Tag Archives: prevention

WHY IT TAKES SO LONG TO MAKE A CORONAVIRUS VACCINE

We wish it would just go away—this stupid Coronavirus/Covid-19 pandemic. You’d think with today’s medical knowledge and advanced technology all it would take is leading scientists around the world to come together, snap their fingers, and immediately slop-out an effective vaccine. Then, we could get back to the “Old Normal”.

Not so fast. There’s nothing quick or easy about making an effective Covid-19/Coronavirus inoculation.

When this thing started, I wrote a post titled Just How Deadly is Novel Coronavirus and Covid-19? Like a lot of pieces, I looked for an intriguing subject, researched it to understand the basics, then wrote it to share with others. Creating a Coronavirus/Covid-19 vaccine is an evolving issue, and I wanted to know more about how long it will be before a preventive treatment is widely available.

An article on my HuffPost feed satisfied my curiosity, and it’ll inform you, too, about when we can expect an effective coronavirus vaccine. Unfortunately, the answer is no time soon. There are good reasons why it takes so long to make a vaccine. Rather than writing new content about this complicated issue, I’m sharing what I received from the Huff.

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As of the end of April, 2020, the World Health Organization was tracking 71 coronavirus vaccines in preclinical trials, with five additional candidates already in clinical trials. Given how recently the COVID-19 pandemic began spreading, it might seem promising that there’s already a lot of activity on the immunization front.

With so many potential vaccines in testing, you also may wonder why medical experts say it will take at least 12 to 18 months before one is ready to go. If a coronavirus vaccine did make it to market on such a timetable, it would actually be the fastest turnaround in history. Currently, that record belongs to the mumps vaccine, which was approved for use in just four years back in the 1960s. For Ebola, a vaccine took five years to develop.

More commonly, the development of a vaccine takes eight to 10 years. Can a COVID-19 vaccine be created any faster? There’s certainly hope, but no certainty.

“I’d say the 12 to 18 months that’s been bandied about by some experts is realistic, but it’s [also] optimistic,” said James Cutrell, director of the infectious disease fellowship program at the University of Texas Southwestern Medical Center in Dallas. “It is based on the assumption that each phase of trials goes according to plan, with an optimistic time frame at each of those stages.”

Here’s what goes into each phase of developing a vaccine.

We often think of vaccines as treatments for illness, but they’re not exactly that, said Kelvin Lee, a professor of chemical and biomolecular engineering at the University of Delaware and director of the National Institute for Innovation in Manufacturing Biopharmaceuticals. Vaccines are given to people who are well to keep them from getting sick.

“It’s very different from developing medicine where someone is ill and you are trying to make them better. In a healthy population, you don’t want the vaccine to have negative consequences,” he said.

First, Lee said, researchers will study the virus and attempt to determine which type of vaccine may work best.

Microscopic view of Coronavirus, a pathogen that attacks the respiratory tract.

There are several kinds of vaccines. Some have a tiny, weakened bit of live virus, which triggers a protective immune response in your body but does not cause the actual illness. Some contain inactive virus that creates a similar response in the body. And some utilize genetically engineered RNA or DNA, which carries “directions” to make the type of protein that can prevent the virus from binding to our cells and making us ill.

Once researchers decide which vaccine route they think will work best, they get to testing.

“This is where time really comes into play,” Lee said. “Even after you do lab tests to make sure it works in the proverbial petri dish, in many cases vaccines will undergo tests in animals to ensure that it’s going to be safe for humans and has the desired response. And then, where it really starts to take time is in the human clinical trials.”

To roll out a vaccine requires a lot of safety testing. During Phase 1, researchers take a small number of healthy volunteers and test the vaccine for serious side effects, Cutrell explained.

Phase 2 involves smaller studies looking at efficacy, he said. This includes figuring out the best dosage of the vaccine, the scheduling of dosages if you need multiple ones, and more. Scientists will consider whether the vaccine still appears safe enough and whether the immune response or antibody buildup is great enough to warrant moving on to additional clinical studies.

In Phase 3, you will see larger field studies.

“You would take a susceptible population, vaccinate some while having a control group, and monitor the effect over time and see if there’s any difficulty,” Cutrell said.

Here, researchers may look for common, short-term side effects and at what dosages those side effects pop up.

“All that has to be done first, and then if Phase 3 shows the vaccine is safe and effective, that’s when you’d look at licensing,” Cutrell said.

Even after you have a working vaccine approved by the Food and Drug Administration, it still takes time to mass-produce and distribute it across the country.

The goal is to vaccinate huge numbers of people, “so you then develop immunity in the community that would protect against larger outbreaks,” Cutrell said.

Testing and monitoring ― essentially Phase 4 ― continue even after the vaccine is generally available because it takes time to ensure safety, Lee said. “You don’t know if something bad is going to happen a month later, two months later, a year later.”

Common side effects of vaccines include redness and pain at the site of injection and maybe a low-grade fever; side effects like seizures or allergic reactions are extremely rare. But the bottom line is that scientists and doctors aim to develop a vaccine where the protective benefits far outweigh the risks.

While it’s hard to say when researchers will have a viable vaccine, there are a few factors that could speed up the timeline for this coronavirus vaccine. Traditional approaches to creating vaccines ― like the use of chicken eggs ― are proven but not necessarily speedy.

“You have some newer technologies that some companies are trying to leverage, where they were already prepared to respond to a pandemic,” said Lee. “You can shorten some of that discovery and early development timeline.”

Newer biotechnology-based methods, sometimes called “cell culture methods,” could make for more rapid development, he said. Additionally, with a pandemic circling the world, American researchers are hardly alone.

“You’ve got private companies and scientists trying to work together on the vaccine. That collaboration can certainly help accelerate the timeline,” Lee said. “Scientists will still want to minimize risks and ensure the safest possible rollout of a vaccine. “But given the outbreak globally and the impact it’s having, I can imagine there are ways to design trials to accelerate testing,”

There could also be an unconventional study design for the coronavirus vaccine, according to a new report published in the Journal of Infectious Diseases. In place of traditional Phase 3 trials, volunteers at low risk of developing a severe form of COVID-19 ― healthy people without chronic conditions in their 20s, for instance ― might opt in for a “human challenge study.” They could be exposed to the coronavirus, monitored closely and given the best care.

This type of study would involve fewer participants and could be done in less time than a traditional Phase 3. Of course, the idea would need to be rigorously discussed beforehand as ethics rules generally forbid deliberately infecting human beings with a serious disease.

Besides vaccine trials, researchers are testing potential treatments for COVID-19. Instead of preventing the disease, these aim to make sick people well again.

“One of the treatments that has gotten a lot of attention is remdesivir, but the data available so far is fairly limited,” Cutrell said. No trials comparing use of the antiviral drug against a control group have been published so far. That said, studies are coming, including a National Institutes of Health clinical trial comparing remdesivir against a placebo.

There are also drugs that could potentially address the immune system’s response to the virus.

“A lot of times patients with this virus get sicker in the second week of their illness ― and it’s not the virus, but the immune system that makes them get quite sick,” Cutrell said. “They experience an exaggerated state of inflammation or ‘cytokine storm.’”

Some drugs that might dampen the immune system’s effects are currently in clinical trials. Then there’s the now-controversial drug hydroxychloroquine, which has long been used for malaria or inflammatory conditions like rheumatoid arthritis or lupus. Although the drug received a lot of early attention, the studies showing potential benefits for COVID-19 patients have been mostly anecdotal with no control groups to compare against.

“There are also concerns about safety, including cardiac issues and arrhythmias that give doctors pause,” Cutrell said, noting that the FDA recently advised Americans not to use hydroxychloroquine outside of a hospital setting.

Finally, COVID-19 might be treatable with convalescent plasma.

“This is where people who have had the disease and recovered donate plasma, and that plasma is given to someone with an active stage of disease,” Cutrell explained.

The antibodies and proteins in that plasma could potentially help someone with COVID-19 recover. (You may be able to donate plasma if you have recovered from the coronavirus.)

Until we have a vaccine or meaningful treatment, we need to proceed with caution, ramp up testing and isolate the sick quickly if we hope to get back to some “semblance of normalcy,” Cutrell said.

“In my opinion, before we have effective treatment or vaccine, we will have to behave similarly to South Korea, Singapore or Hong Kong, with widespread access to testing, contact tracing and isolation, quarantining people in cases of potential contact,” he said. “In doing this, they’ve been able to stave off having large scale epidemics in their country and are allowed to be a little more open than other places where those things are not in place.”

“Of course, those countries have not yet seen second waves of the virus.”

“That approach requires constant vigilance,” Cutrell acknowledged. But even as scientists and doctors work to develop effective treatments and a vaccine, he said “thoughtful and incremental” strategies can help us move forward to “a period of more normal activities.”

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Note from the HuffPost: Experts are still learning about the novel coronavirus. The information in this story is what was known or available as of the end of April, 2020, but it’s possible guidance around COVID-19 could change as scientists discover more about the virus. Please check the Centers for Disease Control and Prevention for the most updated recommendations.

Here’s the link to my first DyingWords post titled Just How Deadly is Novel Coronavirus and Covid-19?

JUST HOW DEADLY IS NOVEL CORONAVIRUS AND COVID-19?

There’s a new viral kid on the block and he’s mean. Real mean. He goes by Novel (New) Coronavirus (SARS-CoV-2), and gives you the previously unknown disease termed COVID-19. That’s the biological term for Corona Virus Disease identified during the dying days of 2019. Now, in two and a half months, this nasty bug has virally spread from a small shop in China to the far corners of the world. It’s on an unprecedented multiple-mutation path, and that’s what makes it so deadly.

Severe Acute Respiratory Syndrome caused by the Coronavirus of 2019 (SARS-CoV-2) is particularly dangerous for people with compromised immune systems. That profile takes in newborns, the elderly, folks with immunity disorders and those in generally weak health. This combined demographic comprises a huge part of the human population.

Microscopic view of Coronavirus, a pathogen that attacks the respiratory tract.

There are two parts to this pandemic that’s scaring the pants off people. One is the virus itself which is a brand new member of the Corona genus. The other is the disease it causes which everyone now recognizes as the name COVID-19. How bad this will get is anyone’s guess, but the world health authorities are preparing for panic.

There is little need to panic, though. The key to surviving this outbreak and “flattening the curve” as the containment process is called, is knowledge and caution. Properly protected, you can minimize your exposure of viral transmission and respond quickly if you’re contaminated. Keeping your distance in social settings, washing/decontaminating  your hands and shielding your face (eyes/nose/mouth) are the most important things you can do—they’re the three top tools to tackle the threat.

What is the Novel Coronavirus?

A virus is a microscopic speck of organic non-cellular material that sits on the fringe of being alive and being inert. On its own, a virus has a limited existence unless it finds a host of organic cell matter. That can be human, animal, plant or any other life form that replicates itself through cellular division.

According to information from the National Center for Biotechnology Information (NCBI), there are millions of different viruses above, on and in the Earth. NCBI has identified 75,000 separate viral genome sequences and has 5,000 of these described in detail. Coronavirus-19 was new to them, and they’re doing everything in their power to figure this one out. It’s not coming easily.

To survive and thrive, a virus must find its way to a host and invade its cells. In humans, that happens through absorption into your airways, eyes or an opening in your skin. Once a virus attaches itself to your cell, it transmits encoded instructions to make the cell copy the virus’s genetic profile and essentially produce clones.

The Coronavirus of 2019 isn’t satisfied with cloning itself. It wants to mutate and create biologically diverse offspring. That presents an enormous challenge to epidemiologists who get a vaccine made for one strain, only to find the bug is far ahead of them with mutants.

The Coronavirus-19 is perfectly suited for mutating. It’s a single-strand ribonucleic acid (RNA) based bug which is simple, quick and cheap to reproduce. Many other viruses are double-strand deoxyribonucleic acid (DNA) creatures. They’re much harder to duplicate and change form.

The RNA-based Coronavirus-19 presents another problem. Its specialty is attacking the lungs and causing acute respiratory disease. This results in pneumonia.

Pneumonia is a deadly disorder. It’s usually the coup-de-grace for virally-infected people who have no natural ability to fight back. It’s also extremely difficult for medical professionals to treat pneumonia. Combined, pneumonia is a serious development in deteriorating health.

Where Did Coronavirus-19 Originate and Where is it Going?

Medical investigators are certain that this virus first infected a human being at a marketplace in Wuhan, China. The market is primarily a seafood shop, but it does deal in live animals. One worker was exposed to the virus there in mid-December of 2019, and medical experts feel it’s highly likely the bug came from a bat.

Normally, viruses don’t easily transmit from animals or plants to humans. There are exceptions like the swine flu that came from pigs and the bird flu that started in fowl. However, this seems to be the first bat-related viral outbreak except for rabies infections which can also be deadly.

Once the epidemic became a pandemic, it spread like wildfire. By the way, an epidemic is a local outbreak that defies containment. A pandemic (from the Greek words “pan” meaning “all” and “demos” meaning “people”) is a word-wide viral fire that’s out of control.

That’s the current situation with the world fighting the Coronavirus-19 pandemic. (This piece was published on March 21, 2020). No one knows where it’s headed. The only certain thing is that it’s highly contagious and not at all contained.

Two days ago, the Governor of California wrote to the President of the United States with a plea for federal help to curb the COVID-19 pandemic. Clearly, the Governor sees this as a crisis of monumental proportion. This is a quote from the letter:

“California has been disproportionately impacted by repatriation efforts over the past month. Our state and health care delivery system are significantly impacted by the rapid increase in COVID-19 cases. Our case rate is doubling every four days. We project that 56 percent of California’s population—25.5 million people—will be infected with the virus over the next 8 weeks.”

The Governor states the situation is grave. He tells the President that California’s health care resources will be so overloaded with COVID-19 response that they won’t be able to address critical acute care needs like heart attacks, strokes and vehicle accidents. He also equates the crisis as threatening all of America.

It’s not just America that’s in peril. It seems China has some reprieve after taking draconian steps to quarantine people, however, countries like Italy are getting it bad. And it’s not just “first world” places like Europe and North America that are going to suffer. This bug is now everywhere except Antarctica.

Why is Coronavirus-19 and COVID-19 so Threatening?

One reason—probably the main reason—that COVID-19 is so threatening is because humans have no natural immunity to animal-transferred viral invasion. There is nothing that can be done about COVID-19 except riding it out while your body naturally fights it off. That takes time, and many infected people simply can’t afford the luxury of time.

There is no medicine or vaccine to treat Coronavirus-19 infections and COVID-19 disease. At least not yet. Your body only has two options. One is for your immune system to directly attack and kill the viral copies and mutations. The other is for your immune system to cut off and kill compromised cell tissue.

Coronavirus-19 is a lung killer. Its habitat is the respiratory system and, once in place, your body will create mechanisms to fight the lung invasion. That means making fluids and this is what pneumonia is. If you’re in an overall weak condition, your body cannot control your lung fluids. You slowly drown, and there’s little can be done—even if you’re in intensive care.

Another factor in why Coronavirus-19 is so threatening is that it has an unusual rate of mutation. So far, scientists have isolated two distinct Coronavirus-19 strains. One is the “S” stain which occurs in about 30 percent of diagnosed cases. The other is the “L” strain conversely found in 70 percent. Alarmingly, the L-strain is much more aggressive and it mutated from its S cousin.

Epidemiologists around the world are extremely concerned that more strains of Coronavirus-19 are in the works. In perspective, the S-strain Coronavirus-19 is ten times more potent than the seasonal influenza virus which makes an annual visit. No one knows how strong these projected “superbugs” like L-strain will be.

How Does the Coronavirus-19 Spread?

The Coronavirus-19 requires physical contact to spread between bodies. It requires an infected person to give it to another directly or indirectly. Direct contact examples are sneezing and breathing in droplets, handshakes or sharing infected objects. Indirect contamination occurs when a droplet of human body fluid (usually mucous) lands on a surface where it’s picked up by another party.

Common surfaces like public pin-pads, handrails and doorknobs are ideal spots for a Coronavirus-19 to hold on and wait. Cash is another filthy substance that flows between hands and harbors the fugitive. In fact, cash can be a worst offender, both paper and coin.

How long the virus stays volatile is a good question. Current literature suggests a virus like this one can stay active for anywhere from a few hours to many days. Temperature, humidity and surface composition are factors in virus survival. So is air movement and competing contaminants like chemicals and other pathogens.

The Coronavirus-19 is a tiny, tiny particle. It’s so small that it can only be seen through an electron microscope. However, it’s big in numbers and there can be an enormous amount of individual virus particles in a single drop of snot.

All it takes is one single virus particle to infect you. From there, the Coronavirus-19 virus has a rapid rate of multiplying. You can pick up a virus and be symptomatic in no time. You can also be infected and be asymptomatic throughout your infectious period.

There simply isn’t enough known about this novel virus to write a playbook for it. As a virus rule-of-thumb, most people are contagious for a 14-day period from scooping the bug till it’s over. That, however, is not a done deal. You can be a walking viral machine and not know it. That goes for the person beside you.

What Can be Done to Stop the Spread of Novel Coronavirus-19?

The short answer is “lots”. It starts with isolating people with infections until the bug has run its course and they’re no longer contagious. That’s a bitter and expensive pill to swallow, but it’s the only thing that works. At least until a vaccine comes along and that’s some time out.

Total isolation, or quarantine actions, are harsh steps. However, they’re nowhere near as harsh as the other alternative which is spectacular sickness and death. If quarantine/isolation measures aren’t practical, then social distancing is the next best measure. A distance suggestion is 3 to 6 feet or 1 to 2 meters, but the further the better seems the safest.

Washing your hands frequently or using an alcohol-based hand sanitizer is mandatory. Soap and ethanol are mortal enemies to the Coronavirus-19, and it’s hand-to-face contact that really spreads this guy around. There are no known scientific studies to determine where hoarding toilet paper fits into your viral protection plan, but there’s plenty of proof suggesting TP is helpful for other bodily functions.

Gloves, on the other hand, are excellent protectors for one-time or single use. That’s provided you refrain from touching your face while being gloved-up which is easier said than done. Bear in mind that your skin is as good a protector as a latex covering. The trick is washing your hands or discarding your gloves between contacting your mucous membrane orifices.

There are varying opinions about mask effectiveness. Some feel masks are better defenses to protect others from you than vice versa. The Coronavirus isn’t often airborne except for an immediate expulsion in close range. If you peel off your mask while still having contaminated hands or gloves, it’s pointless protection. Also, conventional surgical masks, or even regular respirators, don’t protect your eyes. Full face shields are much better.

It’s all about limiting exposure, keeping your distance and minimizing unsanitary hand-to-face contact.

The trick to taming this terrible threat is mass-cooperation between our fellow human beings. This is the time to stop all non-essential exposure. It’s a suck-back and reload situation. It might be a good time to just read a book while staying home.

So far, there’s been amazing interaction between health authorities and political personnel. This is a unique time in human history. What makes this different from other pandemics is that our experts have much better communication ability than in past outbreaks and have responded, for the most part, with speed.

So has cooperation among the public. There’s been some fear factor and some fake news. That goes on with every crisis, and that’s to be expected in this one, too. The Coronavirus-19 fight will be won. Unfortunately, there’ll be casualties along the way.

Casualties fall into two groups in our interconnected society. One is health care workers and pandemic victims. The other group is financial—business and personal. There’ll be few segments not taking a punch in the gut from this new kid’s viral viciousness. Yet, our societies will survive and so will you.

The key to surviving this viral outbreak and “flattening the curve” as the containment process is called, is knowledge and caution. Properly protected, you can minimize your exposure to viral transmission and respond quickly if you’re contaminated. Keeping your distance in social settings, washing/disinfecting your hands and shielding your face (eyes/nose/mouth) are the most important things you can do—they’re the three top tools to tackle the threat.

Post Publication Note (23Mar2020): This graph was supplied by a DyingWords follower:


Post Publication Note (24Mar2020): CalTech Interview with Virologist Dr, David Ho.