine was 94% effective. We were told the aim was to eventually arrive at something 50% effective, that this would be game changing, and here we have one that’s nearly perfect, on the first try, and arriving years before predicted in shareholder propaganda. A real miracle in own lifetime! Everyone was thrilled. Here was our ONE legit vaccine CANDIDATE. But the company was clear to note that their work had not been peer reviewed and that this phase of testing wasn’t scheduled to conclude until October 27, 2022, almost two years away. (What the company didn’t mention was that it had yet to bring any product to market, ever, even under normal circumstances without the pressure of a global pandemic. This would be their first and, they hoped, would be delivered in the billions.)

Only 48 hours later another press release arrived. “Pfizer and BioNTech Conclude Phase 3 Study of COVID-19 Vaccine Candidate.” The announcement explained that, after concluding the final phase of their study, efficacy analysis of their mRNA-based vaccine candidate proves their vaccine is 95% effective. What?! Another miracle! First shot, ideal, and 30 months ahead of schedule!!! The press release went further, offering that, along with there being no serious safety concerns, “based on current projections, the company expects to produce up to 50 million vaccine doses in 2020 [less than two months from the publication of this press release] and up to 1.3 billion doses by the end of 2021.” All of this came despite the US National Library of Medicine database showing that, as with Moderna, Pfizer's combined Phase 2/3 trials are not estimated to reach completion for years, not until 2023 (fitting with the WHO blueprint.)

Not a week later, on November 23rd, AstraZeneca reported its trial vaccine, named AZC1222 (a genetically modified chimpanzee virus made to express SARS-CoV2 proteins) had an average efficacy rate of 70%. Miracle number three!!! (Or perhaps five – but, I mean, who’s counting?) And all in the same week!!! The company reported it would be ready with a capacity of up to three billion doses in 2021. And just like the others, according to required reporting databases, Phase 3 of AZD1222 trials had an estimated completion date of October 2022.

HOW DID WE GET HERE?

So, here we already had five highly safe and highly effective vaccines arriving in weeks, really, when one or two ever arriving and being approved over a period of years or even decades was deemed naively ambitious, and suggestions of as much offered the public unwarranted optimism. And, as such, in response to a clangor of medical miracles, public health experts were questioned and needed to explain the contradiction.

As you can find on the Government of Canada website today, the rapid production of mRNA vaccines was said to be possible “because they're made in a lab using materials that are easily available.” That was their response. But, of course, that's not what differentiates these vaccines from traditional ones and wouldn’t explain how AZ or the Russian or Chinese vaccines arrived in effectively the same time as mRNA shots from Pfizer or Moderna. So none of this makes sense. And that’s not what other sources tell us, either. Philip Ball reported in Nature in December 2020:

The world was able to develop COVID-19 vaccines so quickly because of years of previous research on related viruses and faster ways to manufacture vaccines, enormous funding that allowed firms to run multiple trials in parallel, and regulators moving more quickly than normal.

That sounds more plausible and is similar to what’s found in the CDC’s official publications and on their website. Regardless, what part of either explanation was unknown to all the above medical, emerging disease, vaccination, biotech, and pharma company experts and insiders or, especially, the WHO Scientific Advisory Group and those enlisted to establish their Coordinated Global Research Roadmap? Well, none of it was unknown. All of this is in the WHO blueprint. Knowledge of years of prior research on coronaviruses was part of the equation too (and in CBC and NYT reporting), as was unprecedented funding, removal of barriers, going all-in on mRNA vaccines, running trials in parallel, etc. That WAS the plan. That’s HOW they arrived at their three-year timeline. By these unprecedented measures they axed a decade from the timeline. Moderna didn’t take the three-year blueprint and then apply these time- and barrier-reducing strategies to arrive at a viable vaccine in mere months. Three years was the unprecedented and overly ambitious plan requiring a whole banquet of miracles that we were praying for.

AM I HIGH?

 I don’t know what happened with any of this. All I know is that in just nine months I watched leading experts go from:

A) ‘Don't plan on a COVID-19 vaccine as it's unlikely to ever arrive; you can't just conjure them up like that’ to

B) ‘It may be possible to reduce a decade of vaccine development down to just three years. So, we could have something by 2022 if we are very lucky and experience a series of miracles, but anything more ambitious is unethical at best.’

And then in no time we went from:

B) 'Not less than three years...' to

C) ‘We may have a single viable vaccine candidate in about a year and a half (perhaps by late 2021)’

And then, seemingly overnight, we found ourselves at:

D) ‘So, actually, it’s only Winter of 2020 and we've got many highly safe and effective vaccines. Oh and, did we mention, they’re already in a million people across the globe?’

Here are three explanations I've come up with for the above:

1) No seasoned expert (in any social and scientific field that touches this pandemic) who has spoken to the media in a year has even the vaguest of grasps of the state of their own (or seemingly any) discipline

2) Billions of us just witnessed a broad spectrum of simultaneous miracles performed on multiple continents (which effectively puts to shame the entire Abrahamic canon and should cause the birth of a plethora of new vaccine-based religions)

or

3) With the promise of unprecedented profits and facilitated by public money and government emergency-use authorizations (the waving of liability), pharmaceutical companies were all too happy to break every medical and ethical protocol we’ve developed over a century

What is an alternative (that incorporates even some of the above well-known and readily available facts from effectively every leading source) to the above conspiracy theory I’m nursing?

Okay, I’m done.

(We can talk about “94% effective” at some other time...)

--UPDATE--

Dec 2022

From there, all our media reported that on December 14th of 2020 we had our first Pfizer vaccine doses arrive here in Canada and that we were prioritizing those of us who are elderly and Indigenous. Still, according to Pfizer.com, in a section titled About Our Landmark Trial, their Phase 3 clinical trial “…began July 27, 2020, and completed enrollment of 46,331 participants in January 2021.” So, by their one recording, they hadn’t completed even their enrollment for their third phase until months after vaccine approval came through, Emergency Use Authorization was granted, and their vaccine started being given to the most vulnerable of the general public. What am I missing or failing to understand here? The meaning of the term enroll? What?

(And dozens more highly safe, extremely effective, and approved vaccines have arrived every month since, let us not forget. To date we have: Abdala, Ad26.COV2.S, BBIBP-CorV, CanSino, Convidicea, CoronaVac [formerly PiCoVacc], Covaxin [aka BBV152], COVIran Barekat, CoviVac, Covovax, Cov-Pars Razi, EpiVacCorona, Fakharavac, Gamaleya, Janssen, Medigen-Dynavax, MVC, QazVac, ShenzhenKangtai, Sinopharm-Wuhan, Soberana 2, Soberana Plus, Spikogen, Sputnik Light, WIBP, ZF2001, ZyCoVD…)