There must be progress in COVID-19 vaccine development beyond the occasional optimistic report from one R&D developer or another. After all, the same Russian hackers who enjoyed themselves disrupting the 2016 election – the APT29 (aka “Cozy Bear”) group – is busy hacking into the computers of pharmaceutical companies working on the solution. They are particularly focused on the US and the UK. What do they know? But let’s assume that somehow, some way, we get there.
First, there’s timing issue. As Dr. Anthony Fauci has said repeatedly, there is no way to guarantee a viable vaccine within a stated time period, even as he is hopeful that we get there within 12 to 18 months. Certainly not remotely likely, as the President suggests, by the end of the year. It could actually take years. Time includes the period of development and a very important period of testing. Testing for what? If it works? Sure. But for how long? There are at least three reactive variables that need to be present for a shot (pun intended) at an effective preventative.
What if it works for just 60 or 90 days and wears off? Booster shots? For how long? How many? What if there are dire side effects in a significant number of the inoculated population? What if each dose is prohibitively expensive to produce or if the developer decides to add a huge mark-up to guarantee profits? What if the manufacturing protocols limit how much and how quickly that vaccine can be manufactured? What if the vaccine itself degrades when temperature changes or it is shaken during transport? Or just the passage of time?
If we do pull off having a viable vaccine even within those 12 to 18 months, that alone would be a record. Vaccines usually take a decade or more from conception, development and testing to being ready for deployment. And if the vaccine isn’t instantly available in the millions of doses needed just here in the United States, who gets if first? Healthcare workers in the front lines? Folks with family members or fellow workers who have tested positive? Will it have any impact on people who have already tested positive? Essential workers? Rich people with good connections for medical care? Pregnant women? Older people and those with specific vulnerabilities? And what if a better vaccine comes along very quickly? Or if the first vaccine is only a partial preventative?
Viruses are nasty critters with unpredictability build into their genetic model, nature’s design to push a virus to mutate, adapt and find ways to resist containment. “One of our immune system’s main attributes is that it can remember what viruses look like so that our cells know how to fight them off if they infect us again. When we’ve been vaccinated against a pathogen or exposed to it naturally, we usually suffer less severe symptoms, or none at all.
“In the case of coronavirus, which is believed to have just recently evolved to infect humans, it’s not yet clear if, or for how long, a person who has survived COVID-19 is protected against reinfection. More conclusive antibody research is needed to determine whether those who have already had the virus will need a vaccine, or if those who do get the vaccine will eventually need booster shots as maintenance.” PBS News Hour, July 8th. We might cut back on the testing, but here’s what most vaccines go through:
“Under normal circumstances, candidate vaccines first go through preclinical trials in which animals like mice or monkeys are inoculated. Researchers then evaluate whether their bodies produced an immune response that would potentially protect against infection in humans, and look for any adverse side effects.
“After that, successful candidates are eligible to be tested in humans. During the first phase of clinical trials, researchers give the vaccine to a small number of healthy adults to check for safety and immunogenicity, or the vaccine’s ability to prompt its desired immune response. The second phase of this effort, which involves several hundred volunteers, looks for any unwanted side effects and determines what dose produces the most effective immune response.
“The third and final phase of vaccine testing continues to evaluate safety and effectiveness by inoculating thousands, even tens of thousands, of volunteers and determines how well the vaccine prevents infection while noting any rare side effects associated with it that didn’t become apparent during earlier phases.
“If all of these steps are successfully completed, researchers can submit their data for review by the Food and Drug Administration’s Center for Biologics Evaluation and Research. That division is responsible for approving vaccines, overseeing their production and continuing to monitor them once they’re on the market. Only about 6 percent of candidate vaccines are ever approved for commercial use.” PBS. Tests usually do not include subjects with obvious vulnerabilities, since the test itself might kill or severely injure them. But these just might be the people who need it most.
Do we begin the manufacturing process during these trials? And if we do, and the trials prove what we’ve manufactured does not work… “The Defense Department, one of the agencies partnering on the Trump administration’s national vaccine development initiative, has said that officials ‘expect to be producing large quantities of vaccines while the clinical trials are still underway,’ so that there is no delay in manufacturing once ‘safety and efficacy have been demonstrated.
“Operation Warp Speed is aiming to ‘deliver 300 million doses of a safe, effective vaccine’ by January 2021, according to the Department of Health and Human Services. In order to do that, billions of federal dollars are being allocated to scale up manufacturing of a handful of promising candidates before they’re actually authorized for distribution. It’s a financial risk that most private companies would be loath to take, but a necessary gamble for the government in the context of the pandemic.” PBS. Wishful thinking on steroids formulated by bureaucracies that have never supervised such a massive effort? We don’t even have remotely enough glass phials to contain all that vaccine, and no one seems to be addressing that issue at any meaningful level. Back to lovely China?
We need to keep the virus from replicating or use the body to be fooled into accelerating that replication. Can we coat the virus to prevent it from making contract with vulnerable human cells? Can antibodies simply stop the virus from being able to enter cells in the first place? Or can we teach the human T-cells, etc. to do the trick?
Here’s where some of the leading candidates sit in the United States (and there are well over a hundred different efforts around the world): “Among the 21 global candidate vaccines currently moving through clinical trials, Operation Warp Speed has begun to single out a handful of contenders by offering them funding, including AstraZeneca, Moderna and Novavax and Johnson & Johnson. The criteria for how those companies were chosen is not fully clear, a concern that lawmakers have pointed out and pushed Trump administration officials for answers.” PBS.
We have a science-skeptic President who makes unfounded statements all the time, has a proclivity to shoot from the hip and often encourages his constituents to engage in risky behavior that only makes a bad situation that much worse. That’s why the United States, unlike Western Europe, Korea, Singapore, Taiwan, etc. (and even China), has the highest CV-19 infection and resulting morality rate on earth. But Donald Trump is pushing his federal agencies to produce… when they just might not be able to do so. For those who prefer to believe that the virus will just burn itself out or that “herd immunity” will eventually render the virus relatively ineffective, there medical experts who tell us that COVID-19 just might not die out without a lot of help from a viable vaccine.
“Dr. Robert Redfield, director of the Centers for Disease Control and Prevention, estimates that between 5 to 8 percent of the U.S. population has been infected with coronavirus so far. He emphasized during last week’s Senate hearing that it would take several years to achieve herd immunity through natural exposure, hence the urgent need for an effective vaccine… ‘The goal of this vaccine is going to be to keep you out of the hospital and keep you out of the morgue.’” PBS. Trump just stopped Redfield from testifying before Congress! Oh, and herd immunity needs to have reach at least 60% of the population. See my June 13th Are We Just Going to Learn to Live with Massive Death Tolls? blog for more details.
And finally, as a challenge to effectiveness, what if people just plain won’t accept the vaccine even when it does become available. Could that keep the virus going for a lot longer? “Once a vaccine is finally approved, manufactured and available for widespread distribution, the question then becomes whether individuals and families want to be inoculated. A recent poll from The Associated Press and the NORC Center for Public Affairs research found that just 49 percent of people in the U.S. plan to actually get an eventual COVID-19 vaccine.
“The poll also found that 40 percent of Black people and 23 percent of Hispanic people don’t intend to get vaccinated at all. In the case of the Black community, that stance may be in part rooted in general mistrust of the medical establishment. Black Americans have long suffered from lack of access to quality medical care, and even outright abuse at the hands of researchers.
“But in the context of the pandemic, those numbers are troubling, given that Black and Hispanic individuals, in addition to Native people, are four to five times more likely to be hospitalized due to COVID-19 infection. The Centers for Disease Control and Prevention states that ‘long-standing systemic health and social inequities’ are responsible for putting marginalized people at an increased risk of experiencing ‘severe’ illness due to the virus, regardless of age.” PBS. We live in a country where too many selfish people, young and “nothing can hurt me” people, who even reject wearing a mask and social distancing… to save the lives of others.
Posts
No comments:
Post a Comment