This is an extraordinary scientific achievement, but is it safe?
The average vaccine takes approximately 10 years to develop. There are currently two COVID-19 vaccines (Pfizer/BioNTech and Moderna) that will likely be authorized and released to the public within a year of the discovery of the virus. How can a safe vaccine possibly be developed so fast?
These will be the fastest vaccines ever developed, by a margin of years. The next fastest vaccine ever approved for public use was the mumps vaccine, and that took 4 years.
Unfortunately, that speed has made a lot of people nervous. Will the vaccine be safe? Are they skipping steps? How is this process moving so fast?
According to Pew Research, 77% of Americans think it's very or somewhat likely a COVID-19 vaccine will be approved in the United States before its safety and effectiveness are fully understood.
But regardless of the fear and doubt, we need a vaccine. We are now losing over 2,000 American lives per day to COVID-19. Numerous health experts have warned that this pandemic will not truly be over until we have a vaccinated population.
Part of the fear is related to the mystery surrounding the process of vaccine creation. Almost no one who isn't integrally involved in vaccine development understands how long it takes to create a vaccine or why it takes so long. So to most Americans speed doesn't seem like a feat of modern science, it seems like cutting corners. Here are all the (genuinely not scary) reasons why this vaccine is being developed so much faster than any in history.
Operation Warp Speed
Operation Warp Speed (OWS) is a coordinated government effort to defeat this virus as quickly as possible. It is a partnership between the Department of Defense and the Department of Health and Human services to make resources available to the private companies involved in creating vaccines, testing, and therapeutics for COVID-19. In practice, OWS has focused primarily on the creation of vaccines and has already spent billions ensuring that the vaccine development, manufacturing, and distribution process can move as efficiently as possible.
The US program is bankrolling the development and production of six promising coronavirus vaccine candidates. This has already sped up the process significantly and will likely play an even larger role in the manufacturing process. Medical research of any kind often moves slowly because it's expensive and risky.
Funding is hard to secure, because in order to prove a vaccine is successful (and therefore profitable) you have to have tests, and to do tests, you need money. It's sort of a catch-22 that is only ended when someone decides to make a risky bet.
Betting on vaccines is risky, because if it ends up being unsuccessful (the majority of vaccines never make it to market), that money is just gone. The US government chose to take the gamble.
The US has spent $10 billion through OWS on the most promising vaccine candidates, ensuring they don't have to wait for private funding to move through each phase of the process.
Many people are concerned that these drug companies are skipping steps in the race to create a vaccine, but what's actually happening is that multiple steps in the process are being done simultaneously.
Steps that are usually done sequentially are being done at the same time. For example, some labs are running combined Phase 1 and Phase 2 human trials or having vaccine development manufacturing facilities ready even before a vaccine is finalized. This increases the financial risk, but not the product risk.
Typically, clinical trials set up their own independent panels of scientists, known as a data safety monitoring board or DSMB, to watch out for safety concerns or early signs of success. But all of the vaccine trials in Operation Warp Speed are sharing a common DSMB. This allows the DSMB to review the data from all the trials from the various vaccines concurrently. That shared data expedites the process and quickly identifies which vaccines are effective and which aren't without wasting time and resources.
Saad Omer, director of the Yale Institute of Global Health, explains that this is not a huge difference. "There's really just a subtle difference in how the trials are run. If the trials were separate, you would publish the full data, and then recruit a new set of participants. For a combined trial, the data and safety monitoring board would look at the interim data and determine whether it's still worth continuing the trial." This continuous monitoring cuts the inefficiencies out of the process without changing the safety standards.
Years of Prior Research
The research stage of vaccine development is often one of the longest. The College of Physicians of Philadelphia states that this exploratory phase "often lasts 2-4 years." Thankfully, much of the research needed for the COVID-19 vaccine had already been done before the novel coronavirus even appeared.
The term "coronavirus" includes a family of several known viruses that cause respiratory tract illnesses that range from the common cold to such potentially deadly illnesses as severe acute respiratory syndrome (SARS), which killed almost 800 people during an epidemic that occurred in 2002 and 2003. After the SARS outbreak, research on coronaviruses increased significantly. So when SARS-Cov-2 or COVID-19 appeared, vaccine work on some of its relatives had already been underway. This gave scientists a significant head start.
Another way in which scientists weren't exactly starting from scratch on this vaccine is thanks to the messenger RNA or mRNA technology. mRNA technology is a completely new vaccine technology that is being used in both the Pfizer/BioNTech vaccine and the Moderna vaccine. Both the Pfizer/BioNTech and Moderna vaccine use mRNA to trigger the immune system to produce protective antibodies without using actual samples of the virus.
While this mRNA science hasn't created a successful vaccine before now, the ideas behind an mRNA vaccine have been studied and tested extensively for over 30 years.
In the natural world, the body relies on millions of tiny proteins to keep itself alive and healthy, and it uses mRNA to tell cells which proteins to make. The concept behind an mRNA vaccine is simple: If you can design your own synthetic mRNA, you could tell the body to create whatever proteins you want, including antibodies to vaccinate against infection.
Messenger RNA vaccines are a game-changer in terms of speed. The mRNA vaccines produced by Pfizer/BioNTech and Moderna are faster to develop as they don't require companies to produce protein or weakened pathogens for the vaccine.
Traditional vaccines typically use a weakened version of the disease or a protein piece of it, but because these are grown in eggs or cells, developing and manufacturing vaccines takes a long time. In contrast, the genetic material mRNA is efficient to make, and highly customizable.
Short but Large Phase 3
When a new vaccine is tested on humans, it is tested in three phases. Each phase increases in size and scope. The length of study for phase 3 clinical trials is usually 1 to 4 years and normally involves 300 to 3,000 patients.
COVID-19 is killing over 2,000 Americans a day, so we don't have time to wait for a lengthy trial. To resolve this issue, they have increased the trial size significantly. Pfizer's phase 3 trial had 43,000 volunteers, and Moderna's had 30,000.
These are what are called "event-driven trials." Basically an event in this case is when one of the volunteers gets sick with COVID-19. Once a trial reaches a previously decided on number of events, they check how many of the people that got sick were given the real vaccine and how many were given the placebo. This shows how effective the vaccine actually was.
The incredibly large trial size and the prevalence of the disease has allowed the "events" to occur quickly, making it easy to test the efficacy of the vaccine. Normally clinical trials can be held back by low volunteer numbers and low disease prevalence. However, COVID-19 spreads rapidly and pretty much all adults seem to be susceptible, which makes these problems irrelevant.
The only downside of a shorter but larger trial is that you don't get to see what long-term effects the vaccine will have. But scientists agree that the chances of long-term complications are extremely unlikely because of how vaccines work. Deborah Fuller, Ph.D, who is a vaccine scientist with UW Medicine, explains, "Most of their job is done in the first few days, then the vaccine is gone from your body. So what's left is that immune response to the vaccine."
Emergency Use Authorization
At the end of the vaccine making process, when the trials are finished and the research is done, companies submit a Biologics License Application (BLA) to the FDA. The BLA usually takes about a year to gain approval. To speed up the process, COVID-19 vaccines are seeking an Emergency Use Authorization (EUA) before they are even done collecting data.
Under an EUA, a company can produce and distribute a vaccine that hasn't officially been approved. This is a process meant for one purpose: to save lives. The FDA will only grant an EUA if they believe that the expected benefits outweigh the possible risks of the vaccine.
Early in the pandemic, the FDA issued a list of requirements they would need from a company before they would consider issuing an EUA for a vaccine. Those guidelines included information about how many people had to be involved in trials, how long the follow up with them had to be, and what information had to be included in their reports.
To ensure that this EUA isn't about cutting corners, the FDA has appointed an independent advisory board to aid them in their decision about the vaccine. On Thursday this week the FDA is scheduled to convene a meeting of that advisory board, known as VRBPAC, to review Pfizer's Covid-19 vaccine for emergency use authorization.
This vaccine is coming, and it's coming quickly. At first that might seem scary, but in reality it's just a perfect confluence of events that have allowed scientific minds to do the impossible. Operation Warp Speed, years of usable research, combining steps, a differently designed phase 3, and emergency use authorizations have all come together to create the perfect situation to make a safe and effective vaccine—in record time.
For more well-researched, unbiased information on today's biggest issues, follow Alexandra's Instagram account The Factivists.
And how do we apply the principle of "the temporary" not only to science but to our daily lives?
On a daily basis, we hear that we should "follow the science" with regard to COVID-19. What does that mean in the context of COVID, exactly? Moreover, based on humanity's lived experience of "following the science" what does that mean in general?
By definition, "science" consists of establishing and testing falsifiable hypotheses. Once tested, a hypothesis becomes established as fact until some new element of the testing environment finds it wanting in some respect.
As a result, scientists - or, more likely, a lonely iconoclastic scientist - test a new hypothesis that refines, or even explodes, the previous hypothesis resulting in a new hypothesis. That new hypothesis becomes the latest established fact and subsequent generations marvel at their benighted ancestors who accepted the previous hypothesis.
In other words, "following the science" means accepting the temporary positions of constantly evolving human knowledge. Such knowledge has been historically disproven when more refined measurement, better information, or a genius insight comes along. Given the shortening interval required to double the total sum of human knowledge, these positions become ever more temporary.
In terms of the development of geocentric astronomy, consider the millennium that passed from the ancients to Ptolemy. A mere 500 years passed before Copernicus revolutionized the field with heliocentrism. Only 200 years elapsed before Newton elucidated the laws of motion and gravitation.
True, it was the same 200-year interval that lapsed before Einstein's quantum leap to his theory of relativity. But less than 30 years later Fr. Lemaitre posited the Big Bang theory. Since then our knowledge of physics has evolved at such a dizzying pace that every few years there are groundbreaking discoveries that change our conception (or at least scientists' conceptions) of the universe.
Here's the point: when we "follow the science" we are correct for increasingly short intervals of time. This is because we are continually learning that fundamental elements of our understanding are wrong, or woefully incomplete.
Systems we use to describe the world have gaping holes that render a system such as geo-centrism obsolete with the introduction of heliocentrism. It was inevitable that heliocentrism would be usurped by the concept of an infinite ever-expanding universe - revealing our previous understanding to be at a preschool level compared to a doctoral program.
Following the science has long been the refuge of totalitarians. How did White Supremacists in the antebellum South justify their critical race theory? With science - carefully reasoned studies and tracts that they claimed to demonstrate the genetic inferiority of Blacks.
How did the Nazi party justify its version of critical race theory? With science - carefully controlled experiments on supposed genetic deficient populations carried out by the likes of Mengele.
How did the 20th-century Marxists justify wiping out millions in the Ukraine, the Cultural Revolution, or the Killing Fields - just to name a few? With science - as they touted the revealed truth of Social Science that requires the inevitability of class struggle.
Even the Catholic Church - a supposed "enemy of science" - actually suppressed Galileo in the name of science. The real charge against him was not disagreement with his theories, but that he presented the theories as fact in the face of established science at the time.
Pick your bugaboo authoritarian regime at random and you'll find that each and every one bases its authority on "science".
So, let's bring this back to COVID.
The very same authorities have told us to "follow the science" all along. Not surprisingly, that science is constantly changing. COVID seemed nothing more than a nuisance until it turned into an existential threat to humanity that required shutting down our economy.
That shutdown was supposed to be two weeks so that we could flatten the curve. But then it turned into the oxymoron of eradicating an unstoppable, communicable virus.
Wearing masks was unnecessary until it turned out to be necessary. The virus wasn't transmitted person-to-person until we realized it was transmitted person-to-person.
The Swedish approach to minimizing economic lockdown was a grossly negligent mistake that put lives at risk. But then we realized that lockdowns themselves caused more human harm and suffering than the actual virus. This goes on and on, with breathless anxiety-inducing instructions as to what we should do as responsible citizens.
If we give this a charitable reading, we can assume people are acting in good faith who realize that their "science" changes rapidly as human knowledge of COVID expands. If true, then we should take their revealed science with a healthy dose of salt and wait for it to change in short order.
If we give it a less than charitable reading, then we can assume that this is an agenda propagated by authoritarians seeking power. In an election year during which so much power is at stake, this notion isn't at all far-fetched.
As for me, I go back to simple scientific discussions about diet. During my lifetime I've seen amusing swings in scientific opinion in this regard.
Are eggs good or bad for you? Sometimes eggs have been viewed as a death sentence by cholesterol consumption - guaranteed to give you a heart attack. At other times, eggs have been touted as an essential part of your diet that promotes brain health.
Is red meat good or bad for you? Sometimes red meat lurks as a killer. At other times red meat leads the way to weight loss and energy.
As it happens, I like both eggs and red meat. Indeed, I find myself to be more energetic, happier, and more productive when I include both in my diet. Others may disagree based on a different lived experience. Fine by me, but I suspect a scientist won't convince either one of us one way or the other. After all, we have our actual experience.
So, when people tell you to "follow the science" my recommendation would be to study this rapidly changing and evolving body of knowledge and get to understand what science actually means.
Further, I'd suggest that you question the agenda of anyone who presents "science" as a settled matter that only supports their own conclusions.
Finally, I'd suggest that the practicality of your own lived experience counts for much more than esoteric theory. After all, whether explained by Ptolemy, Copernicus, Newton, or Einstein, we find our feet firmly on the ground.
Margaret Caliente is a professional athlete turned internet entrepreneur and Manhattan-based journalist.
Want to READ MORE?
The world is both hotter and more overcrowded than ever before. Naturally, these things are intertwined.
World Population Day was established in 1989 by the United Nations Council in order to draw attention to population issues. Back then, the world's population stood at 5.198 billion. Thirty years later, there are 7.7 billion people in the world, with an estimated 360,000 more being born each day.
It's hard to think about overpopulation without thinking about climate change, which threatens the livelihoods of every single one of these new children.
Climate change's consequences have already begun to emerge, and needless to say, they will worsen exponentially if climate change continues at its current rate. Effects include rising sea levels, tens of thousands of heat-related deaths, polluted air, a spike in chronic illnesses, severe droughts, mass extinctions that ruin ecological systems and destroy agriculture, and many natural disasters such as hurricanes and wildfires that will devastate infrastructure and generate massive flows of refugees. We've already seen these things, in the devastating 2018 California wildfires, in hurricanes like Sandy and Maria, in the drought that was a root cause of the Syrian refugee crisis, and in so many other instances.
Image via Undark
These events are only the tip of the iceberg. A 2018 UN report announced that we have twelve years to reverse the worst effects of climate change; if we fail to essentially keep temperatures from rising above 1.5C, hundreds of millions of people will suffer the consequences.
Certainly, the vastness of our world's population is a root cause of this deadly warming. According to Business Today, "One of the greatest consequences of growing population, which is perhaps a great threat to our livelihood as well, is the quick depletion of natural resources." More people means more carbon burned, more resources consumed, more people falling through the cracks.
In a merely theoretical sense, it seems logical that humanity's population explosion would happen concurrently with exponential climate change and ecological disaster, because the way our population has grown is anything but natural.
Prior to the Industrial Revolution, human society followed a particular law: As populations grow, food supplies decrease, and so the population decreases, and the food supply increases. This is the same rule that keeps animal populations in check. However, since the dawn of industry, human beings have been producing more and more food and resources to support our burgeoning population, effectively placing ourselves at the top of the food chain, subsequently displacing animal populations, and decimating our natural resources.
Now, we are reaching a breaking point.
Image via MarketWatch
However, it's too simplistic to say that the amount of people in the world is directly proportional to the rate of climate change. It's true that the locations where the largest percentages of children are being born are the places that will be most severely damaged by the rising tides and hurricanes that are stemming from warming. According to Time Magazine, rapid population growth will only lock these nations into cycles of poverty, making it extremely difficult for these places to rebound from climate change's effects. However, these places are not the ones producing the majority of carbon emissions: That honor is reserved for developed countries, like the US.
The real cause of climate change is not overpopulation alone. It's the mentality that has allowed oil companies to grow into the massive corporations they are; and that has allowed Americans, who comprise 5% of the global population, to consume 25% of the world's resources, and that has allowed many childless couples in the US to consume far more resources than couples with children. That mentality has led us to accumulate endlessly without paying any heed to natural balances or equity.
Therefore, reducing the population is actually not the most important step that needs to be taken in order to combat climate change. This is because, according to Vox, it's not that the resources we have can't support a larger population: the US could successfully feed 400 million people simply by consuming locally what we are currently exporting. The problem is that we can't maintain the kinds of resource-guzzling, carbon-based lifestyles that we—and particularly, the extremely wealthy—have become accustomed to living. Simply reducing the number of people but not addressing our society's problem with carbon and consumption will have a negligible effect on the climate. In actuality, lower fertility rates can lead to higher GDP, as childless folks can accumulate more resources that they in turn spend on flights and other energy-guzzling activities.
Image via RT.com
Though population control would help, it's far more important that we figure out how to re-distribute resources in a sustainable way, rather than wasting such a vast amount of resources like we do in America. In the end, slashing carbon emissions—and, concurrently, shifting our cultural obsession with accumulation and individualism to an emphasis on egalitarianism—is still by far the most important thing we can do for the climate.
Even so, having fewer children and making education and birth control more widely accessible would be hugely significant overall. Furthermore, deciding not to have a child is totally a viable, impactful way to combat climate change (and it's possibly even the ethical choice, given the ecological mess that new generations will find themselves involuntarily subjected to).
Because if we remain on the path we're on? The population will just continue to expand, hitting a projected 8 billion by 2050. Soon enough, natural disasters will result in the deaths of millions; more people will starve or die in refugee camps; and then, as water becomes undrinkable and the planet becomes too hot for any growing thing, that will be the end of this whole experiment called life.
Scientists have accidentally boosted the enzyme that's breaking down ocean plastic—and that's a huge step.
In the Pacific Ocean, at least 79,000 metric tons of plastic waste are floating across an area exceeding 1.5 million square kilometers. The latest measurements of the Great Pacific Garbage Patch revealed that it's constantly growing and that its accumulation of plastic is accelerating. Also increasing is the world's plastic consumption. We use over 320 million metric tons annually, the majority of which ends up in our oceans. This decade saw more plastic produced than any other in history. Since 1992, China has been importing nearly half of the planet's plastic waste for recycling. But starting this year, the country is refusing all nonindustrial plastics and limiting imports of paper waste. Suddenly, this recyclable material is falling into landfills because recycling plants can't keep up.
Researchers estimate that after China's ban, 111 million metric tons of plastic waste will have to find room elsewhere. Too much of that plastic (as much as a third) will likely end up in our oceans.
Good news came in February, when Japanese scientists announced that they had discovered the first species of bacteria that break down polyethylene terephthalate (PET). Commonly called polyester, PET is one of the most commonly used plastics and makes up a significant amount of the pollution in rivers, lakes and oceans. The bacteria, called Ideonella Sakaiensis 201-F6, contains enzymes that can break down the molecular bonds of PET in under six weeks.
The Great Pacific Garbage Patch
It appears that the bacteria evolved their "appetite" for PET as global pollution increased over the past century. But, as the scientists investigated the bacteria's biological processes, a lucky accident unveiled the organisms' greater potential.
They had experimented on the plastic-eating enzyme to study its evolution. Subsequent testing showed the surprising result of their adjustments: they had made the enzyme even better at breaking PET's molecular bonds.
This astonishing discovery points directly to large-scale uses of this enzyme in reducing plastic pollution around the world. When the modified enzyme breaks down the PET, it reverts the plastic to its base components. Unlike standard recycling, which can only reuse the plastic in limited ways, such as clothing or bags, the enzyme's process could allow broken down PET to become new PET, turning plastic waste back into new plastic.
Plastics are made from feedstocks derived from natural gas processing and crude oil refining. If the enzyme can successfully break down plastic into its original parts on a large scale, it will simultaneously reduce the amount of plastic polluting the oceans and reduce the amount of fossil fuels used to produce new plastic. It would be a step toward true recycling, where the recycled material contributes no waste to landfills.
The researchers only made a 20% improvement to the efficiency of the enzyme but the "only," in this measurement, is optimistic. Their goal is to optimize its performance even further, until its widespread use is practical and effective. They have even considered inserting this enzyme into other super-resilient bacteria that can survive in extremely harsh conditions.
Scientists continue to search for other strains of bacteria and fungi that have evolved similar skills. Enzymes are an ideal agent for plastic breakdown because they have no environmental side effects. This discovery opens another source of hope to a world facing increasingly dire warnings and little help from its governments. Perhaps nature has, once again, found its own solution in the absence of human innovation. And, perhaps, this bacteria offers exactly the creative spark that human scientists need to design their own long-term solutions.